Moreno Raúl, Kandzari David E, Kirtane Ajay J, Windecker Stephan, Latib Azeem, Kedhi Elvin, Mehran Roxana, Price Matthew J, Simon Daniel I, Worthley Stephen G, Spriggs Douglas, Tolleson Thaddeus, Nazif Tamim, Golwala Harsh, Kander Nathan H, Liew Houng B, Sardella Gennaro, Tamburino Corrado, Lung Te-Hsin, Mahoney Cecile, Stone Gregg W
Hospital La Paz, Madrid, Spain.
Piedmont Heart Institute, Atlanta, Georgia.
J Soc Cardiovasc Angiogr Interv. 2022 Aug 13;1(6):100432. doi: 10.1016/j.jscai.2022.100432. eCollection 2022 Nov-Dec.
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.
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.
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 ( = .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 ( = .50).
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.
小参考血管直径（RVD）是冠状动脉支架置入术后缺血事件的预测指标。在因高出血风险（HBR）而无法进行长期双联抗血小板治疗（DAPT）的患者中，患有小血管疾病（SVD）的患者构成了一个特别高危的亚组。在此，我们评估了一种耐用聚合物佐他莫司洗脱冠状动脉支架（ZES）用于治疗HBR且接受1个月DAPT的SVD患者的效果。
在前瞻性、多中心Onyx ONE（1个月DAPT）Clear研究中，纳入了1506例接受ZES治疗且在30天时停用DAPT的HBR患者。将血管造影核心实验室确定的RVD≤2.5 mm的病变患者（SVD组）与无SVD的患者的临床结局进行比较。主要终点是1至12个月内心脏死亡或心肌梗死的复合终点。
489例（32.5%）患者接受了小血管直径治疗。与无SVD的患者相比，SVD患者更可能为女性、既往接受过经皮介入治疗且患有多支冠状动脉疾病。两组之间在病变、器械或手术成功率方面无显著差异。SVD患者和无SVD患者的主要终点的Kaplan-Meier率估计分别为8.5%和6.8%（P = 0.425）。在任何次要终点方面均未发现显著差异。SVD患者和无SVD患者的支架血栓形成的Kaplan-Meier率分别为0.6%和0.8%（P = 0.50）。
在接受ZES和1个月DAPT治疗的HBR患者中，SVD患者12个月的缺血和出血结局良好，与较大管径血管患者的结局相当。
