Next Article in Journal
Basis of PD1/PD-L1 Therapies
Next Article in Special Issue
Predictors for Target Vessel Failure after Recanalization of Chronic Total Occlusions in Patients Undergoing Surveillance Coronary Angiography
Previous Article in Journal
Transoral Robot-Assisted Surgery in Supraglottic and Oropharyngeal Squamous Cell Carcinoma: Laser Versus Monopolar Electrocautery
Previous Article in Special Issue
Antithrombotic Therapy for Percutaneous Cardiovascular Interventions: From Coronary Artery Disease to Structural Heart Interventions
 
 
Search for Articles:
Title / Keyword
Author / Affiliation / Email
Journal
Article Type
 
 
Advanced Search
 
Section
Special Issue
Volume
Issue
Number
Page
 
Journals
JCM
Volume 8
Issue 12
10.3390/jcm8122167
jcm-logo
Submit to this Journal Review for this Journal Propose a Special Issue
► Article Menu

Article Menu

share Share announcement Help format_quote Cite question_answer Discuss in SciProfiles thumb_up
...
Endorse textsms
...
Comment
first_page
settings
Order Article Reprints
Font Type:
Arial Georgia Verdana
Font Size:
Aa Aa Aa
Line Spacing:
Column Width:
Background:
Review

Bioresorbable Vascular Scaffolds—Dead End or Still a Rough Diamond?

by
Mateusz P. Jeżewski
1,
Michał J. Kubisa
1,
Ceren Eyileten
1,
Salvatore De Rosa
2,
Günter Christ
3,
Maciej Lesiak
4,
Ciro Indolfi
2,
Aurel Toma
5,
Jolanta M. Siller-Matula
1,5,* and
Marek Postuła
1
1
Department of Experimental and Clinical Pharmacology, Centre for Preclinical Research and Technology, Medical University of Warsaw, 02091 Warsaw, Poland
2
Department of Medical and Surgical Sciences, Division of Cardiology, “Magna Graecia” University, 88100 Catanzaro, Italy
3
Department of Cardiology, 5th Medical Department with Cardiology, Kaiser Franz Josef Hospital, 31100 Vienna, Austria
4
1st Department of Cardiology, Poznan University of Medical Sciences, 1061701 Poznań, Poland
5
Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, 231090 Vienna, Austria
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2019, 8(12), 2167; https://doi.org/10.3390/jcm8122167
Submission received: 11 November 2019 / Revised: 2 December 2019 / Accepted: 4 December 2019 / Published: 7 December 2019
(This article belongs to the Special Issue New Technologies for the Treatment of Coronary and Structural Heart Diseases)
Browse Figures
Versions Notes

Abstract

:
Percutaneous coronary interventions with stent-based restorations of vessel patency have become the gold standard in the treatment of acute coronary states. Bioresorbable vascular scaffolds (BVS) have been designed to combine the efficiency of drug-eluting stents (DES) at the time of implantation and the advantages of a lack of foreign body afterwards. Complete resolution of the scaffold was intended to enable the restoration of vasomotor function and reduce the risk of device thrombosis. While early reports demonstrated superiority of BVS over DES, larger-scale application and longer observation exposed major concerns about their use, including lower radial strength and higher risk of thrombosis resulting in higher rate of major adverse cardiac events. Further focus on procedural details and research on the second generation of BVS with novel properties did not allow to unequivocally challenge position of DES. Nevertheless, BVS still have a chance to present superiority in distinctive indications. This review presents an outlook on the available first and second generation BVS and a summary of results of clinical trials on their use. It discusses explanations for unfavorable outcomes, proposed enhancement techniques and a potential niche for the use of BVS.

1. Introduction

Cardiovascular disease is the most common cause of death, and by the year 2030, up to 44% of the adult US population is projected to suffer from some form of it, including ischaemic heart disease and acute coronary syndromes [1]. The effective restoration and maintenance of coronary vessel patency is a major problem requiring evaluation [2]. The idea of vascular restoration after the implantation of coronary stents has projected the development of bioresorbable vascular scaffolds (BVS) at the forefront of technological advancement in the field of coronary devices [3,4,5,6]. The design of BVS was prompted in an attempt to solve the limitations of durable drug eluting stents (DES), including (i) the occurrence of very late stent thrombosis (VLST), (ii) late expansive and adaptive vessel remodelling, (iii) anatomical limitations in case of surgical revascularization and (iv) impairment of computer tomography imaging [7,8]. After the initial excessive enthusiasm around BVS, the community was overly disappointed by the results of clinical trials. Complete resorption and improved vasomotor response of first generation of BVS which were believed to result in a reduced risk of target lesion failure (TLF) and stent thrombosis (ST) have been largely questioned [9,10,11,12,13]. In particular, the resorption time for the first commercially available BVS, ABSORB, has turned out to be substantially longer than initially thought. Therefore, it has been hypothesized that the resorption process itself or its delay can trigger complications [14,15,16]. A poor safety profile, especially in terms of target vessel myocardial infarction (TVMI) and an ST of 3 year follow up in ABSORB, as well as the negative results of the Amsterdam Investigator-Initiated ABSORB Strategy All-Comers Trial (AIDA) induced the manufacturer, Abbott Vascular, to halt the commercialization of ABSORB BVS [17,18,19]. Similarly, despite good outcomes of the BIOSOLVE I trial, the DREAMS BVS is still not ready for clinical use as the sparse data available stem from a small number of nonrandomized studies, conducted on a small number of patients [20,21,22,23]. Nevertheless, thanks to the encouraging results from the BIOSOLVE II and III studies which report very good outcomes in the 184 patients enrolled, with a more complex anatomical setting, we are facing a steady rise in the clinical use of the Magmaris stent within the ongoing prospective registry BIOSOLVE IV [24,25].
Overall, BVS appear to be a ‘critical’ development phase, and the currently clinically available BVS were given a class III indication for clinical use outside of studies in the current European Society of Cardiology (ESC) guidelines [26]. However, the disappointing outcomes mentioned above derive from studies in which optimal implantation strategies, proper imaging and long and potent platelet inhibition have not been extensively applied. On the contrary, it is proved that proper assessment of the target vessel segment with intravascular ultrasonography (IVUS) or optical coherence tomography (OCT) together with pre- and/or post-dilation can efficiently improve safety profile of BVS [27,28,29]. Thus, it is highly possible that refined second generation scaffolds with optimized implantation technique and proper imaging may restore the position of BVS and be competitive towards DES.
Our systematic review discusses the hypothetical advantages of BVS in the light of disappointing results obtained so far in clinical trials. Additionally, we aimed to explore possible methods to improve BVS performance starting from the design of next generation BVS and ending with procedural and pharmacological highlights.

2. Potential Advantages of BVS over Current Generation DES

Fully bioresorbable stents consist of synthetic biodegradable polymers that are intended to initially display functions similar to DES, and then dissolve within months after implantation, which may lead to the restoration of vasomotor function. In order to hold their promise, BVS should provide all potential advantages without sacrificing too much in terms of performance in comparison to DES. Another noticeable phenomenon (unrealistic using a solid metal stent) is the restoration of endothelial function with secondary reduction of atherosclerotic plaque [30,31]. After dissolving, it allows to maintain the integrity of the artery and return to its physiological properties (systolic and diastolic), thereby facilitating a beneficial remodeling and, consequently, causing a reduced passage for persistent inflammation (Figure 1) [31,32]. Therefore, a hypothesis has been put forward regarding the benefits of BVS, especially in younger patients or those with acute coronary syndromes, in which the metal stain is less likely to heal [33]. Among other features, the unfailing of the covered side branches after resorption, as well as avoiding the effect of a ‘full metal coat’, especially during diffuse disease, were also foreseen, providing early treatment of restenosis in the stent without additional layers of metal stents occupying the space [34]. BVS also give the possibility of a surgical revascularization procedure [31]. Moreover, this new technology also has significant benefits in the patient’s personal preferences to avoid having a permanent foreign body [32]. However, data available so far show us that most promises associated with the advantage of resorption had been overestimated. In fact, an ultimate demonstration of most potential advantages of BVS, such as restoration of the physiological function of vessels and endothelium, and the possibility of future surgical interventions within the same lesion, are still lacking [35].

3. Overview of First and Second Generation BVS

The first generation of BVS was initiated by ABSORB and DESolve scaffolds based on poly-L-lactic acid (PLLA) and DREAMS G1 scaffold based on magnesium [36,37]. Second generation of BVS embraces constantly expanding variety of scaffolds with enhanced properties and novel features. PLLA-based ART (Terumo, Tokyo, Japan) and DESolve Cx plus, the tyrosine analogue-based Fantom (REVA Medical, Inc., San Diego, CA, USA) and the magnesium-based Magmaris (Biotronik, Berlin, Germany) were introduced to clinical practice. The general characteristics of BVS are presented in Table 1. Yet, the variety of other devices based on polymers, metallic alloys or their combination remains in development [38,39]. Their development originates from an attempt to arrange a scaffold with thinner struts. The diameter of struts may not exceed 100 µm, whereas in the first generation it ranged from 150 µm [40]. The reduced thickness is believed to cause less blood flow disturbances and therefore to be associated with a lower risk of in-ST and a shorter requirement of dual antiplatelet therapy (DAPT). Additionally, tiny meshes become covered with a thinner layer of neointima and protected from the narrowing of the vessel lumen [41]. The newest devices are made of either magnesium alloy or polymers, including derivatives of PLLA and deaminotyrosine polycarbonate. These materials ensure greater resistance to fractures during post-implantation dilation and attain mechanical properties comparable to ordinary DES [30,42,43,44].
The ABSORB stent has a PLLA backbone, strut thickness is about 150 μm, with a bioresorbable coating of poly-D,L-lactic (PDLLA) with a thickness of 7 μm, secreting everolimus with a similar pharmacokinetics to the Xience DES [31,34,35,45,46,47,48,49]. Due to the presence of ester bonds between the PLLA and PDLLA monomers, degradation occurs by stepwise hydrolysis. In the final stage, either PLLA or PDLLA particles degrade entirely to lactic acid, or remnants smaller than 2 μm are phagocytized by macrophages [31,50]. Degradation is a mild, progressive process with minimal inflammatory reaction [51]. In order to obtain the appropriate mechanical framework of these stents, it became necessary to increase the thickness of the strut, because of lower tensile strength, reduced stiffness and the chance of deformation [35,52]. Studies have shown that in order to avoid strut rupture or abnormal decomposition, ABSORB stents require accurate lesion, judicious patient selection and an appropriate implantation technique, as they are able to stretch up to 0.7 mm beyond the nominal diameter [36,53]. ABSORB stents are radiolucent and therefore may not be visualized in fluoroscopy. For this reason, the stent at both ends was provided with two platinum markers, present to allow radiographic recognition. However, due to their tiny dimensions they identification requires high quality fluoroscopic imaging [52].
DESolve has a similar strut thickness (150 μm in the first generation), is composed of a PLLA-based scaffold and equipped with two platinum-iridium markers to enable radiographic visualization. The second generation, DESolve Cx plus, has a strut thickness of 120 µm, with a length of 14 to 28 mm and a diameter of 2.5 to 4.0 mm [54]. In the initial version, it eluted novelists at a rate of 80% during a month after implantation [55,56,57]. High flexibility enables extension up to 5 mm, without risk of breakage and provides greater radial strength in the vessel during the critical period of up to 4 months after implantation. In addition, DESolve scaffolds presents were observed of passively expand within 1 h after implantation, whereas ABSORB stents present a tendency to recoil [56,57]. However, under experimental conditions it was noticed that this ‘autocorrect’ feature is able to generate only small radial forces, so that it improves stent positioning, but does not exert a relevant impact on the vessel wall [58]. It has been hypothesized that it may either contribute to the reduced risk of malfunction of the stent immediately after implantation or may prove to be a beneficial feature in acute myocardial infarction, where the stent may be undersized. However, there is no data to support this concept [54]. The new model also promises biodegradation in the first year by as much as 95% with the assumption of full resorption of the stent up to 2 years [54,56,59]. After this period, the polymer is replaced with a loose net mainly composed of proteoglycan, followed by a new connective tissue [54]. DESolve scaffolds differ, therefore, from ABSORB stents due to the properties of self-expansion and increased tolerance to excessive stretching.
DREAMS G1 stent is based on a frame made of absorbable magnesium alloy. Magnesium attains better mechanical properties such as a higher capacity of elongation and an increased tensile strength, allowing to use a thinner strut structure [54,60]. Due to the intrinsic radiolucency of magnesium and lack of markers mounted, the first generation stents are not visible in conventional imaging, but at the same time they are compatible with magnetic resonance imaging (MRI). These stents have bioresorbable coating of poly-lactic-co-glycolic acid (PLGA) eluting paclitaxel, and decompose in approximately 3–4 months [20,22,61,62,63]. The absorption of the magnesium alloy is a two-stage process, starting on the luminal surface of the scaffold, progressing towards the layers, until only the trace of hydroxyapatite remains at the site of implantation. In addition, magnesium reacts with water to form magnesium hydroxide, which starts the corrosion process [56]. Corrosion, however, does not proceed to the same extent on all sides, preferring the lateral surfaces of the struts. The initial crystal structure of magnesium hydroxide is gradually transformed into an amorphous body with a high-water content. After a time, the material is absorbed again through the core-infiltration of the cells [20]. In addition, some in vitro studies have shown that elevated magnesium concentrations in the coronary arteries per se reduce smooth muscle cell proliferation and increased endothelial cell proliferation [60,64]. Another advantage of these devices was the evidence of lower thrombogenicity in animal studies [60]. Despite the anti-arrhythmic properties of magnesium and its inhibitory effect on the release of endothelin-1, no adverse effects have been observed due to stent degradation [20,65]. The next generation, DREAMS 2 BVS (Magmaris), was enhanced in following ways: (i) its coating was thickened from 1 µm to 7 µm and converted from PLGA to PLLA, (ii) paclitaxel was substituted with sirolimus with greater elution (1.4 μg/mm2), and (iii) the strut thickness increased to 150 µm × 140 µm [61].
The main highlight of the Fantom scaffold is its intrinsic radio-opacity. The presence of iodinated tyrosine analogue polymer enables more precise deployment and non-invasive radiological assessment throughout the whole degradation time. The content of iodine in a single device is negligible in comparison with the amount administered in a contrast media [38].

4. Real-World BVS Performance—Outcomes and Evaluation

The safety and efficacy of BVS devices in clinical trials are presented in Figure 2 and Table 2. As for now, the superiority of any BVS over DES has not been shown in a randomized trial.
The first data describing BVS performance stems from a single arm ABSORB I study comprising of a 5 year observation of 130 patients in total. Safety and efficacy were assessed by observing events of ST and occurrence of major adverse cardiac effects (MACE). MACE was defined as nonfatal stroke, nonfatal myocardial infarction and cardiovascular death. The 5 year results were promising, inasmuch as in both cohorts no ST was observed, and the MACE rate ranged from 3.4% to 11% in cohorts A and B, respectively. It indicated that ABSORB BVS has a potential to overtake DES in the terms of safety profile and led to trials directly comparing ABSORB BVS with Xience V DES [31,72]. ABSORB II and ABSORB III studies were prospective, randomized, single-blind, multi-center trials which aimed on proving the non-inferiority of ABSORB BVS versus drug eluting Xience V DES. The primary endpoints of the study enclosed comparison of cardiac death (CD), TVMI and target lesion revascularization (TLR) rates one year after implantation, while secondary endpoints included the assessment of primary endpoint parameters at 2–5 years’ time and the assessment of ST, VLST and cost-related data.
The ABSORB II trial was the first to report inferiority of ABSORB BVS. 3 year follow-up was associated with a two-fold greater risk of TLF in comparison with Xience V (10% vs. 5%; p = 0.0425) [17,80]. Later, 2 year and 3 year observations in ABSORB III trials demonstrated ABSORB BVS inferiority in terms of overall ST and TLF driven mainly by TVMI [66,67]. Finally, the preliminary 30 day results of the most up to date and most populous ABSORB IV study revealed lower acute device success rate (94.6% vs. 99.0% (P < 0.0001)), greater risk of TLF (5.0% vs. 3.7%; p = 0.02) and greater ischemia-driven target vessel revascularization rate (ID-TVR) (1.2% vs. 0.2%; p = 0.003) [68]. Simultaneously, cumulative meta-analyses embracing ABSORB II, III, AIDA, EVERBIO II and TROFI II trials indicated the superiority of DES in the terms of both TLF and overall ST [9,10,69,70]. So far, only two country-specific trials (ABSORB JAPAN and ABSORB CHINA) demonstrated superiority of ABSORB BVS over Xience V DES [71,74]. The published meta-analyses and the results of the ABSORB IV trial formed the basis of the decision to cease production of ABSORB BVS in late 2017.
DREAMS G1 performance was assessed in 1 and 3 years’ long observation in the course of the BIOSOLVE I study [21,23]. The BIOSOLVE I trial included 46 patients with silent ischemia, stable or unstable angina and assessed angiographic and IVUS follow-up at 6 and 12 months together with 3 years’ clinical follow-up. In opposition to ABSORB trials, proper implantation strategy elements such as pre-dilatation were compulsory [20]. TLF occurrence at 6 months and 12 months is presented in Table 3. While no cardiac deaths or ST events were observed, the final results available in 3 year follow-up indicated 6.6% of TLF, 4.3% ischemia driven target lesion revascularization (ID-TLR) and 2.2% TVMI. Based on the angiographic results, it was assumed that DREAMS still could not compete with the 3rd generation of DES. BIOSOLVE-II and BIOSOLVE-III trials have been designed to observe its performance 3 years after implantation. As for now, data is available for 184 patients with single and multiple lesions in up to 2 years’ follow-up. Pooled analysis concluded with no trace of thrombosis, and TLF occurred in 3.3% and 5.9% of patients in the BIOSOLVE-II and BIOSOLVE-III groups respectively. It is worth noting that four cardiac deaths were observed among both groups [22,24].
BIOSOLVE-IV—a prospective, observational trial—is currently ongoing and aims at enrolling 2054 patients to be followed-up for 5 years. First year outcomes for the first 400 patients were recently published [25]. Procedural success was achieved in all but three patients. Target lesion failure (TLF) (primary endpoint) was registered in 4.3% of patients, and was exclusively composed of target lesion revascularizations. The rate of target vessel myocardial infarction was 0.88% and a single definite scaffold thrombosis was reported (0.3%) 10 days after implantation in a calcified lesion after a 5 day interruption of DAPT to perform a surgical minimally invasive revascularization of a non-target vessel.
Despite DESolve’s greater self-expansion properties and its unique self-correction property, which helps to avoid malapposition, no study proved its superiority over DES [54]. In addition, recent observational studies indicated propitious results [76,77]. Nevertheless, a non-complete follow-up represents the study’s limitations in long-term DESolve performance and the risk of late complications, e.g., VLST has not been properly investigated yet. As a consequence, the first generation of DESolve did not find application on the market. As such, the next generation, DESolve CX plus, has been halted.
The performance of Fantom scaffolds has been examined in two studies: Fantom I and Fantom II, including 7 and 117 patients respectively. The Fantom I pilot trial resulted in preserved patency in target vessels observed in IVUS after four months and no cardiac events after six months [78]. The multi-centre Fantom II trial observed short-term procedural success in 99.1% of cases, a 2.8% rate of MACE and one event of in-ST after six months. Investigators and commenters find these results comparable with other BVS. More encouraging results are anticipated from Cohort B of the Fantom II study, including 240 patients and nine month follow-up [79,82].

5. Anatomy of Failure: Explanation for Unfavorable Outcomes

As for now, the superiority of BVS over DES has not been shown in a randomized trial. A series of large-scale, post-registration studies showed long-term performance to be influenced by factors on every step of application of BVS, i.e., from device design to procedural specifics and vascular properties at the site of implantation (Figure 3) [83,84]. Optical analysis of intraluminal changes brings closer an explanation of the inferiority of BVS in clinical trials. Firstly, BVS implantation correlates with a greater asymmetry index (AI) and eccentricity index (EI) of the vessel in long term follow-up [85]. EI is defined as the ratio of minimum and maximum scaffold/stent diameter per cross section, while AI is defined as the ratio of minimal to maximal device diameter [85]. The greater the AI and EI value, the less symmetric the vessel section. Greater AI and EI were the consequence of the fact that ABSORB BVS is ‘less forgiving’ in case of inadequate deployment technique. Improper implantation, and consequently greater AI and EI, was determined to have a direct and significant impact on TLF occurrence in the ABSORB group [85,86]. Additionally, in numerous trials, the implantation of ABSORB correlated with lower minimal lumen diameter than Xience V, more extensive vessel remodeling, greater late luminal loss and decreased mean lumen area [17,87,88].
Furthermore, as shown by randomized studies, after the implantation of bioresorbable stents, a lower minimal diameter of the vessel lumen significantly increased initial stenosis which results in a greater risk of recoil in vivo [53,81,89]. The mentioned phenomena were caused by an increased strut thickness, greater than in DES; bulky, discontinuous, malapposed struts; structural disruption; and finally, incomplete resorption (even in 3 year observation time (the PRAGUE-19 trial)) [73,86]. Mentioned factors led to greater neointimal hyperplasia, greater volume of intraluminal masses and eventually greater coronary artery lumen narrowing, resulting in device failure [90,91]. Thus, it is highly probable that the failure of ABSORB was caused by a combination of faulty device design and a far from optimal implantation technique.
BVS are much more demanding in terms of the implantation technique and require specific protocol called the ‘PSP technique’ (Prepare the lesion, Size adequately, Post-dilate). Prior to implantation, it is necessary to perform an in-depth target segment imaging, in order to accurately assess the dimensions of the vessel and detect the presence of possible calcification [20,32,35,92,93]. Recent studies and reconsideration of the results of five ABSORB studies correlate with accurate adjustment of a scaffold and optimal post-dilation with a lower risk of TLF, and excessive pre-dilation with a lower risk of ST [94,95,96]. Therefore, BVS should not be implanted in places which cannot be accessed with a pre-dilating balloon. In next step, the scaffold should be expanded gradually by means of a five second pressure increase by two atmospheres, and the target pressure should be maintained for 30 s [32]. On the contrary, proper positioning of DES is a one-step procedure with limited time of ischemia [20]. However, prolonged ischemia appears not to impact BVS efficacy, and their use may be warranted even in chronic total coronary occlusions [97].
Recent studies have identified clinical scenarios which require particular attention. Desirable post-dilation steps cannot be performed safely on scaffolds longer than 28 mm, due to the risk of breakage. Therefore, long lesions demand a specific ‘scaffold to scaffold’ technique to avoid overlapping, resulting in impaired radial strength [98]. The use of BVS in lesions located on vessel bifurcations is associated with an acceptable risk of TLR, however, still greater than in use of DES [99]. Eventually, BVS are contraindicated in aorto-ostial lesions [100]. Acute coronary syndromes seemed to be a propitious target for BVS due to feature of restoration of the native vessel lumen and vasomotor function. This indication is supported by the results of randomized TROFI II and ISAR- ABSORB MI trials on STEMI patients treated with either ABSORB BVS or DES, which concluded with a comparable healing score and risk of adverse events [70,75].
The first-generation BVS ABSORB seems to increase the risk of ST and TVMI as shown by recent meta-analyses [101,102,103,104,105]. Furthermore, analysis of the data collected by several registries shows that this BVS associates with a high rate of early (within 30 days) definite or probable ST of 1.3–1.5% [106,107]. Moreover, 1 year after implantation, the definite or probable ST rates are markedly higher (up to 3.1%) than the rates detected by the randomized trials [108,109,110,111,112,113,114]. This apparently higher thrombogenicity may be caused by two major limitations of the first-generation thick-strut poly-lactic acid BVS. First, mechanical limitations of the BVS demand a more elaborate percutaneous coronary intervention (PCI) technique [115]. This may increase the risk of suboptimal scaffold implantation. Second, structural limitations of the BVS lead to the creation of laminar flow disruptions [116]. This may serve as a nidus for inter-strut thrombus formation.
The mean number and length of BVS implantation and its relation to the incidence of ST is illustrated in Figure 3, based on data from randomized controlled trials and registries with ≥100 patients that report a 6–12 month follow-up and BVS details [81,101,102,103,104,106,107,108,109,110,111,112,113,114,117,118,119,120,121,122,123]. Only the ASSURE registry, which included 183 patients, reported no cases of ST at 1 year follow-up [119]. However, the mean number and length of the implanted BVS in the ASSURE registry were comparable to those in the selected patient populations of the randomized controlled trials. Thus, it suggests that the cohort of the ASSURE registry was rather a low risk population and that this may account for the low event rate that has been observed [102]. Figure 4 illustrates that there is a trend toward an association between the stent length/number of implanted stents per patient and the incidence of ST. Since late ST is a crucial concern in the use of BVS, a long-term (at least 3–5 years) observation period should be warranted in upcoming trials.

6. Niche for BVS and Optimization of BVS Action

The excellent performance of DES makes them a tough benchmark to beat. The current generation of DES provides a very good vascular scaffolding with excellent radial strength. In fact, their use is associated with low rates of restenosis, ST or MACE [125,126,127,128]. Nevertheless, there are still concerns about their use [20,43,129]. The constant presence of a durable metallic prosthesis impairs vasomotor response vasodilation and causes a prolonged inflammatory reaction, which may eventually manifest in clinical observation [71,130,131,132,133]. Hence, BVS are believed to be distinctively beneficial in younger patients [73]. BVS may also serve patients’ personal preferences to avoid carrying a permanent foreign body [32]. BVS theoretically enable surgical revascularization at the site of implantation, however this concept has not been yet appraised in a clinical trial [31]. On the other hand, the group of preferred candidates is limited to those who clearly take advantage of the resolution of the scaffold. BVS are still discouraged in patients with limited life expectancy, inasmuch as a still uncertain safety profile prevails over the possible benefits associated with biodegradation [60].
The next generations of BVS resolving without antiproliferative drugs may overcome recent concerns about the use of DES in the management of peripheral artery disease. After years of satisfactory performance, the elution of paclitaxel is currently suspected to increase late mortality [134]. Despite the lack of an exact mechanism linking the action of an antiproliferative drug and all-cause mortality, the Vascular Leaders Forum convened by physicians, manufacturers and the Food and Drug Administration (FDA) in March, 2019 recommends cautious monitoring and reconsideration of alternative treatment options [135]. These circumstances may facilitate further development and show new indications for BVS.
The importance of routine pre-procedural imaging and strict compliance to the PSP technique should be highlighted [136,137]. The PSP technique is distinctively beneficial in the case of aggravated risk of thrombosis, e.g., in diabetic patients [124,138]. In line with this concept, the use of a longer inflation time, as suggested by the producer, allows better for device expansion and a more homogeneous apposition [53]. In order to select the proper size of BVS, the measurement of the target’s diameter was observed to be equally accurate under the guidance of either angiography or OCT [139]. Eventually, MRI enables non-invasive and non-radiative assessment of BVS patency after implantation and may be an alternative for patients with recurrent angina after angioplasty [140]. Despite the design of comparable radial strength of BVS to DES, it was noted that excessive stretching decreases its radial strength and elasticity and consequently leads to breakage [32,115,141]. This observation was confirmed in an experiment performed on a computational model. An arrangement of a mesh and the dimensions of a single strut determine the specific post-dilation size of a scaffold at which optimal mechanical and drug release properties are attained [142]. It is worth noting that available BVS devices are not equal in terms of their mechanical properties. PLLA-based scaffolds attain greater bending stiffness but lower radial strength, and tend more to recoil than magnesium-based scaffolds [58]. Among polymer-based scaffolds, the DESolve device attains greater flexibility and adapts better adaptation to the shape of the vessel [57,143]. These features are likely to contribute to upcoming studies as specific indications for certain devices. Greater radial strength may be utilizable in large vessels, while greater elasticity in tortuous vessels.
Another important issue is the residual high platelet reactivity (HPR) under DAPT, which represents one of the major determinants for worse outcomes of patients after PCI [144,145,146,147]. Therefore, the existence of a therapeutic window of platelet reactivity for P2Y12 pathway inhibition was proposed [148]. Indeed, it has been shown previously in an all-comer PCI population that if both the P2Y12 and cyclooxygenase-1 pathway inhibition of DAPT are personalized using Multiplate (a “point of care” platelet function assay which determines multiple electrode platelet aggregometry), HPR rates improve along with the clinical outcomes of patients [149,150,151]. Therefore, it would be interesting to know whether personalizing DAPT, by intensifying the treatment in the case of HPR to P2Y12 receptor blocker and/or aspirin, would have an impact on the rates of ST after BVS implantation. Personalization of DAPT remains a controversial issue because the randomized trials on this subject had considerable shortcomings [152,153]. Nevertheless, it has been already shown that strict peri- and post-interventional optimization of platelet reactivity improves patient outcomes at 30 days in an all-comers PCI population who underwent metallic stent implantation [149,150,151]. It might be that optimizing platelet reactivity may be of even greater importance in BVS implantation, primarily because the thicker struts of the first-generation scaffold disrupt laminar flow and thereby increase the risk of thrombus formation [116]. In our opinion, not even the best implantation technique is capable of completely counteracting this inherent limitation of the current BVS. This suggests that to improve patient outcomes after PCI with this BVS, it might be necessary to optimize the platelet reactivity. Several catheterization laboratories intensify platelet inhibition through the routine prescription of the newer potent P2Y12 receptor blockers for a longer duration (up to 3 years) to reduce the rates of ST after BVS implantation. A currently ongoing study on the administration of ticagrelor after the use of BVS in coronary vessels is believed to elucidate this matter [154,155].

7. Conclusions

After the initial excessive enthusiasm around BVS stemming from the dream of disappearing stents, clinical trials brought a great disillusionment. Existing DES devices still remain first choice in majority of cases and at the moment it is hard to believe that the current BVS could jeopardize their position. The next generations of BVS are anticipated to overcome the limitations which emerged in the initial clinical experiences. In particular, the procedural complexity and higher than expected restenosis and thrombosis represent major limitations. In fact, both technological advances and clinical expertise are about to shed new light on application of BVS devices.

Author Contributions

Writing—original draft preparation, M.P.J., M.J.K., C.E., A.T. and J.M.S.-M.; writing-review and editing, M.P.J., M.J.K., C.E., S.D.R., G.C., M.L., C.I., A.T., J.M.S.-M. and M.P.; visualization, M.P.J., C.E., M.L. and J.M.S.-M.; supervision, S.D.R., G.C., M.L., C.I., J.M.S.-M. and M.P.

Funding

This work was implemented with CEPT infrastructure financed by the European Union-the European Regional Development Fund within the Operational Program “Innovative economy” for 2007–2013.

Conflicts of Interest

The authors declare no conflict of interest.

References

  1. Townsend, N.; Nichols, M.; Scarborough, P.; Rayner, M. Cardiovascular disease in Europe—Epidemiological update 2015. Eur. Heart J. 2015, 36, 2696–2705. [Google Scholar] [CrossRef] [Green Version]
  2. Benjamin, E.J.; Blaha, M.J.; Chiuve, S.E.; Cushman, M.; Das, S.R.; Deo, R. Heart Disease and Stroke Statistics-2017 Update: A Report from the American Heart Association. Circulation 2017, 135, e146–e603. [Google Scholar] [CrossRef]
  3. Schmidt, T.; Abbott, J.D. Coronary Stents: History, Design, and Construction. J. Clin. Med. 2018, 7, 126. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  4. Vahl, T.P.; Gasior, P.; Gongora, C.A.; Ramzipoor, K.; Lee, C.; Cheng, Y. Four-year polymer biocompatibility and vascular healing profile of a novel ultrahigh molecular weight amorphous PLLA bioresorbable vascular scaffold: An OCT study in healthy porcine coronary arteries. EuroIntervention 2016, 12, 1510–1518. [Google Scholar] [CrossRef] [PubMed]
  5. Gonzalo, N.; Otaegui, I.; Rumoroso, J.R.; Gutiérrez, H.; Alfonso, F.; Marti, G. Device specificity of vascular healing following implantation of bioresorbable vascular scaffolds and bioabsorbable polymer metallic drug-eluting stents in human coronary arteries: The ESTROFA OCT BVS vs. BP-DES study. EuroIntervention 2018, 14, e1295–e1303. [Google Scholar] [CrossRef] [Green Version]
  6. Kereiakes, D.J.; Onuma, Y.; Serruys, P.W.; Stone, G.W. Bioresorbable Vascular Scaffolds for Coronary Revascularization. Circulation 2016, 134, 168–182. [Google Scholar] [CrossRef] [Green Version]
  7. Serruys, P.W.; Ormiston, J.A.; Onuma, Y.; Regar, E.; Gonzalo, N.; Garcia-Garcia, H.M. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 2009, 373, 897–910. [Google Scholar] [CrossRef]
  8. Tesfamariam, B. Bioresorbable vascular scaffolds: Biodegradation, drug delivery and vascular remodeling. Pharm. Res. 2016, 107, 163–171. [Google Scholar] [CrossRef]
  9. Montone, R.A.; Niccoli, G.; De Marco, F.; Minelli, S.; D’Ascenzo, F.; Testa, L. Temporal Trends in Adverse Events After Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: A Meta-Analysis of Randomized Controlled Trials. Circulation 2017, 135, 2145–2154. [Google Scholar] [CrossRef]
  10. Zhang, X.L.; Zhu, Q.Q.; Kang, L.N.; Li, X.L.; Xu, B. Mid- and Long-Term Outcome Comparisons of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents: A Systematic Review and Meta-analysis. Ann. Intern. Med. 2017, 167, 642–654. [Google Scholar] [CrossRef]
  11. Gheorghe, L.; Millán, X.; Jimenez-Kockar, M.; Gomez-Lara, J.; Arzamendi, D.; Danduch, L.; Agudelo, V.; Serra, A. Bioresorbable vascular scaffolds in coronary chronic total occlusions: Clinical, vasomotor and optical coherence tomography findings at three-year follow-up (ABSORB-CTO study). EuroIntervention 2019, 15, 99–107. [Google Scholar] [CrossRef] [PubMed]
  12. Mori, H.; Virmani, R.; Finn, A.V. Bioresorbable vascular scaffolds: Implication of very late scaffold thrombosis. Coron. Artery Dis. 2017, 28, 533–538. [Google Scholar] [CrossRef] [PubMed]
  13. Alfonso, F.; Cuesta, J. Bioresorbable Vascular Scaffolds Restenosis: Pathophysiology and Predictors. JACC Cardiovasc. Interv. 2017, 10, 1828–1831. [Google Scholar] [CrossRef] [PubMed]
  14. De Rosa, S.; Indolfi, C. Letter by De Rosa and Indolfi regarding article, “Clinical presentation and outcomes of coronary in-stent restenosis across 3-stent generations”. Circ. Cardiovasc. Interv. 2015, 8. [Google Scholar] [CrossRef] [Green Version]
  15. Indolfi, C.; Mongiardo, A.; Spaccarotella, C.; Caiazzo, G.; Torella, D.; De Rosa, S. Neointimal proliferation is associated with clinical restenosis 2 years after fully bioresorbable vascular scaffold implantation. Circ. Cardiovasc. Imaging 2014, 7, 755–757. [Google Scholar] [CrossRef] [Green Version]
  16. Serruys, P.W.; Onuma, Y.; Garcia-Garcia, H.M.; Muramatsu, T.; Dudek, D.; Thuesen, L. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: A multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention 2014, 9, 1271–1284. [Google Scholar] [CrossRef]
  17. Serruys, P.W.; Chevalier, B.; Sotomi, Y.; Cequier, A.; Carrié, D.; Piek, J.J.; Van Boven, J.; Marcello, D.; Dariusz, D.; McClean, D.; et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): A 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet 2016, 388, 2479–2491. [Google Scholar] [CrossRef]
  18. Chevalier, B.; Cequier, A.; Dudek, D.; Haude, M.; Carrie, D.; Sabaté, M.; Windecker, S.; Reith, S.; de Sousa Almeida, M.; Campo, G.; et al. Four-year follow-up of the randomised comparison between an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II Trial). EuroIntervention 2018, 13, 1561–1564. [Google Scholar] [CrossRef]
  19. Wykrzykowska, J.J.; Kraak, R.P.; Hofma, S.H.; van der Schaaf, R.J.; Arkenbout, E.K.; IJsselmuiden, A.J.; Joëlle, E.; Ivo, M.; Ruben, Y.G.; Karel, T.K.; et al. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N. Engl. J. Med. 2017, 376, 2319–2328. [Google Scholar] [CrossRef]
  20. Rapetto, C.; Leoncini, M. Magmaris: A new generation metallic sirolimus-eluting fully bioresorbable scaffold: Present status and future perspectives. J. Thorac. Dis. 2017, 9 (Suppl. S9), 903–913. [Google Scholar] [CrossRef] [Green Version]
  21. Haude, M.; Erbel, R.; Erne, P.; Verheye, S.; Degen, H.; Böse, D. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial. Lancet 2013, 381, 836–844. [Google Scholar] [CrossRef]
  22. Haude, M.; Ince, H.; Abizaid, A.; Toelg, R.; Lemos, P.A.; von Birgelen, C.; Evald, H.C.; William, W.; Franz-Josef, N.; Christoph, K.; et al. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. Eur. Heart J. 2016, 37, 2701–2709. [Google Scholar] [CrossRef] [Green Version]
  23. Haude, M.; Erbel, R.; Erne, P.; Verheye, S.; Degen, H.; Vermeersch, P. Safety and performance of the DRug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicentre, first-in-man BIOSOLVE-I trial. EuroIntervention 2016, 12, e160–e166. [Google Scholar] [CrossRef] [PubMed]
  24. Haude, M.; Ince, H.; Kische, S.; Abizaid, A.; Tölg, R.; Alves, L.P. Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months: Pooled outcomes of BIOSOLVE-II and BIOSOLVE-III. EuroIntervention 2017, 13, 432–439. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  25. Verheye, S.; Wlodarczak, A.; Montorsi, P.; Bennett, J.; Torzewski, J.; Haude, M. Safety and performance of a resorbable magnesium scaffold under real-world conditions: 12-month outcomes of the first 400 patients enrolled in the BIOSOLVE-IV registry. EuroIntervention 2019. [Google Scholar] [CrossRef] [Green Version]
  26. Neumann, F.J.; Sousa-Uva, M. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur. Heart J. 2019, 40, 87–165. [Google Scholar] [CrossRef] [PubMed]
  27. Cortese, B.; di Palma, G.; Cerrato, E.; Latini, R.A.; Elwany, M.; Orrego, P.S.; Seregni, R.G. Clinical and angiographic outcome of a single center, real world population treated with a dedicated technique of implantation for bioresorbable vascular scaffolds. The FAtebenefratelli Bioresorbable Vascular Scaffold (FABS) registry. J. Interv. Cardiol. 2017, 30, 427–432. [Google Scholar] [CrossRef]
  28. Li, H.; Rha, S.W.; Choi, C.U.; Oh, D.J. Optical Coherence Tomography and Stent Boost Imaging Guided Bioresorbable Vascular Scaffold Overlapping for Coronary Chronic Total Occlusion Lesion. Yonsei Med. J. 2017, 58, 1071–1074. [Google Scholar] [CrossRef] [Green Version]
  29. Caiazzo, G.; Longo, G.; Giavarini, A.; Kilic, I.D.; Fabris, E.; Serdoz, R.; Alessio, M.; Nicolas, F.; Gioel, G.; Seccob, S.; et al. Optical coherence tomography guidance for percutaneous coronary intervention with bioresorbable scaffolds. Int. J. Cardiol. 2016, 221, 352–358. [Google Scholar] [CrossRef]
  30. Caiazzo, G.; Kilic, I.D.; Fabris, E.; Serdoz, R.; Mattesini, A.; Foin, N. Absorb bioresorbable vascular scaffold: What have we learned after 5 years of clinical experience? Int. J. Cardiol. 2015, 201, 129–136. [Google Scholar] [CrossRef]
  31. Onuma, Y.; Dudek, D.; Thuesen, L.; Webster, M.; Nieman, K.; Garcia-Garcia, H.M. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: The ABSORB cohort A trial. JACC Cardiovasc. Interv. 2013, 6, 999–1009. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  32. Khamis, H.; Sanad, O.; Elrabbat, K.; Attia, A.; Adel, M.; Alkady, H.; Masoud, A. Bioresorbable vascular scaffold (BVS) for the treatment of native coronary artery stenosis: One year outcome. Egypt. Heart J. 2016, 68, 253–259. [Google Scholar] [CrossRef] [Green Version]
  33. Otsuka, F.; Vorpahl, M.; Nakano, M.; Foerst, J.; Newell, J.B.; Sakakura, K.; Robert, K.; Elena, L.; Aloke, V.F.; Frank, D.K.; et al. Pathology of second-generation everolimus-eluting stents versus first-generation sirolimus- and paclitaxel-eluting stents in humans. Circulation 2014, 129, 211–223. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  34. Yamaji, K.; Kimura, T.; Morimoto, T.; Nakagawa, Y.; Inoue, K.; Soga, Y. Very long-term (15 to 20 years) clinical and angiographic outcome after coronary bare metal stent implantation. Circ. Cardiovasc. Interv. 2010, 3, 468–475. [Google Scholar] [CrossRef] [Green Version]
  35. Pavasini, R.; Serenelli, M.; Gallo, F.; Bugani, G.; Geraci, S.; Vicinelli, P.; Campo, G. Effectiveness and safety of the ABSORB bioresorbable vascular scaffold for the treatment of coronary artery disease: Systematic review and meta-analysis of randomized clinical trials. J. Thorac. Dis. 2017, 9 (Suppl. S9), 887–897. [Google Scholar] [CrossRef] [Green Version]
  36. Onuma, Y.; Serruys, P.W. Bioresorbable scaffold: The advent of a new era in percutaneous coronary and peripheral revascularization? Circulation 2011, 123, 779–797. [Google Scholar] [CrossRef] [Green Version]
  37. Campos, C.M.; Muramatsu, T.; Iqbal, J.; Zhang, Y.J.; Onuma, Y.; Garcia-Garcia, H.M. Bioresorbable drug-eluting magnesium-alloy scaffold for treatment of coronary artery disease. Int. J. Mol. Sci. 2013, 14, 24492–24500. [Google Scholar] [CrossRef] [Green Version]
  38. Regazzoli, D.; Leone, P.P.; Colombo, A.; Latib, A. New generation bioresorbable scaffold technologies: An update on novel devices and clinical results. J. Thorac. Dis. 2017, 9 (Suppl. S9), 979–985. [Google Scholar] [CrossRef] [Green Version]
  39. Waksman, R.; Zumstein, P.; Pritsch, M.; Wittchow, E.; Haude, M.; Lapointe-Corriveau, C. Second-generation magnesium scaffold Magmaris: Device design and preclinical evaluation in a porcine coronary artery model. EuroIntervention 2017, 13, 440–449. [Google Scholar] [CrossRef]
  40. Giacchi, G.; Ortega-Paz, L.; Brugaletta, S.; Ishida, K.; Sabaté, M. Bioresorbable vascular scaffolds technology: Current use and future developments. Med. Devices 2016, 9, 185–198. [Google Scholar] [CrossRef] [Green Version]
  41. Foin, N.; Lee, R.D.; Torii, R.; Guitierrez-Chico, J.L.; Mattesini, A.; Nijjer, S. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int. J. Cardiol. 2014, 177, 800–808. [Google Scholar] [CrossRef] [PubMed]
  42. Bil, J.; Gil, R.J. Bioresorbable vascular scaffolds—What does the future bring? J. Thorac. Dis. 2016, 8, E741–E745. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  43. Katagiri, Y.; Stone, G.W.; Onuma, Y.; Serruys, P.W. State of the art: The inception, advent and future of fully bioresorbable scaffolds. EuroIntervention 2017, 13, 734–750. [Google Scholar] [CrossRef] [PubMed]
  44. Joner, M.; Ruppelt, P.; Zumstein, P.; Lapointe-Corriveau, C.; Leclerc, G.; Bulin, A. Preclinical evaluation of degradation kinetics and elemental mapping of first- and second-generation bioresorbable magnesium scaffolds. EuroIntervention 2018, 14, e1040–e1048. [Google Scholar] [CrossRef] [PubMed]
  45. Bangalore, S.; Kumar, S.; Fusaro, M.; Amoroso, N.; Attubato, M.J.; Feit, F. Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: A mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation 2012, 125, 2873–2891. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  46. Cassese, S.; Katagiri, Y.; Byrne, R.A.; Brugaletta, S.; Alfonso, F.; Räber, L. Angiographic and clinical outcomes of STEMI patients treated with bioresorbable or metallic everolimus-eluting stents. A pooled analysis of individual patient data from 2 randomized trials. EuroIntervention 2019. [Google Scholar] [CrossRef] [Green Version]
  47. La Manna, A.; Chisari, A.; Giacchi, G.; Capodanno, D.; Longo, G.; Di Silvestro, M. Everolimus-eluting bioresorbable vascular scaffolds for treatment of complex chronic total occlusions. EuroIntervention 2017, 13, 355–363. [Google Scholar] [CrossRef]
  48. La Manna, A.; Chisari, A.; Giacchi, G.; Capodanno, D.; Longo, G.; Di Silvestro, M. Systemic Pharmacokinetics of Everolimus Eluted from the Absorb Bioresorbable Vascular Scaffold: An ABSORB III Substudy. J. Am. Coll. Cardiol. 2015, 66, 2467–2469. [Google Scholar] [CrossRef] [Green Version]
  49. Tanabe, K.; Popma, J.J.; Kozuma, K.; Saito, S.; Muramatsu, T.; Nakamura, S. Multislice computed tomography assessment of everolimus-eluting Absorb bioresorbable scaffolds in comparison with metallic drug-eluting stents from the ABSORB Japan randomised trial. EuroIntervention 2018, 14, e1020–e1028. [Google Scholar] [CrossRef]
  50. Ang, H.Y.; Bulluck, H.; Wong, P.; Venkatraman, S.S.; Huang, Y.; Foin, N. Bioresorbable stents: Current and upcoming bioresorbable technologies. Int. J. Cardiol. 2017, 228, 931–939. [Google Scholar] [CrossRef]
  51. Ali, Z.A.; Serruys, P.W.; Kimura, T.; Gao, R.; Ellis, S.G.; Kereiakes, D.J. 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: A systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. Lancet 2017, 390, 760–772. [Google Scholar] [CrossRef]
  52. Varcoe, R.L.; Thomas, S.D.; Rapoza, R.J.; Kum, S. Lessons Learned Regarding Handling and Deployment of the Absorb Bioresorbable Vascular Scaffold in Infrapopliteal Arteries. J. Endovasc. Ther. 2017, 24, 337–341. [Google Scholar] [CrossRef] [PubMed]
  53. Sorrentino, S.; De Rosa, S.; Ambrosio, G.; Mongiardo, A.; Spaccarotella, C.; Polimeni, A.; Jolanda, S.; Daniele, T.; Gianluca, C.; Ciro, I. The duration of balloon inflation affects the luminal diameter of coronary segments after bioresorbable vascular scaffolds deployment. BMC Cardiovasc. Disord. 2015, 15, 169. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  54. Mattesini, A.; Bartolini, S.; Dini, C.S.; Valente, S.; Parodi, G.; Stolcova, M.; Di Mario, C. The DESolve novolimus bioresorbable Scaffold: From bench to bedside. J. Thorac. Dis. 2017, 9 (Suppl. S9), 950–958. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  55. Nef, H.M.; Wiebe, J.; Foin, N.; Blachutzik, F.; Dörr, O.; Toyloy, S.; Hamm, C.W. A new novolimus-eluting bioresorbable coronary scaffold: Present status and future clinical perspectives. Int. J. Cardiol. 2017, 227, 127–133. [Google Scholar] [CrossRef]
  56. Abizaid, A.; Costa, R.A.; Schofer, J.; Ormiston, J.; Maeng, M.; Witzenbichler, B. Serial Multimodality Imaging and 2-Year Clinical Outcomes of the Novel DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold System for the Treatment of Single De Novo Coronary Lesions. JACC Cardiovasc. Interv. 2016, 9, 565–574. [Google Scholar] [CrossRef]
  57. Ormiston, J.A.; Webber, B.; Ubod, B.; Darremont, O.; Webster, M.W. An independent bench comparison of two bioresorbable drug-eluting coronary scaffolds (Absorb and DESolve) with a durable metallic drug-eluting stent (ML8/Xpedition). EuroIntervention 2015, 11, 60–67. [Google Scholar] [CrossRef]
  58. Schmidt, W.; Behrens, P.; Brandt-Wunderlich, C.; Siewert, S.; Grabow, N.; Schmitz, K.P. In vitro performance investigation of bioresorbable scaffolds - Standard tests for vascular stents and beyond. Cardiovasc. Revasc. Med. 2016, 17, 375–383. [Google Scholar] [CrossRef]
  59. Verheye, S.; Ormiston, J.A.; Stewart, J.; Webster, M.; Sanidas, E.; Costa, R.; Ribamar, C., Jr.; Daniel, C.; Andrea, S.A.; Ibraim, P.; et al. A next-generation bioresorbable coronary scaffold system: From bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results. JACC Cardiovasc. Interv. 2014, 7, 89–99. [Google Scholar] [CrossRef] [Green Version]
  60. de Pommereau, A.; de Hemptinne, Q.; Varenne, O.; Picard, F. Bioresorbable vascular scaffolds: Time to absorb past lessons or fade away? Arch. Cardiovasc. Dis. 2018. [Google Scholar] [CrossRef]
  61. Haude, M.; Ince, H.; Abizaid, A.; Toelg, R.; Lemos, P.A.; von Birgelen, C. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet 2016, 387, 31–39. [Google Scholar] [CrossRef]
  62. Ghimire, G.; Spiro, J.; Kharbanda, R.; Roughton, M.; Barlis, P.; Mason, M. Initial evidence for the return of coronary vasoreactivity following the absorption of bioabsorbable magnesium alloy coronary stents. EuroIntervention 2009, 4, 481–484. [Google Scholar] [CrossRef] [PubMed]
  63. Varenhorst, C.; Lindholm, M.; Sarno, G.; Olivecrona, G.; Jensen, U.; Nilsson, J.; Jörg, C.; Stefan, J.; Bo, L. Stent thrombosis rates the first year and beyond with new- and old-generation drug-eluting stents compared to bare metal stents. Clin. Res. Cardiol. 2018, 107, 816–823. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  64. Sternberg, K.; Gratz, M.; Koeck, K.; Mostertz, J.; Begunk, R.; Loebler, M.; Beatrice, S.; Anne, S.; Petra, H.; Georg, H.; et al. Magnesium used in bioabsorbable stents controls smooth muscle cell proliferation and stimulates endothelial cells in vitro. J. Biomed. Mater. Res. B Appl. Biomater. 2012, 100, 41–50. [Google Scholar] [CrossRef] [PubMed]
  65. Berthon, N.; Laurant, P.; Fellmann, D.; Berthelot, A. Effect of magnesium on mRNA expression and production of endothelin-1 in DOCA-salt hypertensive rats. J. Cardiovasc. Pharmacol. 2003, 42, 24–31. [Google Scholar] [CrossRef] [PubMed]
  66. Kereiakes, D.J.; Ellis, S.G. 3-Year Clinical Outcomes with Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial. J. Am. Coll. Cardiol. 2017. [Google Scholar] [CrossRef]
  67. Ellis, S.G.; Kereiakes, D.J. Everolimus-Eluting Bioresorbable Vascular Scaffolds in Patients with Coronary Artery Disease: ABSORB III Trial 2-Year Results; American College of Cardiology Annual Scientific Session: Washington, DC, USA, 2017. [Google Scholar]
  68. Stone, G.W.; Ellis, S.G.; Gori, T.; Metzger, D.C.; Stein, B.; Erickson, M. Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial. Lancet 2018, 392, 1530–1540. [Google Scholar] [CrossRef]
  69. Arroyo, D.; Gendre, G.; Schukraft, S.; Kallinikou, Z.; Müller, O.; Baeriswyl, G.; Stauffera, J.C.; Goya, J.J.; Tognia, M.; Cooka, S.; et al. Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds: Two-year clinical outcomes of the EVERBIO II trial. Int. J. Cardiol. 2017, 243, 121–125. [Google Scholar] [CrossRef]
  70. Katagiri, Y.; Onuma, Y. Three-year follow-up of the randomised comparison between an everolimus-eluting bioresorbable scaffold and a durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction (TROFI II trial). EuroIntervention 2018, 14, e1224–e1226. [Google Scholar] [CrossRef]
  71. Kimura, T.; Kozuma, K.; Tanabe, K.; Nakamura, S.; Yamane, M.; Muramatsu, T. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur. Heart J. 2015, 36, 3332–3342. [Google Scholar] [CrossRef]
  72. Serruys, P.W.; Ormiston, J.; van Geuns, R.J.; de Bruyne, B.; Dudek, D.; Christiansen, E.; Bernard, C.; Pieter, S.; Dougal, M.; Jacques, K.; et al. A Polylactide Bioresorbable Scaffold Eluting Everolimus for Treatment of Coronary Stenosis: 5-Year Follow-Up. J. Am. Coll. Cardiol. 2016, 67, 766–776. [Google Scholar] [CrossRef] [PubMed]
  73. Toušek, P.; Kočka, V.; Malý, M.; Kozel, M.; Petr, R.; Hajsl, M. Long-term follow-up after bioresorbable vascular scaffold implantation in STEMI patients: PRAGUE-19 study update. EuroIntervention 2016, 12, 23–29. [Google Scholar] [CrossRef] [PubMed]
  74. Xu, B.; Yang, Y.; Han, Y.; Huo, Y.; Wang, L.; Qi, X. Comparison of everolimus-eluting bioresorbable vascular scaffolds and metallic stents: Three-year clinical outcomes from the ABSORB China randomised trial. EuroIntervention 2018, 14, e554–e561. [Google Scholar] [CrossRef] [PubMed]
  75. Byrne, R.A.; Alfonso, F.; Schneider, S.; Maeng, M.; Wiebe, J.; Kretov, E. Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: The Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial. Eur. Heart J. 2019, 40, 167–176. [Google Scholar] [CrossRef] [PubMed]
  76. Abizaid, A.; Vrolix, M.; Costa, J.R.; Chamie, D.; Abizaid, A.; Castro, J. TCT-330 Multi-Center Evaluation of a Novel 120 μm Novolimus-Eluting, Fully Bioresorbable Coronary Scaffold: First Report of 6-month Imaging and 12-Month Clinical Results. J. Am. Coll. Cardiol. 2017, 70, 135–136. [Google Scholar] [CrossRef]
  77. Nef, H.; Wiebe, J.; Boeder, N.; Dörr, O.; Bauer, T.; Hauptmann, K.E. A multicenter post-marketing evaluation of the Elixir DESolve((R)) Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study. Catheter. Cardiovasc. Interv. 2018, 92, 1021–1027. [Google Scholar] [CrossRef]
  78. de Ribamar Costa, J.; Abizaid, A.; Chamie, D.; Lansky, A.; Kochman, J.; Koltowski, L. Initial results of the fantom 1 trial: A first-in-man evaluation of a novel, radiopaque sirolimus-eluting bioresorbable vascular scaffold. J. Am. Coll. Cardiol. 2016, 67, 232. [Google Scholar] [CrossRef]
  79. Abizaid, A.; Carrié, D.; Frey, N.; Lutz, M.; Weber-Albers, J.; Dudek, D. 6-Month Clinical and Angiographic Outcomes of a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold: The FANTOM II Study. JACC Cardiovasc. Interv. 2017, 10, 1832–1838. [Google Scholar] [CrossRef]
  80. Kraak, R.P.; Grundeken, M.J.; Hassell, M.E.; Elias, J.; Koch, K.T.; Henriques, J.P. Two-year clinical outcomes of Absorb bioresorbable vascular scaffold implantation in complex coronary artery disease patients stratified by SYNTAX score and ABSORB II study enrolment criteria. EuroIntervention 2016, 12, e557–e565. [Google Scholar] [CrossRef]
  81. Puricel, S.; Arroyo, D.; Corpataux, N.; Baeriswyl, G.; Lehmann, S.; Kallinikou, Z. Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds. J. Am. Coll. Cardiol. 2015, 65, 791–801. [Google Scholar] [CrossRef] [Green Version]
  82. Ellis, S.G. Fantom Bioresorbable Scaffold: Verse, But Not Yet Chorus (An Incomplete Composition). JACC Cardiovasc. Interv. 2017, 10, 1839–1840. [Google Scholar] [CrossRef] [PubMed]
  83. Ellis, S.G.; Gori, T.; Serruys, P.W.; Nef, H.; Steffenino, G.; Brugaletta, S. Clinical, Angiographic, and Procedural Correlates of Very Late Absorb Scaffold Thrombosis: Multistudy Registry Results. JACC Cardiovasc. Interv. 2018, 11, 638–644. [Google Scholar] [CrossRef] [PubMed]
  84. Mahmud, E.; Reeves, R.R. Bioresorbable Vascular Scaffolds: Back to the Drawing Board. JACC Cardiovasc. Interv. 2018, 11, 645–647. [Google Scholar] [CrossRef]
  85. Suwannasom, P.; Sotomi, Y.; Ishibashi, Y.; Cavalcante, R.; Albuquerque, F.N.; Macaya, C. The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial. JACC Cardiovasc. Interv. 2016, 9, 1231–1242. [Google Scholar] [CrossRef]
  86. Costa, J.R.; Abizaid, A. Bioresorbable Coronary Scaffolds: Deployment Tips and Tricks and the Future of the Technology. Methodist DeBakey Cardiovasc. J. 2018, 14, 42–49. [Google Scholar] [CrossRef]
  87. Zhang, Y.J.; Bourantas, C.V.; Muramatsu, T.; Iqbal, J.; Farooq, V.; Diletti, R. Comparison of acute gain and late lumen loss after PCI with bioresorbable vascular scaffolds versus everolimus-eluting stents: An exploratory observational study prior to a randomised trial. EuroIntervention 2014, 10, 672–680. [Google Scholar] [CrossRef]
  88. Serruys, P.W.; Katagiri, Y.; Sotomi, Y.; Zeng, Y.; Chevalier, B.; van der Schaaf, R.J. Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents. J. Am. Coll. Cardiol. 2017, 70, 60–74. [Google Scholar] [CrossRef]
  89. Danzi, G.B.; Sesana, M.; Arieti, M.; Villa, G.; Rutigliano, S.; Aprile, A. Does optimal lesion preparation reduce the amount of acute recoil of the Absorbe BVS? Insights from a real-world population. Catheter. Cardiovasc. Interv. 2015, 86, 984–991. [Google Scholar] [CrossRef]
  90. Onuma, Y.; Sotomi, Y.; Shiomi, H.; Ozaki, Y.; Namiki, A.; Yasuda, S. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: Insights from the randomised ABSORB Japan trial. EuroIntervention 2016, 12, 1090–1101. [Google Scholar] [CrossRef]
  91. Kochman, J.; Tomaniak, M.; Jąkała, J.; Proniewska, K.; Legutko, J.; Roleder, T. First serial optical coherence tomography assessment at baseline, 12 and 24 months in STEMI patients treated with the second generation ABSORB bioresorbable vascular scaffold. EuroIntervention 2017. [Google Scholar] [CrossRef]
  92. Oberhauser, J.P.; Hossainy, S.; Rapoza, R.J. Design principles and performance of bioresorbable polymeric vascular scaffolds. EuroIntervention 2009, 5, 15–22. [Google Scholar] [CrossRef] [PubMed]
  93. Ortega-Paz, L.; Brugaletta, S.; Sabaté, M. Impact of PSP Technique on Clinical Outcomes Following Bioresorbable Scaffolds Implantation. J. Clin. Med. 2018, 7, 27. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  94. Imori, Y.; D’Ascenzo, F.; Gori, T.; Münzel, T.; Ugo, F.; Campo, G. Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter “real-world” registry. Cardiol. J. 2016, 23, 374–383. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  95. Yamaji, K.; Brugaletta, S.; Sabaté, M.; Iñiguez, A.; Jensen, L.O.; Cequier, A. Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: An Angiographic and Optical Coherence Tomography TROFI II Substudy. JACC Cardiovasc. Interv. 2017, 10, 1867–1877. [Google Scholar] [CrossRef]
  96. Stone, G.W.; Abizaid, A.; Onuma, Y.; Seth, A.; Gao, R.; Ormiston, J. Effect of Technique on Outcomes Following Bioresorbable Vascular Scaffold Implantation: Analysis from the ABSORB Trials. J. Am. Coll. Cardiol. 2017, 70, 2863–2874. [Google Scholar] [CrossRef]
  97. Polimeni, A.; Anadol, R.; Münzel, T.; Geyer, M.; De Rosa, S.; Indolfi, C.; Gori, T. Bioresorbable vascular scaffolds for percutaneous treatment of chronic total coronary occlusions: A meta-analysis. BMC Cardiovasc. Disord. 2019, 19, 59. [Google Scholar] [CrossRef]
  98. Abizaid, A.; Ribamar Costa, J., Jr. Bioresorbable Scaffolds for Coronary Stenosis: When and How Based Upon Current Studies. Curr. Cardiol. Rep. 2017, 19, 27. [Google Scholar] [CrossRef]
  99. Geraci, S.; Kawamoto, H.; Caramanno, G.; Ruparelia, N.; Capodanno, D.; Brugaletta, S. Bioresorbable Everolimus-Eluting Vascular Scaffold for Long Coronary Lesions: A Subanalysis of the International, Multicenter GHOST-EU Registry. JACC Cardiovasc. Interv. 2017, 10, 560–568. [Google Scholar] [CrossRef]
  100. Gori, T.; Wiebe, J.; Capodanno, D.; Latib, A.; Lesiak, M.; Pyxaras, S.A. Early and midterm outcomes of bioresorbable vascular scaffolds for ostial coronary lesions: Insights from the GHOST-EU registry. EuroIntervention 2016, 12, e550–e556. [Google Scholar] [CrossRef]
  101. Cassese, S.; Byrne, R.A.; Ndrepepa, G.; Kufner, S.; Wiebe, J. Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: A meta-analysis of randomised controlled trials. Lancet 2016, 387, 537–544. [Google Scholar] [CrossRef]
  102. Stone, G.W.; Gao, R.; Kimura, T.; Kereiakes, D.J.; Ellis, S.G.; Onuma, Y. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: A patient-level, pooled meta-analysis. Lancet 2016, 387, 1277–1289. [Google Scholar] [CrossRef]
  103. MiYaZaKi, Y.; Zeng, Y.; TUMMala, K.; STaneTiC, B.; TiJSSen, J. Early, late and very late incidence of bioresorbable scaffold thrombosis: A systematic review and meta-analysis of randomized clinical trials and observational studies. Minerva Cardioangiol. 2017, 65, 32–51. [Google Scholar] [CrossRef]
  104. Lipinski, M.J.; Escarcega, R.O.; Baker, N.C.; Benn, H.A.; Gaglia, M.A.; Torguson, R.; Waksman, R. Scaffold Thrombosis After Percutaneous Coronary Intervention with ABSORB Bioresorbable Vascular Scaffold: A Systematic Review and Meta-Analysis. JACC Cardiovasc. Interv. 2016, 9, 12–24. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  105. Kang, S.H.; Gogas, B.D.; Jeon, K.H.; Park, J.S.; Lee, W.; Yoon, C.H. Long-term safety of bioresorbable scaffolds: Insights from a network meta-analysis including 91 trials. EuroIntervention 2018, 13, 1904–1913. [Google Scholar] [CrossRef] [PubMed]
  106. Capranzano, P.; Longo, G.; Tamburino, C.I.; Gargiulo, G.; Ohno, Y. One-year outcomes after Absorb bioresorbable vascular scaffold implantation in routine clinical practice. EuroIntervention 2016, 12, e152–e159. [Google Scholar] [CrossRef]
  107. Capodanno, D.; Gori, T.; Nef, H.; Latib, A.; Mehilli, J.; Lesiak, M. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: Early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention 2015, 10, 1144–1153. [Google Scholar] [CrossRef] [Green Version]
  108. Hoppmann, P.; Kufner, S.; Cassese, S.; Wiebe, J.; Schneider, S.; Pinieck, S.; Laugwitz, K.L. Angiographic and clinical outcomes of patients treated with everolimus-eluting bioresorbable stents in routine clinical practice: Results of the ISAR-ABSORB registry. Catheter. Cardiovasc. Interv. 2016, 87, 822–829. [Google Scholar] [CrossRef]
  109. Tröbs, M.; Achenbach, S.; Röther, J.; Klinghammer, L.; Schlundt, C. Bioresorbable vascular scaffold thrombosis in a consecutive cohort of 550 patients. Catheter. Cardiovasc. Interv. 2016, 88, 872–880. [Google Scholar] [CrossRef]
  110. Gori, T.; Schulz, E.; Hink, U.; Kress, M.; Weiers, N.; Weissner, M.; Münzel, T. Clinical, Angiographic, Functional, and Imaging Outcomes 12 Months After Implantation of Drug-Eluting Bioresorbable Vascular Scaffolds in Acute Coronary Syndromes. JACC Cardiovasc. Interv. 2015, 8, 770–777. [Google Scholar] [CrossRef] [Green Version]
  111. Kraak, R.P.; Hassell, M.E.; Grundeken, M.J.; Koch, K.T.; Henriques, J.P.; Piek, J.J. Initial experience and clinical evaluation of the Absorb bioresorbable vascular scaffold (BVS) in real-world practice: The AMC Single Centre Real World PCI Registry. EuroIntervention 2015, 10, 1160–1168. [Google Scholar] [CrossRef] [Green Version]
  112. Widimsky, P.; Petr, R.; Tousek, P.; Maly, M.; Linkova, H.; Vrana, J.; Kocka, V. One-Year Clinical and Computed Tomography Angiographic Outcomes After Bioresorbable Vascular Scaffold Implantation During Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction: The PRAGUE-19 Study. Circ. Cardiovasc. Interv. 2015, 8, e002933. [Google Scholar] [CrossRef] [PubMed]
  113. Hoye, A.; van Domburg, R.T.; Sonnenschein, K.; Serruys, P.W. Percutaneous coronary intervention for chronic total occlusion of the coronary artery with the implantation of bioresorbable everolimus-eluting scaffolds. Poznan CTO-Absorb Pilot Registry. EuroIntervention 2016, 12, e144–e151. [Google Scholar] [CrossRef]
  114. Robaei, D.; Back, L.; Ooi, S.Y.; Pitney, M.; Jepson, N. Twelve-Month Outcomes with a Bioresorbable Everolimus-Eluting Scaffold: Results of the ESHC-BVS Registry at Two Australian Centers. J. Invasive Cardiol. 2016, 28, 316–322. [Google Scholar] [PubMed]
  115. Tamburino, C.; Latib, A.; Sabate, M.; Mehilli, J.; Gori, T.; Achenbach, S. Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: A European perspective. EuroIntervention 2015, 11, 45–52. [Google Scholar] [CrossRef] [Green Version]
  116. Tenekecioglu, E.; Poon, E.K.; Collet, C.; Thondapu, V.; Torii, R.; Bourantas, C.V. The Nidus for Possible Thrombus Formation: Insight from the Microenvironment of Bioresorbable Vascular Scaffold. JACC Cardiovasc. Interv. 2016, 9, 2167–2168. [Google Scholar] [CrossRef]
  117. Mattesini, A.; Secco, G.G.; Dall’Ara, G.; Ghione, M.; Rama-Merchan, J.C.; Lupi, A. ABSORB biodegradable stents versus second-generation metal stents: A comparison study of 100 complex lesions treated under OCT guidance. JACC Cardiovasc. Interv. 2014, 7, 741–750. [Google Scholar] [CrossRef] [Green Version]
  118. Brugaletta, S.; Gori, T.; Low, A.F.; Tousek, P.; Pinar, E.; Gomez-Lara, J. Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: The BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc. Interv. 2015, 8, 189–197. [Google Scholar] [CrossRef] [Green Version]
  119. Wöhrle, J.; Naber, C.; Schmitz, T.; Schwencke, C.; Frey, N.; Butter, C.; Mathey, D.G. Beyond the early stages: Insights from the ASSURE registry on bioresorbable vascular scaffolds. EuroIntervention 2015, 11, 149–156. [Google Scholar] [CrossRef]
  120. Sabaté, M.; Windecker, S.; Iñiguez, A.; Okkels-Jensen, L.; Cequier, A.; Brugaletta, S.; Pilgrim, T. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: Results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial. Eur. Heart J. 2016, 37, 229–240. [Google Scholar] [CrossRef]
  121. Christ, G.; Hafner, T.; Siller-Matula, J.M.; Francesconi, M.; Grohs, K.; Wilhelm, E.; Podczeck-Schweighofer, A. Platelet inhibition by abciximab bolus-only administration and oral ADP receptor antagonist loading in acute coronary syndrome patients: The blocking and bridging strategy. Thromb. Res. 2013, 132, e36–e41. [Google Scholar] [CrossRef]
  122. Vaquerizo, B.; Barros, A.; Pujadas, S.; Bajo, E.; Jiménez, M.; Gomez-Lara, J.; Serra, A. One-Year Results of Bioresorbable Vascular Scaffolds for Coronary Chronic Total Occlusions. Am. J. Cardiol. 2016, 117, 906–917. [Google Scholar] [CrossRef] [PubMed]
  123. Ojeda, S.; Pan, M.; Romero, M.; de Lezo, J.S.; Mazuelos, F.; Segura, J.; Medina, A. Outcomes and computed tomography scan follow-up of bioresorbable vascular scaffold for the percutaneous treatment of chronic total coronary artery occlusion. Am. J. Cardiol. 2015, 115, 1487–1493. [Google Scholar] [CrossRef] [PubMed]
  124. Capranzano, P.; Capodanno, D.; Brugaletta, S.; Latib, A.; Mehilli, J.; Nef, H.; Mattesini, A. Clinical outcomes of patients with diabetes mellitus treated with Absorb bioresorbable vascular scaffolds: A subanalysis of the European Multicentre GHOST-EU Registry. Catheter. Cardiovasc. Interv. 2018, 91, 444–453. [Google Scholar] [CrossRef] [PubMed]
  125. Palmerini, T.; Kirtane, A.J.; Serruys, P.W.; Smits, P.C.; Kedhi, E.; Kereiakes, D.; De Waha, A. Stent thrombosis with everolimus-eluting stents: Meta-analysis of comparative randomized controlled trials. Circ. Cardiovasc. Interv. 2012, 5, 357–364. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  126. Authors/Task Force members; Windecker, S.; Kolh, P.; Alfonso, F.; Collet, J.P.; Cremer, J.; Jüni, P. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur. Heart J. 2014, 35, 2541–2619. [Google Scholar] [CrossRef] [PubMed]
  127. Iqbal, J.; Serruys, P.W.; Silber, S.; Kelbaek, H.; Richardt, G.; Morel, M.A.; Windecker, S. Comparison of zotarolimus- and everolimus-eluting coronary stents: Final 5-year report of the RESOLUTE all-comers trial. Circ. Cardiovasc. Interv. 2015, 8, e002230. [Google Scholar] [CrossRef] [Green Version]
  128. Fallesen, C.O.; Antonsen, L.; Thayssen, P.; Jensen, L.O.; Lee, P.H.; Lee, S.W.; Brugaletta, S. How should I treat a bioresorbable vascular scaffold edge restenosis and intra-scaffold dissection? EuroIntervention 2018, 13, 1730–1734. [Google Scholar] [CrossRef]
  129. Colombo, A.; Azzalini, L. Bioresorbable scaffolds: Reflections after a setback—Losing a battle does not mean losing the war! EuroIntervention 2017, 13, 785–786. [Google Scholar] [CrossRef]
  130. Stettler, C.; Wandel, S.; Allemann, S.; Kastrati, A.; Morice, M.C.; Schömig, A.; Goy, J.J. Outcomes associated with drug-eluting and bare-metal stents: A collaborative network meta-analysis. Lancet 2007, 370, 937–948. [Google Scholar] [CrossRef]
  131. FinnAV, J.; NakazawaG, K.; NewellJ, J. Pathological correlates of late drug-eluting stent thrombosis: Strut coverage as a marker of endothelialization. Circulation 2007, 115, 2435–2441. [Google Scholar] [CrossRef] [Green Version]
  132. Finn, A.V.; Nakazawa, G.; Joner, M.; Kolodgie, F.D.; Mont, E.K.; Gold, H.K.; Virmani, R. Vascular responses to drug eluting stents: Importance of delayed healing. Arter. Thromb. Vasc. Biol. 2007, 27, 1500–1510. [Google Scholar] [CrossRef] [PubMed]
  133. Joner, M.; Finn, A.V.; Farb, A.; Mont, E.K.; Kolodgie, F.D.; Ladich, E.; Virmani, R. Pathology of drug-eluting stents in humans: Delayed healing and late thrombotic risk. J. Am. Coll. Cardiol. 2006, 48, 193–202. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  134. Katsanos, K.; Spiliopoulos, S.; Kitrou, P.; Krokidis, M.; Karnabatidis, D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J. Am. Heart Assoc. 2018, 7, e011245. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  135. Beckman, J.A.; White, C.J. Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients with Peripheral Artery Disease? Circulation 2019. [Google Scholar] [CrossRef]
  136. Ali, Z.A.; Karimi Galougahi, K.; Shlofmitz, R.; Maehara, A.; Mintz, G.S.; Abizaid, A.; Stone, G.W. Imaging-guided pre-dilatation, stenting, post-dilatation: A protocolized approach highlighting the importance of intravascular imaging for implantation of bioresorbable scaffolds. Expert Rev. Cardiovasc. Ther. 2018, 16, 431–440. [Google Scholar] [CrossRef]
  137. Ortega-Paz, L.; Capodanno, D.; Gori, T.; Nef, H.; Latib, A.; Caramanno, G.; Wiebe, J. Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: Development and internal validation of the PSP score. EuroIntervention 2017, 12, 2110–2117. [Google Scholar] [CrossRef] [Green Version]
  138. Markovic, S.; Kugler, C.; Rottbauer, W.; Wöhrle, J. Long-term clinical results of bioresorbable absorb scaffolds using the PSP-technique in patients with and without diabetes. J. Interv. Cardiol. 2017, 30, 325–330. [Google Scholar] [CrossRef]
  139. Heeger, C.H.; Schedifka, A.S.; Meincke, F.; Spangenberg, T.; Wienemann, H.; Kreidel, F. Optical coherence tomography-guided versus angiography-guided implantation of everolimus-eluting bioresorbable vascular scaffolds: Comparison of coverage, apposition and clinical outcome. The ALSTER-OCT ABSORB registry. Cardiol. J. 2018. [Google Scholar] [CrossRef] [Green Version]
  140. von Zur Mühlen, C.; Reiss, S.; Krafft, A.J.; Besch, L.; Menza, M.; Zehender, M.; Reinöhl, J. Coronary magnetic resonance imaging after routine implantation of bioresorbable vascular scaffolds allows non-invasive evaluation of vascular patency. PLoS ONE 2018, 13, e0191413. [Google Scholar] [CrossRef]
  141. Capodanno, D. Bioresorbable Scaffolds in Coronary Intervention: Unmet Needs and Evolution. Korean Circ. J. 2018, 48, 24–35. [Google Scholar] [CrossRef] [Green Version]
  142. Ferdous, J.; Kolachalama, V.B.; Kolandaivelu, K.; Shazly, T. Degree of bioresorbable vascular scaffold expansion modulates loss of essential function. Acta Biomater. 2015, 26, 195–204. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  143. Mattesini, A.; Boeder, N.; Valente, S.; Löblich, K.; Dörr, O.; Secco, G.G. Absorb vs. DESolve: An optical coherence tomography comparison of acute mechanical performances. EuroIntervention 2016, 12, e566–e573. [Google Scholar] [CrossRef] [PubMed]
  144. Stone, G.W.; Witzenbichler, B.; Weisz, G.; Rinaldi, M.J.; Neumann, F.J. Platelet reactivity and clinical outcomes after coronary artery implantation of drug-eluting stents (ADAPT-DES): A prospective multicentre registry study. Lancet 2013, 382, 614–623. [Google Scholar] [CrossRef]
  145. Siller-Matula, J.M.; Trenk, D.; Schrör, K.; Gawaz, M.; Kristensen, S.D.; Storey, R.F.; Huber, K. Response variability to P2Y12 receptor inhibitors: Expectations and reality. JACC Cardiovasc. Interv. 2013, 6, 1111–1128. [Google Scholar] [CrossRef]
  146. Mangiacapra, F.; Patti, G.; Barbato, E.; Peace, A.J.; Ricottini, E.; Vizzi, V. A therapeutic window for platelet reactivity for patients undergoing elective percutaneous coronary intervention: Results of the ARMYDA-PROVE (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty-Platelet Reactivity for Outcome Validation Effort) study. JACC Cardiovasc. Interv. 2012, 5, 281–289. [Google Scholar] [CrossRef] [Green Version]
  147. Byrne, R.A.; Stefanini, G.G.; Capodanno, D.; Onuma, Y.; Baumbach, A.; Escaned, J. Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: Executive summary. Eur. Heart J. 2018, 39, 1591–1601. [Google Scholar] [CrossRef] [Green Version]
  148. Tantry, U.S.; Bonello, L.; Aradi, D.; Price, M.J.; Jeong, Y.H.; Angiolillo, D.J. Consensus and update on the definition of on-treatment platelet reactivity to adenosine diphosphate associated with ischemia and bleeding. J. Am. Coll. Cardiol. 2013, 62, 2261–2273. [Google Scholar] [CrossRef]
  149. Christ, G.; Siller-Matula, J.M.; Francesconi, M.; Dechant, C.; Grohs, K.; Podczeck-Schweighofer, A. Individualising dual antiplatelet therapy after percutaneous coronary intervention: The IDEAL-PCI registry. BMJ Open 2014, 4, e005781. [Google Scholar] [CrossRef]
  150. Siller-Matula, J.M.; Gruber, C.; Francesconi, M.; Dechant, C.; Jilma, B.; Delle-Karth, G. The net clinical benefit of personalized antiplatelet therapy in patients undergoing percutaneous coronary intervention. Clin. Sci. 2015, 128, 121–130. [Google Scholar] [CrossRef]
  151. Siller-Matula, J.M.; Francesconi, M.; Dechant, C.; Jilma, B.; Maurer, G. Personalized antiplatelet treatment after percutaneous coronary intervention: The MADONNA study. Int. J. Cardiol. 2013, 167, 2018–2023. [Google Scholar] [CrossRef]
  152. Siller-Matula, J.M.; Hintermeier, A.; Kastner, J.; Kreiner, G.; Maurer, G.; Kratochwil, C. Distribution of clinical events across platelet aggregation values in all-comers treated with prasugrel and ticagrelor. Vascul. Pharmacol. 2016, 79, 6–10. [Google Scholar] [CrossRef] [PubMed]
  153. Siller-Matula, J.M.; Jilma, B. Why have studies of tailored anti-platelet therapy failed so far? Thromb. Haemost. 2013, 110, 628–631. [Google Scholar] [CrossRef] [PubMed]
  154. Kubisa, M.J.; Jezewski, M.P.; Gasecka, A.; Siller-Matula, J.M.; Postuła, M. Ticagrelor—Toward more efficient platelet inhibition and beyond. Ther. Clin. Risk Manag. 2018, 14, 129–140. [Google Scholar] [CrossRef] [PubMed] [Green Version]
  155. Brugaletta, S.; Gomez-Lara, J.; Caballero, J.; Ortega-Paz, L.; Teruel, L. TIcaGrEloR and Absorb bioresorbable vascular scaffold implantation for recovery of vascular function after successful chronic total occlusion recanalization (TIGER-BVS trial): Rationale and study design. Catheter. Cardiovasc. Interv. 2018, 91, 1–6. [Google Scholar] [CrossRef] [Green Version]
Jcm 08 02167 g001 550
Figure 1. Timeline of bioresorbable vascular scaffolds (BVS) resorption and its interactions with vessel wall [6,16]. Presented course of phases and events is a generalization for available BVS. Certain time points are specific for ABSORB BVS-see Table 1. Abbreviations: BVS, bioresorbable vascular scaffold; OCT, optical coherence tomography.
Figure 1. Timeline of bioresorbable vascular scaffolds (BVS) resorption and its interactions with vessel wall [6,16]. Presented course of phases and events is a generalization for available BVS. Certain time points are specific for ABSORB BVS-see Table 1. Abbreviations: BVS, bioresorbable vascular scaffold; OCT, optical coherence tomography.
Jcm 08 02167 g001
Jcm 08 02167 g002 550
Figure 2. Comparison of incidence rate of major adverse events in randomized trials: (a) target lesion failure, (b) myocardial infarction, (c) cardiac death and (d) all device thrombosis. Figure presents data from ABSORB, AIDA, EVERBIO II and TROFI II trials. The circle diameter represents the number of patients in respective trials [17,19,66,67,68,69,70].
Figure 2. Comparison of incidence rate of major adverse events in randomized trials: (a) target lesion failure, (b) myocardial infarction, (c) cardiac death and (d) all device thrombosis. Figure presents data from ABSORB, AIDA, EVERBIO II and TROFI II trials. The circle diameter represents the number of patients in respective trials [17,19,66,67,68,69,70].
Jcm 08 02167 g002
Jcm 08 02167 g003 550
Figure 3. Comparison of the causes of device thrombosis in drug eluting stents (DES) and bioresorbable vascular scaffolds (BVS) [12].
Figure 3. Comparison of the causes of device thrombosis in drug eluting stents (DES) and bioresorbable vascular scaffolds (BVS) [12].
Jcm 08 02167 g003
Jcm 08 02167 g004 550
Figure 4. Bubble graph showing the relationship between the mean number and length of the implanted scaffolds and the incidence of scaffold thrombosis at the 6–12 month follow-up. Only randomized controlled trials, or registries with ≥100 patients that reported the required scaffold implantation details and had a follow-up duration of 6–12 months were included. The circle diameter indicates the reported percentage of definite or probable scaffold thrombosis [19,80,81,102,107,112,113,114,117,119,120,124].
Figure 4. Bubble graph showing the relationship between the mean number and length of the implanted scaffolds and the incidence of scaffold thrombosis at the 6–12 month follow-up. Only randomized controlled trials, or registries with ≥100 patients that reported the required scaffold implantation details and had a follow-up duration of 6–12 months were included. The circle diameter indicates the reported percentage of definite or probable scaffold thrombosis [19,80,81,102,107,112,113,114,117,119,120,124].
Jcm 08 02167 g004
Table
Table 1. Summary of efficacy and safety of the bioresorbable vascular scaffolds in clinical trials. Poly-L-lactic acid, PLLA; poly-D,L-lactic, PDLA.
Table 1. Summary of efficacy and safety of the bioresorbable vascular scaffolds in clinical trials. Poly-L-lactic acid, PLLA; poly-D,L-lactic, PDLA.
DeviceMaterialYear of Receiving CE MarkingDrug ElutedStrut Thickness (µm)Minimal Resolution Time (months)
First generation
ABSORBPLLA2012everolimus156>36
DESolvePLLA2014novolimus150<24
DESolve Cx plusPLLA2017novolimus120<24
DREAMS 1GMagnesium alloy2015paclitaxel1209–12
Second generation
Magmaris
(DREAMS 2G)		Magnesium alloy2016sirolimus1209–12
FantomTyrosine polycarbonate2017sirolimus12536
ARTPDLLA2015none1706
Table
Table 2. Summary of the efficacy and safety of the bioresorbable vascular scaffolds in clinical trials. Target lesion failure, TLF; Target lesion revascularization TLR.
Table 2. Summary of the efficacy and safety of the bioresorbable vascular scaffolds in clinical trials. Target lesion failure, TLF; Target lesion revascularization TLR.
Study/Publication DateStudy TypeFollow-Up TimeNo of PatientsNo of Devices per PatientLength of Devices (mm)TLF
(%)		ScT
Definite/Probable
(%)		MI
(%)		TLR
(%)		Cardiac Death
(%)		Commercial Funding
ABSORB (Abbott, Lake County, IL, USA)
ABSORB Cohort A [31]/Mar 2008Observational5 years30112 or 183.40/03.410.30Abbott Vascular
ABSORB Japan [71]/Dec 2015Randomized1 year4001–28, 12 or 184.21.5/1.53.42.60Abbott Vascular
ABSORB Cohort B [72]/Feb 2016Observational5 years10111814.00/03.011.00Abbott Vascular
PRAGUE-19 [73]/May 2016Observational3 years1131<2411.51.8/0.91.83.51.8Abbott Vascular
ABSORB II [17]/Nov 2016Randomized3 years3351–2<48103.0/3.08.07.01.0Abbott Vascular
ABSORB China [74]/Oct 2017Randomized3 years2381–2<246.80.4/0.43.44.70.4Abbott Vascular
ABSORB III [67]/Oct 2017Randomized2 years13221–2<243.71.91.32.60.5Abbott Vascular
ABSORB III [66]/Dec 2017Randomized3 years13221–2<2413.42.34.27.30.9Abbott Vascular
ABSORB IV [68]/Oct 2018Randomized1 year12961–3>2451520Abbott Vascular
AIDA [19]/Jun 2017Randomized2 years9241–2N/A11.73.1/0.47.172Abbott Vascular
EVERBIO II [69]/Sep 2017Randomized2 years78N/AN/A211.23231.2Abbott Vascular, Biosensors International, Boston Scientific
TROFI II [70]/Nov 2018Randomized3 years9518, 12, 18 or 285.32.13.24.22.1Abbott Vascular, Terumo
ISAR- ABSORB MI [75]/Dec 2018Randomized1 year173117.01.2/0.60.64.82.3Abbott Vascular
DESolve NX (Elixir Medical Corporation, Milpitas, CA, USA)
DESolve First-in-Man trial [59]/Jan 2014Observational1 year151–214 or 186.70.86.76.76.7Elixir Medical
DESolve 2 years [56]/Mar 2016Observational2 years122114 or 187.40.81.64.03.2Elixir Medical
DESolve Cx [76]/Oct 2017Observational6 months50114, 18, 13 or 2800000Elixir Medical
DESolve PCMF Study [77]/Nov 2018Observational12 months1021–214, 18 or 282,01.0/01,01,00Elixir Medical
DREAMS (Biotronik, Berlin, Germany)
BIOSOLVE-I [23]/Jun 2016Observational3 years461166.602.24.30Biotronik AG
BIOSOLVE-II [22,24]/Sep 2016Observational2 years1181–2≤215.900.93.41.7Biotronik AG
BIOSOLVE-II and BIOSOLVE-III [24]/Jul 2017Observational6 months1841–2≤213.300.61.71.1Biotronik AG
Fantom (REVA Medical Inc., San Diego, CA, USA)
Fantom I [78]/Apr 2016Observational4 months71180N/A
Fantom II [79]/Sep 2017Observational6 months117118 or 242.60.91.71.70REVA Medical
Table
Table 3. Summary of incidence of primary endpoints in randomized studies comparing BVS and drug-eluting stents (DES).
Table 3. Summary of incidence of primary endpoints in randomized studies comparing BVS and drug-eluting stents (DES).
StudyCompared Devices
(No of Patients in Groups)		TVF
RR/HR (95% CI)		Ischemia Driven TLR
RR/HR (95% CI)		Cardiac Death
RR/HR (95% CI)		TVMI
RR/HR (95% CI)		Device Thrombosis Probable/Definitive RR/HR (95% CI)
ABSORB Japan [71]ABSORB BVS vs. Xience DES
(266/134)		1.15
[0.48, 2.72]
p = 0.75		1.17
[0.31, 4.46]
p = 1.00		N/A1.51
[0.41, 5.47]
p = 0.76		1.02
[0.19, 5.47]
p = 1.00
ABSORB II [17]ABSORB BVS vs. Xience DES
(335/166)		2.11
[1.00, 4.44]
p = 0.0425		1.65
[0.46, 5.92]
p = 0.56		0.50
[0.10, 2.43]
p = 0.56		5.70
[1.36, 23.87]
p = 0.0061		N/A
p = 0.0331
ABSORB China [74]ABSORB BVS vs. Xience DES
(236/235)		1.00
[0.51, 1.94]
p = 0.99		1.66
[0.61, 4.49]
p = 0.31		0.33
[0.03, 3.17]
p = 0.37		2.99
[0.61, 14.65]
p = 0.28		N/A
P = 0.50
ABSORB III [66]ABSORB BVS vs. Xience DES
(1322/686)		1.41
[1.10, 1.81]
p = 0.006		1.23
[0.85, 1.79]
p = 0.27		1.17
[0.51, 2.69]
p = 0.71		1.47
[1.02, 2.11]
p = 0.03		3.12
[1.21, 8.05]
p = 0.01
ABSORB IV [68]ABSORB BVS vs. Xience DES
(1296/1308)		1.35
[0.93, 1.97]
p = 0.11		2.28
[0.99, 5.25]
p = 0.0457		N/A1.23
[0.84, 1.81]
p = 0.29		4.05
[0.86, 19.06]
p = 0.06
AIDA [19]ABSORB BVS vs. Xience DES
(924/921)		1.12
[0.85, 1.48]
p = 0.43		1.17
[0.86, 1.58]
p = 0.31		0.78
[0.42, 1.44]
p = 0.43		1.60
[1.01, 2.53]
p = 0.04		3.87
[1.78, 8.42]
P < 0.001
EVERBIO II [81]ABSORB BVS vs. Promus Element and Biomatrix Flex DES
(78/160)		p = 0.12p = 0.23p = 0.55p = 0.11N/A
TROFI II [70]ABSORB BVS vs. Xience DES
(95/96)		p = 0.465p = 0.678N/Ap = 0.327p = 0.55
ISAR-Absorb II [75]ABSORB BVS vs. EES
(173/89)		1.04
[0.39, 2.78]		0.84
[0.27, 2.57]		1.02
[0.19, 5.58]		0.51
[0.03, 8.20]		0.51
[0.07, 3.62]

Share and Cite

MDPI and ACS Style

Jeżewski, M.P.; Kubisa, M.J.; Eyileten, C.; De Rosa, S.; Christ, G.; Lesiak, M.; Indolfi, C.; Toma, A.; Siller-Matula, J.M.; Postuła, M. Bioresorbable Vascular Scaffolds—Dead End or Still a Rough Diamond? J. Clin. Med. 2019, 8, 2167. https://doi.org/10.3390/jcm8122167

AMA Style

Jeżewski MP, Kubisa MJ, Eyileten C, De Rosa S, Christ G, Lesiak M, Indolfi C, Toma A, Siller-Matula JM, Postuła M. Bioresorbable Vascular Scaffolds—Dead End or Still a Rough Diamond? Journal of Clinical Medicine. 2019; 8(12):2167. https://doi.org/10.3390/jcm8122167

Chicago/Turabian Style

Jeżewski, Mateusz P., Michał J. Kubisa, Ceren Eyileten, Salvatore De Rosa, Günter Christ, Maciej Lesiak, Ciro Indolfi, Aurel Toma, Jolanta M. Siller-Matula, and Marek Postuła. 2019. "Bioresorbable Vascular Scaffolds—Dead End or Still a Rough Diamond?" Journal of Clinical Medicine 8, no. 12: 2167. https://doi.org/10.3390/jcm8122167

Note that from the first issue of 2016, this journal uses article numbers instead of page numbers. See further details here.

Article Metrics

Back to TopTop