Coronary Stenting in High Bleeding Risk Patients With Small Coronary Arteries Followed by One-Month Dual Antiplatelet Therapy: Onyx ONE Clear

Abstract

Background: Small reference vessel diameters (RVDs) are a predictor of ischemic events after coronary stenting. Among patients at high bleeding risk (HBR) precluding long-term dual antiplatelet therapy (DAPT), those with small vessel disease (SVD) constitute an especially high-risk subgroup. Here, we evaluated the results of a durable-polymer, coronary zotarolimus-eluting stent (ZES) for the treatment of patients with SVD at HBR with 1-month DAPT.

Methods: In the prospective, multicenter Onyx ONE (One-Month DAPT) Clear study, 1506 patients at HBR treated with a ZES that discontinued DAPT at 30 days were included. The clinical outcomes of patients undergoing treatment of lesions with an RVD of ≤2.5 mm (SVD group, as determined by the angiographic core laboratory) were compared with patients without SVD. The primary end point was the composite of cardiac death or myocardial infarction between 1 and 12 months.

Results: Small vessel diameter treatment was performed in 489 (32.5%) patients. Patients with SVD were more likely to be women, have undergone a previous percutaneous intervention, and have multivessel coronary artery disease than patients without SVD. There were no significant differences in lesion, device, or procedural success between the groups. The Kaplan-Meier rate estimate of the primary end point was 8.5% and 6.8% in patients with SVD and those without SVD, respectively (P = .425). No significant differences were found in any secondary end point. The Kaplan-Meier rate of stent thrombosis was 0.6% and 0.8% in patients with SVD and those without SVD, respectively (P = .50).

Conclusions: Among patients at HBR treated with a ZES and 1-month DAPT, those with SVD had favorable 12-month ischemic and bleeding outcomes, which were comparable with those of patients with larger caliber vessels.

Keywords: bleeding risk; coronary stenting; percutaneous coronary intervention.

Graphical abstract

Figure 1

The use of dual antiplatelet therapy, single antiplatelet therapy, and oral anticoagulants in Onyx ONE(One-Month DAPT)Clear patients with and without small vesseldiseasethrough 12 months. SAPT, DAPT, and OAC use are illustrated comparing patients with and without SVD. AC, anticoagulant; DAPT, dual antiplatelet therapy; OAC, oral anticoagulant; SAPT, single antiplatelet therapy; SVD, small vessel disease.

Figure 2

Kaplan-Meier curves (inset, zoom in) for time to first events from 1 to 12 months for patients with and without small vessel disease. (A) Cardiac death and myocardial infarction, (B) target lesion revascularization, and (C) probable and definite stent thrombosis. ARC, Academic Research Consortium; CD, cardiac death; MI, myocardial infarction; PCI, percutaneous coronary intervention; SVD, small vessel disease; TLR, target lesion revascularization.

Central Illustration

Onyx ONE (One-Month DAPT) Clear: a subanalysis of patients with small coronary arteries. CD, cardiac death; DAPT, dual antiplatelet therapy; MI, myocardial infarction; PCI, percutaneous coronary intervention; RVD, reference vessel diameter; SVD, small vessel disease; DAPT, dual antiplatelet therapy.