RESUMO
BACKGROUND The optimal duration of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI) varies based on ischemic and high bleeding risk (HBR) factors. METHODS Onyx ONE Clear was a prospective, global, multicenter study to assess the safety and effectiveness of 1-month DAPT in patients with HBR treated with Resolute Onyx zotarolimus-eluting stents (ZES). Patients with coronary artery disease and at least 1 HBR criterion were enrolled and prescribed DAPT for 1 month post-ZES implantation, followed by single antiplatelet therapy (SAPT) thereafter. The primary endpoint was composite of cardiac death or myocardial infarction (MI) from 1 month to 1 year. The current analysis presents final 2-year results from the study. RESULTS A total of 1,507 patients were analyzed at 2 years. Mean age was 74.0 9.5 years, 32.2% female, 38.8% with type 2 diabetes, 36.0% with previous revascularization, and 48.7% presented with an acute coronary syndrome. Patients were enrolled with mean 1.6 HBR criteria and 44.6% met 2 HBR criteria. Lesion characteristics included 50.0% moderate-to-severe calcification and 78.5% B2/C lesions. At 2 years, 81.1% of patients remained on SAPT, 5.6% received DAPT, and 12.5% were prescribed oral anticoagulation only. The composite of cardiac death or MI between 1 month and 2 years was 11.7%, with rates of 5.3% for cardiac death and 7.4% for MI. Most MIs were non-Q wave (6.7%). Rates of other secondary endpoints between 1 month and 2 years included 0.9% definite or probable stent thrombosis, 13.0% targetlesion failure, 4.7% clinically driven target-lesion revascularization, 2.6% stroke, and 6.2% Bleeding Academic Research Consortium (BARC) 3 to 5 bleeding events (Table 1). CONCLUSION Among patients with HBR treated with Resolute Onyx DES and SAPT after 1 month, 2-year ischemic event rates were acceptable despite an ongoing risk of major bleeding.