Department of Internal Medicine and Cardiovascular Centre, Seoul National University Hospital, Seoul, Republic of Korea.
Department of Internal Medicine and Cardiovascular Centre, Seoul National University Hospital, Seoul, Republic of Korea.
Clin Ther. 2020 May;42(5):954-958.e6. doi: 10.1016/j.clinthera.2020.02.022. Epub 2020 Mar 26.
To evaluate the safety and efficacy of glycoprotein IIb/IIIa inhibitors (GPIs) in patients with acute myocardial infarction (AMI) in the presence of intracoronary thrombus undergoing percutaneous coronary interventions.
This study, performed from January 1, 2004, to November 31, 2014, at 55 centers in Korea, was based on the Grand Drug-Eluting Stent registry, which is a Korean, nationwide, multicenter, pooled registry of drug-eluting stents. The registry enrolled all-comers without any exclusion criteria except patient withdrawal of consent. A total of 1329 patients with AMI who had an overt intracoronary thrombus at the initial coronary angiography were analyzed. The efficacy end point was a 1-year major adverse cardiovascular event, defined as a composite of all death, myocardial infarction, target lesion revascularization, and stent thrombosis. The primary safety end point was any 30-day bleeding event.
GPIs were associated with a significantly higher rate of any bleeding events at 30 days (0.9% vs 2.9% in the non-GPI and GPI groups, respectively; P = 0.015), whereas GPI use was the only significant independent predictor of 30-day bleeding events by multivariable Cox proportional hazards regression analysis (hazard ratio = 4.76; 95% CI, 1.66-13.64; P = 0.004). Regarding the efficacy end points, no significant differences were noted according to GPI use (7.0% vs 9.0%, P = 0.287), and GPI use has no significant effect on 1-year major adverse cardiovascular events (hazard ratio = 1.33; 95% CI, 0.82-2.15; P = 0.253).
Early upstream use of GPIs should not be considered even in the presence of an intracoronary thrombotic occlusion. ClinicalTrials.gov identifier: NCT03507205.
评估急性心肌梗死(AMI)合并经皮冠状动脉介入治疗(PCI)时冠状动脉内血栓患者使用糖蛋白 IIb/IIIa 抑制剂(GPI)的安全性和有效性。
本研究于 2004 年 1 月 1 日至 2014 年 11 月 31 日在韩国 55 个中心进行,基于韩国全国多中心药物洗脱支架注册研究——大药物洗脱支架注册研究。该注册研究纳入了所有患者,除了患者撤回同意,无任何排除标准。共分析了 1329 例 AMI 患者,这些患者在初始冠状动脉造影时存在明显的冠状动脉内血栓。疗效终点是 1 年主要不良心血管事件,定义为死亡、心肌梗死、靶病变血运重建和支架血栓形成的复合终点。主要安全性终点是任何 30 天出血事件。
GPI 组 30 天任何出血事件发生率显著高于非 GPI 组(0.9%比 2.9%;P=0.015),多变量 Cox 比例风险回归分析显示,GPI 使用是 30 天出血事件的唯一显著独立预测因素(风险比=4.76;95%CI,1.66-13.64;P=0.004)。关于疗效终点,GPI 使用与否无显著差异(7.0%比 9.0%;P=0.287),GPI 使用对 1 年主要不良心血管事件无显著影响(风险比=1.33;95%CI,0.82-2.15;P=0.253)。
即使存在冠状动脉内血栓闭塞,也不应早期常规使用 GPI。临床试验注册号:NCT03507205。