Drug-eluting Stents In Patients Research Articles

Outcomes of Drug-Eluting Stents in comparison to Bare Metal Stents in Cancer Patients with Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis

Background. Studies have demonstrated poor prognosis in cancer patients who undergo percutaneous coronary intervention (PCI) for coronary artery disease (CAD). Cancer patients receiving PCI are at increased risk of in-stent thrombosis, bleeding, hospital readmissions, and cardiovascular and noncardiovascular mortality when compared to patients without cancer. It is unclear if the poor outcomes in cancer patients are related to the stent type utilized for PCI. This meta-analysis attempts to identify differences in efficacy and safety outcomes when comparing drug-eluting stents (DESs) with bare metal stents (BMSs) in cancer patients. Methods. This meta-analysis is reported according to the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Medline, Scopus, and Cochrane Central Register of Controlled Trials were systematically searched to identify relevant studies. Risk of bias was assessed using the Modified Newcastle-Ottawa scale and Cochrane risk of bias tool. The primary outcomes of interest were in-stent thrombosis, bleeding, and mortality. Results. Four studies comprising of 54,414 patients met the inclusion criteria. There was no difference in in-stent thrombosis (odds ratio (OR): 0.79; 95% confidence interval (CI): 0.58–1.07), bleeding events (OR: 1.38; 95% CI: 0.77–2.49), or in-hospital mortality (OR: 1.92; 95% CI: 0.83–4.43) when comparing cancer patients who underwent PCI with DES vs BMS. Conclusions. This meta-analysis demonstrates no difference in mortality, bleeding, or in-stent thrombosis between revascularization with BMS vs DES in patients with cancer and CAD. Cancer patients included in this meta-analysis experienced higher rates of mortality, bleeding, and in-stent thrombosis after PCI compared to all-comers described in the literature.

Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial

Intravascular ultrasound-guided percutaneous coronary intervention has been shown to result in superior clinical outcomes compared with angiography-guided percutaneous coronary intervention. However, insufficient data are available concerning the advantages of intravascular ultrasound guidance for patients with an acute coronary syndrome. This trial aimed to investigate whether the use of intravascular ultrasound guidance, as compared with angiography guidance, improves the outcomes of percutaneous coronary intervention with contemporary drug-eluting stents in patients presenting with an acute coronary syndrome. In this two-stage, multicentre, randomised trial, patients aged 18 years or older and presenting with an acute coronary syndrome at 58 centres in China, Italy, Pakistan, and the UK were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention or angiography-guided percutaneous coronary intervention. Patients, follow-up health-care providers, and assessors were masked to random assignment; however, staff in the catheterisation laboratory were not. The primary endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularisation at 1 year after randomisation. This trial is registered at ClinicalTrials.gov, NCT03971500, and is completed. Between Aug 20, 2019 and Oct 27, 2022, 3505 patients with an acute coronary syndrome were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention (n=1753) or angiography-guided percutaneous coronary intervention (n=1752). 1-year follow-up was completed in 3504 (>99·9%) patients. The primary endpoint occurred in 70 patients in the intravascular ultrasound group and 128 patients in the angiography group (Kaplan-Meier rate 4·0% vs 7·3%; hazard ratio 0·55 [95% CI 0·41-0·74]; p=0·0001), driven by reductions in target vessel myocardial infarction or target vessel revascularisation. There were no significant differences in all-cause death or stent thrombosis between groups. Safety endpoints were also similar in the two groups. In patients with an acute coronary syndrome, intravascular ultrasound-guided implantation of contemporary drug-eluting stents resulted in a lower 1-year rate of the composite outcome of cardiac death, target vessel myocardial infarction, or clinically driven revascularisation compared with angiography guidance alone. The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. For the Mandarin translation of the abstract see Supplementary Materials section.

One-Year Outcome of Drug-Coated Balloon vs. Drug-Eluting Stent in Patients Undergoing Initial Percutaneous Coronary Intervention (PCI) for De Novo Lesion.

Drug-eluting stents (DES) are the major treatment option in percutaneous coronary intervention (PCI). Recently, drug-coated balloon (DCB) utilization has been increasing globally, leading to the expected new strategy of "stent-less PCI." This study aimed to evaluate the one-year outcome of DCB compared to DES. Patients who underwent initial PCI for de novo lesions in our institution from January 2018 to December 2021 (n=337) were subjected to retrospective analysis. Among them, 75 patients were treated with DCB, while 262 patients were treated with DES. Target lesion failure (TLF) was evaluated during the follow-up period. The proportion of PCIs for ACS was significantly lower in the DCB group (DCB, n=23, 30.7% vs. DES, n=143, 54.6%; p=0.001). The median device diameter and length in the DES group were larger than those in the DCB group (DCB, 2.60 mm vs. DES, 2.98 mm; p<0.001; DCB, 19.1 mm vs. DES, 25.2 mm; p<0.001). There was no significant difference between the DCB and DES groups in lesion calcification. The proportion of ostial lesions was significantly higher in the DCB group (DCB, n=13, 17.3% vs. DES, n=21, 8.0%; p=0.018). The cumulative rate of TLF (DCB, n=5, 6.7% vs. DES, n=18, 6.9%; p=0.951) did not significantly differ between the DCB and DES groups. DCB may be as effective a strategy as DES in the patient who underwent initial PCI for a de novo lesion.

Efficacy and safety of durable versus biodegradable polymer drug-eluting stents in patients with acute myocardial infarction complicated by cardiogenic shock

The clinical impact of different polymer technologies in newer-generation drug-eluting stents (DESs) for patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains poorly understood. We investigated the efficacy and safety of durable polymer DESs (DP-DESs) compared with biodegradable polymer DESs (BP-DESs). A total of 620 patients who underwent percutaneous coronary intervention with newer-generation DESs for AMI complicated by CS was divided into two groups based on polymer technology: the DP-DES group (n = 374) and the BP-DES group (n = 246). The primary outcome was target vessel failure (TVF) during a 12-month follow-up, defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Both the DP-DES and BP-DES groups exhibited low stent thrombosis rates (1.3% vs. 1.6%, p = 0.660). The risk of TVF did not significantly differ between the two groups (34.2% vs. 28.5%, hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.69–1.29, p = 0.721). This finding remained consistent after adjustment with inverse probability of treatment weighting (28.1% vs. 25.1%, HR 0.98, 95% CI 0.77–1.27, p = 0.899). In AMI patients complicated by CS, the risk of a composite of cardiac death, myocardial infarction, or target vessel revascularization was not significantly different between those treated with DP-DESs and those treated with BP-DESs.Trial registration: RESCUE registry, https://clinicaltrials.gov/ct2/show/NCT02985008, NCT02985008.

Clinical outcomes with biodegradable versus durable polymer drug-eluting stents in patients with ST-elevation myocardial infarction

BackgroundCoronary drug-eluting stents (DES) built with either durable (DP) or biodegradable (BP) polymeric coatings have been largely tested and are extensively available for routine use. However, their comparative performance remains an open question, particularly in more complex subsets of patients. AimsWe evaluated the outcomes of patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI) using DP-DES versus BP-DES in a large multicenter real-world registry. MethodsThe population comprised patients with STEMI treated with pPCI within 12 h of symptoms onset. Those treated with more than one DES who received different polymer types were excluded. The final cohort for analysis was selected after propensity score matching (PSM), computed to generate similar groups of DP DES versus BP DES. Primary endpoint was the incidence of major adverse cardiac events (MACE), defined as the composite of total death, myocardial infarction and target lesion revascularization at 2 years. ResultsFrom January 2017 to April 2022, a total of 1527 STEMI patients underwent pPCI with a single DES type (587 DP-DES; 940 BP-DES). After PSM, 836 patients (418 patients in the DP-DES and 418 patients in the BP-DES groups), comprised the final study population. Both study groups had a similar baseline profile. Patients treated with BP-DES group had similar rates of MACE (15.3 % vs. 19.4 %, HR 0.69, 95 % CI 0.50–0.94, p = 0.022). Rates of target lesion revascularization was lower in BP DES group (0.7 % vs. 3.8 %, HR 0.17, 95 % CI 0.05–0.51, p = 0.006). ConclusionIn a cohort of STEMI patients submitted to pPCI, BP and DP DES had similar rates of the primary outcome. Patients treated with BP DES, however, had a decreased incidence of TLR at after 2-year follow-up.

The Efficacy of Drug-Coated Balloons and Drug-Eluting Stents in Infrapopliteal Revascularization: A Meta-analysis.

The study aimed to compare the effectiveness of drug-coated balloon (DCB) and drug-eluting stents (DESs) to standard endovascular techniques like percutaneous transluminal angioplasty (PTA) and bare metal stent (BMS) for treating infrapopliteal artery disease. Including 8 DCB trials and 4 DES trials, this meta-analysis of 12 recent randomized controlled trials (RCTs) is comprehensive. We searched MEDLINE, EMBASE, Science of Web, Cochrane, and PubMed for this meta-analysis. We searched these databases for papers from their inception to February 2023. We also analyzed the references given in the listed studies and any future study that cited them. No language or publication date restrictions were applied to the 12 RCTs. The experimental group includes 8 DCB studies and 4 DES investigations, the DCB group is primarily concerned with the paclitaxel devices, whereas the DES group is preoccupied with the "-limus" devices. Key clinical outcomes in this study were primary patency and binary restenosis rates. This study's secondary outcomes are late lumen loss (LLL), clinically-driven target lesion revascularization (CD-TLR), limb amputation, and all-cause mortality. The evidence quality was assessed using Cochrane risk-of-bias. The PROSPERO registration number for this study is CRD42023462038. Only 108 of 1152 publications found satisfied qualifying criteria and contained data. All 13 RCTs have low to moderate bias. Drug-coated balloons and DESs were compared in the excluded study. The analysis comprised 2055 participants from 12 RCTs that met the inclusion criteria, including 1417 DCB patients and 638 DES patients. Drug-coated balloons outperform traditional methods in short-term monitoring of primary patency, binary restenosis, and CD-TLR. The benefits fade over time, and the 2 techniques had similar major amputation rates, mortality rates, and LLL. Drug-eluting stents outperform conventional procedures in primary patency, binary restenosis, and CD-TLR during medium-term to short-term follow-up. Comparing the 2 methods, major and minor amputations, death rate, and LLL were similar. Comparison of DES and DCB with PTA or BMS shows that DES had better follow-up results. DCB has positive short-term results, but long-term effects differ, however, more research is needed to determine when DES and DCB should be used in medical procedures. The provision of additional evidence to substantiate the advancement of drug-coated balloon (DCB) therapy in the treatment of lower limb arteriosclerosis obliterans, particularly in the below-the-knee area characterized by high calcium load and significant occlusion, is comparable in efficacy to conventional procedures. This finding is advantageous for the progress of interventional revascularization. The advancement and efficacy of DCB have resulted in improved treatment outcomes for medical practitioners in clinical settings. Our research incorporates the most recent randomized experiments.

Impact of Target Lesion Revascularization on Long-Term Mortality After Percutaneous Coronary Intervention for Left Main Disease

BackgroundAlthough target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) for unprotected left main coronary artery (LMCA) disease is not rare, its timing of occurrence and prognostic impact on long-term mortality is uncertain. ObjectivesThis study sought to investigate TLR incidence over time and its impact on mortality after PCI with drug-eluting stents (DES) for LMCA disease. MethodsUsing a pooled data from 4 multicenter observational registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents], IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization], MAIN-COMPARE [Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization], and PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease]), we evaluated 1,397 patients with LMCA disease treated with DES and available long-term mortality data. The association between TLR and the 10-year risk of mortality was examined by multivariable Cox proportional hazards regression, with TLR as a time-varying covariate. ResultsDuring maximum follow-up of 10 years (median 6.8 years), TLR occurred in 118 patients and its 10-year cumulative incidence was 10.8%. TLR mostly occurred within 2 years after initial PCI and decreased over time: early-stage TLR (within 2 years) in 73 (61.9%) patients and late-stage TLR (beyond 2 years) in 45 (38.1%) patients. Among all TLR patients, 23 patients underwent coronary artery bypass grafting and 95 underwent repeat PCI. In the time-varying multivariable Cox model, the presence of TLR was not significantly associated with an increased risk of mortality (adjusted HR: 0.90; 95% CI: 0.50-1.63; P = 0.73). ConclusionsAlthough the incidence of ischemia-driven TLR was mostly common within 2 years after left main PCI, TLR occurred steadily during the 10-year follow-up period. However, given that such patients were optimally revascularized, the prognostic impact of TLR on mortality was not substantial. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133; Observational Study for Left Main Disease Treatment [IRIS-MAIN]; NCT01341327; Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease [MAIN COMPARE]; NCT02791412; Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968)

Sex-based differences in ischemic cardiovascular and bleeding outcomes following implantation of drug-eluting stent in patients at high bleeding risk

BackgroundPatients with high bleeding risk (HBR) may exhibit uncertain adherence to dual antiplatelet therapy (DAPT) following drug-eluting stent (DES) implantation. The current population-based cohort study aimed to investigate the sex-based differences in adverse outcomes among the HBR population by analyzing the National Health Insurance Research Database in Taiwan. MethodsPatients who had HBR features defined by the Academic Research Consortium (ARC) and received DES implantation between January 1, 2007, and December 31, 2017, were enrolled. Propensity score matching was adopted to select 3,981 pairs with similar clinical cardiovascular risks but different sexes. A competing risk model was performed to evaluate the risk of adverse ischemic events (cardiac death, nonfatal myocardial infarction, and ischemic stroke) and any bleeding events in both sexes. Noncardiac death was considered a competing risk. ResultsWithin a 5-year follow-up, the incidence rates (per 1,000 person-year (95% confidence interval (CI)) of composite ischemic events and any bleeding events in males were respectively 44.09 (40.25–48.30) and 42.55 (38.79–46.68), while those in females were respectively 40.18 (36.51–44.23) and 42.35 (38.57–46.51). After adjustment for clinical variables, male patients had a marginally increased risk in the composite ischemic events (adjusted subdistribution hazard ratio (SHR) = 1.15 (1.00–1.31), p = 0.045) and a similar risk of any bleeding events (adjusted SHR = 1.00 (0.88–1.15), p = 0.946) compared with female patients. ConclusionsOf the HBR population, males had an increased risk of ischemic outcomes but a similar risk of bleeding compared with females following DES implantation.

Drug-coated balloons versus drug-eluting stents in patients with acute myocardial infarction undergoing percutaneous coronary intervention: an updated meta-analysis with trial sequential analysis

BackgroundDrug-coated balloons (DCBs) are an established strategy for coronary artery disease. However, the new generation drug-eluting stent (DES) is recommended for patients with Acute myocardial infarction (AMI) for coronary artery revascularization. Our aim is to provide a comprehensive appraisal of the efficacy of DCBs in patients with AMI undergoing PCI.MethodsWe searched the WOS, PubMed, Scopus, and Cochrane CENTRAL till March 2023, for studies that compared DCBs versus DES in patients with AMI undergoing PCI. We used a random-effects model to compare major adverse cardiac events (MACE), cardiac death, all-cause death, myocardial infarction, target lesion revascularization (TLR), stent thrombosis, Late lumen Loss (LLL), and minimum lumen diameter (MLD) between the two groups.ResultsThirteen studies comprising 2644 patients were included. The pooled OR showed non-inferiority of DCB over DES in terms of MACE (OR = 0.89, 95% CI [0.57 to 1.40], p = 0.63). When we defined MACE as a composite of cardiac death, MI, and TLR; the pooled OR favored DCB over DES (OR = 0.50, 95% CI [0.28 to 0.9], p = 0.02). Moreover, DCB was not inferior to DES in terms of all-cause mortality (OR = 0.88, 95% CI: 0.43 to 1.8, p = 0.73), cardiac mortality, (OR = 0.59, 95% CI: 0.22 to 1.56, p = 0.29), MI (OR = 0.88, 95% CI: 0.34 to 2.29, p = 0.79), stent thrombosis (OR = 1.21, 95% CI: 0.35 to 4.23, p = 0.76), TLR (OR = 0.9, 95% CI: 0.43 to 1.93, p = 0.8), LLL (MD = -0.6, 95% CI: -0.3 to 0.19, p = 0.64), or MLD (MD = -0.4, 95% CI: -0.33 to 0.25, p = 0.76).ConclusionOur meta-analysis indicated that DCB intervention was not inferior to DES in the PCI setting in patients with AMI, and can be recommended as a feasible strategy in AMI.PROSPERO registrationCRD42023412757.

Resultados tras 5 años de cirugía o abordaje percutáneo en coronariopatía grave. Metanálisis de ensayos aleatorizados con reconstrucción del tiempo hasta el evento

Introduction and objectivesThere is controversy about the optimal revascularization strategy in severe coronary artery disease (CAD), including left main disease and/or multivessel disease. Several meta-analyses have analyzed the results at 5-year follow-up but there are no results after the fifth year. We conducted a systematic review and meta-analysis of randomized clinical trials, comparing results after the fifth year, between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) using drug-eluting stents in patients with severe CAD. MethodsWe analyzed all clinical trials between January 2010 and January 2023. The primary endpoint was all-cause mortality. The databases of the original articles were reconstructed from Kaplan-Meier curves, simulating an individual-level meta-analysis. Comparisons were made at certain cutoff points (5 and 10 years). The 10-year restricted median survival time difference between CABG and PCI was calculated. The random effects model and the DerSimonian-Laird method were applied. ResultsThe meta-analysis included 5180 patients. During the 10-year follow-up, PCI showed a higher overall incidence of all-cause mortality (HR, 1.19; 95%CI, 1.04-1.32; P=.008)]. PCI showed an increased risk of all-cause mortality within 5 years (HR, 1.2; 95%CI, 1.06-1.53; P=.008), while no differences in the 5–10-year period were revealed (HR, 1.03; 95%CI, 0.84-1.26; P=.76). Life expectancy of CABG patients was slightly higher than that of PCI patients (2.4 months more). ConclusionsIn patients with severe CAD, including left main disease and/or multivessel disease, there was higher a incidence of all-cause mortality after PCI compared with CABG at 10 years of follow-up. Specifically, PCI has higher mortality during the first 5 years and comparable risk beyond 5 years.

Long term safety of paclitaxel coated balloon for de novo non-small coronary lesions

Abstract Background The efficacy of drug-coated balloons (DCB) for treating de novo coronary stenoses in non-small lesions remains unclear. Purpose To evaluate the long-term efficacy of DCB to second-generation drug eluting stent (DES) in de novo, non-small coronary lesions. Methods Patients treated with paclitaxel-DCB were compared with patients from two second-generation drug eluting stent (DES) registries. Only patients having DES-only or DCB-only strategies were included; those with in-stent restenosis, a device diameter&amp;lt;2.5mm, DES bailout post-DCB treatment, or combined use of DES and DCB were excluded. The primary endpoint was a patient-oriented composite endpoint (PoCE) defined as all-cause death, any non-fatal myocardial infarction (MI), any stroke, and any revascularization at 2-year. Differences in the risk of PoCE between cohorts were compared and adjusted by inverse probability of treatment weighting (IPTW). Results The study included 6,284 patients with 5,399 treated with DES and 885 with DCB. The mean device diameters were 3.05 mm and 2.88 mm in the DES and DCB cohort, respectively. At 2-year follow-up, the primary endpoint occurred in 531 (9.8%) patients receiving DES and 92 (10.4%) patients treated with DCB (HRcrude:1.10, 95%CI:0.88-1.37, P=0.418; HRIPTW:1.08, 95%CI:0.79-1.47, P=0.639; Figure 1). All-cause death occurred in 230 (4.3%) patients in the DES group and 11 (1.2%) patients in the DCB group (HRIPTW:0.27, 95%CI: 0.12-0.57), any non-fatal MI occurred in 56 (1.0%) patients in the DES group and 13 (1.5%) patients in the DCB group (HRIPTW:0.94, 95%CI:0.39-2.25), any stroke occurred in 108 (2.0%) patients in the DES arm and 8 (0.9%) patients in the DCB group (HRIPTW:0.63, 95%CI: 0.29-1.39), and any repeat revascularization occurred in 199 (3.7%) patients in the DES arm and 69 (7.8%) patients in the DCB group (HRIPTW:2.10, 95%CI: 1.43-3.11). Conclusion We did not observe DCB to be associated with a higher rate of PoCE than DES in patients with de novo coronary lesions which were ≥2.5mm in diameter. However, DCB was associated with significantly lower mortality and significantly higher rates of repeat revascularization than DES.Figure 1

Abstract 13590: Comparative Efficacy and Safety of Bare-Metal versus Drug-Eluting Stents in Managing Saphenous Venous Graft Disease: A Meta-Analysis and Systematic Review

Introduction: Current understanding of the relative safety and efficacy of bare metal stents (BMS) vs. drug eluting stents (DES) in patients with saphenous venous graft disease (SVGD) relies on analysis of small datasets. Methods: Literature search was performed using PubMed, Embase and Web of Science to identify relevant articles on outcomes of BMS vs. DES in patients with SVGD. A random effects model was used to calculate odds ratios (ORs) for several safety and efficacy outcomes including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), total vessel revascularization (TVR), in-stent restenosis, and stent thrombosis. Results: Of 3644 total citations on the initial search, 40 studies comprising 83,151 (33,306 BMS, 49,845 DES) patients qualified for quantitative analysis. The mean age was 72 years, and the mean ejection fraction was 47%. The inter group proportion of hypertension was 78% vs. 83%, diabetes mellitus was 37% vs. 14%, and hyperlipidemia was 69% vs. 78% in patients with BMS vs. DES, respectively (Table). Patients receiving DES had significantly lower odds of MACE (OR 0.63, 95% CI 0.52-0.77), and its components; TLR (OR 0.67, 95% CI 0.49-0.92), TVR (OR 0.61, 95% CI 0.46-0.81); and stent restenosis (OR 0.61, 95% CI 0.45-0.84) compared with BMS (Figure). The risk of stent thrombosis (OR 0.84, 95% CI 0.61-1.15) was similar between the two groups. Conclusions: Compared with BMS, patients receiving DES for SVGD demonstrated a lower risk of adverse events, stent stenosis, and need for revascularization.

First randomised controlled trial comparing the sirolimus-eluting bioadaptor with the zotarolimus-eluting drug-eluting stent in patients with de novo coronary artery lesions: 12-month clinical and imaging data from the multi-centre, international, BIODAPTOR-RCT

The DynamX™ bioadaptor is the first coronary implant technology with a unique mechanism of unlocking the bioadaptor frame after polymer resorption over 6 months, uncaging the vessel while maintaining a dynamic support to the vessel. It aims to achieve the acute performance of drug-eluting stents (DES) with the advantages of restoration of vessel function. This international, single blinded, randomised controlled (1:1) trial compared a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 34 hospitals in Europe, Japan and New Zealand. Patients with de novo coronary lesions and absence of acute myocardial infarction were enrolled from January 2021 to Feburary 2022. The implantation of the bioadaptor followed the standards of DES. An imaging subset of 100 patients had angiographic and intravascular ultrasound assessments, and 20 patients additionally optical coherence tomography. Data collection will continue through 5 years, we herein report 12-month data based on an intention-to-treat population. This trial is registered at ClinicalTrials.gov (NCT04192747). 445 patients were randomised between January 2021 and February 2022. Device, lesion and procedural success rates, and acute gain were similar amongst the groups. The primary endpoint, 12-month target lesion failure, was 1.8% [95% CI: 0.5; 4.6] (n=4) versus 2.8% [95% CI: 1.0; 6.0] (n=6), pnon-inferiority < 0.001 for the bioadaptor and the DES, respectively (Δ-1.0% [95% CI:-3.3; 1.4]). One definite or probable device thrombosis occurred in each group. The 12-month imaging endpoints showed superior effectiveness of the bioadaptor such as in-device late lumen loss (0.09mm [SD 0.34] versus 0.25mm [SD 0.39], p=0.04), and restored compliance and cyclic pulsatility (%mid in-device lumen area change of 7.5% versus 2.7%, p<0.001). This is the first randomised controlled trial comparing the novel bioadaptor technology against a contemporary DES. The bioadaptor demonstrated similar acute performance and 12-month clinical outcomes, and superior imaging endpoints including restoration of vessel function. The study was funded by Elixir Medical.

Results beyond 5-years of surgery or percutaneous approach in severe coronary disease. Reconstructed time-to-event meta-analysis of randomized trials

Introduction and objectivesThere is controversy about the optimal revascularization strategy in severe coronary artery disease (CAD), including left main disease and/or multivessel disease. Several meta-analyses have analyzed the results at 5-year follow-up but there are no results after the fifth year. We conducted a systematic review and meta-analysis of randomized clinical trials, comparing results after the fifth year, between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) using drug-eluting stents in patients with severe CAD. MethodsWe analyzed all clinical trials between January 2010 and January 2023. The primary endpoint was all-cause mortality. The databases of the original articles were reconstructed from Kaplan-Meier curves, simulating an individual-level meta-analysis. Comparisons were made at certain cutoff points (5 and 10 years). The 10-year restricted median survival time difference between CABG and PCI was calculated. The random effects model and the DerSimonian-Laird method were applied. ResultsThe meta-analysis included 5180 patients. During the 10-year follow-up, PCI showed a higher overall incidence of all-cause mortality (HR, 1.19; 95%CI, 1.04-1.32; P=.008)]. PCI showed an increased risk of all-cause mortality within 5 years (HR, 1.2; 95%CI, 1.06-1.53; P=.008), while no differences in the 5–10-year period were revealed (HR, 1.03; 95%CI, 0.84-1.26; P=.76). Life expectancy of CABG patients was slightly higher than that of PCI patients (2.4 months more). ConclusionsIn patients with severe CAD, including left main disease and/or multivessel disease, there was higher a incidence of all-cause mortality after PCI compared with CABG at 10 years of follow-up. Specifically, PCI has higher mortality during the first 5 years and comparable risk beyond 5 years.

TCT-77 Drug-Coated Balloons Versus Drug-Eluting Stents in Patients With In-Stent Restenosis: An Updated Meta-Analysis With Trial Sequential Analysis

TCT-77 Drug-Coated Balloons Versus Drug-Eluting Stents in Patients With In-Stent Restenosis: An Updated Meta-Analysis With Trial Sequential Analysis

Prognostic Impact of Drug-Coated Balloons in Patients With Diabetes Mellitus: A Propensity-Matched Study

Patients with diabetes mellitus (DM) are at higher risk of restenosis and stent thrombosis after percutaneous coronary intervention (PCI) and drug-eluting stent (DES) positioning. Whether drug-coated balloons (DCB) can offer any benefit in this subset of patients has been seldom cleared out and was the aim of the present propensity-matched cohort study, that compared the prognostic impact of DCB versus DES in patients with DM who underwent PCI. Patients with DM enrolled in the NOvara-BIella-TREnto (NOBITRE) Registry were identified and matched according to propensity score, to a control population of patients with DM treated with DES. The primary study end point was the occurrence of major adverse cardiovascular events (MACEs). A total of 150 patients were identified in the DCB group and matched with 150 DES-treated patients. Patients treated with DCB displayed more often a previous cardiovascular history and received a more complete pharmacological therapy. Target vessel diameter and the percentage of stenosis were lower in patients with DCB, whereas binary in-stent restenosis was more common (p<0.001, p=0.003, and p<0.001, respectively). Paclitaxel-eluting balloon represented the most common strategy in the DCB group, whereas Zotarolimus-eluting stents were used in half of the DES population. At a median follow-up of 545.5days, MACE occurred in 54 (19.4%) of patients, with no difference according to the PCI strategy (21.6% vs 17.3%, adjusted hazard ratio [95% confidence interval]1.51 [0.46 to 4.93], p=0.50). Major ischemic end points were slightly increased in patients treated with DCB, whereas overall death was significantly reduced (3.6% vs 10.9%; adjusted hazard ratio [95% confidence interval]0.27 [0.08 to 0.91], p=0.03). In conclusion, the present propensity-matched study shows that, in patients with DM who underwent PCI for in-stent restenosis or de novo lesions, the use of DCB is associated with a similar rate of MACE and a modest increase in target lesion failure, but a significantly improved survival as compared with DES.

Short Versus Long Duration of Dual Antiplatelet Therapy After Second-Generation Drug-Eluting Stents Implantation in Patients with Diabetes.

Duration of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI) remains uncertain, with increasing data suggestive of acceptable short-term duration. Metabolically accelerated atherosclerosis associated with diabetes makes it essential to study short-term DAPT in this subgroup. With limited studies determining optimal DAPT strategies after second-generation stents in this subset, we aimed to establish the optimal duration of DAPT in the diabetic population using second-generation stents. To determine optimal DAPT duration in diabetic population undergoing PCI in 2nd generation stents. We conducted an electronic database search of randomized controlled trials from PubMed/Medline, Embase, Cochrane, and Web of Science databases. A meta-analysis was conducted comparing outcomes of short-term (3-6 months) DAPT therapy versus long-term (12 months) DAPT therapy in the diabetic population undergoing PCI with second-generation stents. A total of 5 randomized controlled trials were included with a total of 3117 diabetic patients. Short-term DAPT did not show any statistical difference from long-term DAPT in achieving primary outcomes (relative ratio: 0.96, 95% confidence interval (CI) 0.68-1.35, P = 0.84). Overall mortality (OR 0.92; 95% CI, 0.52-1.63, P = 0.98), myocardial infarction [odds ratio (OR)OR 1.02; 95% CI, 0.53-1.94, P = 0.85], stent thrombosis (OR 1.20; 95% CI, 0.55-2.60, P = 0.55), target vessel revascularization (OR 1.10; 95% CI, 0.45-2.73, P = 0.74), and stroke (OR 0.50; 95% CI, 0.082-2.43, P = 0.81) did not show any statistical difference between the 2 groups. Similarly, a subgroup analysis of study population comparing 6 versus 12 months of DAPT in diabetic population did not show any difference in net primary outcomes (relative ratio: 0.86, 95% CI 0.45-1.45, P = 0.60). There was no significant heterogeneity noted between the 2 groups. This meta-analysis showed no statistically significant benefit of longer DAPT over shorter DAPT therapy in patients undergoing PCI with drug-eluting stent in patients with diabetes.

Drug-Coated Balloons Versus Drug-Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction: A Meta-Analysis of Randomized Trials

Drug-Coated Balloons Versus Drug-Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction: A Meta-Analysis of Randomized Trials

Biodegradable or durable polymer drug-eluting stents in patients with coronary artery disease: ten-year outcomes of the randomised NEXT Trial.

There are no randomised trials reporting clinical outcomes of biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at 10years. We aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES. The randomised NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT) was originally designed to evaluate the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at 1year and the primary safety endpoint of death or myocardial infarction (MI) at 3years. In this extended follow-up study, clinical outcomes were compared from 1year after stent implantation up to 10years between patients with BP-BES and DP-EES. From May to October 2011, NEXT enrolled atotal of 3,241patients from 98 centres in Japan. The current study population consisted of 2,417patients (1,204patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58). TLR occurred in 15.9% of patients in the BP-BES group and in 14.1% of the DP-EES group (HR 1.12, 95% CI: 0.90-1.40; p=0.32). In alandmark analysis at 1year, the cumulative incidences of death or MI and TLR were not significantly different between the 2 groups. The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1year and up to 10years after stent implantation.

P108 FIVE YEARS RESULTS OF BIORESORBABLE VASCULAR SCAFFOLDS VERSUS CONVENTIONAL DRUG–ELUTING STENTS. A META–ANALYSIS OF RANDOMIZED CONTROLLED TRIALS

Abstract Background Bioresorbable vascular scaffolds (BVS) were designed to reduce the rate of late adverse events observed in conventional drug–eluting stents (DES) by dissolving once they have restored lasting patency. Objectives Compare the safety and efficacy after five years, of BVS versus DES in patients receiving percutaneous coronary intervention for coronary artery disease in randomized controlled trials (RCT). Methods Data collection: We applied the methods recommended by the Preferred Reporting Items for Systematic Reviews and Meta–Analyses (PRISMA) statement. We searched Pubmed, and the Cochrane Central Register for randomized controlled trials (RCT) that evaluated log–term results (at least 60 months) of BVS versus DES in patients underwent percutaneous coronary intervention. Outcome: The primary outcomes were target lesion failure (TLF), stent thrombosis, myocardial infarction, all–causes mortality, and cardiac mortality Statistical Analysis: The analyses were performed using RevMan version 5.3. The results are presented odds ratios (OR) for dichotomous outcomes (Generic Inverse Variance random effect model) with 95% confidence interval (CI). Results Five full texts met inclusion criteria. A total of 4994 patients were included (2927 patients randomized to BVS and 2067 patients randomized to DES), Target lesion failure: At five years of follow–up, the number of TLFs was significantly higher in patients randomized to BVS (OR 1.23 (1.04–1.45) p=0.02). Stent thrombosis: at 5 years the number of stent thrombosis is significantly higher in patients randomized to BVS (OR 3.06 (1.93–4.87) p&amp;lt;0.0001) Myocardial infarction: also in this case the number of myocardial infarctions is significantly higher in patients with BVS (OR 1.40 (1.13–1.73) p=0.002) All–cause mortality: there were no differences between the two groups (OR 0.89 (0.71–1.12) p=0.33) Cardiac mortality: no difference between the two groups (OR 0.81 (0.58–1.13) p=0.21. Conclusions Summary evidence from the included RCTs showed that DES are much safer and more effective than BVS in long term follow up.