Biodegradable polymer sirolimus-eluting or durable polymer zotarolimus-eluting stents in high bleeding-risk patients with acute coronary syndrome: the BIOFLOW-DAPT randomized trial.

Abstract

Aims: Patients at high bleeding risk (HBR) and acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) are at high risk of adverse outcomes. We investigated the clinical outcomes and their consistency after biodegradable polymer sirolimus-eluting (BP-SES) or durable polymer zotarolimus-eluting stent (DP-ZES) implantation in HBR patients with or without ACS.

Methods and results: The per-protocol population of the BIOFLOW-DAPT randomized control trial (RCT) consisted of HBR patients with (n = 541) or without ACS (n = 1245) who were randomized to BP-SES or DP-ZES and underwent 1 month dual antiplatelet therapy (DAPT). The primary efficacy and safety endpoints were target lesion failure (TLF), defined as the composite endpoint of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (cd-TLR) as well as major bleeding defined as BARC 3 or 5 (according to Bleeding Academic Research Consortium classification) and definite/probable stent thrombosis (ST). At 1 year, patients with ACS suffered from higher cardiac death rates (3.4 vs. 1.3%, log-rank P = 0.004) but similar TLF (6.8 vs. 6.7%, P = 0.992), TV-MI (2.8 vs. 4.5%, P = 0.100), cd-TLR (1.4 vs. 2.1%, P = 0.300), major bleeding (4.2 vs. 3.1%, P = 0.266), and ST (0.2 vs. 0.9%, P = 0.098) compared with no ACS patients. The rate of TLF and of all secondary endpoints was consistent with BP-SES or DP-ZES across ACS strata.

Conclusion: HBR patients with ACS are at higher risk of cardiac death than those without ACS and experience a consistent outcome with BP-SES or DP-ZES followed by 1 month DAPT at 1 year follow-up.

Clinical trial registration: NCT04137510.