Biodegradable Polymer Drug-eluting Stents Research Articles

TCT-51 Assessment of Durable Polymer and Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction

TCT-51 Assessment of Durable Polymer and Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction

Comparative Clinical Performance of Two Types of Drug-Eluting Stents with Abluminal Biodegradable Polymer Coating: Five-Year Results of the DESTINY Randomized Trial

Introduction and Objectives: The Stents Coated with the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the InspironTM sirolimus-eluting stent (SES) with the control BiomatrixTM Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. Methods: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. Results: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. Conclusions: The novel InspironTM stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation BiomatrixTM Flex biolimus-eluting stent.

Impact of one-month DAPT followed by aspirin monotherapy in patients undergoing percutaneous coronary intervention according to clinical presentation: a post hoc analysis of the randomised One-Month DAPT trial.

The impact of 1-month dual antiplatelet therapy (DAPT) followed by aspirin monotherapy according to clinical presentation has not been elucidated. This study aimed to compare the impact of 1-month DAPT followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation (1-month DAPT after PF-DCS) vs 6-12-month DAPT followed by aspirin monotherapy after biodegradable polymer drug-eluting stent (BP-DES) implantation (6-12-month DAPT after BP-DES) according to clinical presentation. This is a post hoc analysis of the One-Month DAPT trial. The primary outcome was the composite of major adverse cardiac and cerebrovascular events (MACCE; a composite of cardiac death, non-fatal myocardial infarction, target vessel revascularisation, and stroke) and major bleeding. Among 1,828 patients with stable coronary artery disease (CAD), 1-month DAPT after PF-DCS resulted in lower rates of the primary outcome than 6-12-month DAPT after BP-DES (3.9% vs 6.5%; hazard ratio [HR] 0.59, 95% confidence interval [CI]: 0.39-0.90; p=0.012). However, among 1,192 patients with acute coronary syndrome (ACS), the rates of the primary outcome were not significantly different between the two therapy groups (5.6% vs 3.6%; HR 1.57, 95% CI: 0.91-2.70; p=0.102) and a significant interaction was observed between therapy and clinical presentation regarding the primary outcome (Pint=0.005). A significant interaction was observed in MACCE (Pint=0.016), but not in major bleeding (Pint=0.276). In patients undergoing drug-eluting stent implantation for non-complex lesions, the benefits of 1-month DAPT followed by aspirin monotherapy for a composite of ischaemic and bleeding outcomes were found in patients with stable CAD, but not in those with ACS. gov: NCT02513810.

Comparison of biodegradable and durable polymer drug-eluting stents in acute coronary syndrome: a meta-analysis

ObjectiveTo compare the safety and effectiveness between biodegradable polymer drug-eluting stents (BP-DES) and durable polymer drug-eluting stents (DP-DES) in patients with acute coronary syndrome (ACS).DesignMeta-analysis of randomised controlled trials (RCTs).Primary...

Long-Term Clinical Outcomes Between Biodegradable and Durable Polymer Drug-Eluting Stents: A Nationwide Cohort Study.

BackgroundDespite the theoretical benefits of biodegradable polymer drug-eluting stents (BP-DES), clinical benefits of BP-DES over durable polymer DES (DP-DES) have not been clearly demonstrated. Using data from a large-volume nationwide cohort, we compared long-term clinical outcomes between BP-DES- and DP-DES-treated patients.MethodsA retrospective cohort study that enrolled all patients who underwent percutaneous coronary intervention (PCI) with new-generation DES between 2010 and 2016 in Korea was conducted by using the National Health Insurance Service database. The outcomes of interest were all-cause death, cardiovascular death, and myocardial infarction (MI).ResultsA total of 127,731 patients treated with new-generation DES with thin struts (<90 μm) were enrolled for this analysis. After stabilized inverse probability of treatment weighting, the incidence of all-cause death was significantly lower in patients treated with BP-DES (n = 19,521) at 5 years after PCI (11.3 vs. 13.0% in those treated with DP-DES [n = 108,067], hazard ratio [HR] 0.92, 95% confidence interval [CI], 0.88–0.96, p < 0.001), while showing no statistically significant difference at 2 years after PCI (5.7 vs. 6.0%, respectively, HR 0.95, 95% CI, 0.89–1.01, p = 0.238). Similarly, use of BP-DES was associated with a lower incidence of cardiovascular death (7.4 vs. 9.6% in those treated with DP-DES, HR 0.82, 95% CI, 0.77–0.87, p < 0.001), and MI (7.4 vs. 8.7%, respectively, HR 0.90, 95% CI, 0.86–0.94, p = 0.006) at 5 years after PCI. There was no statistically significant difference of cardiovascular death (4.6 vs. 4.9%, respectively, HR 0.93, 95% CI, 0.85–1.01, p = 0.120) and MI (5.0 vs. 5.1%, respectively, HR 0.98, 95% CI, 0.92–1.05, p = 0.461) at 2 years after PCI.ConclusionsImplantation of BP-DES was associated with a lower risk of all-cause death, cardiovascular death, and MI compared with DP-DES implantation. This difference was clearly apparent at 5 years after DES implantation.Clinical Trial RegistrationClinicalTrial.gov, NCT04715594.

Late Catch-up In-Stent Restenosis and Stent Thrombosis for 2nd Generation Biodegradable Polymer Drug Eluting Stents

Second generation drug-eluting stents (DES) have reduced the rate of in-stent restenosis (ISR) to &lt; 10% [1, 2] in patients undergoing PCI. However, late catch-up in-stent restenosis remains an issue despite the advent in drug-eluting stent technology from 1st to 2nd generation drug eluting stents. The late catch-up phenomenon has been associated with serious consequences and adverse events and remains an important issue in modern practice, despite medical advances with more biocompatible and biodegradable polymers, as well as new therapeutic agents and thinner scaffolds in the development of 2nd generation DES polymer systems. The idea behind biodegradable polymers has been to provide a more controlled elution profile for DES drugs, allowing for long-term therapeutic, but sub-toxic, drug levels in the arterial tissue to prevent ISR and stent thrombosis. However, the late catch-up phenomenon remains an issue resulting in 2ndary revascularization beyond the first year of primary PCI, as it is defined as ISR &gt;1 year. Late stent thrombosis (&lt;1 year) and very late stent thrombosis (&gt;1 year) also remain an issue for biodegradable polymer systems. A long-term presence of the polymer can cause inflammation and thrombogenesis, which is dependent upon polymer degradation kinetics in case of biodegradable polymer DES systems. However, the cause of late catch-up restenosis and stent thrombosis is multi-factorial from a drug-in-polymer formulation perspective of drug release kinetics, e.g., drug elution profile, drug physiochemical properties, and polymer degradation kinetics. It appears that the focus should be on controlling burst release for both late catch-up restenosis and stent thrombosis phenomena.

Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study.

In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). The aim of this study was to evaluate the effects of ticagrelor monotherapy after three-month DAPT in patients undergoing PCI, according to DES type. In the current sub-analysis from TWILIGHT, patients were stratified into three groups based on DES type: durable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Bleeding and ischaemic outcomes were assessed at one year after randomisation. Out of 5,769 patients, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES. Compared with ticagrelor plus aspirin, ticagrelor monotherapy had significantly lower BARC type 2, 3 or 5 bleeding compared with DAPT; DP-EES (3.8% vs 6.7%; HR 0.56, 95% CI: 0.41-0.78), DP-ZES (4.6% vs 6.9%; HR 0.66, 95% CI: 0.42-1.04) and BP-DES (4.2% vs 7.9%; HR 0.52, 95% CI: 0.33-0.81; pinteraction=0.76). Ticagrelor monotherapy resulted in similar rates of death, MI, or stroke: DP-EES (4.2% vs 4.3%; HR 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs 3.1%; HR 1.32; 95% CI: 0.75-2.33); BP-DES (3.9% vs 4.2%; HR 0.92; 95% CI: 0.54-1.55; pinteraction=0.60). In both unadjusted and covariate-adjusted analyses, DES type was not associated with any differences in ischaemic or bleeding complications. As compared with ticagrelor plus aspirin, ticagrelor monotherapy after a short DAPT duration lowered bleeding complications without increasing the ischaemic risk, irrespective of DES type. We observed no significant differences among DES types.

Comparison of biodegradable and newer generation durable polymer drug-eluting stents with short-term dual antiplatelet therapy: a systematic review and Bayesian network meta-analysis of randomized trials comprising of 43,875 patients.

Newer generation durable polymer drug-eluting stents (DP-DES) and biodegradable polymer DES (BP-DES) have similar efficacy with dual-antiplatelet therapy (DAPT) duration of > 6months. However, this difference in outcomes have not been well studied in shorter DAPT regime. This study compares the safety and efficacy profiles of DP-DES and BP-DES based on short-term (1-3months), intermediate-term (4-6months) and standard DAPT (6-12months) durations. A search was conducted on Embase and Medline for Randomized Controlled Trials (RCTs) comparing stent types, and DAPT durations. Primary endpoints include cardiac death, myocardial infarction (MI), definite stent thrombosis, stroke, target vessel revascularization (TVR) and major bleeding. Network analysis was conducted to summarize the evidence. A total of 15 RCTs involving 43,875 patients were included. DP-DES was associated with significantly lower major bleeding rates compared to BP-DES (RR 0.44, Crl 0.22-0.83) in short-term DAPT. Among DP-DES patients, short-term DAPT was associated with lower major bleeding risk compared to standard DAPT (RR 0.47, CrI 0.32-0.69). This favorable bleeding profile with short DAPT was not found in BP-DES patients. Cardiacdeath, MI, definite stent thrombosis, stroke and TVR rateswere similar across the various DAPT durations and stent types. Our preliminary findings demonstrated comparable efficacy and safety outcomes between BP-DES and newer generation BP-DES across various DAPT durations. In patients requiring short DAPT, DP-DES had more favourable major bleeding profile compared to BP-DES, without compromising anti-thrombotic efficacy.

Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents in Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock: Results from the RESCUE Registry

Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents in Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock: Results from the RESCUE Registry

Real-World Long-Term Clinical Outcomes of Ultrathin Strut Biodegradable Polymer Drug-Eluting Stents in Korean ST-Segment-Elevation Myocardial Infarction (STEMI) Patients with or without Acute Heart Failure Undergoing Primary Percutaneous Coronary Intervention.

Biodegradable polymers (BDPs) and ultrathin struts were recently introduced to drug-eluting stents (DES) to further improve outcomes. In this study, we analyzed and compared the effect of the ultrathin strut BDP-DES (UBDP-DES) with the conventional durable polymer-DES (DP-DES) in patients with ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PPCI). A total of 356 STEMI patients (n = 160 in the UBDP-DES group and n = 196 in the DP-DES group) were enrolled. The primary endpoint was target lesion failure (TLF), including cardiac death, target vessel myocardial infarction, and ischemic-driven, target lesion revascularization (ID-TLR). The mean age was 60.3 ± 12.7 years (male 81.7%), and the median follow-up duration was 63.8 months. TLF was numerically more frequent in the UBDP-DES group (8.1% vs. 4.1%; HR 2.14; 95% CI 0.89–5.18; p = 0.091). Propensity score matching (PSM) was performed to balance discrepancies in the baseline characteristics due to patients in the UBDP-DES group initially having more unstable vital signs. However, after PSM (n = 116 in each group), there was no significant difference in TLF (5.3% vs. 5.3%; HR 1.04, 95% CI 0.34-3.22; p = 0.947) or other secondary endpoints including ID-TLR. In the subgroup analysis, subjects with initial acute heart failure (AHF), defined as Killip class ≥ 3, were associated with 13.6% chance of 30-day mortality (9-fold of those without AHF), although chances of repeat revascularization were low (3.0%). Among patients with AHF, the UBDP-DES group was associated with a numerically higher chance of TLF compared with the DP-DES group. There was no difference in TLF between groups in patients without AHF. This study showed that UBDP-DES has long-term clinical outcomes similar to those of conventional DP-DES in real-world Korean STEMI patients receiving PPCI, especially in those without initial AHF.

Biodegradable polymer drug eluting stents versus durable polymer drug eluting stents for percutaneous coronary intervention

Abstract 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.

Real-World Clinical Outcomes of Indigenous Biodegradable Polymer Drug-Eluting Stents.

IntroductionThe durable polymer has been shown to cause neoatherosclerosis, and chronic local inflammation, predisposing individuals to in-stent restenosis and stent thrombosis (ST). The biodegradable polymer stents, which degrade after the desired function of drug release is achieved, allow for endothelial healing. Indigenous coronary stent manufacturing and its use are on the rise nowadays, and their safety and efficacy have been studied in well-structured clinical trials. However, data are scarce on their safety and efficacy in the real-world clinical setting. In this study, we examine the real-world one-year performance of bioresorbable or polymer-free stents manufactured in India.Materials and methodsThis was a single-center, single-arm prospective observational study involving 210 patients undergoing intracoronary stenting using bioabsorbable or polymer-free drug-eluting stents (DES) from Indian manufacturers. All patients were followed up for 12 months prospectively for any major clinical events.ResultsThe mean age of the enrolled patients was 57.04 years (IQR: 34-84 years), among which 159 (75.7%) were male; 99 (43.8%) patients had presented with acute myocardial infarction (MI). A total of 294 stents were deployed with a mean diameter of 3.1 ±0.4 mm, and a mean length of 29.4 ±9.1 mm. Two patients had experienced major adverse cardiovascular events (MACE). After three months of follow-up, one patient developed ST, and the same patient developed a cerebrovascular accident (CVA) after six months. After one year of follow-up, one patient died of cardiac causes.ConclusionBased on our findings, in the real-world clinical setting, the indigenously made biodegradable polymer DES are both safe and effective.

Factors Influencing 1st and 2nd Generation Drug-Eluting Stent Performance: Understanding the Basic Pharmaceutical Drug-in-Polymer Formulation Factors Contributing to Stent Thrombosis Do We Really Need to Eliminate the Polymer?

Drug-eluting stents (DES) have a major role in treating cardiovascular disease. The evolution of bare metal stents into 1st generation durable-polymer DES (DP-DES) reduced the rate of in-stent restenosis (ISR) and the need for repeat-revascularization. However, clinical outcomes showed similar rates of late stent thrombosis (ST<1 year) and higher rates of very late stent thrombosis (ST>1 year) necessitating the advent of 2nd generation more biocompatible polymer DES and biodegradable-polymer DES (BP-DES) that reduced ST rates with shorter dual anti-platelet therapy (DAPT). Despite the improvements in drugs and polymer biocompatibility for both durable and biodegradable polymers, stent thrombosis remains an issue. Doubts remain about the safety and efficacy of the more biocompatible 2nd generation durable polymers in respect to vessel inflammatory and thrombogenic response as compared to biodegradable polymers despite clinical trial and meta-analyses evidence indicating that 2nd generation DP-DES are non-inferior to BP-DES for stent thrombosis. A long-term presence of the polymer can cause inflammation and thrombogenesis. However, the cause of stent thrombosis is multi-factorial from a drug-in-polymer formulation perspective; e.g., drug release kinetics, drug physiochemical and pharmacological properties, degradation kinetics; polymer biocompatibility and hemocompatibility and coating properties. It appears that the focus should be on controlling burst release and developing more biocompatible, durable polymers, especially considering the cost of PCI utilizing biodegradable, polymer-free and bioresorbable scaffolds. This may give an insight into certain DP-DES effectiveness as compared to BP-DES for the existing clinical data and improve future stent development.

1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy AfterPolymer-Free Drug-Coated StentImplantation: One-Month DAPT Trial.

The aim of this study was to determine whether 1month of dual-antiplatelet therapy (DAPT) followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation is noninferior to 6 to 12months of DAPT after biodegradable-polymer drug-eluting stent (BP-DES) implantation. It is necessary to determine the optimal minimal duration of DAPT followed by aspirin monotherapy after percutaneous coronary intervention (PCI). In this trial, 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions were randomized to 1-month DAPT after PF-DCS (n=1,507) or 6- to 12-month DAPT after BP-DES (n=1,513). The primary endpoint was the 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding (noninferiority hypothesis margin of 3%). The primary endpoint occurred in 88 patients (5.9%) in the 1-month DAPT after PF-DCS group and 98 patients (6.5%) in the 6- to 12-month DAPT after BP-DES group (absolute difference-0.7%; upper limit of 1-sided 97.5% confidence interval: 1.33%; P< 0.001 for noninferiority). The occurrence of major bleeding was not different (1.7% vs 2.5%; P=0.136). There was no difference in the occurrence of stent thrombosis (0.7% vs 0.8%; P=0.842). Among patients who underwent PCI for noncomplex lesions, 1-month DAPT followed by aspirin monotherapy after PF-DCS implantation was noninferior to 6- to 12-month DAPT after BP-DES implantation for the 1-year composite of cardiovascular events or major bleeding. The present findings need to be interpreted in the setting of different types of stents according to antiplatelet strategy. (A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-Eluting Stent Implantation; NCT02513810).

Biodegradable polymer drug-eluting stents versus durable polymer drug-eluting stents for percutaneous coronary intervention: a contemporary registry-based analysis.

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). 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. Similar rates of the composite outcome were observed throughout the entire follow-up. Target lesion revascularization rates were lower in the BP-DES group at 1-year but equalized within 5 years.

Multivessel percutaneous coronary intervention with thin-strut biodegradable versus durable polymer drug-eluting stents in ST-segment elevation myocardial infarction: A subgroup analysis of the BIOSTEMI randomized trial

BackgroundRandomized evidence comparing newer-generation drug-eluting stents for multivessel percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) is limited. We sought to investigate clinical outcomes in STEMI patients undergoing multivessel PCI with thin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus durable polymer everolimus-eluting stents (DP-EES). MethodsWe performed a subgroup analysis of the BIOSTEMI (NCT02579031) randomized trial, which included individual patient data from STEMI patients enrolled into the BIOSCIENCE (NCT02579031) study. STEMI patients randomly allocated to BP-SES or DP-EES were divided into those undergoing multivessel versus culprit lesion-only PCI. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial re-infarction or clinically indicated target lesion revascularization (TLR), within 24 months. ResultsAmong 1707 STEMI patients, 145 patients underwent multivessel PCI. At 2 years, TLF occurred in 2 patients (2.8%) treated with BP-SES and 13 patients (18.7%) treated with DP-EES (hazard ratio [HR], 0.14; 95% confidence interval (CI), 0.03–0.61; p = 0.009) in the multivessel PCI group, and in 40 (5.3%) and 61 (8.2%) patients treated with BP-SES and DP-EES respectively (HR, 0.64; 95%CI, 0.43–0.96; p = 0.03; p for interaction = 0.050) in the culprit lesion-only PCI group. In the multivessel PCI group, the rates of clinically indicated TLR (0% vs. 12.4%) and target vessel myocardial re-infarction (0% vs. 4.6%) at 2 years were lower in patients treated with BP-SES compared with DP-EES. ConclusionIn a subgroup analysis of the BIOSTEMI trial, BP-SES were associated with lower 2-year TLF rates compared to DP-EES in STEMI patients undergoing multivessel PCI.

Biodegradable polymer-coated thin strut sirolimus- -eluting stent versus durable polymer-coated everolimus-eluting stent in the diabetic population.

The number of patients with diabetes mellitus (DM) presenting with coronary artery disease is increasing and accounts for more than 30% of patients undergoing percutaneous coronary interventions (PCI). The biodegradable polymer drug-eluting stents were developed to improve vascular healing. It was sought herein, to determine 1-year clinical follow-up in patients with DM treated with the thin strut biodegradable polymer-coated sirolimus-eluting stent (BP-SES) versus durable coating everolimus-eluting stent (DP-EES). Patients were retrospectively analyzed with DM were treated with either a BP-SES (ALEX™, Balton, Poland, n = 670) or a DP-EES (XIENCE™, Abbott, USA, n = 884) with available 1 year clinical follow-up using propensity score matching. Outcomes included target vessel revascularization (TVR) as efficacy outcome and all-cause death, myocardial infarction, and definite/probable stent thrombosis as safety outcomes. After propensity score matching 527 patients treated with BP-SES and 527 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between both groups. In-hospital mortality was 3.23% in BP-SES vs. 2.09% in DP-EES group (p = 0.25). One-year followup demonstrated comparable efficacy outcome TVR (BP-SES 6.64% vs. DP-EES 5.88%; p = 0.611), as well as similar safety outcomes of all-cause death (BP-SES 10.06% vs. DP-EES 7.59%; p = 0.158), myocardial infarction (BP-SES 7.959% vs. DP-EES 6.83%; p = 0.813), and definite/probable stent thrombosis (BP-SES 1.14% vs. DP-EES 0.76%; p = 0.525). The thin-strut biodegradable polymer coated, sirolimus-eluting stent demonstrated comparable clinical outcomes at 1-year after implantation to DP-EES. These data support the relative safety and efficacy of BP-SES in diabetic patients undergoing PCI.

Differential impact of abluminal groove-filled biodegradable-polymer sirolimus-eluting stent versus durable-polymer everolimus-eluting stent on and off dual antiplatelet therapy.

Current guidelines recommend dual antiplatelet therapy (DAPT) following percutaneous coronary intervention for 6-12 months in patients with acute coronary syndrome (ACS) and 3-6 months in those with chronic coronary syndromes (CCS). Whether DAPT duration has a differential effect on outcomes following treatment of ischemic coronary disease with durable versus biodegradable drug-eluting stent (DES) is poorly defined. The TARGET All Comer study was a randomized trial of patients with ischemic coronary artery disease assigned to treatment with either a biodegradable polymer DES (Firehawk) or a durable polymer DES (XIENCE). This pre-specified TARGET AC sub-analysis sought to evaluate the 2-year clinical outcomes before and after DAPT discontinuation. The primary endpoint was target lesion failure (TLF). A total of 1,296 (78.4%) of 1,653 randomized patients were included in this substudy, of which 1,210 (93.4%) remained on DAPT at 6 months, 863 (66.6%) at 12 months, and 409 (31.6%) at 2 years. There was no difference in TLF between patients treated with Firehawk and XIENCE stents from index procedure to DAPT discontinuation (8.0 and 7.7%, p > .99) or after DAPT discontinuation (2.9 vs. 3.8%, p = .16). After DAPT discontinuation, target vessel myocardial infarction (1.3 vs. 3.3%, p = .07), and ischemia-driven target lesion revascularization (0.5 vs. 1.9%, p = .06) favored treatment with Firehawk. Although TLF was comparable for both Firehawk and XIENCE stent groups before and after DAPT discontinuation, after DAPT discontinuation, there was a trend for less target vessel myocardial infarction and ischemia-driven revascularization with the biodegradable polymer DES.

Two-Year Clinical Outcomes of Biodegradable Polymer vs. Durable Polymer Drug-Eluting Stent Implantation in Patients With End-Stage Renal Disease on Dialysis.

Background: There are limited data comparing clinical outcomes between biodegradable polymer and durable polymer drug-eluting stents (BP-DES and DP-DES, respectively) in patients with end-stage renal disease (ESRD).Methods and Results: This study enrolled 229 ESRD patients who underwent successful percutaneous coronary intervention (PCI) for 400 lesions with 472 DES, with 2-year clinical outcomes compared between the BP-DES and DP-DES groups. The primary outcome measure was the incidence of target lesion revascularization (TLR), whereas secondary outcome measures were the occurrence of cardiac death (CD), myocardial infraction (MI), stent thrombosis (ST), target vessel revascularization (TVR), non-TVR, and major adverse cardiac events (MACE), defined as a composite of CD, MI, and TVR. Multivariate analysis was used to identify predictors of TLR occurrence. The 2-year incidence of TLR did not differ significantly between the BP-DES and DP-DES groups (P=0.274). In addition, there were no significant differences in the 2-year incidence of CD (P=0.144), MI (P=0.812), ST (P=0.241), TVR (P=0.434), non-TVR (P=0.375), or MACE (P=0.841) between the 2 groups. Multivariate analysis showed that diabetes (P=0.021) was independently associated with TLR occurrence.Conclusions: BP-DES and DP-DES had comparable safety and efficacy profiles over a 2-year follow-up period after PCI in ESRD patients.

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial

Introduction and ObjectivesThe Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions – DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. MethodsA total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. ResultsAt five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. ConclusionsThe novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.