Division of Cardiovascular Medicine Toho University Ohashi Medical Center Tokyo Japan.
Department of Cardiology Kurashiki Central Hospital Kurashiki Japan.
J Am Heart Assoc. 2020 May 18;9(10):e015439. doi: 10.1161/JAHA.119.015439. Epub 2020 May 12.
Background The balance between ischemic and bleeding events and their association with platelet reactivity in patients receiving antiplatelet therapy after percutaneous coronary intervention (PCI), which differs among regions, is not fully evaluated for East Asians. We examined ischemic/bleeding events and platelet reactivity in Japanese patients undergoing PCI and determined associations between high/low platelet reactivity and clinical outcomes. Methods and Results PENDULUM (Platelet Reactivity in Patients with Drug Eluting Stent and Balancing Risk of Bleeding and Ischemic Event) is a prospective, multicenter registry of Japanese patients with PCI. Primary end points were incidence of first major adverse cardiac and cerebrovascular events (MACCE) and first major bleeding events at 12 months post-PCI. Platelet reactivity (P2Y reaction unit [PRU] value) was measured at 12 to 48 hours post-PCI; patients were grouped as having high PRU (>208), optimal PRU (>85 to ≤208), and low PRU (≤85). MACCE and major bleeding occurred in 4.4% and 2.8% of 6267 patients, respectively. The mean±SD PRU value was 182.1±77.1. MACCE was significantly higher in the high PRU (5.7%; n=2227) versus the optimal PRU group (3.6%; n=3002). The hazard ratio (HR) for high PRU versus optimal PRU level was significantly higher for MACCE (adjusted HR, 1.53; 95% CI, 1.14-2.06 [=0.004]); stent thrombosis followed the same trend. Incidence of major bleeding did not differ significantly between groups. A high PRU level was significantly associated with MACCE in both patients with and patients without acute coronary syndrome. Conclusions These real-world data suggest an association between high platelet reactivity and cardiovascular events in Japanese patients undergoing PCI. The trend was the same in both patients with and patients without acute coronary syndrome. REGISTRATION URL: https://www.umin.ac.jp/ctr. Unique identifier: UMIN 000020332.
在接受经皮冠状动脉介入治疗（PCI）后的抗血小板治疗患者中，不同地区的缺血性和出血性事件之间的平衡及其与血小板反应性的关系尚未得到充分评估。我们检查了接受 PCI 的日本患者的缺血/出血事件和血小板反应性，并确定了高/低血小板反应性与临床结局之间的关系。
PENDULUM（药物洗脱支架患者血小板反应性与出血和缺血事件风险平衡）是一项前瞻性、多中心的日本 PCI 患者注册研究。主要终点是 12 个月时首次主要不良心脑血管事件（MACCE）和首次主要出血事件的发生率。在 PCI 后 12 至 48 小时测量血小板反应性（P2Y 反应单位[PRU]值）；患者分为高 PRU（>208）、最佳 PRU（>85 至≤208）和低 PRU（≤85）。6267 例患者中，MACCE 和大出血的发生率分别为 4.4%和 2.8%。平均±SD PRU 值为 182.1±77.1。高 PRU 组（5.7%；n=2227）的 MACCE 显著高于最佳 PRU 组（3.6%；n=3002）。高 PRU 与最佳 PRU 水平相比，MACCE 的危险比（HR）显著升高（调整 HR，1.53；95%CI，1.14-2.06[=0.004]）；支架血栓形成也呈现出相同的趋势。各组之间主要出血的发生率无显著差异。高 PRU 水平与接受 PCI 的日本患者的 MACCE 显著相关，无论患者是否患有急性冠状动脉综合征。
这些真实世界的数据表明，在接受 PCI 的日本患者中，高血小板反应性与心血管事件之间存在关联。在急性冠状动脉综合征患者和非急性冠状动脉综合征患者中均存在这种趋势。
https://www.umin.ac.jp/ctr. 独特标识符：UMIN 000020332.
