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Background: Large-scale randomized comparison of drug-eluting stents (DES) based on durable polymer versus biodegradable polymer technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study aimed to prove the noninferiority of the durable polymer DES (DP-DES) compared with the biodegradable polymer DES (BP-DES) in such patients. Methods: The HOST-REDUCE-POLYTECH-ACS (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases—Comparison of Reduction of Prasugrel Dose or Polymer Technology in ACS Patients) trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, noninferiority trial comparing the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary end point was a patient-oriented composite outcome (a composite of all-cause death, nonfatal myocardial infarction, and any repeat revascularization) at 12 months. The key secondary end point was device-oriented composite outcome (a composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization) at 12 months. Results: A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, patient-oriented composite outcome occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (absolute risk difference, –1.2%; P non inferiority P =0.038), mostly because of a reduction in target lesion revascularization. The rate of spontaneous nonfatal myocardial infarction and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% versus 0.8%; P =0.513 and 0.1% versus 0.4%; P =0.174, respectively). Conclusions: In ACS patients receiving percutaneous coronary intervention, DP-DES was noninferior to BP-DES with regard to patient-oriented composite outcomes at 12 months after index percutaneous coronary intervention. Registration: URL: https://wwwclinicaltrials.gov ; Unique identifier: NCT02193971.

PURPOSE OF REVIEW: The current article will review recently published clinical studies that evaluate very thin or ultrathin-strut drug-eluting stents (DES), focusing on major randomized clinical trials in broad patient populations. RECENT FINDINGS: Multiple randomized trials recently assessed the clinical performance of novel very thin to ultrathin-strut DES. Most randomized trials established noninferiority of the novel device. To date, only one major randomized clinical trial (i.e., BIOFLOW V) showed superiority of an ultrathin-strut biodegradable polymer-coated sirolimus-eluting stent over a very thin-strut durable polymer-coated everolimus-eluting stent in a relatively broad patient population. There are signals that the same ultrathin-strut biodegradable polymer-coated sirolimus-eluting stent may improve clinical outcome in specific patient populations. For example, in the randomized BIOSTEMI trial, 1-year superiority of the ultrathin-strut DES was found in patients presenting with an acute ST-segment elevation myocardial infarction. Yet, substudies of large randomized trials that assessed patients with small-vessel treatment showed equivocal results. SUMMARY: Although two randomized trials showed advantages for ultrathin-strut DES, other clinical trials provided no significant evidence that ultrathin-strut DES improve clinical outcome. The question whether ultrathin-strut DES may reduce the repeat revascularization risk following implantation in small vessels is a matter of further debate and future research.

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 ...

Aims The Firehawk is a thin-strut coronary stent with a sirolimus and biodegradable polymer complex that are localized in abluminal grooves. The TARGET All Comers study found similar safety and efficacy of the Firehawk compared with the durable polymer everolimus-eluting XIENCE stent at 1- and 2-years follow-up. The aim of this study was to assess comparative clinical outcomes at 3 years. Methods and results The TARGET All Comer study is a prospective, multicenter, randomized, non-inferiority trial. A total of 1653 patients were randomly allocated to receive either the Firehawk or XIENCE stent. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization. At 3-year follow-up, TLF occurred in 11.9% in the Firehawk group and 11.5% in the XIENCE group (p=0.84). The event rates of individual components of TLF were comparable for the 2 groups. Landmark analyses between 1 and 3 years showed no significant difference of TLF for the Firehawk versus XIENCE stent. The incidence of very late definite or probable stent thrombosis was 0.8% in the Firehawk group and 1.4% in the XIENCE group (p=0.24). Conclusions The 3-year follow-up of the TARGET All Comers study showed comparable safety and efficacy profiles of the biodegradable polymer Firehawk and the durable polymer XIENCE stent.

Background Invasive angiography with subsequent revascularization is a widely used treatment method in patients with coronary heart disease. Although biodegradable polymer drug eluting stents (BP-DES) have been used for almost a decade now, clinical trials regarding their long-term outcomes are both sparse and inconsistent. We aimed to compare the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) with BP-DES versus durable polymer drug eluting stents (DP-DES). Methods Among 11,517 PCIs with second generation drug eluting stents preformed in our institution between 2007 and 2019, we identified 8042 procedures performed using DP-DES and 3475 using BP-DES. The primary outcome was the composite of all-cause mortality, recurrent myocardial infarction (re-MI), target vessel revascularization (TVR) and coronary artery bypass grafting (CABG). Propensity score matching was used to create a well-balanced cohort. Results Mean follow up was 4.8 years. Of the 3,413 matched pairs, 21% were females, and the mean age was 66. At one year, the primary outcome occurred in 9.6% patients versus 8.3% (p=0.05), and TVR rate was 4.1% versus 3% (p=0.005) in patients with DP-DES and BP-DES respectively. Within 5 years, the primary outcome occurred in in 24.9% versus 24.8% (p=0.83), and the rate of TVR was 9.8% versus 9.1% (p=0.07) in patients with DP-DES and BP-DES respectively. Conclusions Similar rates of the composite outcome were observed throughout the entire follow-up. TVR rates were lower in the DP-DES group at 1-year but equalized within 5 years. Funding Acknowledgement Type of funding sources: None.

Background Polymer-free (PF) stents were designed as an alternative to durable-polymer (DP) drug-eluting stents to minimize the time on dual antiplatelet treatment for patients at high-risk of bleeding. Nonetheless, the efficacy and safety of PF vs. DP stents in patients undergoing percutaneous coronary intervention (PCI) remain controversial. Methods We performed a metanalysis with currently available studies that assessed the effect of PF-stents vs. DP-stents after performing a systematic search. The endpoints analyzed were all-cause death, myocardial infarction, target lesion revascularization (TLR) and probable or definite stent thrombosis. The raw numbers of incident end-points reported in each study were used. We performed analyses in short and long term (1 year follow-up) studies. Results We included 12464 patients from 8 studies (5 short-term and 3 long-term): 6723 treated with PF-stents and 5741 with DP stents. Females represented 23.3% (n=3284) and 33.7% (n=4202) were included in the setting of acute coronary syndromes. As shown in the figure, PF-stents were associated to lower incidence of all-cause mortality (HR: 0.91 95% CI 0.84–0.98; p=0.016) and TLR (HR: 0.88 95% CI 0.80–0.96; p=0.003). No differences were observed in the risk of cardiovascular death (HR: 0.96 95% CI 0.86–1.06 p=0.415), myocardial infarction (HR: 0.90 95% CI 0.80–1.01; p=0.061) or probable-definite stent thrombosis (HR: 0.92 95% CI 0.74–1.14; p=0.447). Finally, no differences in the primary end-point (HR: 0.92 95% CI 0.83–1.03; p=0.143) were detected with PF-stents vs. DP-stents. No significant heterogenicity was observed in any of the endpoints, except for the incidence of stent thrombosis. Conclusions Under current PCI techniques the use of PF-stent might be associated to better outcomes, especially in terms of all-cause mortality and TLR. Funding Acknowledgement Type of funding sources: None.

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

Introduction: The increasing complexity of patients undergoing percutaneous coronary intervention (PCI) regarding both coronary anatomy and comorbidities requires dedicated devices. The Resolute Onyx (R-Onyx, Medtronic, CA, USA) stent is a novel durable polymer zotarolimus-eluting stent (ZES) promising better deliverability, increased radiopacity and lower thrombogenicity.Areas covered: In this review, we discuss device features, preclinical evidence, and clinical studies including patients treated with R-Onyx. The BIONYX and Onyx ONE studies were two major landmark trials demonstrating non-inferiority of R-Onyx as compared to other latest generation devices. We also elaborate on alternative innovations in drug-eluting stent (DES) technology and how R-Onyx fits into this field.Expert opinion: R-Onyx is designed to address the challenges of contemporary PCI, but evidence on its clinical performance is largely derived from studies on older generation devices from the ZES family. Nonetheless, all clinical studies on R-Onyx consistently show excellent outcomes, with particularly low rates of stent thrombosis, making it a promising candidate for short dual antiplatelet regimens. In addition, R-Onyx is available with a wide range of stent diameters allowing accurate sizing for both very small and very large coronary vessels.

Background Extended long‐term follow‐up data of new‐generation drug‐eluting stents in patients with diabetes mellitus is scant. The aim of this study is to assess the 10‐year clinical outcome of new‐generation biodegradable polymer‐based sirolimus‐eluting stents (Yukon Choice PC) versus permanent polymer‐based everolimus‐eluting stents (XIENCE) in patients with and without diabetes mellitus. Methods and Results In a prespecified subgroup analysis, outcomes of patients with or without diabetes mellitus treated with drug‐eluting stents were compared. The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The analysis includes a total of 1951 patients (560 patients with and 1391 patients without diabetes mellitus) randomized to treatment with Yukon Choice PC (n=1299) or Xience (n=652). Regarding the primary end point, at 10 years patients with diabetes mellitus showed significantly higher major adverse cardiac event rates than patients without diabetes mellitus ( P P =0.91; HR, 1.01; 95% CI, 0.79–1.30) nor without diabetes mellitus ( P =0.50; HR, 0.94; 95% CI, 0.79–1.21). Rates of definite/probable stent thrombosis were 2.3% in patients with and 1.9% in patients without diabetes mellitus (HR, 1.27; 95% CI, 0.34–2.60; P =0.52), without significant differences between study devices. Conclusions The clinical outcome of patients with diabetes after percutaneous coronary intervention with different new‐generation drug‐eluting stents is considerably worse than that of patients without diabetes mellitus, with event rates constantly increasing out to 10 years. Registration URL: https://clinicaltrials.gov . Unique Identifier: NCT00598676.

Aims We aimed to compare the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) with biodegradable polymer drug-eluting stents (BP-DES) versus durable polymer drug-eluting stents (DP-DES). Methods and results Among 11 517 PCIs with second-generation DES performed in our institution between 2007 and 2019, we identified 8042 procedures performed using DP-DES and 3475 using BP-DES. The primary outcome was target lesion failure, the composite target lesion revascularization (TLR), target vessel myocardial infarction and death. Propensity score matching was used to create a well-balanced cohort. Mean follow-up was 4.8 years. Of the 3413 matched pairs, 21% were females, and the mean age was 66 years. At 1 year, the primary outcome occurred in 8.3% patients versus 7.1% (P = 0.07), and TLR rate was 3% versus 2% (P = 0.006) in patients with DP-DES and BP-DES respectively. Within 5 years, the primary outcome occurred in 23.1% versus 23.4% (P = 0.44), and the rate of TLR was 7.2% versus 6.5% (P = 0.07) in patients with DP-DES and BP-DES, respectively. Conclusion Similar rates of the composite outcome were observed throughout the entire follow-up. target vessel revascularization rates were lower in the DP-DES group at 1 year but equalized within 5 years.

Background: Uncertainty exists over whether stents commonly used for percutaneous coronary intervention have comparable short- and long-term safety. The objective of this study was to determine the outcomes of patients treated with bioabsorbable polymer everolimus-eluting (BP-EES; Synergy, Boston Scientific), durable polymer everolimus-eluting (DP-EES; XIENCE, Abbott Vascular), or durable polymer zotarolimus-eluting (DP-ZES; Resolute, Medtronic) stents in routine clinical practice. Methods: All percutaneous coronary intervention cases from 48 hospitals performed after the introduction of the BP-EES stent in 2015 until the first quarter of 2018 were included. Propensity-matched multivariable analysis was used to adjust for differences in baseline characteristics and procedural variables. After matching, we performed pair-wise comparisons between DP-EES and BP-EES, DP-EES and DP-ZES, and BP-EES and DP-ZES for in-hospital postpercutaneous coronary intervention outcomes. We also evaluated 2-year postdischarge mortality in a subset of patients who could be matched to Medicare data. Results: During the study period, 53 724 percutaneous coronary intervention cases were performed. A total of 59% of patients were treated with DP-EES stents, 14% with BP-EES stents, and 27% with DP-ZES stents. Although baseline characteristics of patients differed between stent types, these differences were attenuated after matching. In the matched cohort, there was no difference in in-hospital mortality, stent thrombosis, or postprocedural stroke (a falsification end point) between BP-EES, DP-EES, and DP-ZES. After matching, there was no difference in 2-year postdischarge mortality (DP-EES versus BP-EES hazard ratio 0.91, P =0.50; DP-EES versus DP-ZES hazard ratio 1.03, P =0.77; BP-EES versus DP-ZES hazard ratio 1.20, P =0.29). Conclusions: Our data suggest similar risk-adjusted in-hospital outcomes among drug-eluting stent platforms commonly used in clinical practice. The absence of a difference in 2-year mortality between BP-EES, DP-EES, and DP-ZES suggests that stent choice decisions could be made based on other factors, including durability, availability, and cost.

Background Newest generation drug-eluting stents (DES) combining ultrathin cobalt chromium platforms with biodegradable polymers may reduce target lesion failure (TLF) as compared to second generation DES among patients with acute coronary syndrome (ACS). While previous studies indicated a potential benefit within the first two years after percutaneous coronary intervention (PCI), it remains uncertain whether the clinical benefit persists after complete degradation of the polymer coating. Purpose To compare the long-term effects of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer everolimus-eluting stents (DP-EES) for PCI in patients with ACS. Methods We performed a subgroup analysis of ACS patients included into the BIOSCIENCE trial (NCT01443104), a randomized trial comparing BP-SES with DP-EES. The primary endpoint of the present post-hoc analysis was TLF, a composite of cardiac death, target vessel myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR), at 5 years. Results Among 2,119 patients enrolled between March 2012 and May 2013, 1,131 (53%) presented with ACS (ST-segment elevation myocardial infarction, 36%). Compared to patients with stable CAD, ACS patients were younger, had a lower baseline cardiac risk profile, including a lower prevalence of hypertension, hypercholesterolaemia, diabetes mellitus, and peripheral artery disease, and had a greater incidence of previous revascularization procedures. At 5 years, TLF occurred similarly in 89 patients (cumulative incidence, 16.9%) treated with BP-SES and 85 patients (16.0%) treated with DP-EES (RR 1.04; 95% CI 0.78–1.41; p=0.78) in patients with ACS, and in 109 patients (24.1%) treated with BP-SES and 104 patients (21.8%) treated with DP-EES (RR 1.11; 95% CI 0.85–1.45; p=0.46) in stable CAD patients (p for interaction=0.77) (Figure 1, Panel A). Cumulative incidences of cardiac death (8% vs. 7%; p=0.66), target vessel MI (5.2% vs. 5.8%; p=0.66), clinically indicated TLR (8.9% vs. 8.3%; p=0.63) (Figure 1, Panel B-D), and definite thrombosis (1.4% vs. 1.0%; p=0.57) at 5 years were similar among ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between clinical presentation and treatment effect of BP-SES versus DP-EES. Conclusion In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term clinical outcomes between ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES at five years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Unrestricted research grant to the institution from Biotronik AG, Switzerland

Background New-generation biodegradable-polymer platinum chromium everolimus-eluting stent (BP-PtCr-EES) is available, which has different polymer and alloy compare to more established stent design, a durable-polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES). Purpose To compare neointimal coverage (NIC) between BP-PtCr-EES and DP-CoCr-EES by using coronary angioscopy (CAS). Methods A total of 36 patients (44 stents) with BP-PtCr-EES or DP-CoCr-EES who underwent CAS at 1 year after stenting were investigated. We compared angioscopic findings assessed by angioscopy between BP-PtCr-EES (n=18) and DP-CoCr-EES (n=26). NIC grade and yellow plaque grade (YPG) was adopted from earlier reports from grade 0 to 3. We determined maximum (max-) and minimum (min-) NIC grade and heterogeneity score (HGS = max NIC grade minus min NIC grade). We also assessed YPG and the presence of thrombus (TH). Results Six lesions (33.3%) in BP-PtCr-EES group and 7 (26.9%) lesions in DP-CoCr-EES group were culprit lesions of acute coronary syndrome, which did not statistically differ between the two groups (p=0.74). And there were no significant differences in stent diameter (BP-PtCr-EES: 2.97±0.39 mm vs DP-CoCr-EES: 3.14±0.45 mm, p=0.22) and length (BP-PtCr-EES: 26.9±7.9 mm vs DP-CoCr-EES: 28.4±8.0 mm, p=0.54). In terms of CAS findings, BP-PtCr-EES group has better neointimal coverage than DP-CoCr-EES group (max NIC grade: 2.6±0.7 vs 2.0±0.9, p=0.01. min NIC grade: 1.1±0.8 vs 0.5±0.5, p Conclusion Superior neointimal coverage and less YPG or TH were observed by CAS in the BP-PtCr-EES group at 1 year after stenting. Clinical significance was still unknown because of no clinical events in both groups. Prospective and large populations studies may be required. Funding Acknowledgement Type of funding source: None

Background The difference of chronic neointimal conditions of biodegradable polymer-coated and durable polymer-coated drug-eluting stent have not been well investigated. Objective We aimed to compare the angioscopic findings among SYNERGY biodegradable polymer-coated everolimus-eluting stent (BP-EES), ULTIMASTER biodegradable polymer-coated sirolimus-eluting stent (BP-SES), and XIENCE Alpine durable polymer-coated everolimus-eluting stent (DP-EES) 8 months after stent implantation. Methods Patients who underwent implantation of BP-EES (n = 30), BP-SES (n = 26), or DP-EES (n = 21) in Osaka Rosai Hospital from December 2015 to April 2017 were retrospectively enrolled. Coronary angioscopic evaluation including dominant grade of neointimal coverage (NIC) over the stent, maximum yellow plaque grade, and existence of red thrombi were performed 8 months after stent implantation. The incidence of major adverse cardiac events (MACE) including cardiac death, nonfatal myocardial infarction, and target vessel revascularization were assessed 1 year after coronary angioscopic evaluation among the three groups. Results The patient and lesion characteristics were similar among the three groups. Dominant grade of NIC and maximum yellow plaque grade were not significantly different among BP-EES, BP-SES, and DP-EES groups [mean ± SD, 1.50 ± 0.73, 1.58 ± 0.64, and 1.33 ± 0.48 (P = 0.38) and 0.83 ± 0.59, 0.81 ± 0.75, and 0.95 ± 0.38 (P = 0.68), respectively]. The existence of red thrombi was similar among the three groups [20, 12, and 19% (P = 0.67)]. There was no significant difference in the MACE 1 year after coronary angioscopic evaluation among the three groups [0, 8, and 0% (P = 0.13)]. Conclusions Coronary angioscopic findings revealed that BP-EES, BP-SES, and DP-EES produced similar favorable NIC 8 months after stent implantation.

The purpose of this study was to evaluate the vessel healing status 3 months after stent implantation of bioresorbable-polymer drug-eluting stents (BP-DESs) in comparison with durable-polymer DESs (DP-DESs) by angioscopy. Study design was a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful angioscopic examination at planned 3-month follow-up after the DES implantation in the native coronary artery were enrolled. We evaluated main, maximum, minimum strut coverage grades and coverage heterogeneity score defined as a difference between maximum and minimum coverage grades. All lesions were divided into three segments: proximal, mid, and distal segments. A total of 108 patients (66.6 ± 10 years) with 124 lesions were analyzed (BP-DES 57 patients 61 lesions 226 segments vs. DP-DES 57 patients 63 lesions 203 segments; six patients had both BP-DES and DP-DES). Patient and lesion demographics, procedural characteristics were well balanced. Main coverage grade (mean ± standard error; 1.08 ± 0.02 vs. 1.05 ± 0.03, p = 0.354) and minimum coverage grade (1.00 ± 0.00 vs. 1.00 ± 0.00, p > 0.999) were not significantly different between BP-DES and DP-DES groups. Maximum coverage grade was significantly higher in the BP-DES than in the DP-DES (1.45 ± 0.04 vs. 1.35 ± 0.04, p = 0.049). Coverage heterogeneity score did not differ between BP-DES and DP-DES groups (1.05 ± 0.07 vs. 0.90 ± 0.07, p = 0.162). At 3-month follow-up, the current BP-DES had higher maximum stent coverage than the contemporary DP-DES, while main and minimum coverage grades and heterogeneity of the neointimal coverage were comparable. Further prospective randomized trials should be conducted to evaluate the clinical significance of the present imaging results.

Coronary percutaneous interventions have evolved from plain old balloon angioplasty (POBA) to stent implantation, which itself evolved from bare-metal stents (BMS) to the new biodegradable stents which try to restore endothelial function. Currently, the most commonly used stent is the everolimus-eluting stent.This review will cover the current status of durable polymer everolimus-eluting stent, its history, and future perspectives. Nowadays, the everolimus-eluting stent is the most used device in the acute and chronic settings due to its safety and efficacy.Durable polymer everolimus-eluting stent, supported by much evidence, has demonstrated its efficacy and safety, not only in de novo artery lesions, but in multiples scenarios, such as the acute setting and diabetic population, becoming one of the most polyvalent stents available. Nowadays, research is focused on the reduction of antiplatelet treatment duration. Similar rates of stent thrombosis with short dual antiplatelet treatment regimens of 1 to 3 months compared to pronged treatment have been observed. However, specific studies should be performed to evaluate this possibility.

Coronary artery stenting is the treatment of choice for patients requiring coronary angioplasty. We describe the major advancements with this technology. There have been significant developments in the design of stents and adjunctive medical therapies. Newer-generation drug-eluting stents (DES) have almost negligible restenosis rates and, when combined with proper anti-platelet treatment and optimal deployment, a low risk of stent thrombosis. The introduction of newer-generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new antiproliferative agents has further improved the safety profile of early-generation DES. In parallel the effectiveness has been kept, with a significant reduction in the risk of target lesion revascularization compared with the early-generation DES. However, to date, the development of completely bioresorbable vascular scaffolds has failed to achieve further clinical benefits and has been associated with increased thrombosis. Newer-generation DES-including both durable polymer as well as biodegradable polymer-have become the standard of care in all patient and lesion subsets, with excellent long-term results.

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.

New-generation drug-eluting stents (DES) represent the current standard of care in patients undergoing percutaneous coronary intervention (PCI). Biodegradable polymer DES (BP-DES) were recently developed to overcome current limitations of newer-generation durable polymer DES (DP-DES) attributed to sustained inflammatory responses induced by permanent polymers. The Orsiro DES (Biotronik AG, Bülach, Switzerland) is a novel thin-strut cobalt-chromium sirolimus-eluting stent with biodegradable polymer that features some of the latest developments in DES technology. Areas covered: This article aims to review the currently available evidence on the clinical performance of the Orsiro BP-DES and its future perspectives. Expert commentary: The Orsiro DES is a recent newer-generation BP-DES that combines a highly deliverable thin-strut cobalt-chromium stent platform and a unique hybrid concept with passive and active coatings designed to enhance tissue biocompatibility. In preclinical and intravascular imaging studies, the Orsiro BP-DES was shown to induce low inflammation and promote very early arterial healing. Recently, large randomized non-inferiority clinical trials have shown similar short- and mid-term efficacy and safety outcomes with Orsiro BP-DES compared with currently established newer-generation DES among all-comers and high-risk subgroups. The potential clinical superiority of Orsiro BP-DES over Xience DP-DES in patients with STEMI is currently investigated in the BIOSTEMI trial (NCT02579031).

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 Resolute zotarolimus eluting stent (ZES) is a next-generation durable polymer, thin-struts drug eluting stent. Although several randomized and observational studies have proven its safety and efficacy, long-term follow-up data are still limited. This prospective, multicenter, single arm study, showed favorable 5-year outcomes in patients undergoing Resolute ZES implantation, with considerably low rate of repeated revascularization and stent thrombosis. Data on long-term performance of next-generation drug eluting stents are of paramount importance to adequately inform decision-making in contemporary clinical practice.

Background: Long-term outcomes in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention with a drug-eluting stent are unclear. Therefore, we aimed to evaluate long-term adverse events in HBR patients undergoing percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent implantation. Methods: We analyzed stratified data from 4 all-comers postapproval registries. Patients with at least 1 of the following criteria were categorized as HBR: age ≥75 years, history of major bleeding (MB), history of stroke, chronic oral anticoagulant use, chronic kidney disease, anemia, or thrombocytopenia. Additionally, in a separate analysis, patients were categorized according to the recently published Academic Research Consortium HBR criteria. The Kaplan-Meier method was used for time-to-event analyses. Coronary thrombotic events (CTE) included myocardial infarction or definite/probable stent thrombosis. MB was defined according to the TIMI (Thrombolysis in Myocardial Infarction) or GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) scales. Impact of CTE and MB on subsequent risk of mortality was assessed using multivariable Cox regression with MB and CTE included as time-updated covariates. Results: Of the total 10 502 patients included, 3507 (33%) were identified as HBR. Compared with non-HBR patients, those at HBR had more comorbidities, higher lesion complexity, and a higher risk of 4-year mortality (Hazard Ratio [HR] 4.38 [95% CI, 3.76–5.11]). Results were qualitatively similar when using Academic Research Consortium criteria to define HBR. Risk of mortality was increased after CTE (HR 5.02 [95% CI, 3.93–6.41]), as well as after MB (HR 4.92 [95% CI, 3.82–6.35]). Of note, this effect was consistent across the spectrum of bleeding risk ( P -interaction test 0.97 and 0.06, respectively). Conclusions: Compared with the non-HBR population, HBR patients experienced worse 4-year outcomes after percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent. Both CTE and MB had a significant impact on subsequent risk of mortality irrespective of bleeding risk.

Background: The ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) demonstrated comparable performance to durable-polymer everolimus-eluting stent (DP-EES) in randomized controlled trials. The purpose of this study was to evaluate the performance of a BP-SES compared with a DP-EES in calcified or small vessel lesions, which represent higher risk of restenosis. Methods: From the pooled BIOFLOW (BIOFLOW-II, IV, and V; BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions ) randomized controlled trials, a total of 1553 BP-SES and 784 DP-EES patients with valid 1-year follow-up data were available. Coronary lesions were assessed for the presence of moderate-to-severe calcification or small vessels (reference vessel diameter, ≤2.75 mm) by core laboratory analysis. One-year clinical outcomes were assessed with or without the lesion subsets between BP-SES and DP-EES. Results: Baseline characteristics were similar between the groups. Among patients with small vessel disease, target lesion failure (8.0% versus 12.4%; P P P =0.056), and cardiac death (1.9% versus 0.3%; P =0.081) were numerically higher in DP-EES than in BP-SES. In the noncalcified lesion analysis, target vessel myocardial infarction in DP-EES was significantly higher than in BP-SES. Stent thrombosis was similar between the stents in both lesion groups. Conclusions: Among patients with more complex disease representing a higher risk of target lesion failure, the effectiveness of an ultrathin-strut BP-SES compared with a thin-strut DP-EES was maintained through 1 year. Registration: URL: https://www.clinicaltrials.gov . Unique identifiers: NCT01356888, NCT01939249, NCT02389946.

Background The true benefit of biodegradable polymer drug-eluting stent (BP-DES) over second-generation durable polymer drug-eluting stent (DP-DES) expected to be represented during late period of follow-up after percutaneous coronary intervention (PCI), but prior meta-analysis only evaluated short-term outcomes. Purpose We aimed to compare the long-term clinical outcomes after PCI with BP-DES versus second-generation DP-DES by a meta-analysis of randomized controlled trials. Methods Randomized controlled trials comparing BP-DES with second-generation DP-DES implantations were searched through PubMed, MEDLINE, EMBASE, and Cochrane databases. All-cause death, cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), and definite/probable stent thrombosis (ST) were compared between the groups. In addition, a landmark analysis with the landmark set at 1-year and a subgroup analysis based on stent characteristics were performed. Results Fifteen trials that included a total of 21311 randomized patients with at least 2 years follow-up were analyzed. At a median follow-up of 4.2 years, no significant differences in the risks of all-cause death (odds ratio [OR] 1.03, 95% confidence interval [CI] 0.94–1.14), cardiac death (OR 1.03, 95% CI 0.88–1.20), MI (OR 0.90, 95% CI 0.79–1.01), TVR (OR 0.96, 95% CI 0.82–1.12), TLR (OR 0.97, 95% CI 0.85–1.11), and definite/probable ST (OR 0.84, 95% CI 0.67–1.05) were found between the groups. In the 1-year landmark analysis, the rates of all-cause death (OR 1.04, 95% CI 0.93–1.17), cardiac death (OR 1.11, 95% CI 0.92–1.36), MI (OR 0.94, 95% CI 0.79–1.13), TVR (OR 0.95, 95% CI 0.73–1.23), TLR (OR 1.00, 95% CI 0.80–1.24), and definite/probable ST (OR 0.94, 95% CI 0.67–1.31) were similar between the groups. There were comparable rates of any study endpoints between the groups regardless of stent platform (stainless steel vs. alloy), the polymer degradation period (6 months) or the drug release duration (6 months) of BP-DES, or the DAPT duration (≥6 months vs. ≥12 months). However, the use of BP-DES with sirolimus eluting (OR 0.82, 95% CI 0.70–0.97), circumferential drug distribution (OR 0.79, 95% CI 0.65–0.96), thin strut (defined as Clinical outcomes Conclusions In this meta-analysis, long-term clinical outcomes were equivalent between BP-DES and second-generation DP-DES implantations. However, among BP-DESs, the improved risks of MI in those with sirolimus eluting, circumferential drug distribution, thin strut, or ultrathin strut and decreased rates of TVR in those with circumferential drug distribution were noted.

Background Biodegradable polymer drug-eluting stent (BP-DES) has been developed to improve clinical outcomes after percutaneous coronary intervention (PCI) for patients presenting coronary artery disease (CAD). Although BP-DES showed non-inferior safety and efficacy to durable polymer DES (DP-DES) in several randomized clinical trials, hemodialysis (HD) patients, who have been well known as high risk population for adverse events, were excluded in the most of trials. Therefore, there are limited data comparing the clinical outcomes between BP-DES and DP-DES in HD patients with CAD after PCI. Purpose The purpose of this study was to investigate clinical outcomes in HD patients after BP-DES implantation compared with those after DP-DES implantation. Methods We retrospectively analyzed 234 HD patients (male 74%, mean age 71±10 years) undergoing PCI for 404 lesions with 472 DESs (71 patients for 138 lesions with 170 BP-DESs [91 Ultimaster and 79 Synergy] and 163 HD patients for 266 lesions with 302 DP-DESs [219 Xience, 53 Promus and 30 Resolute]) from 2011 to 2017. Two-year clinical outcomes were compared between BP-DES group and DP-DES group. The primary outcome measure was the incidence of target lesion revascularization (TLR), while the secondary outcome measures were the occurrence of cardiac death (CD), stent thrombosis (ST), myocardial infraction (MI), target vessel revascularization (TVR), non-TVR and major adverse cardiac event (MACE) defined as a composite of CD, MI, and TVR. Outcome measures were estimated by the Kaplan-Meier method and the differences between BP-DES group and DP-DES group were assessed by the log-rank test. We also conducted Cox's proportional hazard model to identify predictors for TLR occurrence. Results Baseline patient and lesion characteristics were similar between the two groups. The two-year incidence of TLR was not significantly different between BP-DES group and DP-DES group (14.1% vs. 22.2%, p=0.391). The two-year incidences of CD (17.3% vs. 17.5%, p=0.381), ST (0% vs. 3.9%, p=0.133), MI (4.2% vs. 5.8%, p=0.965), TVR (21.3% vs. 27.5%, p=0.586), non-TVR (26.1% vs. 31.3%, p=0.439) and MACE (41.1% vs. 42.6%, p=0.526) were also not different between the two groups. After multivariate analysis, diabetes mellitus (hazard ratio 1.97; 95% confidence interval 1.03–3.78, p=0.004) was independently associated with TLR occurrence in HD patients. Two-year clinical outcomes of HD patient Conclusions At two-year follow-up after PCI, BP-DES had comparable safety and efficacy profiles to DP-DES in HD patients presenting CAD. Acknowledgement/Funding None

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.

Aims: The PRISON IV trial investigated the next-generation sirolimus-eluting stent (SES) with ultra-thin struts and biodegradable polymer against the second-generation everolimus-eluting stent (EES) with thin struts and durable polymer in patients with successfully recanalised chronic total occlusions (CTO). In this study, we examined the secondary optical coherence tomography endpoints. Methods and results: The main PRISON IV trial randomised 330 patients to either SES or EES. At nine months, 281 (85%) patients underwent repeat angiography. Of these, 60 consecutive patients received optical coherence tomography divided over both stent groups. The mean number of struts analysed was 750±337 and 633±358 in SES and EES patients, respectively (p=0.07). The minimal lumen area, minimal stent area, maximal neointima area and neointimal thickness were comparable between the groups (4.8±2.1 and 4.4±1.5 mm2; 5.3±1.8 and 5.3±1.4 mm2; 2.5±2.0 and 2.2±1.5 mm2; 0.7±1.7 and 0.4±0.2 mm). The percentage of uncovered struts was higher with EES (6.2±7.5% and 11.9±13.4%, p=0.04), whereas the percentage of malapposed struts and mean number of coronary evaginations were significantly higher with SES (2.9±4.0% and 1.2±2.4%, p=0.02; 18.5±17.7 and 5.3±3.1, p=0.004). Conclusions: The optical coherence tomography findings of this substudy demonstrated improved strut coverage with ultra-thin strut SES with bioresorbable polymer compared to thin-strut EES with durable polymer in CTO. On the other hand, SES showed a higher rate of stent strut malappositon and coronary evaginations. The clinical relevance of these findings remains to be demonstrated.

Background The choice of optimal drug‐eluting stent therapy for patients with diabetes mellitus ( DM ) undergoing percutaneous coronary intervention remains uncertain. We aimed to assess the long‐term clinical outcomes after percutaneous coronary intervention with biodegradable polymer sirolimus‐eluting stents ( BP ‐ SES ) versus durable polymer everolimus‐eluting stents ( DP ‐ EES ) in patients with DM . Methods and Results In a prespecified subgroup analysis of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization) trial ( NCT 01443104), patients randomly assigned to ultrathin‐strut BP ‐ SES or thin‐strut DP ‐ EES were stratified according to diabetic status. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, at 5 years. Among 2119 patients, 486 (22.9%) presented with DM . Compared with individuals without DM, patients with DM were older and had a greater baseline cardiac risk profile. In patients with DM, target lesion failure at 5 years occurred in 74 patients (cumulative incidence, 31.0%) treated with BP ‐ SES and 57 patients (25.8%) treated with DP ‐ EES (risk ratio, 1.23; 95% CI , 0.87–1.73 [ P =0.24]). In individuals without DM, target lesion failure at 5 years occurred in 124 patients (16.8%) treated with BP ‐ SES and 132 patients (16.8%) treated with DP ‐ EES (risk ratio, 0.98; 95% CI, 0.77–1.26 [ P =0.90; P for interaction=0.31]). Cumulative 5‐year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis were similar among patients with DM treated with BP ‐ SES or DP ‐ EES . There was no interaction between diabetic status and treatment effect of BP ‐ SES versus DP ‐ EES . Conclusions In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout 5 years between patients with DM treated with ultrathin‐strut BP ‐ SES or thin‐strut DP ‐ EES . Clinical Trial Registration URL : https://www.clinicaltrials.gov/ . Unique identifier: NCT 01443104.

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

Background Polymer-free drug-eluting stents (PF-DES) were introduced with the aim of reducing the risk of stent thrombosis associated with durable polymer drug-eluting stents (DP-DES). The comparison of safety and efficacy profiles between these two stent platforms remains unclear. Materials and methods We conducted electronic database searches for randomized controlled trials (RCTs) comparing patients treated with either PF-DES or DP-DES. Outcomes included definite or probable stent thrombosis (ST), myocardial infarction (MI), cardiac death, all-cause death, target lesion revascularization (TLR), and target vessel revascularization (TVR). A random-effects model was used to derive risk ratios (RRs) with 95% confidence intervals (CIs). Subgroup analyses based on different variables were also performed. After screening a total of 1026 articles, the present meta-analysis included 13 RCTs comprising 8021 patients. Results No significant differences were found for the risks of definite or probable ST (RR, 0.94; 95% CI, 0.62–1.43; P = 0.77), MI (RR, 1.06; 95% CI, 0.85–1.33; P = 0.61), cardiac death (RR, 0.98; 95% CI, 0.80–1.21; P = 0.88), all-cause death (RR, 0.87; 95% CI, 0.76–1.00; P = 0.06), TLR (RR, 1.12; 95% CI, 0.94–1.33; P = 0.22), and TVR (RR, 1.18; 95% CI, 0.87–1.61; P = 0.29). Similarly, no significant differences were found for all outcomes regardless of anti-proliferative drug, except for an increased risk of TLR for polymer-free paclitaxel-eluting stents compared with DP-DES (RR, 2.32, 95% CI, 1.30–4.14; P = 0.005). Conclusions Our findings showed that PF-DES and DP-DES confer equivalent safety and efficacy profiles, with similar rates of stent thrombosis., Highlights • Polymer-free and durable polymer drug-eluting stents confer similar safety and efficacy profiles. • There were comparable rates of stent thrombosis between the two stent platforms. • Further trials with greater length of follow-up are warranted to assess long-term safety and efficacy outcomes.

Background: Biodegradable polymer sirolimus-eluting stents (BP-SESs) have been reported to be noninferior compared with durable polymer everolimus-eluting stents (DP-EES) in a randomized clinical trial. We sought to compare the efficacy and safety of an ultrathin strut BP-SES with a DP-EES in an all-comers population. Methods and Results: Among 7640 consecutive patients who underwent percutaneous coronary intervention between March 2011 and June 2015, 4638 patients were exclusively treated with BP-SES (N=1896; 3137 lesions) or DP-EES (N=2742; 4468 lesions). After propensity score matching within strata of clinical indications, the final study population consisted of 2902 matched patients (BP-SES 2406 lesions and DP-EES 2368 lesions). The primary device-oriented composite end point (DOCE) included cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1 year. BP-SES (6.9%) was noninferior to DP-EES (8.0%) with respect to device-oriented composite end point (hazard ratio [HR], 0.85; 95% CI, 0.65–1.11; P for noninferiority P for superiority=0.24). No differences in cardiac death (BP-SES, 2.3% versus DP-EES, 3.0%; HR, 0.76; 95% CI, 0.49–1.20; P =0.25), myocardial infarction (BP-SES, 4.6% versus DP-EES, 4.6%; HR, 1.00; 95% CI, 0.71–1.40; P =0.99), or target lesion revascularization (BP-SES, 2.8% versus DP-EES, 2.5%; HR, 1.11; 95% CI, 0.71–1.74; P =0.65) were observed. The rate of periprocedural myocardial infarction was comparable between the 2 groups (2.1% versus 2.2%; HR, 0.97; 95% CI, 0.59–1.58; P =0.89). The rate of definite stent thrombosis was similarly low throughout 1 year (BP-SES, 0.8% versus DP-EES, 0.8%; HR, 1.00; 95% CI, 0.45–2.22; P =1.00). Conclusions: In a consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, BP-SES was noninferior to DP-EES for device-oriented composite end point at 1 year. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02241291.

Background The Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) is a new-generation biodegradable polymer drug-eluting stent with the thinnest strut thickness to date developed to improve the percutaneous treatment of patients with coronary artery disease. We perform a meta-analysis of randomized clinical trials (RCTs) comparing the efficacy and safety of an ultra-thin, Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) compared with durable polymer drug-eluting stents (DP-DESs). Methods Medline, Embase, and CENTRAL databases were searched for randomized controlled trials comparing the safety and efficacy of O-SES versus DP-DES. Paired reviewers independently screened citations, assessed risk of bias of included studies, and extracted data. We used the Mantel-Haenszel method to calculate risk ratio (RR) by means of a random-effects model. Results Six RCTs with a total of 6949 patients were selected. All included trials were rated as low risk of bias. The O-SES significantly reduced the risk of myocardial infarction (RR 0.78, 95% confidence interval [CI] 0.62–0.98; I2 = 0%; 10 fewer per 1000 [from 1 fewer to 18 fewer]; high quality) compared with the DP-DES. There was no significant difference between O-SES and DP-DES in the prevention of stent thrombosis (RR: 0.75; 95% CI: 0.52–1.08), cardiac death (RR: 0.93; 95% CI: 0.63–1.36), target lesion revascularization (RR 1.10, 95% CI 0.86–1.42) and target vessel revascularization (RR 0.97, 95% CI 0.78–1.21). Conclusion Among patients undergoing percutaneous coronary intervention, O-SES resulted in significantly lower rates of myocardial infarction than DP-DES and had a trend toward reduction in stent thrombosis.

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

This editorial refers to ‘Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction—TROFI II trial’[†][1], by M. Sabate et al ., on page 229. Bioresorbable stents (BRS) represent a disruptive technology with potential for improving long-term outcomes after percutaneous intervention.1 The principal advantage of BRS compared with conventional metallic stent technology is that the device is broken down by the body after its useful function has been served, potentially restoring normal vessel anatomy over the long term and ameliorating the risk of late adverse events in the treated arterial segment.2 Two such devices have received CE mark approval for use; both are based on polylactic acid stent backbones: the everolimus-eluting Absorb stent (Abbott Vascular, Abbott Park, IL, USA) in 2011 and the novolimus-eluting DESolve stent (Elixir Medical, Sunnyvale, CA, USA) in 2013. However, current approval processes leading to CE mark are based on conformity testing (i.e. performance as intended) and assessment of safety, and generally do not require comparative efficacy assessment against existing devices.3 In fact, BRS are generally more challenging to implant in comparison with metallic stents, and careful patient and lesion selection is crucial to ensuring good results with this technology.4 Moreover, clinical experience with these devices remains rather limited, and further comparative efficacy data are required before we can be sure of the place of these devices in day-to-day practice. Encouraging results have been reported with the Absorb BRS compared with conventional metallic drug-eluting stents (DES) in small randomized trials enrolling patients presenting with stable or unstable angina.5, … [1]: #fn-2

Objective: Durable polymer sirolimus-eluting stents (DP-SES) are associated with a low risk of stent thrombosis; biodegradable polymer drug-eluting stents (BP-DES) were designed to reduce these risks. However, their benefits are still variable. Method: We undertook a meta-analysis of randomized trials identified by systematic searches of Medline, Embase, and the Cochrane Database. Results: Eleven studies (9,676 patients) with a mean follow-up of 22.6 months were included. Overall, compared with DP-SES, BP-DES significantly lowered the rate of definite or probable stent thrombosis (RR, 0.73; 95% CI, 0.55-0.97; p = 0.03; I2 = 0.0%) due to a decreased risk of very late stent thrombosis (RR, 0.26; 95% CI, 0.11-0.63; p = 0.00; I2 = 0.0%). However, BP-DES were associated with a comparable rate of early and late stent thrombosis. Meanwhile, BP-DES were associated with a broadly equivalent risk of target vessel revascularization (RR, 0.90; 95% CI, 0.78-1.03; p = 0.13; I2 = 0.0%), cardiac death (RR, 0.89; 95% CI, 0.72-1.09; p = 0.24; I2 = 0.0%), myocardial infarction (RR, 1.03; 95% CI, 0.84-1.26; p = 0.79; I2 = 0.0%), and major adverse cardiac events (MACE; RR, 0.91; 95% CI, 0.83-1.0; p = 0.08; I2 = 0.0%). Furthermore, angiographic data showed that in-stent and in-segment late luminal loss were similar between the two groups. Conclusions: Compared with DP-SES, BP-DES were associated with a lower rate of very late stent thrombosis and an equivalent risk of MACE. Larger randomized studies are needed to confirm this finding.

Stent thrombosis and clinically driven restenosis are rare in the era of newer generation DES. The Synergy bioresorbable polymer DES appears to be comparable to other durable polymer and other bioabsorbable polymer DES in terms of safety and efficacy at 1-year post implantation. Further long-term study is needed to determine the specific role of the Synergy stent and other DES with bioabsorbable polymers.

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

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

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.

Biodegradable polymer-based drug-eluting stents are thought to be safer than durable polymer-based stents. However, the long-term vascular response remains unclear. The aim of this study was to compare the biocompatibility of durable polymer-based sirolimus-eluting (SES) and everolimus-eluting (EES) stents with biodegradable polymer-based biolimus-eluting (BES) stents in a porcine coronary model. Stents were implanted in porcine coronaries. Acetylcholine challenge tests and optical coherence tomography (OCT) examination were performed at one month. Animals were sacrificed at three and six months (n=6 each), and the stents were analysed histologically. At one month, acetylcholine challenge tests revealed a trend towards greatest vasoconstriction in SES, less in BES, and least in EES, but the differences were not significant. OCT analysis demonstrated the highest incidence of uncovered struts in SES, followed by BES, while EES showed almost complete strut coverage (41.7±27.0%, 24.5±23.8%, 0.4±0.8%, respectively; p=0.004). Upon histological analysis at three months, SES showed a significantly higher inflammatory score than BES and EES (2.9±1.4, 0.8±0.9, 0.5±0.4, respectively; p=0.001), and this was maintained at six months (1.6±1.5, 0.3±0.3, 0.4±0.6, respectively; p=0.049). While SES showed an increased inflammatory reaction, EES and BES showed minimal inflammation. These results indicate that the late inflammatory reaction does not necessarily depend on degradability of the polymer, if the combination of the drug, metal, and polymer is biocompatible.

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