Clinical Outcomes with Thin Versus Thick Strut Polymer-free Biolimus-coated Stents at 3 Years

Overview

Journal Open Heart

Publisher BMJ Publishing Group

Specialty Cardiology & Vascular Diseases

Date 2024 Jun 18

PMID 38890129

Authors

Franz R Eberli

Keith G Oldroyd

Philip Urban

Mitchell W Krucoff

Marie-Claude Morice

Jean-Francois Tanguay

Martin B Leon

Philippe Brunel

Luc Maillard

Janus Lipiecki

Stephane Cook

Jacques Berland

Thomas Hovasse

Didier Carrie

Diana Schutte

Sara Sadozai Slama

Philippe Garot

Affiliations

Soon will be listed here.

Abstract

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.

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