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Coronary Stenting in High Bleeding Risk Patients With Small Coronary Arteries Followed by One-Month Dual Antiplatelet
Raúl Moreno1, David E Kandzari2, Ajay J Kirtane3,4
1Hospital La Paz, Madrid, Spain.
Insights
Patients with small vessel disease (SVD) treated with a zotarolimus-eluting stent (ZES) and short dual antiplatelet therapy (DAPT) experienced comparable ischemic and bleeding outcomes to those with larger vessels.
Area of Science:
- Interventional Cardiology
- Vascular Medicine
- Biomedical Engineering
Background:
- Small reference vessel diameters (RVDs) predict ischemic events post-coronary stenting.
- High bleeding risk (HBR) patients with small vessel disease (SVD) are a particularly high-risk subgroup.
- Evaluating zotarolimus-eluting stents (ZES) in HBR patients with SVD using 1-month DAPT.
Purpose of the Study:
- To assess the efficacy and safety of ZES in HBR patients with SVD treated with a 1-month DAPT regimen.
- To compare clinical outcomes between SVD and non-SVD patients within the HBR population.
Main Methods:
- Prospective, multicenter Onyx ONE Clear study included 1506 HBR patients treated with ZES and 1-month DAPT.
- SVD group defined by RVD ≤2.5 mm (angiographic core laboratory).
- Primary endpoint: composite of cardiac death or myocardial infarction from 1 to 12 months.
Main Results:
- 489 patients (32.5%) had SVD; they were more likely women, with prior PCI, and multivessel disease.
- No significant differences in lesion, device, or procedural success between SVD and non-SVD groups.
- 12-month primary endpoint rates: 8.5% (SVD) vs. 6.8% (non-SVD), P=.425. Stent thrombosis rates were 0.6% (SVD) vs. 0.8% (non-SVD), P=.50.
Conclusions:
- HBR patients with SVD treated with ZES and 1-month DAPT showed favorable 12-month ischemic and bleeding outcomes.
- Outcomes in the SVD group were comparable to patients with larger vessels.
- Short DAPT duration is a viable strategy for HBR patients with SVD undergoing ZES treatment.
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.
