Patients With Diabetes at High Bleeding Risk With 1-Month Dual Antiplatelet Therapy: Onyx ONE Clear Results

Background: Patients with diabetes mellitus (DM) are at a higher risk of ischemic events compared with patients without DM. Percutaneous coronary intervention (PCI) with the Resolute Onyx zotarolimus-eluting stent (ZES) followed by 1-month dual antiplatelet therapy (DAPT) is safe and effective in patients with high bleeding risk. However, outcomes in patients with DM are not fully understood. Methods: Onyx ONE Clear was a prospective, multicenter study that included patients receiving the Resolute Onyx ZES during PCI and 1-month DAPT. The primary end point was a composite of cardiac death (CD) or myocardial infarction from 1 month to 12 months. Results: Among the Onyx ONE Clear population (N = 1506), 39% had DM. Patients with DM had a higher incidence of hypertension, hyperlipidemia, and previous PCI and a higher body mass index than patients without DM. Patients with diabetes were also younger, more likely to be anemic, and experience renal failure. After adjusting for baseline differences between the groups, the Kaplan–Meier rates of CD or myocardial infarction (9.3% vs 6.1%; P =.122, unadjusted P =.010) and target lesion failure (10.2% vs 7.7%; P =.294, unadjusted P =.056) between 1 month and 12 months were not significantly different in patients with and without DM. The rates of target lesion revascularization were also similar in both groups, and stent thrombosis was very low and comparable in both arms after adjusting for baseline differences. Non-CD and bleeding were more frequent in patients with DM. Conclusions: Patients with diabetes treated with the Resolute Onyx ZES followed by 1-month DAPT had favorable 12-month ischemic outcomes after accounting for baseline differences between patients with and without DM, supporting the safety and efficacy of the treatment in selected patients with DM at high bleeding risk.