Search Results (114)

The current management of patients with acute coronary syndrome (ACS) and bleeding disorders, such as hemophilia, is supported by small retrospective studies or expert consensus documents. Moreover, people with hemophilia are less likely to receive invasive treatments like percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for ACS compared to those without hemophilia, which could affect their cardiovascular outcomes. A multidisciplinary team with an expert hematologist is essential to properly define the therapeutic strategy, which should balance both the thrombotic and bleeding risks. We report a clinical case that illustrates an alternative revascularization strategy for hemophilic patients presenting with ACS and with a pattern of diffuse coronary atherosclerotic disease (CAD), encompassing drug-coated balloons (DCBs) in combination with spot stenting. The proposed approach might avoid a full-length drug-eluting stent (DES) implantation and also allow a short dual antiplatelet therapy (DAPT) regimen that is desirable in patients at a very high bleeding risk (HBR) like hemophiliacs. Furthermore, we have provided a review of the available literature on this topic and a focus on the main recommendations for managing ACS, in response to the presented clinical case. Finally, this article aims to share information and develop more confidence in the current guidelines on the treatment of hemophiliacs who need myocardial revascularization. Full article

With the advancement of interventional coronary procedures, drug-coated balloons have become an increasingly common alternative to drug-eluting stents in the treatment of various lesions. This paradigm shift stems from several advantages that DCBs entail, including a reduction in stent length burden, the possibility of late vessel positive remodeling, and the preservation of bifurcation anatomy. Conversely, several studies compared the efficacy of DCB treatment to stents or POBA in various scenarios. In this review, we will discuss the areas in which a DCB can be of paramount importance. We will begin by examining the role of DCBs in in-stent restenosis, for which the current practice guidelines do not clearly state the role of this technology, as opposed to the previous ones, in which it was mentioned as a first-line armamentarium. We will then discuss the indications and advantages of using DCBs in de novo lesions, concerning both small and large vessels, with growing emphasis on diffuse lesions. Lastly, we will address the current data on the use of DCBs in special scenarios such as the treatment of chronic total occlusion and left main and bifurcation lesions, without forgetting the primordial role of drug-eluting stents in all these lesions. Full article

Drug-coated balloons (DCBs) have emerged as a promising alternative therapeutic strategy to traditional drug-eluting stent (DES) implantation in various coronary artery lesion scenarios, aiming to minimize complications associated with permanent metallic scaffolds, such as chronic inflammation, delayed vessel healing, and stent thrombosis. This review systematically evaluates the current clinical evidence supporting the use of DCBs across diverse anatomical and clinical contexts, including small-vessel disease, in-stent restenosis, bifurcation lesions, diffuse coronary lesions, acute coronary syndromes, and chronic total occlusions, as well as in special patient populations such as individuals with diabetes mellitus or at high bleeding risk. The literature analysis incorporated recent randomized controlled trials, observational studies, and real-world registries, highlighting the clinical efficacy, safety profiles, and specific advantages of DCB angioplasty. The findings consistently demonstrated non-inferior clinical outcomes of DCBs compared to DESs across multiple lesion types, with particular benefits observed in special populations, including reduced restenosis rates and comparable major adverse cardiac events (MACEs). Nevertheless, clinical data gaps remain, emphasizing the need for larger, longer-term randomized trials to refine patient selection and procedural techniques. In conclusion, DCB angioplasty represents a viable and effective alternative to conventional stenting, particularly advantageous in complex lesions and specific patient subsets, pending further definitive evidence. Full article

Background/Objectives: We sought to confirm the performance and safety of the Pantera Lux paclitaxel-coated balloon (pDCB) when used as per the instructions for use at a single high-volume center. Methods: In this retrospective analysis, 386 consecutive patients were categorized into three groups: the treatment of drug-eluting stent in-stent restenosis (DES-ISR) lesions (n = 191), bare-metal stent in-stent restenosis (BMS-ISR) lesions (n = 127), and de novo lesions (n = 68). The primary endpoint at 12 months was target-lesion revascularization (TLR). Secondary endpoints were device success, target-vessel myocardial infarction (TV-MI), and cardiac death. Results: The baseline characteristics were balanced between the groups, with a median age of 71.3 years, 25% being female, 32% being diabetic. The majority presented with chronic coronary syndrome (82.9%). Type C lesions were more often observed in the DES-IRS group as compared with the BMS-IRS and de novo groups (15.6% vs. 7.9% vs. 7.4%, p < 0.001). Cutting balloons were more often used in the DES-IRS group (41.0% vs. 19.7% vs. 1.5%, p < 0.001). The residual stenosis rate was 7.6% vs. 3.3% vs. 7.3% (p = 0.002). The TLR at 12 months was 8.9% vs. 2.4% vs. 1.5% (p = 0.013). Device success was achieved in 98.8% vs. 98.5% vs. 100% of cases (p = 0.8). TV-MI occurred in 3.2% vs. 0.8% vs. 1.5% (p = 0.5) and cardiac death in 2.6% vs. 0.0% vs. 2.9% (p = 0.13) in DES-IRS vs. BMS-IRS vs. de novo lesions. Conclusions: In this single-center observation, we confirmed the safety and efficacy of the Pantera Lux paclitaxel-coated balloon for the treatment of DES-IRS, BMS-IRS, and de novo lesions with low TLR rates at 12 months. Full article

Background: In patients with coronary artery disease, bare-metal stents (BMS) are considered a safer but less effective treatment than drug-eluting stents (DES). Oral colchicine therapy may compensate for this limitation of BMS. This randomized trial compared the cost-effectiveness of two different revascularization strategies during percutaneous coronary intervention (PCI). Methods: Between March 2020 and April 2022, 410 patients were randomly treated with PCI with BMS plus colchicine (BMS-CO: 205 patients) or DES (205 patients) The patients in the BMS-CO group received 0.5 mg oral doses of colchicine for 3 months. The primary endpoint was major adverse cardiac and cerebrovascular events (MACEs), defined as the composite of death, myocardial infarction, stroke, or target vessel revascularization (TVR), and the costs of each treatment strategy. The secondary endpoints included the individual components of MACEs. Results: No significant differences were observed in baseline characteristics, and 76% of the patients presented with acute coronary syndromes. The median follow-up period was 36.8 months. Five percent of the patients in the BMS-CO group discontinued study medication. The cumulative incidence of MACEs was not significantly different, with 12.7% in the BMS-CO group and 15.6% in the DES2G group (p = 0.39) as well individual components of the clinical endpoint. The cumulative costs were lower in the BMS-CO group than in the DES2G group (USD 4826.4 ± 2512 vs. USD 5708 ± 3637, p < 0.001). Conclusions: In the 3 years, the DES strategy failed to be cost-saving compared to BMS-CO. However, due to the small sample size, the equivalence in clinical outcomes with both strategies can occur by chance (NCT04382443). Full article

Drug-eluting stents, which release antiproliferative agents such as sirolimus and everolimus, were developed to reduce the risk of restenosis associated with bare-metal stents. However, despite their proven clinical efficacy, concerns remain regarding in-stent restenosis due to delayed endothelial healing and the risk of late thrombotic events. In this study, we aimed to determine the vascular effects of sirolimus and everolimus on isolated human saphenous vein (SV) samples obtained from patients undergoing coronary artery bypass surgery. SV rings were subjected to sirolimus and everolimus in acute and pretreatment conditions in vitro. Increasing concentrations of sirolimus (10⁻⁸–10⁻⁵ M), everolimus (10⁻⁸–10⁻⁵ M), and their vehicle were administered to SV rings precontracted with phenylephrine (Phe,10⁻⁶–5 × 10⁻⁶ M) to evaluate their direct vascular effects. Additionally, SV rings were incubated (16 h) either with sirolimus (10⁻⁵ M), everolimus (10⁻⁶ M), or the vehicle. Thereafter, the contractile responses to Phe (10⁻⁸–10⁻⁴ M), and the endothelium-dependent and endothelium-independent relaxant responses to acetylcholine (ACh, 10⁻⁸–10⁻⁴ M) and sodium nitroprusside (SNP,10⁻⁸–10⁻⁴ M) were determined, respectively. Our findings demonstrated that sirolimus and everolimus did not exert direct relaxant and modulatory effects on vascular function in isolated human SVs. Hence, the preservation of contractile and relaxant responses with sirolimus and everolimus may have clinical implications in the context of DES implantation. Full article

Background: The increasing prevalence of severe calcified coronary artery disease has expanded the role of rotational atherectomy (RA) in percutaneous coronary intervention (PCI). In the drug-eluting stent (DES) era, RA remains a key tool for complex lesion modification. This review focuses on its clinical outcomes and evolving indications. Methods: This review was conducted as a narrative review, focusing on the most relevant clinical studies regarding RA in the DES era. Articles were identified through a systematic PubMed search. Results: Comparing to early-generation DES, new-generation DES (NG-DES) demonstrate superior outcomes due to thinner struts and biocompatible polymers. RA plays a critical role in challenging scenarios, including chronic total occlusions and de novo small vessel lesions. Despite these advances, further randomized controlled trials are needed to validate the long-term safety and efficacy of RA-based strategies. Conclusions: This review highlights the clinical outcomes of RA in the DES era and its evolving role in contemporary cardiology. RA has shown promising potential for broader clinical applications in complex coronary artery disease. However, critical knowledge gaps remain. Further research is needed to refine RA-based strategies. Full article

Background: There are no data regarding the outcomes of patients with stent thrombosis (ST) being treated with drug-coated balloon (DCB) angioplasty. Our aim was to compare the outcomes of patients with ST treated with DCB vs. a drug eluting stent (DES). Methods: In this registry analysis, we identified all patients treated for ST in our institution from June 2011 until November 2019. We excluded patients who died in the cath lab, patients with uncrossable lesions, and patients treated with thrombectomy only. Patient outcomes were obtained from Hospital Episodes Statistics from NHS England. The primary endpoint of this study was the composite of cardiovascular mortality, acute coronary syndrome, or target lesion revascularisation. The data were analysed with Cox regression and Kaplan–Meier estimator plots. Results: A total of 173 patients were identified; 92 treated with DCB-only, 36 with balloon angioplasty (BA), 26 with DES, and 19 with a combination of DES and DCB. We compared the outcomes of 92 patients with DCB versus 20 patients with DES, all of which had presented with late or very late ST. There was no difference between DCB and DES in terms of the primary endpoint (p = 0.06). Multivariate analysis identified diabetes (adverse) and the use of GPIIbIIIa inhibitor (favourable) as the only independent predictors of the primary endpoint. Implantation of a DES was independently associated with worse cardiovascular mortality. Conclusions: This is the first study assessing the outcomes of patients with ST treated with DCB only. It has demonstrated that DCBs are an attractive therapeutic option with a tendency towards favourable outcomes when compared to DESs. Full article

Introduction: Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is a cornerstone of the management of ischemic heart disease. However, in-stent restenosis (ISR) remains a significant clinical challenge, occurring in approximately 5–10% of patients undergoing PCI. This study is designed to compare the efficacy and safety of the primary therapeutic approaches for DES-ISR, specifically drug-coated balloons (DCBs)—paclitaxel-coated balloons (PCBs) and sirolimus-coated balloons (SCBs)—with a new-generation everolimus-eluting stent (EES), contributing to the evolving field of personalized medicine. Methods and Analysis: This prospective, multicentre, randomised, non-inferiority trial aims to enroll 150 patients with DES-ISR, who will be randomised into one of the following: SCB, PCB, or EES. The primary endpoint comparing DCB and EES is late lumen loss (LLL) at 6 months, as measured by quantitative coronary angiography (QCA). Secondary endpoints comparing the three arms include a device-oriented composite endpoint, intraluminal gain, optical coherence tomography (OCT) measured LLL, and correlations between LLL and quantitative flow ratio (QFR). The primary endpoint will be analysed using a non-inferiority design, with a margin set at 0.25 mm, for which the sample size was calculated. Statistical analysis of the primary endpoint will be conducted on an intention-to-treat basis with a one-tailed Mann–Whitney U test with a significance level of 95. Secondary endpoints will be analysed via superiority testing using ANOVA, the Kruskal–Wallis test, logistic regression, or Fisher’s exact test, as appropriate. Ethics and Dissemination: The study protocol has been approved by the Medical Devices Department of the Hungarian National Institute of Pharmacy and Nutrition, ensuring compliance with ethical standards as outlined in the Declaration of Helsinki. All investigators declare no conflicts of interest related to this study. The trial is registered in ClinicalTrials.gov under the ID: NCT04862052. Full article

Arterial diseases (ADs) are a significant health problem, with high mortality and morbidity rates. Endovascular interventions, such as balloon angioplasty (BA), bare-metal stents (BMSs), drug-eluting stents (DESs) and drug-coated balloons (DCBs), have made significant progress in their treatments. However, the issue has not been fully resolved, with restenosis remaining a major concern. In this context, bioresorbable vascular stents (BVSs) have emerged as a promising area of investigation. This manuscript includes articles that assess the use of BVSs. Studies have identified ongoing challenges, such as negative vascular remodeling and elastic recoil post-angioplasty, stent-related injury, and in-stent restenosis following BMS placement. While DESs have mitigated these issues to a considerable extent, their durable structures are unable to prevent late stent thrombosis and delay arterial recovery. BVSs, with their lower support strength and tendency towards thicker scaffolds, increase the risk of scaffold thrombosis. Despite inconsistent study results, the superiority of BVSs over DESs has not been demonstrated in randomized trials, and DES devices continue to be the preferred choice for most cases of arterial disease. Esprit BTK (Abbott Vascular) received approval from the US FDA for below-knee lesions in 2024, offering hope for the use of BVSs in other vascular conditions. Enhancing the design and thickness of BVS scaffolds may open up new possibilities. Large-scale and longer-term comparative studies are still required. This article aims to provide an overview of the use of biodegradable stents in the endovascular treatment of vascular stenosis. Full article

The interventional treatment of coronary artery disease (CAD) has undergone significant improvements thanks to technological innovations. Nowadays, percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is the standard of care for the treatment of CAD. Nevertheless, the non-negligible incidence of in-stent restenosis (ISR) and suboptimal results in various anatomical settings has led to the development of drug-coated balloons (DCBs). DCBs are catheter-based balloons whose surface is coated with an anti-proliferative drug (mainly Paclitaxel or Sirolimus) loaded onto the balloon surface with different technologies and dose concentrations. In the beginning, these devices were used for the treatment of ISR showing an excellent efficacy profile in the inhibition of intimal hyperplasia. Subsequently, several studies evaluated their use in other angiographical and clinical contexts such as de novo lesions, small vessel disease, diffuse coronary disease, bifurcation lesions, acute coronary syndromes, high-bleeding risk and diabetic patients. This comprehensive review aims to describe the main DCB platforms on the market, their fields of application with the main supporting studies and their future perspectives. Full article

Background: The performance of an everolimus-eluting bioresorbable scaffold (BRS) was inferior to an everolimus-eluting metallic drug-eluting stent (DES) with permanent polymer, mainly due the mechanical features of BRS technology. The performance of BRS as compared to metallic DES with bioresorbable polymers remains unstudied. Methods: This prospective, randomized, multicenter, clinical trial enrolled patients who underwent coronary stenting for de novo coronary lesions. Patients were randomly assigned to bioresorbable polymer everolimus-eluting stents (BP-EES) or everolimus-eluting BRS. The primary endpoint was percentage diameter stenosis (in-device) at 6- to 8-month angiographic surveillance. The main secondary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death/target vessel-myocardial infarction/target lesion revascularization assessed after 12 months and 5 years. Results: The trial was prematurely terminated after the enrollment of 117 of 230 patients (BP-EES, n = 60; BRS, n = 57) due to safety issues associated with BRS technology. The primary endpoint of in-device diameter stenosis at angiographic surveillance was 12.5 ± 7.7% with BP-EES versus 19.3 ± 16.5% with BRS (p = 0.01). The DOCE occurred in 5.0% in the BP-EES group versus 12.3% of patients in the BRS group (hazard ratio [HR] 2.48, 95% confidence interval [CI] 0.64–9.58, p = 0.19) after 12 months and in 11.7% in the BP-EES group versus 26.4% of patients in the BRS group (HR 2.38, 95% CI 0.97–5.84, p = 0.06) after 5 years. Conclusions: BP-EES showed superior mid-term angiographic performance compared with BRS. Clinical event rates did not differ significantly between the groups up to 5 years of follow-up. These results should be interpreted with caution in view of the premature discontinuation of the study. Full article

Background: The rate of in-stent restenosis (ISR) is decreasing; however, it is still a challenge for contemporary invasive cardiologists. Therapeutic methods, including drug-eluting balloons (DEBs), intravascular lithotripsy, excimer laser coronary atherectomy, and imaging-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES), have been implemented. Patients with diabetes mellitus (DM) are burdened with a higher risk of ISR than the general population. Aims: DM-Dragon is aimed at evaluating the clinical outcomes of ISR treatment with DEBs vs. DES, focusing on patients with co-existing diabetes mellitus. Methods: The DM-Dragon registry is a retrospective study comprising data from nine high-volume PCI centers in Poland. A total of 1117 patients, of whom 473 individuals had DM and were treated with PCI due to ISR, were included. After propensity-score matching (PSM), 198 pairs were created for further analysis. The primary outcome of the study was target lesion revascularization (TLR). Results: In DM patients after PSM, TLR occurred in 21 (10.61%) vs. 20 (10.1%) in non-diabetic patients, p = 0.8690. Rates of target vessel revascularization (TVR), target vessel myocardial infarction, device-oriented composite endpoint (DOCE), and cardiac death did not differ significantly. Among diabetic patients, the risk of all-cause mortality was significantly lower in the DEB group (2.78% vs. 11.11%, HR 3.67 (95% confidence interval, CI) [1.01–13.3), p = 0.0483). Conclusions: PCI with DEBs is almost as effective as DES implantation in DM patients treated for ISR. In DM-Dragon, the rate of all-cause death was significantly lower in patients treated with DEBs. Further large-scale, randomized clinical trials would be needed to support these findings. Full article

Background and Objectives: Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) is often associated with longer total stent length. Our aim was to evaluate the long-term safety and effectiveness of bioresorbable scaffold (BRS) implantation in CTO to avoid using a full metal jacket. Materials and Methods: We conducted a single-center prospective longitudinal case study including 34 patients who underwent PCI of CTO with at least one BRS and drug-eluting stent (DES) implantation (n = 27) or BRS-only at the Latvian Centre of Cardiology between 2016 and 2018. Quantitative coronary angiography (QCA) and intravascular ultrasound were performed during the index procedure and long-term follow-up. Results: Of 34 patients with a mean age of 60.6 ± 9.5 years, 76.5% were male. The most common CTO artery was the right coronary artery (73.5%, n = 25). The median length of occlusion was 23.0 mm (interquartile range (IQR) = 13.9–32.7), with a total mean BRS/DES length of 49.6 ± 20.4 mm. During the median follow-up of 5.6 years (IQR = 5.0–5.9), the primary endpoint of target vessel re-occlusion occurred in 5.9% (n = 2) of patients. Target lesion revascularization (TLR) was performed in 35.3% (n = 12) of patients, with a mean time to TLR of 62.5 (95% confidence interval (CI), 53.9–71.2) months. Through QCA, there was a statistically significant increase in median residual diameter stenosis (20.1–31.4%, p < 0.01) and residual length of stenosis (5.2–7.1%, p = 0.04) compared with the index procedure. Conclusions: Our study demonstrates that BRS is a safe and feasible option for PCI of CTO, allowing for the avoidance of long segment stenting and ensuring long-term patency of the coronary artery. Full article

Background: Percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) for chronic total coronary occlusions (CTOs) improves clinical symptoms and quality of life. However, data on drug-coated balloon (DCB)-based PCI in CTO lesions are limited. Methods: A total of 200 patients were successfully treated for CTO lesions, either with DCB alone or in combination with DES (DCB-based PCI). They were compared with 661 patients who underwent second-generation DES implantation for CTO from the PTRG-DES registry (DES-only PCI). The endpoint was major adverse cardiovascular events (MACEs), which included a composite of cardiac death, myocardial infarction, stent or target lesion thrombosis, target vessel revascularization, and major bleeding at 2 years. Results: In the DCB-based PCI group, 49.0% of patients were treated with DCB only and 51.0% underwent the hybrid approach combining DCB with DES. Bailout stenting was performed in seven patients (3.5%). The DCB-based PCI group exhibited fewer stents (1.0; IQR: 0.0–1.0 and 2.0; IQR: 1.0–3.0, p < 0.001), shorter stent lengths (6.5 mm; IQR: 0.0–38.0 mm and 42.0 mm; IQR: 28.0–67.0 mm, p < 0.001), and lower usage of small stents with a diameter of 2.5 mm or less (9.8% and 36.5%, p < 0.001). Moreover, the DCB-based PCI group had a lower rate of MACEs than the DES-only PCI group (3.1% and 13.2%, p = 0.001) at 2-year follow-up. Conclusions: The DCB-based PCI approach significantly reduced the stent burden, particularly in the usage of small stent diameters, and resulted in a lower risk of MACEs compared to DES-only PCI in CTO lesions. Full article