# Polymeervrije biolimus-stent bij hoog bloedingsrisico met ACS: Leaders Free substudie

*geplaatst 2017-04-01 · Algemeen · European heart journal · doi 10.1093/eurheartj/ehw203 · https://hartvaat.nl/2017/04/01/polymeervrije-biolimus-stent-bij-hoog-bloedingsrisico-met-acs-leaders-free-subst/*

Substudie van Leaders Free bij ACS-patiënten met hoog bloedingsrisico behandeld met polymeervrije biolimus-stents en slechts 1 maand DAPT.

## English: Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: a Leaders Free ACS sub-study.

This Leaders Free substudy evaluated polymer-free biolimus-coated stents with only 1 month of DAPT in high-bleeding-risk ACS patients, demonstrating the feasibility of ultra-short antiplatelet therapy even in the acute coronary setting.

## Abstract (original, from the publication)

AIMS: Although a true clinical challenge, high bleeding risk patients with an acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) have never been specifically studied. Leaders Free ACS, a pre-specified Leaders Free sub-study, determined efficacy, and safety of a combination of 1-month dual anti-platelet therapy (DAPT) with implantation of either a polymer-free Biolimus-A9-coated stent (BA9-DCS) or a bare-metal stent (BMS) in these patients. METHODS AND RESULTS: Leaders Free included 2466 patients undergoing PCI who had at least 1 of 13 pre-defined factors for an increased bleeding risk. Of these, 659 ACS patients were included in this analysis (BA9-DCS 330, BMS 329). At 12-month follow-up, treatment with the BA9-DCS was more effective (clinically driven target-lesion revascularization 3.9 vs. 9.0%, P = 0.009) and safer (cumulative incidence of cardiac death, myocardial infarction, or definite or probable stent thrombosis 9.3 vs. 18.5%, P = 0.001), driven by significantly lower rates of cardiac mortality (3.4 vs. 6.9%, P = 0.049) and myocardial infarction (6.9 vs. 13.8%, P = 0.005). CONCLUSION: We believe that the results of this sub-analysis from the Leaders Free trial are likely to significantly impact clinical practice for high bleeding risk patients presenting with an ACS: the use of a BMS can, in our view, no longer be recommended, and, given the paucity of available data for second-generation DES with shortened DAPT in these patients, the BA9-DCS should currently be considered as the device with the strongest evidence to support its use for this indication.

Auteurs: Christoph K Naber, Philip Urban, Paul J Ong, Mariano Valdes-Chavarri, Alexandre A Abizaid, Stuart J Pocock, Franco Fabbiocchi, Christophe Dubois, Samuel Copt, Samantha Greene, Marie-Claude Morice

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Bron: European heart journal, https://doi.org/10.1093/eurheartj/ehw203. Bijgewerkt 2026-07-03T13:25:56Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.