Key result
3-month DAPT is non-inferior to 12-month DAPT after Firehawk stenting, cutting major bleeding ~39%.
Why the study?
Discontinuing DAPT within 3 months after drug-eluting stent implantation may reduce bleeding risk without increasing ischaemic events, but whether 3-month DAPT is as safe as a 12-month regimen after Firehawk stent implantation remained unconfirmed.
Does a 3-month DAPT regimen prevent net adverse clinical and cerebral events compared to a 12-month DAPT regimen in patients undergoing PCI with biodegradable-polymer sirolimus-eluting stents?
Does a 3-month DAPT regimen prevent net adverse clinical and cerebral events compared to a 12-month DAPT regimen in patients undergoing PCI with biodegradable-polymer sirolimus-eluting stents?
In patients receiving a biodegradable-polymer sirolimus-eluting stent, a 3-month DAPT regimen is non-inferior to a 12-month regimen for net adverse clinical events and significantly reduces major bleeding between 3 and 18 months.
Answers are grounded in this paper and cite their sources.
Supports 3-month DAPT after Firehawk stenting to reduce bleeding; confirms safety of abbreviated regimens with biodegradable-polymer sirolimus-eluting stents.
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).
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Yang et al. (2025) studied this question. In patients treated with Firehawk stents, 3-month DAPT was non-inferior to 12-month DAPT for primary events (10.1% vs 10.9%) and reduced major bleeding (2.7% vs 4.4%).
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