Coronary disease & ACSRandomised controlled trial
Biodegradable polymer sirolimus-eluting or durable polymer zotarolimus-eluting stents in high bleeding-risk patients with acute coronary syndrome: the BIOFLOW-DAPT randomized trial
- randomized control trial (RCT)
- per-protocol population
Authors' 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.
Study context
- Population
- High bleeding risk (HBR) patients with or without acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), randomized to BP-SES or durable polymer zotarolimus-eluting stent (DP-ZES) and undergoing 1 month dual antiplatelet therapy (DAPT)per-protocol population of the BIOFLOW-DAPT RCT · with ACS 541 · without ACS 1,245
- Comparison
- HBR patients with or without ACS after BP-SES or DP-ZES implantation
- ACSn = 541
- no ACSn = 1,245
Primary result
As reported in the abstract
TLF (composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (cd-TLR)) · 1 year
P = 0.992
Secondary outcomes
%
| Outcome | ACS | no ACS | BP-SES | DP-ZES | P value |
|---|---|---|---|---|---|
| Cardiac death · 1 year · higher with ACS | 3.4 | 1.3 | Not reported in the abstract | Not reported in the abstract | log-rank P = 0.004 |
| TV-MI · 1 year · similar | 2.8 | 4.5 | Not reported in the abstract | Not reported in the abstract | P = 0.100 |
| cd-TLR · 1 year · similar | 1.4 | 2.1 | Not reported in the abstract | Not reported in the abstract | P = 0.300 |
Target lesion failure (TLF) and all secondary endpoints by stent across ACS strata
- consistent with BP-SES or DP-ZES across ACS strata
Safety
%
| Outcome | ACS | no ACS | BP-SES | DP-ZES | P value |
|---|---|---|---|---|---|
| Major bleeding (BARC 3 or 5) · 1 year · similar · primary safety endpoint | 4.2 | 3.1 | Not reported in the abstract | Not reported in the abstract | P = 0.266 |
| Definite/probable ST · 1 year · similar · primary safety endpoint | 0.2 | 0.9 | Not reported in the abstract | Not reported in the abstract | P = 0.098 |
Original publication
Biodegradable polymer sirolimus-eluting or durable polymer zotarolimus-eluting stents in high bleeding-risk patients with acute coronary syndrome: the BIOFLOW-DAPT randomized trial. Eur Heart J Acute Cardiovasc Care. Published 5 August 2026. doi:10.1093/ehjacc/zuag089
Summarised from the published abstract; every number is checked against it