12- vs. 1-month DAPT: comparative outcomes after aspirin cessation with HT supreme stent

Abstract

Introduction: Dual antiplatelet therapy (DAPT) combining aspirin and P2Y12 inhibitors has been the cornerstone antithrombotic regimen following percutaneous coronary intervention (PCI) with drug-eluting stents (DES). While DAPT reduces thrombosis, it potentiates bleeding, which equally impacts survival. Recent trials have shown that shortening DAPT to 1 month can reduce bleeding risks without increasing ischemic events. Despite this, current guidelines continue to recommend >=6 months DAPT as the default. The Healing-Targeted Supreme stent (HT supreme), designed for rapid endothelial healing, aligns sirolimus release with smooth muscle proliferation. Its clinical performance was demonstrated in the PIONEER III trial using the standard 6-12 months DAPT protocol. However, given the stent's advanced healing capacity, the PIONEER IV trial adopted a 1-month DAPT strategy. This pooled analysis compares bleeding and thrombotic outcomes between PIONEER III (standard-DAPT) and PIONEER IV (short-DAPT). Method(s): We compared the clinical outcomes of patients treated with HT Supreme stents in the all-comer PIONEER IV trial and the near-all-comer PIONEER III trial. Both are multicentre, randomised, open-label, non-inferiority trials.In PIONEER IV, patients not on oral anticoagulants received 1-month DAPT followed by ticagrelor monotherapy for 11 months; in PIONEER III, patients received 6 months DAPT (or 12 months for acute coronary syndrome). Major bleeding (Bleeding Academic Research Consortium grades 3 or 5) and major adverse cardiovascular events (MACE, defined as a composite of all-cause death, myocardial infarction, and repeated revascularization) at 12 months were adjudicated by independent clinical event committee. Result(s): A total of 2102 patients were pooled (1051 in each trial). Baseline characteristics were generally similar. However, hypertension and diabetes were more common in PIONEER III, while family history of coronary artery disease was more frequent in PIONEER IV. At 12 months, MACE occurred in 8.1% (n=86) of PIONEER III and 7.7% (n=81) of PIONEER IV, while major bleeding occurred in 2.1% (n=22) and 1.7% (n=18), respectively. A 30-day landmark analysis showed a numerically lower incidence of MACE in PIONEER IV (2.0% vs. 3.7% in PIONEER III, p=0.580), with no rebound in MACE after 1 month (4.5% vs. 5.7%, p=0.320). In adjusted Cox regression, the hazard ratio for MACE was comparable between PIONEER IV and PIONEER III (HR 0.89, 95% CI: 0.64-1.13, p=0.480). In the adjusted Cox regression model, the hazard ratio for bleeding was also comparable between PIONEER IV and PIONEER III (HR 0.71, 95% CI: 0.34-1.47, p=0.360). Conclusion(s): PCI with HT Supreme stents and 1-month DAPT demonstrated comparable MACE and bleeding outcomes to longer DAPT without a rebound in thrombotic events after aspirin cessation. The HT Supreme stents are suitable for a short DAPT strategy, similar to other workhorse DES.