Kidd Stephen K, Bonaca Marc P, Braunwald Eugene, De Ferrari Gaetano M, Lewis Basil S, Merlini Piera A, Murphy Sabina A, Scirica Benjamin M, White Harvey D, Morrow David A
Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
J Am Heart Assoc. 2016 Jul 18;5(7):e003237. doi: 10.1161/JAHA.116.003237.
Our dual aims were as follows: (1) to classify new or recurrent myocardial infarctions (MI) in patients with stable atherosclerosis using the Universal Definition of MI classification system; and (2) to characterize the effects of vorapaxar, a first-in-class platelet protease-activated receptor -1 antagonist, on new or recurrent MI.
We analyzed data from TRA 2°P-TIMI 50, a multinational, randomized, double-blind, placebo-controlled trial of vorapaxar. This analysis included 20 770 patients with previous MI or peripheral arterial disease without a history of transient ischemic attack or stroke. Each new or recurrent MI after randomization that met the trial end point definition was further categorized according to the European Society of Cardiology, American College of Cardiology, American Heart Association, World Heart Federation Universal Definition classification of type and size. Of 1095 incident MIs, 77% were spontaneous (Type 1), with a smaller number (9.8%) of secondary MIs (Type 2). Vorapaxar reduced Type 1 MI (hazard ratio [HR] 0.84, CI 0.73-0.98, P=0.024), with a similar pattern for Type 2 MI (HR 0.74, CI 0.49-1.10, P=0.13). Notably, vorapaxar showed a consistent pattern of reduction across size of MIs, including MIs in the highest Universal MI size class (≥10× upper reference limit, HR 0.83, CI 0.70-0.98, P=0.025). As such, there was a significant reduction in larger, spontaneous MIs (Type 1, ≥10× upper reference limit, HR 0.81, CI 0.67-0.99, P=0.036), and a consistent pattern with respect to fatal MI (HR 0.66, CI 0.39-1.11, P=0.12).
Among stable patients with established atherosclerosis, the most common type of incident MI is spontaneous MI, and the reduction in MI with vorapaxar was consistent across MIs of varying type and size, including spontaneous infarctions ≥10× upper reference limit.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT00526474.
我们的双重目标如下：（1）使用心肌梗死通用定义分类系统对稳定型动脉粥样硬化患者的新发或复发性心肌梗死（MI）进行分类；（2）描述一流的血小板蛋白酶激活受体-1拮抗剂vorapaxar对新发或复发性MI的影响。
我们分析了TRA 2°P-TIMI 50的数据，这是一项关于vorapaxar的多国、随机、双盲、安慰剂对照试验。该分析纳入了20770例既往有心肌梗死或外周动脉疾病且无短暂性脑缺血发作或中风病史的患者。随机分组后符合试验终点定义的每例新发或复发性MI，根据欧洲心脏病学会、美国心脏病学会、美国心脏协会、世界心脏联盟的通用定义对类型和大小进行进一步分类。在1095例新发心肌梗死中，77%为自发性（1型），继发性心肌梗死（2型）较少（9.8%）。Vorapaxar降低了1型心肌梗死（风险比[HR]0.84，可信区间[CI]0.73 - 0.98，P = 0.024），2型心肌梗死也有类似趋势（HR 0.74，CI 0.49 - 1.10，P = 0.13）。值得注意的是，vorapaxar在不同大小的心肌梗死中均呈现出一致的降低趋势，包括通用心肌梗死大小分类中最高级别（≥10×上参考限值）的心肌梗死（HR 0.83，CI 0.70 - 0.98，P = 0.025）。因此，较大的自发性心肌梗死（1型，≥10×上参考限值）有显著降低（HR 0.81，CI 0.67 - 0.99，P = 0.036），且在致命性心肌梗死方面也有一致趋势（HR 0.66，CI 0.39 - 1.11，P = 0.12）。
在已确诊动脉粥样硬化的稳定患者中，新发心肌梗死最常见的类型是自发性心肌梗死，vorapaxar对不同类型和大小的心肌梗死，包括≥10×上参考限值的自发性梗死，均有一致的降低作用。
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