Three vs 12-month DAPT after implantation of biodegradable-polymer sirolimus-eluting coronary stent: a randomised clinical trial

BMC Med. 2025 Dec 24;23(1):690. doi: 10.1186/s12916-025-04515-y.

Abstract

Background: Early discontinuation of dual antiplatelet therapy (DAPT) within 3 months after implantation of drug-eluting stents may reduce bleeding risk without increasing ischaemic events. This study aimed to assess whether 3-month DAPT is as safe as the conventional 12-month regimen in patients treated with Firehawk stents, which have demonstrated 99.9% reendothelialisation at 3 months by optical coherence tomography.

Methods: From January 1, 2019, to April 30, 2022, 2445 patients were randomly assigned to a 3-month (n = 1222) or 12-month DAPT regimen (n = 1223) in this randomised, open-label, non-inferiority trial, patients from 36 centres in China who underwent percutaneous coronary intervention with Firehawk stents. The primary endpoint was a composite of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) at 18 months. The co-equal secondary endpoints were major adverse cardiovascular events, defined as a composite of all-cause death, myocardial infarction and ischaemia-driven target lesion revascularisation, and major bleeding.

Results: From January 1, 2019, to April 30, 2022, 2445 patients were randomly assigned to 3-month (N = 1222) or 12-month DAPT regimen (N = 1223). Adherence to the protocol-defined DAPT duration was 71.0% and 95.5%, respectively. Rates of the primary endpoint were comparable between both groups (10.1% vs 10.9%). Non-inferiority of 3-month DAPT was established (absolute rate difference, - 0.76%; upper limit of 1-sided 97.5% CI, 1.70%; p non-inferiority = 0.0003, with a predefined non-inferiority margin of 3.5%). Rates of co-secondary endpoints showed no significant difference (both p > 0.05). Landmark analysis (3-18 months) showed significant lower rate of major bleeding (2.7% vs 4.4%; p = 0.03) with 3-month DAPT.

Conclusions: In patients treated with Firehawk stents, 3-month DAPT was non-inferior to 12-month DAPT for the primary composite endpoint of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding at 18 months.

Trial registration: NCT03008083 (clinicaltrials.gov).

Keywords: Biodegradable polymer; Drug-eluting stent; Dual antiplatelet therapy; Duration; Net adverse clinical and cerebral event.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Equivalence Trial

MeSH terms

  • Absorbable Implants*
  • Aged
  • China
  • Drug-Eluting Stents* / adverse effects
  • Dual Anti-Platelet Therapy* / methods
  • Female
  • Hemorrhage / chemically induced
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention* / adverse effects
  • Percutaneous Coronary Intervention* / methods
  • Platelet Aggregation Inhibitors* / administration & dosage
  • Platelet Aggregation Inhibitors* / adverse effects
  • Platelet Aggregation Inhibitors* / therapeutic use
  • Polymers
  • Sirolimus* / administration & dosage
  • Sirolimus* / therapeutic use
  • Time Factors

Substances

  • Platelet Aggregation Inhibitors
  • Sirolimus
  • Polymers

Associated data

  • ClinicalTrials.gov/NCT03008083