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Background The advantage of using bioresorbable-polymer drug-eluting stent (BP-DES) compared with second-generation durable-polymer drug-eluting stent (2G DP-DES) still remains controversial in clinical situations. The purpose of this study to evaluate the degree of re-endothelialization and the prevalence of high-grade yellow-colored plaque (YCP), which might concern arterial healing after BP-DES and 2G DP-DES implantation using a high-resolution coronary angioscopy (CAS). Methods In total, 104 DESs (52: 2G DP-DES and 52: BP-DES) were prospectively observed using CAS 12 ± 1 months after coronary intervention. The grade of neointimal coverage (NIC) over the stent was scored on a 4-point scale from 0 (no coverage) to 3 (complete coverage). YCP grade was also scored on a 4-point scale as 0 (white) to 3 (intensive yellow). High-grade YCP was defined as maximum grade ≥2. Moreover, the prevalence of high-grade YCP and the incidence of thrombus were investigated. Results BP-DES revealed better dominant NIC grade and less NIC heterogeneity than 2G DP-DES (p = 0.0001 and p = 0.015, respectively). The prevalence of high-grade YCP was lower for BP-DES than for 2G DP-DES (p = 0.05). However, the incidence of thrombus was not significantly different (p = 0.41). Multivariate analysis identified that low-density lipoprotein cholesterol levels [odds ratio (OR), 1.03; 95% Confidence Interval (CI): 1.01–1.06, p = 0.01] and the usage of BP-DES [OR, 0.36; 95% CI: 0.14–0.91, p = 0.03] as independent predictors of high-grade YCP. Conclusions Compared with 2G DP-DES, BP-DES was less heterogeneous and well-covered NIC and less prevalence of the high-grade YCP implying optimal arterial healing.

The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) has been the focus of much discussion. The risk of late stent thrombosis appears less with newer-generation stents, and polymer-free drug-coated stents (DCS) may improve clinical efficacy relative to a bare metal stent without the potential long-term hazards associated with a durable polymer. Based on the outcomes of recent clinical trials, risk stratification to identify high bleeding risk patients and appropriate selection of a polymer-free drug-coated or durable-polymer zotarolimus-eluting stent may optimize clinical outcomes in patients who require an abbreviated DAPT regimen.

Objectives The aim of this study was to compare late-term clinical outcomes among patients treated with ultrathin-strut (60-μm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and ...

Biodegradable polymer sirolimus-eluting stents (BP-SES) are superior to durable polymer everolimus-eluting stents (DP-EES) with respect to target lesion failure (TLF) at 1 year in patients with ST-segment elevation myocardial infarction (STEMI) ([1][1]). Beyond the biodegradable polymer, BP-SES

Objectives: The authors aimed to compare long-term data of an ultrathin cobalt-chromium stent with passive silicon carbide coating and an active biodegradable polymer that releases sirolimu...

Summary Background The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention. Methods BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946. Findings Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI −6·84 to −0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency −2·6% [95% credible interval −5·5 to 0·1], non-inferiority margin 3·85%, n=2208). Interpretation The outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology. Funding BIOTRONIK.

Objectives This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention. Background Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce. Methods The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization. Results Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17). Conclusions The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population.

The authors sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) to second-generation durable polymer drug-eluting stents (DP-DES).Prior meta-analyses have established the superiority of BP-DES over bare-metal stents and first-generation DP-DES; however, their advantage compared with second-generation DP-DES remains controversial.The authors searched PubMed and Scopus databases for RCTs comparing BP-DES to the second-generation DP-DES. Outcomes included target vessel revascularization (TVR) as efficacy outcome and cardiac death, myocardial infarction (MI), and definite or probable stent thrombosis (ST) as safety outcomes. In addition, we performed landmark analysis for endpoints beyond 1 year of follow-up and a subgroup analysis based on the stent characteristics.The authors included 16 RCTs comprising 19,886 patients in the meta-analysis. At the longest available follow-up (mean duration 26 months), we observed no significant differences in TVR (p = 0.62), cardiac death (p = 0.46), MI (p = 0.98), or ST (risk ratio: 0.83, 95% confidence interval: 0.64 to 1.09; p = 0.19). Our landmark analysis showed that BP-DES were not associated with a reduction in the risk of very late ST (risk ratio: 0.87, 95% confidence interval: 0.49 to 1.53; p = 0.62). Similar outcomes were seen regardless of the eluting drug (biolimus vs. sirolimus), the stent platform (stainless steel vs. alloy), the kinetics of polymer degradation or drug release (6 months vs.6 months), the strut thickness of the BP-DES (thin 100 μm vs. thick100 μm), or the DAPT duration (≥6 months vs. ≥12 months).BP-DES have similar safety and efficacy profiles to second-generation DP-DES.

Biodegradable polymer (BP)-coated drug-eluting stents (DES) were developed to try to accelerate vessel healing and potentially allow a shorter period of mandatory dual-antiplatelet therapy (DAPT) compared with patients treated with durable polymer (DP)-coated DES. The optimal duration of DAPT after

Purpose The BIOFLOW-VI (Biotronik–Safety and Clinical Performance of the Drug Eluting Orsiro Stent in the Treatment of Subjects With De Novo Coronary Artery Lesions–VI) study evaluates the angiographic efficacy, clinical safety, and effectiveness of the ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES) compared with a durable polymer everolimus-eluting stent (DP-EES). This randomized controlled clinical trial was designed to enable approval of new drug-eluting stents in China. Methods A total of 440 eligible patients from 11 sites with up to 2 de novo native coronary artery lesions were randomly assigned to receive either BP-SES (n = 220) or DP-EES (n = 220) from July 2014 to September 2016 in this prospective, multicenter, noninferiority trial. Findings The primary end point of 9-month in-stent late lumen loss (LLL) was 0.05 (0.02) mm in the BP-SES group versus 0.07 (0.02) mm in the DP-EES group, with a mean difference of −0.02 mm (95% CI, −0.06 to 0.03; P = 0.44; Pnoninferiority Implications The randomized BIOFLOW-VI trial showed that BP-SES was noninferior to DP-EES with regard to the primary end point of 9-month in-stent LLL in a Chinese population. ClinicalTrials.gov Identifier: NCT02870985

Emerging clinical trial data in STEMI patients support using an ultra-thin strut biodegradable polymer sirolimus eluting stent (BP-SES), ‘Orsiro’, over contemporary second-generation durable polymer drug eluting stents (DP-DES) however the net clinical outcomes in all-comers is unknown. We

Long term outcomes of biodegradable polymer drug-eluting stents (BP-DES) compared to durable polymer drug-eluting stents (DP-DES), are not well described. A comprehensive search in clinicalTrials.gov, PubMed, EBSCO, Web of Science, google scholar and Ovid was performed for RCTs comparing BP-DES and

Newer-generation drug-eluting stents (DES) reduce mortality and late stent thrombosis compared with bare metal stents and early generation DES. Recent randomized controlled trials (RCT) showed reduction in target lesion revascularization with ultrathin biodegradable-polymer (BP) stents but similar

Drug-eluting stents (DESs) have improved the outcomes of acute myocardial infarction patients (AMI) patients, however, the risk of late stent thrombosis with DES due to delayed healing of vessel wall is still considerable. The aim of this study was to compare the safety and efficacy of biodegradable

Among patients with acute ST-segment elevation myocardial infarction (STEMI), early-generation drug-eluting stents (DES) have been associated with a reduction in target-vessel revascularization compared with bare-metal stents after primary percutaneous coronary intervention. However, this early

Objectives The aim of this study was to investigate the hypothesis that a novel biodegradable polymer–coated, cobalt-chromium (CoCr), sirolimus-eluting stent (BP-SES) is noninferior in safety and efficacy outcomes compared with a durable polymer (DP)-SES. Background No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms, thereby isolating the effect of the polymer type. Methods In this prospective, single-blind, randomized trial conducted at 32 Chinese sites, 2,737 patients eligible for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. The primary endpoint was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. Secondary endpoints included TLF components, and definite/probable stent thrombosis. Results At 12 months, the difference in the primary endpoint of TLF between BP-SES (6.3%) and DP-SES (6.1%) groups was 0.25% (95% confidence interval: −1.67% to 2.17%, p for noninferiority = 0.0002), demonstrating noninferiority of BP-SES to DP-SES. Individual TLF components of cardiac death (0.7% vs. 0.6%, p = 0.62), target vessel myocardial infarction (3.6% vs. 4.3%, p = 0.39), and clinically indicated target lesion revascularization (2.6% vs. 2.2%, p = 0.50) were similar, as were low definite/probable stent thrombosis rates (0.4% vs. 0.6%, p = 0.55). Conclusions In this large-scale real-world trial, BP-SES was noninferior to DP-SES for 1-year TLF. (Evaluate Safety and Effectiveness of the Tivoli ® DES and the Firebird ® DES for Treatment of Coronary Revascularization; NCT01681381 )

Objective The long-term coronary arterial response of biodegradable polymer biolimus-eluting stents (BES) remains unclear. We sought to evaluate the coronary arterial response of biodegradable polymer BES at 5 years after stent implantation using optical coherence tomography (OCT) as compared with that of durable polymer sirolimus-eluting stents (SES) and bare-metal stents (BMS). Methods Five-year follow-up OCT was performed in 30 patients with 33 stents (10 with 12 BES; 10 with 11 SES; 10 with 10 BMS). Quantitative parameters and qualitative characteristics of the neointima were evaluated. A total of 5178 struts (BES, n = 2056; SES, n = 1410; BMS, n = 1712) were analyzed. Results Uncovered struts were found in 15 out of 2055 struts in the BES (weighted estimate 0.01%, 95% confidence intervals [CI]: 0.00–0.33%) and 54 out of 1410 struts in the SES (0.11%, 95% CI: 0.00–3.33%) (odds ratio [OR] 0.12, 95% CI: 0.01–1.95, p = 0.13). None of 1712 struts were uncovered in the BMS. Cross-sectional qualitative analysis of neointimal tissue showed that the frequency of lipid-laden neointima tended to be lower in the BES (2.26%, 95% CI: 0.38–12.3%) compared with the SES (9.90%, 95% CI: 4.37–20.9%; OR 0.21, 95% CI 0.03–1.16, p = 0.07), and was similar to the BMS (2.23%, 95% CI: 0.54–8.74%; OR 0.98, 95% CI 0.13–7.14, p = 0.98). Conclusions Biodegradable polymer BES shows a favorable coronary arterial response compared with SES, but different response with BMS at 5 years follow-up. The observed frequency of in-stent neoatherosclerosis within BES was similar to BMS and tended to be lower than SES.

The use of biodegradable-polymer drug-eluting stents (BP-DES) has been associated with early endothelialization and improved vascular healing. The authors aim to study the real-world clinical outcome of patients who received BP-DES versus second-generation durable-polymer drug-eluting stents (DP-DES

The data on efficacy and safety of the newer resolute-Onyx zotarolimus-eluting stents (R-ZES) in routine clinical practice are limited. The authors sought to compare clinical outcomes between the R-ZES and durable polymer everolimus-eluting stent (DP-EES) in patients who underwent percutaneous

Despite improvements in the platforms of new generation drug-eluting stents (DESs), late stent failure remains a potential concern given that patients can have hypersensitivity reactions to durable polymers (DPs). To overcome this shortcoming, DESs containing biodegradable polymers (BPs) have been

The recent BIOFLOW V trial (ClinicalTrials.gov: [NCT02389946][1]) showed that the Orsiro ultrathin, bioresorbable polymer sirolimus-eluting stent (BP SES) (BIOTRONIK, Buelach, Switzerland) was in statistical favor to the Xience thin, durable polymer everolimus-eluting stent (DP EES) (Abbott Vascular

Delayed strut coverage is an important risk factor for stent thrombosis. The endothelialization rate of bioresorbable polymer drug-eluting stents (BP DES) may be better compared to durable polymer 2nd generation drug eluting stents (DP DES). We pooled data from all optical coherence tomography (OCT

A recent meta-analysis showed better five-year clinical outcomes of biodegradable polymer drug-eluting stents (BP-DES) as compared to the first-generation durable polymer DES (DP-DES). However, long-term data in comparison with the second-generation DP-DES is still scarce. The present systematic

Drug-eluting stents (DES) have improved the outcomes of acute myocardial infarction patients (AMI) patients; however, the risk of late stent thrombosis with DES due to delayed healing of the vessel wall is still considerable. The aim of this study was to compare the safety and efficacy of

The recent BIOFLOW V trial (ClinicalTrials.gov: [NCT02389946][1]) showed that the Orsiro ultrathin, bioresorbable-polymer sirolimus-eluting stent (BP SES) (Biotronik, Buelach, Switzerland) had lower rates of both clinically driven target lesion revascularization (TLR) and target vessel-related

The Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) is designed to reduce chronic adverse cardiovascular events that may occur from the permanent presence of a metallic stent and/or durable polymer. The systemic pharmacokinetic (PK) profile of BVS has not been

A new generation of drug eluting coronary stents are undergoing clinical trial evaluation and being introduced into clinical practice. These technologies comprise a broad range of innovations and include non-polymeric stents, biodegradable polymer coated stents and fully biodegradable scaffolds. The new devices are designed to improve long-term safety and efficacy and overcome limitations associated with a durable polymer and a persistent metallic stent scaffold. At the present time, none have demonstrated convincing superiority over current second generation drug eluting stents and large, long-term randomised controlled trials are required.

Current metallic stents safeguard vessel patency, but long term complications include in-stent thrombosis. Theoretically, bioresorbable scaffolding should reduce the risk of in-stent thrombosis while maintaining early vessel patency. A meta-analysis of the available randomized control trials.

Presence of durable polymers may be associated with late/very late stent thrombosis occurrence and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. We sought to determine the 1-year clinical follow-up in patients

The increased risk of late ischemic events with drug eluting stents (DES) may, in part, be due to persistent inflammation and delayed vascular healing induced by their durable polymer (DP) coating. Biodegradable-polymer (BP-) and polymer-free (PF-) DES were developed in an attempt to mitigate this

Patients with diabetes mellitus (DM) are subjected to adverse outcome following PCI. Randomized, controlled trials have demonstrated comparable clinical outcomes of the bioresorbable polymer sirolimus-eluting stent (BP SES) with a thin strut durable polymer everolimus-eluting stent (DP-EES) that has

Pre-clinical results of a novel open-cell, thin strut, durable polymer, laser cut cobalt chromium sirolimus-eluting stent (Angiolite) were promising. We evaluated the 24-month clinical outcomes associated with percutaneous coronary intervention (PCI) with the Angiolite stent. This was a prospective

Coronary drug-eluting stent development has included new metal alloys, changes in stent architecture and bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been demonstrated in prior randomized trials. BIOFLOW V ([ClinicalTrials.gov][1] [NCT02389946][2

The aim of this study is to compare the safety and efficacy of the biodegradable polymer coated sirolimus-eluting coronary stent (SES, BioMime™, Meril Life Sciences, India) with durable polymer coated everolimus-eluting coronary stent (EES, XIENCE family, Abbott Vascular, California, USA) in de

The trees of the species Rhus vernicifera, Rhus succedanea and Melanorrhoea usitate grow in various regions of Asia and their sap is used, for thousands of years, as coating materials for the most varied kinds of objects. After drying, the sap of these trees forms a very hard and durable polymer, commonly known as oriental lacquer. The sap consists of water, polysaccharides, glycoproteins, enzymes and a mixture of derivatives of catechol whose composition differs with the species. In this work, pyrolysis-gas chromatography/mass spectrometry (Py-GC/MS) was applied successfully to the identification of these species through the analysis of their saps. The saps of the three species of lacquer trees were studied and the method developed was applied to identify a tree whose species was unknown. Results show that pyrolysis is an alternative and efficient technique to identify the species of lacquer trees.

Polymer-free drug-eluting stents(PF-DES) were developed to mitigate the risk of late ischemic events observed with durable-polymer DES (DP-DES). However, trial results are inconsistent with longer-term safety and efficacy of PF-DES unknown. We performed a meta-analysis of randomized controlled