Division of Cardiology, Teikyo University Hospital, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan.
Division of Cardiology, Teikyo University Hospital, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan.
J Cardiol. 2021 Aug;78(2):107-113. doi: 10.1016/j.jjcc.2021.03.015. Epub 2021 Apr 17.
This analysis aimed to evaluate the clinical impact of high bleeding risk (HBR) on adverse events after percutaneous coronary intervention (PCI).
We retrospectively analyzed 1695 patients in the MODEL U-SES study, which was a multicenter, open-label, prospective observational study evaluating safety of 3-month dual antiplatelet therapy (DAPT) after Ultimaster stent (Terumo Corporation, Tokyo, Japan) implantation at 65 sites in Japan. Patients were divided into 2 groups (HBR/Non-HBR) according to modified Academic Research Consortium-HBR criteria. Ischemic/thrombotic event (cardiovascular death, myocardial infarction, ischemic stroke, and stent thrombosis) and bleeding event (Bleeding Academic Research Consortium 3 or 5) at 1 year were evaluated.
Of 1695 patients, 840 patients were categorized as HBR and 855 patients were Non-HBR. One-year follow-up was completed in 95.3%. During 1-year follow-up, ischemic/thrombotic events were observed in 31 cases (1.8%) and bleeding events occurred in 21 cases (1.2%). Presence of HBR was significantly associated with higher incidence of ischemic/thrombotic events as compared to Non-HBR (adjusted hazard ratio, 0.16; 95% confidence interval, 0.05 to 0.50), whereas the incidence of bleeding events did not reach statistical significance between HBR and Non-HBR. In comparison of monotherapy after DAPT, P2Y inhibitor monotherapy after DAPT had comparable ischemic/thrombotic and bleeding events with aspirin monotherapy after DAPT in both HBR and Non-HBR.
In contemporary PCI practice, nearly half of patients had HBR and presence of HBR significantly increased risk of ischemic/thrombotic events. Both aspirin and P2Y inhibitor monotherapy following short DAPT had low and comparable ischemic/bleeding events.
本分析旨在评估高出血风险（HBR）对经皮冠状动脉介入治疗（PCI）后不良事件的临床影响。
我们回顾性分析了 MODEL U-SES 研究中的 1695 例患者，该研究是一项多中心、开放标签、前瞻性观察研究，评估了日本 65 个地点使用 Ultimaster 支架（Terumo Corporation，东京，日本）植入后 3 个月双联抗血小板治疗（DAPT）的安全性。根据改良的学术研究联合会-HBR 标准，患者被分为 2 组（HBR/非-HBR）。评估了 1 年内缺血/血栓事件（心血管死亡、心肌梗死、缺血性卒中和支架血栓形成）和出血事件（Bleeding Academic Research Consortium 3 或 5）。
在 1695 例患者中，840 例患者被归类为 HBR，855 例患者为非-HBR。95.3%的患者完成了 1 年的随访。在 1 年的随访期间，31 例（1.8%）发生缺血/血栓事件，21 例（1.2%）发生出血事件。与非-HBR 相比，HBR 患者的缺血/血栓事件发生率显著升高（调整后的危险比，0.16；95%置信区间，0.05 至 0.50），而 HBR 和非-HBR 之间的出血事件发生率无统计学意义。与 DAPT 后单药治疗相比，DAPT 后 P2Y 抑制剂单药治疗在 HBR 和非-HBR 中与 DAPT 后阿司匹林单药治疗的缺血/血栓和出血事件相当。
在当代 PCI 实践中，近一半的患者存在 HBR，HBR 的存在显著增加了缺血/血栓事件的风险。DAPT 后短期应用阿司匹林和 P2Y 抑制剂单药治疗的缺血/出血事件发生率低且相当。
