Search Results (74)

Fractional flow reserve (FFR) is a standard physiological index for guiding coronary revascularization, with a threshold of >0.80 typically used to defer intervention. However, due to its distinct anatomical and physiological features, the left anterior descending artery (LAD) often exhibits lower FFR values than non-LAD vessels for lesions of similar angiographic severity. These vessel-specific differences raise concerns about applying a uniform FFR cutoff across all coronary territories. Observational studies indicate that LAD lesions deferred at an FFR of 0.80 may have similar or better outcomes than non-LAD lesions do. LAD lesions also tend to show lower post-percutaneous coronary intervention FFR values, suggesting that vessel specific target thresholds may be more prognostically appropriate. Additionally, some evidence suggests that instantaneous wave-free ratio may offer greater prognostic value than FFR, specifically in LAD lesions, a trend not consistently seen in other arteries. In patients with acute myocardial infarction and multivessel disease, the prognostic relevance of non-culprit lesion FFR may vary by coronary territory, particularly in the LAD. This review outlines the physiological rationale and clinical evidence for vessel-specific interpretation of FFR, with a focus on the LAD, and explores its potential clinical implications and limitations. Full article

Background/aim: The aim of this study was to determine predictors of major adverse cardiovascular events, including MACE (mortality, non-fatal recurrent infarction, non-fatal stroke, and target vessel revascularization-TVR) in stable post-STEMI patients. Method: We analyzed STEMI patients without cardiogenic shock at admission included in our STEMI Register. The patients were treated with primary PCI. The follow-up period was eight years. Results: From 1 December 2006 to 31 December 2016, a total of 3079 patients were included in the Register. In the first year, MACE was registered in 348 (11.3%) patients. The remaining patients were considered stable. They were included in further analysis. At eight years, the rates were as follows: MACE 3.9%, non-fatal recurrent infarction 2.1%, TVR 1.8%, non-fatal stroke 0.5%, and mortality 2.1%. Predictors for 8-year MACE were age >60 years (60–69 vs. <60 years HR 1.65; 70–79 vs. <60 years HR 1.82; ≥80 vs. <60 years HR 3.16), EF < 50% (EF 40–49% HR 2.38; EF < 40% HR 2.32), diabetes mellitus (HR 1.49), and 3-vessel coronary artery disease (HR 1.44). Conclusions: Four predictors identified stable post-STEMI patients who remained at a higher risk for the occurrence of MACE. Stable post-STEMI patients with one or more of these risk factors may require more aggressive secondary prevention measures or a personalized approach to improve their prognosis. Full article

Background/Objectives: Despite the potential benefits, intravascular imaging for guiding percutaneous coronary intervention (PCI) remains underutilized. Recent trials have provided new data, prompting a need for updated insights. This study aimed to perform a comprehensive meta-analysis to compare the clinical outcomes of intravascular imaging-guided PCI versus angiography-guided PCI, thereby evaluating the relative effectiveness of these two guidance strategies in improving patient outcomes. Methods: PubMed, Cochrane Library, Embase and Clinicaltrials.gov databases were systematically searched from inception till 25 November 2024. Randomized clinical trials (RCTs) comparing intravascular imaging with coronary angiography in patients undergoing complex PCI were included. Statistical analysis was conducted using a random effects model to calculate pooled risk ratios with 95% confidence intervals (CI). Results: In this meta-analysis of 21 studies involving 18,043 patients, intravascular image-guided PCI significantly reduced the risk of all-cause mortality by 24%, cardiac mortality by 63%, MACE by 35%, target vessel myocardial infarction by 32%, stent thrombosis by 42%, target vessel revascularization by 45%, target lesion revascularization by 34% and myocardial infarction by 22% compared to angiography-guided PCI. There was no significant difference in bleeding events. Conclusions: Intravascular imaging significantly reduces cardiac events, all-cause mortality and revascularization rates in PCI patients. These findings support its broader adoption and potential updates to clinical guidelines. 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

Background: Carotid artery stenting (CAS) with neuroprotection is a widely used treatment for carotid artery stenosis. This study aimed to evaluate the long-term outcomes of CAS using the MER stent (Balton, Poland) and various neuroprotection devices, with subgroup analysis based on predilatation. Methods: A prospective analysis was conducted on patients treated with CAS at four high-volume centers in Poland between October 2016 and May 2017. Patients were stratified into two groups based on whether predilatation was performed. Procedural and clinical outcomes, including major adverse events (MAEs) defined as all-cause death, stroke, and myocardial infarction (MI), were evaluated at 30 days and 5 years post-procedure. Kaplan–Meier analysis and Cox regression models were used to assess event-free survival and predictors of MAEs. Results: The study population consisted of 100 patients (males: 61%) with a mean age of 68 years. Dyslipidemia (84.4% vs. 60.0%, p = 0.007) and smoking (67.3% vs. 44.4%, p = 0.022) differed significantly between the predilatation and non-predilatation groups. The procedural success rate (<30% residual stenosis) was 97%. At 5 years, the overall restenosis rate was 7%, and target vessel revascularization was required in 3% of patients. The cumulative mortality rate was 15%, and two strokes (2%) were recorded. Multivariable regression identified prior CABG as an independent predictor of MAEs (HR 3.5, 95% CI 1.14–10.83, p = 0.03). Conclusions: CAS with the MER stent demonstrated high procedural success and favorable long-term outcomes. Predilatation did not impact outcomes. Neuroprotection was effective in all cases, with no device-related complications reported. Full article

Background: A drug-coated balloon (DCB) is an emerging treatment technology for percutaneous coronary intervention (PCI). However, the prognostic factors of PCI with a DCB remain fully determined. Chronic kidney disease (CKD) is an independent predictor of adverse outcomes in patients with coronary artery disease (CAD) who underwent PCI. The aim of this present study was to clarify the impact of CKD on prognosis in CAD patients who underwent PCI with a DCB. Methods: We enrolled 252 consecutive patients with CAD who underwent PCI with a DCB from 2015 to 2023. The endpoints of this study were composite events including all-cause death, myocardial infarction, target vessel revascularization, stroke, and major bleeding. Results: The prevalence rate of CKD was 48%. Patients with CKD were older and had higher prevalence of hypertension and diabetes mellitus than those without. Kaplan–Meier analysis revealed a significantly higher composite event rate in patients with CKD (log-rank test, p = 0.003). In the multivariate Cox proportional hazards analysis, CKD was independently associated with composite events after adjusting for confounding factors (adjusted hazard ratio 1.985, 95% confidence intervals 1.157–3.406, p = 0.013), mainly driven by all-cause deaths. Conclusions: CKD was associated with unfavorable outcomes in CAD patients who underwent PCI with a DCB. Full article

Background/Objectives: Drug-eluting stents (DESs) remain the standard of treatment for patients with ST-elevation myocardial infarction (STEMI). However, complications such as stent thrombosis and in-stent restenosis still pose significant risks. Drug-coated balloons (DCBs) have emerged as a promising alternative, but data for this clinical scenario are still scarce. The objective was to evaluate the safety and efficacy of DCB culprit-lesion primary percutaneous coronary intervention (pPCI) in patients presenting with STEMI and to evaluate its impact on the microcirculatory territory. Methods: An observational retrospective study was conducted across six European centers. Results: In total, 118 patients were included. Of these, 82.2% were male, with a median age of 67 years (IQR 36–92); 28% patients presented with stent thrombosis and most of them (94%) underwent paclitaxel-DCB-pPCI. The median follow-up was 23.2 months (IQR 6.7–77.3). Target lesion failure (TLF) rates were low (3.4%), with no differences between patients presenting with native coronary vessel and stent thrombosis (4.7% vs. 0%; p = 0.205). Overall mortality rates at follow-up were 7%, with only 1.8% attributed to cardiac causes. A target lesion revascularization (TLR) rate of 1.8% was observed, with no target vessel myocardial infarction reported. A subgroup of patients (42; 35.6%) underwent an adenosine-free angiographic microvascular resistance (AMR) analysis. The median AMR was 4.7 (3.9–5.5) and was greater in the stent thrombosis group than in the native coronary group (5.1 vs. 4.6; p = 0.038) with no clinical differences between patients based on the AMR. Conclusions: DCB-pPCI has emerged as an alternative potential treatment for patients presenting with STEMI, with few long-term adverse cardiac events. Despite the encouraging outcomes, these findings underscore the need for a large randomized clinical trial powered by a relevant clinical outcome in order to elucidate the role of DCB-PCI in patients presenting with STEMI. Full article

Introduction: The number of chronic total occlusion (CTO) revascularization procedures has continuously increased, obtaining better results in recent years. However, there are few data regarding long-term outcomes and no comparisons to planned complex non-CTO percutaneous coronary intervention (PCI). Methods: We included all patients undergoing planned complex PCI. Our main objective was to compare a combined endpoint of all-cause death, myocardial infarction, and target vessel revascularization at the long-term follow-up of CTO PCI versus planned complex non-CTO PCI. We compared the groups using multivariable Cox regression and performed a propensity score matching analysis to control the baseline characteristics. We repeated the analysis for the separate components of the primary endpoint. Results: From January 2018 to June 2023, 1394 complex coronary PCIs were performed at our center. After excluding 393 non-planned cases, 201 CTO PCIs and 800 non-CTO PCIs were included. The mean follow-up was 2.5 ± 1.5 years. The composite endpoint occurred in 23 (11.6%) CTO PCIs and 219 (28.2%) planned non-CTO PCIs. The multivariable Cox regression using the CTO group as the reference showed a lower risk for the primary outcome (HR: 0.59; 95% CI 0.37–0.95; p = 0.031). After matching, a total of 195 adequately balanced pairs were obtained. The CTO group presented a lower risk for the primary combined outcome (HR: 0.46; 95% CI 0.27–0.76; p = 0.003). Conclusions: In patients undergoing planned complex PCI, those in the CTO group presented a reduced risk of all-cause death, myocardial infarction, and target vessel revascularization at the end of the follow-up. Full article

Background: Acute coronary syndrome (ACS) remains the primary cause of mortality worldwide. Performing complex coronary intervention in patients with ACS is considered a significant factor for worsening prognosis. This study aimed to evaluate the prognosis of patients with ACS treated with complex procedures compared to patients with chronic coronary syndrome (CCS). Methods: Among 980 patients from the Polish Complex Registry, we enrolled 829 consecutive patients who underwent complex percutaneous coronary intervention (PCI) for acute or chronic coronary syndrome with a completed one-year follow-up. The primary endpoint is defined as the major adverse cardiac event (MACE) at 12 months, a composite endpoint including all-cause death, target lesion revascularization, target vessel revascularization, and non-fatal myocardial infarction. Results: The incidence of the composite endpoint of MACE at one-year follow-up was comparable between the patients with acute and chronic coronary syndrome who underwent complex PCI (12.4% vs. 7.6%, LogRank p = 0.035). Cox multivariate analysis indicated that ACS is an independent risk factor for death at one-year follow-up. Additionally, age and comorbidities, such as heart failure and chronic kidney disease, along with procedural factors, including lesion length and pre-procedural diameter stenosis, are independent predictors of death in patients with complex lesions. Independent risk factors for MACE at one-year follow-up include age, heart failure, previous PCI, in-stent restenosis, and pre-procedural diameter stenosis. Conclusions: The prognosis of patients with acute and chronic coronary syndrome in the annual follow-up is comparable in the context of cardiovascular events. The clinical presentation of ACS is an independent risk factor for all-cause death. Full article

Background: Sirolimus-coated balloons (SCBs) have emerged as a promising alternative to paclitaxel-coated devices for the treatment of femoropopliteal lesions. However, real-world data on SCB performance in also complex peripheral arterial disease remains unknown. We sought to evaluate the safety and 12-month clinical outcomes of the Selution SLR™ balloon angioplasty in a challenging real-world patient cohort. Methods: This single-center, retrospective observational study with prospective follow-up included 21 patients with symptomatic peripheral arterial disease treated with the Selution SLR™ SCB (Med. Alliance, SA, Mont-sur-Rolle, Switzerland) after vessel preparation with rotational atherectomy, between October 2023 and November 2024. The primary endpoints were technical success, 12-month primary patency, and target lesion revascularization (TLR). Secondary endpoints included major adverse cardiac events (MACE), major adverse limb events (MALE), and changes in Rutherford classification and ankle-brachial index (ABI). Results: The median age was 79 years, with 47.6% of patients over 80 years old. Most patients presented with advanced peripheral atherosclerotic disease (PAD) (Rutherford category V, 47.6%). Lesions were predominantly occlusive (76.2%), with a median length of 130 mm and severe/moderate calcified in 71.4% of cases. Technical success was achieved in 95.2% of procedures. The 12-month primary patency was 95%, with a TLR-Rate of 5%. No major amputations or cardiovascular deaths occurred. Significant improvements in Rutherford category and ABI were maintained at 12 months. Conclusions: In this real-world cohort of patients with complex PAD, vessel preparation-assisted Selution SLR™ angioplasty demonstrated safety and promising 12-month outcomes. These findings support the use of SCBs in also challenging peripheral interventions, though larger-scale data and further follow up are needed in order to establish SCBs’ role as crucial in the treatment algorithm of PAD. Full article

Background/Objectives: The double-kissing (DK) culotte technique is a modification of the culotte technique that employs initial kissing balloon inflation after first stent implantation. The DK culotte technique may improve strut apposition and procedural outcomes; however, data on its efficacy and safety remain limited. This study aimed to investigate the short-term outcomes of bifurcation percutaneous coronary intervention (PCI) using the DK culotte technique compared with those of the culotte technique in patients with acute coronary syndrome (ACS). Methods: This two-center, observational, retrospective study included patients with ACS. Out of 12,132 screened patients, 117 and 122 underwent DK culotte and culotte PCIs, respectively, with 117 and 57 patients remaining after propensity score matching. The primary endpoint was 1-year target lesion failure (TLF), which included cardiovascular death, target vessel myocardial infarction or clinically indicated target lesion revascularization (TLR). Secondary endpoints included major adverse cardiac events (MACEs) comprising myocardial infarction, cardiac death, and TLR; contrast medium amount (mL); and cumulative radiation dose (mGy). Results: At 1 year, TLF occurred in 7% and 12% of the DK culotte and culotte groups, respectively (p = 0.17). No significant differences were observed in MACEs between the groups (13% DK culotte vs. 19% culotte; p = 0.12). Additionally, the DK culotte technique did not cause higher contrast medium usage or cumulative radiation dosage. Conclusions: No statistically significant differences were found in TLF and MACE reduction between ACS patients treated with the DK culotte technique and the culotte technique. The observed trend favoring the DK culotte needs further validation in prospective studies. Full article

Background: It is essential to identify the risk factors for poor clinical outcomes in patients with acute myocardial infarction (AMI). The coronary artery calcium score (CACS) is gathering attention as a predictor for future cardiovascular events. This study aimed to (1) measure CACSs in patients with AMI by non-ECG-gated computed tomography (CT), (2) compare clinical outcomes between patients with a high CACS and a low–intermediate CACS and (3) to elucidate the association between high CACS and clinical outcomes. Methods: We defined the high CACS group as the highest quantile of CACS (Q4) and defined the low–intermediate CACS group as the other quantiles of CACS (Q1–Q3). The primary endpoint was major adverse cardiovascular events (MACE), which were defined as the composite of all-cause death, re-admission for heart failure, non-fatal MI and target vessel revascularization. We included 548 patients with AMI who underwent non-ECG-gated CT and divided them into the high CACS group (CACS ≥ 5346.5, n = 137) and the low–intermediate CACS group (CACS ≤ 5329.3, n = 411). Results: During the median follow-up duration of 535 days, 150 MACE were observed. The Kaplan–Meier curves showed that MACE occurred more frequently in the high CACS group than in the low–intermediate CACS group (p < 0.001). Multivariable Cox hazard analysis revealed that a high CACS was significantly associated with MACE (hazard ratio 1.597, 95% confidence interval 1.081–2.358, p = 0.019) after controlling for multiple confounding factors. Conclusions: Clinical outcomes were worse in AMI patients with a high CACS than in those with a low–intermediate CACS. A high CACS was significantly associated with MACE in multivariate analysis. 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

Peripheral artery disease (PAD) is an atherosclerotic condition commonly complicating type 2 diabetes (T2D), leading to poor quality of life and increased risk of major adverse lower-limb (MALE) and cardiovascular (CV) events (MACE). Therapeutic management of PAD in T2D patients is much more arduous, often due to bilateral, multi-vessel, and distal vascular involvement, in addition to increased systemic polyvascular atherosclerotic burden. On the other hand, the pathophysiological link between PAD and T2D is very complex, involving mechanisms such as endothelial dysfunction and increased subclinical inflammation in addition to chronic hyperglycemia. Therefore, the clinical approach should not ignore vascular protection with the aim of reducing limb and overall CV events besides a mere glucose-lowering effect. However, the choice of the best medications in this setting is challenging due to low-grade evidence or lacking targeted studies in PAD patients. The present review highlighted the strong relationship between T2D and PAD, focusing on the best treatment strategy to reduce CV risk and prevent PAD occurrence and worsening in patients with T2D. The Medline databases were searched for studies including T2D and PAD up to June 2024 and reporting the CV effectiveness and safety of the most used glucose-lowering agents, with no restriction on PAD definition, study design, or country. The main outcomes considered were MACE—including nonfatal acute myocardial infarction, nonfatal stroke, and CV death—and MALE—defined as lower-limb complications, amputations, or need for revascularization. To the best of our current knowledge, GLP-1 receptor agonists and SGLT2 inhibitors represent the best choice to reduce CV risk in T2D and PAD settings, but a personalized approach should be considered. GLP-1 receptor agonists should be preferred in subjects with prevalent atherosclerotic burden and a history of previous MALE, while SGLT2 inhibitors should be used in those with heart failure if overall CV benefits outweigh the risk of lower-limb complications. Full article