Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years.

BACKGROUND: For high bleeding-risk patients (HBR) undergoing percutaneous coronary intervention (PCI), the LEADERS FREE (LF) and LEADERS FREE II (LF II) trials established the safety and efficacy of a stainless steel polymer-free biolimus-coated stent (SS-BCS) with 30 days of dual antiplatelet treatment (DAPT). The LEADERS FREE III (LF III) trial investigated clinical outcomes after PCI with the next-generation cobalt-chromium thin-strut polymer-free biolimus-coated stent (CoCr-BCS) in HBR patients. AIMS: To report the final 3-year results of the LF III trial and compare them to LF II. METHODS: LF III was a prospective, multicentre, open-label single-arm study to evaluate the safety and efficacy of the CoCr-BCS stent. The primary safety endpoint was the composite of cardiac death (CD), myocardial infarction(MI) or definite/probable stent thrombosis (ST). The primary efficacy endpoint was clinically driven target lesion revascularisation (cd-TLR). We performed a propensity-matched comparison to the 3-year outcomes of LF II. RESULTS: After 3 years, CD/MI/ST had occurred in 57 patients (15%, 95% CI 11.8% to 19%) and cd-TLR in 23 (6.2%, 95% CI 4.1% to 9.2%) patients. In a propensity-matched comparison of patients treated with the CoCr-BCS versus the SS-BCS, there were similar rates of CD (6.6% vs 7.8%, p=0.50), MI (7.1% vs 8.3%, p=0.47) and definite/probable ST (1.1% vs 2%, HR 0.56, 95% CI 0.16 to 1.93, p=0.35). The rates of cd-TLR were 5.3% with CoCr-BCS versus 9.8% with SS-BCS (HR 0.54, 95% CI 0.31 to 0.96, p=0.03). CONCLUSION: LF III confirms the long-term safety and efficacy of the CoCr-BCS in HBR patients treated with 1 month of DAPT. TRIAL REGISTRATION NUMBER: NCT02843633, NCT03118895.

Comparison of outcomes in patients with or without ARC-HBR criteria undergoing PCI with polymer-free biolimus coated stents: The BioFreedom France study.

BACKGROUND: The polymer-free biolimus coated stent (BioFreedom) was shown to be superior to bare metal stents in the LEADERS FREE randomized trial in high bleeding risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT). However, there is limited outcome data with this device in an all-comers' population. METHODS: We conducted a prospective single-arm study of patients undergoing percutaneous coronary intervention with the polymer-free biolimus coated stent in 25 centers in France with wide inclusion criteria including multivessel disease, complex lesions, and acute coronary syndromes. The primary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death or target-vessel myocardial infarction (MI) or clinically indicated target lesion revascularization (ci-TLR) at 1-year. The patient population was classified according to the presence (or not) of HBR criteria according to the recent ARC-HBR definition. RESULTS: Between April 2019 and April 2020, 1497 patients were enrolled. TLF occurred in 101 (6.9%) patients, including cardiac death in 35 (2.4%), target vessel MI in 20 (1.4%) and ci-TLR in 65 (4.5%) of them. There were 491 HBR patients (32.8%) and 1006 non-HBR patients. The median duration of DAPT was 74 days in the HBR group versus 348 days in the non-HBR group (p < 0.0001). TLF occurred in 44 (9.2%) of the HBR group and in 57 (5.8%) of the non-HBR group (relative risk 1.62 [95% confidence interval: 1.10-2.41], p = 0015). Compared to the non-HBR group, HBR patients had higher rates of cardiac death (4.4% vs. 1.4%, p = 0.0005) and target vessel MI (2.9% vs. 0.6%, p = 0.0003), but similar rates of ci-TLR. BARC 3-5 bleeding occurred in 6.2% of the HBR group versus 1.4% of the non-HBR group (p < 0.0001). CONCLUSION: In this multicenter all-comers study, HBR patients treated with a polymer-free biolimus coated stent had, compared to non-HBR patients, an increased risk of cardiac death and MI, and despite a shorter duration of DAPT, continued to have higher rates of BARC 3-5 bleeding.

Drug-coated stents versus bare metal stents in Academic Research Consortium-defined high bleeding risk patients.

BACKGROUND: More effective and progressively safer generations of drug-elut-ing stents (DES) have replaced bare metal stents (BMS) in rou-tine clinical practice. However, patients considered to be at high bleeding risk (HBR) have traditionally been underrepresented in pivotal DES trials. AIMS: The aim of this study was to model the safety and effectiveness of drug-coated stents (DCS) versus BMS in HBR patients according to the Academic Research Consortium (ARC) criteria. METHODS: Participants from the LEADERS FREE (LF) and LEADERS FREE II (LFII) studies were pooled into one data set. Participants were treated with 30 days of DAPT. The primary safety (composite of cardiac death, myocardial infarction, or stent thrombosis) and effectiveness (target lesion revascularisation) endpoints were compared between DCS and BMS in the subgroup of patients satisfying the ARC-HBR definition using propensity-score modelling. RESULTS: From the 3,635 participants included in the combined LF and LFII data set, 2,898 (79.7%) satisfied the ARC-HBR criteria (DCS: 1,923; BMS: 975). The primary safety endpoint occurred in 184 (9.8%) and in 132 (13.8%) participants in the DCS and BMS groups, respectively (adjusted HR 0.72, 95% CI: 0.57-0.91; p=0.006). The risk of the primary effectiveness endpoint was also significantly lower with DCS (6.2%) versus BMS (8.8%) (adjusted HR 0.70, 95% CI: 0.52-0.94; p=0.016). The safety and effectiveness of DCS versus BMS were consistent according to ARC-HBR status (p for interaction=0.206 and 0.260, respectively). CONCLUSIONS: DCS are safer and more effective than BMS in an ARC-defined HBR population.

First clinical evidence characterizing safety and efficacy of the new CoCr Biolimus-A9 eluting stent: The Biomatrix Alpha™ registry.

BACKGROUND: The biolimus-eluting stent (BES) was the first to elute anti-proliferative drug from a biodegradable polymer. In the randomized LEADERS trial, a stainless steel BES showed non-inferior efficacy compared to a sirolimus-eluting stent and a long-term safety advantage. We report the first clinical efficacy and safety outcomes of a new thin-strut cobalt chromium biolimus-eluting stent (CoCr-BES) from an international multi-centre registry. METHODS: We studied 400 all-comer patients with coronary disease receiving CoCr-BES at 12 centres, with follow-up at 9 months and 2 years. The primary endpoint was incidence of major adverse cardiac events (MACE) at 9 months comprising cardiac death, myocardial infarction (MI), and clinically indicated target vessel revascularization (ci-TVR). Key protocol elements were the same as the randomized LEADERS trial to enable a historical control for propensity-matched comparison. RESULTS: Mean patient age was 65 ± 11 years, 19% had diabetes, and 55% presented with unstable angina or MI. On discharge, 96% of patients were on dual antiplatelet therapy (DAPT) and 69% were on DAPT at 9 months. MACE at 9 months occurred in 3.9% of patients, cardiac death in 0.8%, MI in 1.1% and ci-TVR in 2.7%. One patient (0.25%) experienced definite or probable stent thrombosis (ST). A propensity-adjusted comparison showed similar clinical outcomes to the BES arm in the LEADERS trial for the primary endpoint MACE. CONCLUSIONS: The new CoCr-BES showed low rates of MACE, MI, ci-TVR and ST at 9 months, similar to the BES arm in LEADERS.