6 to 12-month vs. 1-month dual antiplatelet therapy: comparative outcomes after aspirin cessation with HT supreme stent in the pooled PIONEER III and PIONEER IV trial analysis

Abstract Background DAPT is crucial for preventing ischemic events following drug-eluting stents (DES) PCI, but increases bleeding risks. Randomised controlled trials (RCTs) showed that abbreviated DAPT could reduce bleeding without increasing ischemic risks. However, guidelines continue to recommend ≥6-month DAPT. The sirolimus release of the Healing Target SupremeTM DES (HT Supreme) is precisely timed to inhibit smooth muscle proliferation without excessive endothelium inhibition, showing clinical non-inferiority to XienceTM DES in the PIONEER III RCT with ≥6-month DAPT. The PIONEER IV RCT using 1-month DAPT offers data to compare outcomes under different DAPT regimens. Methods We pooled individual patient data of PIONEER III (NCT02607865, n=1051) and PIONEER IV (NCT0492319, n=1473), both are multicentre RCTs. PIONEER III included patients with CCS, unstable angina, or NSTEMI, who received de novo lesion PCI, excluding left main and CTO, while PIONEER IV included all-comer patients, including STEMI, and complex PCI. After PCI, PIONEER III patients received 6 or 12-month DAPT for CCS and ACS, respectively, while PIONEER IV patients received 1-month DAPT followed by ticagrelor monotherapy for 11 months. The primary endpoint was patient-oriented composite endpoint at 12 months (PoCE, composite of all-cause death, any myocardial infarction, and any revascularisation), adjudicated by independent clinical event committees. Major (Bleeding Academic Research Consortium, BARC 3 or 5) and clinically significant bleeding (BARC 2, 3, or 5) and the combination of PoCE and major bleeding (NACE) were assessed. Results The baseline characteristics of HT-Supreme-treated patients were generally similar. However, hypertension and diabetes were more prevalent in PIONEER III. At 12 months, PoCE occurred in 86(8.2%) and 107(7.3%) PIONEER III and PIONEER IV patients, respectively, p=0.396. The incidence of Major bleeding was 1.4% and 2.1% in PIONEER III and PIONEER IV, p=0.215 while Clinically significant bleeding was similar at 2.8% vs. 2.7%, respectively, p=0.947. The incidence of NACE was 9.9% and 8.4% in PIONEER III and PIONEER IV, respectively, p=0.186. Landmark analysis after 30-day showed PoCE rate of 4.6% and 5.6% (figure) for PIONEER III and PIONEER IV, respectively. The incidence of bleeding was similar at both time points. Conclusion PCI with HT Supreme DES and 1-month DAPT demonstrated comparable PoCE and bleeding rates to longer DAPT without increased PoCE’s after aspirin cessation.For image description, please refer to the figure legend and surrounding text.