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

Autor:	Eberli FR; Municipal Hospital Triemli, Zurich, Switzerland., Oldroyd KG; Biosensors Europe SA, Morges, Switzerland., Urban P; Cardiovascular Department, Cardiovascular European Research Centre, Massy, France., Krucoff MW; Duke Clinical Research Institute, Durham, North Carolina, USA., Morice MC; Cardiovascular European Research Centre, Massy, France., Tanguay JF; Department of Medicine, Montreal Heart Institute, Montreal, Quebec, Canada., Leon MB; Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, New York, USA., Brunel P; Clinique de Fontaine, Dijon, France., Maillard L; GCS ES Axium-Rambot, Aix-en-Provence, France., Lipiecki J; Pole Sante Republique, Clermont-Ferrand, France., Cook S; Cardiology, Université de Fribourg, Fribourg, Switzerland., Berland J; Clinique Saint Hilaire, Rouen, France., Hovasse T; Institut Cardiovasculaire Paris Sud, Massy, France., Carrié D; Cardiology, Centre Hospitalier Universitaire Rangueil, Toulouse, France., Schütte D; Biosensors Europe SA, Morges, Switzerland., Sadozai Slama S; Biosensors Europe SA, Morges, Switzerland s.sadozai@biosensors.com., Garot P; Institut Cardiovasculaire Paris Sud, Massy, France.
Jazyk:	angličtina
Zdroj:	Open heart [Open Heart] 2024 Jun 18; Vol. 11 (1). Date of Electronic Publication: 2024 Jun 18.
DOI:	10.1136/openhrt-2024-002679
Abstrakt:	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. Competing Interests: Competing interests: KGO, and SSS are employees of the sponsor. DS has a consultant relationship with Biosensors. MWK reports grants and personal fees from Biosensors during the conduct of the study and grants and personal fees from Abbott Vascular, Medtronic, OrbusNeich, Terumo, and Cordis/Johnson & Johnson outside the submitted work. PU reports personal fees from Biosensors and others from Centre Européen de Recherche Cardiovasculaire (CERC), Massy, France, during the conduct of the study. J-FT reports grants from the Duke Clinical Research Institute during the conduct of the study; grants from Abbott Vascular, Bayer and Biosensors; other from BMS-Pfizer Alliance; and grants from Novartis outside the submitted work. M-CM reports being the CEO of CERC, Massy, France. MBL reports grants from Edwards Lifesciences, Medtronic and Boston Scientific outside the submitted work. The other authors report no conflicts. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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