TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
J Am Coll Cardiol. 2014 Dec 9;64(22):2318-26. doi: 10.1016/j.jacc.2014.07.997. Epub 2014 Dec 1.
Vorapaxar, a novel antiplatelet therapy, reduces thrombotic events in patients with a history of myocardial infarction (MI) or peripheral artery disease (PAD); however, because of an increased risk of intracranial hemorrhage, it is contraindicated in patients with a history of stroke.
The aim of this study was to investigate the incidence of new ischemic stroke and subsequent death or intracerebral hemorrhage in patients with MI or PAD and no cerebrovascular disease (CVD) treated with vorapaxar.
The TRA 2 °P-TIMI 50 (Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Patients With Atherosclerosis-Thrombolysis In Myocardial Infarction 50) was a randomized, double-blind, placebo-controlled trial of vorapaxar 2.5 mg daily in 26,449 patients with atherosclerosis, stratified by qualifying disease (MI, PAD, or CVD). A total of 20,170 patients with MI/PAD, but no CVD, were enrolled.
In patients with MI/PAD and no prior stroke or transient ischemic attack, vorapaxar reduced first ischemic stroke (hazard ratio [HR]: 0.57, 95% confidence interval [CI]: 0.43 to 0.75; p < 0.001). The risk of hemorrhagic conversion after stroke (HR: 1.19, 95% CI: 0.49 to 2.91; p = 0.70) or death (HR: 1.09, 95% CI: 0.57 to 2.07; p = 0.79) during follow-up was not significantly increased with vorapaxar in patients who had a new ischemic stroke (n = 204). Although hemorrhagic stroke was increased (HR: 2.79, 95% CI: 1.00 to 7.73; p = 0.049), overall stroke was significantly reduced (HR: 0.67, 95% CI: 0.52 to 0.87; p = 0.002).
Vorapaxar reduces ischemic stroke in patients with MI or PAD and no known CVD. There does not appear to be a significant increase in the risk of hemorrhagic conversion or death in patients who experienced a first ischemic stroke on vorapaxar. Although primary hemorrhagic stroke is increased, vorapaxar reduces the total incidence of stroke. (Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis [TRA 2 °P-TIMI 50]; NCT00526474).
Vorapaxar 是一种新型抗血小板治疗药物，可降低有心肌梗死 (MI) 或外周动脉疾病 (PAD) 病史的患者的血栓事件发生率；然而，由于颅内出血风险增加，该药物禁用于有卒中病史的患者。
本研究旨在调查 MI 或 PAD 且无脑血管疾病 (CVD) 的患者使用 Vorapaxar 治疗后新发缺血性卒中及随后的死亡或颅内出血发生率。
TRA 2 °P-TIMI 50（动脉粥样硬化血栓溶解心肌梗死 50 次试验评估 Vorapaxar 预防心脏病发作和卒中的效果）是一项随机、双盲、安慰剂对照的 Vorapaxar 每日 2.5mg 治疗试验，纳入了 26449 例动脉粥样硬化患者，按合格疾病（MI、PAD 或 CVD）分层。共纳入 20170 例 MI/PAD 但无 CVD 的患者。
在 MI/PAD 且无既往卒中或短暂性脑缺血发作的患者中，Vorapaxar 降低了首发缺血性卒中（风险比 [HR]：0.57，95%置信区间 [CI]：0.43 至 0.75；p<0.001）。在发生新发缺血性卒中的患者（n=204）中，卒中后出血性转化（HR：1.19，95%CI：0.49 至 2.91；p=0.70）或死亡（HR：1.09，95%CI：0.57 至 2.07；p=0.79）的风险并无显著增加。尽管出血性卒中增加（HR：2.79，95%CI：1.00 至 7.73；p=0.049），但总体卒中发生率显著降低（HR：0.67，95%CI：0.52 至 0.87；p=0.002）。
Vorapaxar 降低了 MI 或 PAD 且无已知 CVD 的患者的缺血性卒中发生率。在接受 Vorapaxar 治疗的发生首发缺血性卒中的患者中，出血性转化或死亡的风险似乎无显著增加。尽管原发性出血性卒中增加，但 Vorapaxar 降低了卒中总发生率。（评估 Vorapaxar（SCH 530348；MK-5348）预防动脉粥样硬化患者心脏病发作和卒中的效果试验 [TRA 2 °P-TIMI 50]；NCT00526474）。
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