Biodegradable polymer sirolimus-eluting or durable polymer zotarolimus-eluting stents in high bleeding-risk patients with acute coronary syndrome: the BIOFLOW-DAPT randomized trial
In brief
Acute coronary syndrome doubles 1-year cardiac death risk in high-bleeding-risk PCI patients (3.4% vs 1.3%)
In the BIOFLOW-DAPT trial, high-bleeding-risk patients with ACS had a cardiac death rate of 3.4% at one year, compared with 1.3% in those without ACS, while rates of target lesion failure, major bleeding and stent thrombosis were similar regardless of stent type. The findings highlight the need for extra vigilance in ACS patients despite short-duration dual antiplatelet therapy, but do not identify a superior stent.
- Journal
- European heart journal. Acute cardiovascular care (Q1)
- Published
- 5 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Nader Mankerious, Rayyan Hemetsberger, Adrian Wlodarczak, Béla Merkely, Henning Kelbæk, Guillaume Cayla, et al.
- PMID
- 42555546
- DOI
- 10.1093/ehjacc/zuag089
Why clinicians should know about it
- Picked for Critical Care and Intensive Care Medicine (top studies of the week, 9 August 2026): High-quality evidence in a top journal
- Picked for Hematology (top studies of the week, 9 August 2026).
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.