1 TIMI Study Group Brigham and Women's Hospital Boston MA.
2 FACT, DHU FIRE Hôpital Bichat Assistance Publique-Hôpitaux de Paris Paris France.
J Am Heart Assoc. 2018 Nov 20;7(22):e009260. doi: 10.1161/JAHA.118.009260.
Background Ticagrelor reduced cardiovascular death, myocardial infarction (MI), or stroke in patients with prior MI in PEGASUS-TIMI 54 (Prevention of Cardiovascular Events [eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke] in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin). MI can occur in diverse settings and with varying severity; therefore, understanding the types and sizes of MI events prevented is of clinical importance. Methods and Results MIs were adjudicated by a blinded clinical events committee and categorized by subtype and fold elevation of peak cardiac troponin over the upper limit of normal. A total of 1042 MIs occurred in 898 of the 21 162 randomized patients over a median follow-up of 33 months. The majority of the MIs (76%) were spontaneous (Type 1), with demand MI (Type 2) and stent thrombosis (Type 4b) accounting for 13% and 9%, respectively; sudden death (Type 3), percutaneous coronary intervention-related (Type 4a) and coronary artery bypass graft-related (Type 5) each accounted for <1%. Half of MIs (520, 50%) had a peak troponin ≥10x upper limit of normal and 21% of MIs (220) had a peak troponin ≥100× upper limit of normal. A total of 21% (224) were ST-segment-elevation MI STEMI. Overall ticagrelor reduced MI (4.47% versus 5.25%, hazard ratio 0.83, 95% confidence interval 0.72-0.95, P=0.0055). The benefit was consistent among the subtypes, including a 31% reduction in MIs with a peak troponin ≥100× upper limit of normal (hazard ratio 0.69, 95% confidence interval 0.53-0.92, P=0.0096) and a 40% reduction in ST-segment elevation MI (hazard ratio 0.60, 95% confidence interval 0.46-0.78, P=0.0002). Conclusions In stable outpatients with prior MI, the majority of recurrent MIs are spontaneous and associated with a high biomarker elevation. Ticagrelor reduces the MI consistently among subtypes and sizes including large MIs and ST-segment elevation MI. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT01225562.
背景 在 PEGASUS-TIMI 54 研究（既往心肌梗死患者使用替格瑞洛与安慰剂相比在阿司匹林基础上预防心血管事件[如心脏或血管疾病、心脏病发作或中风导致的死亡]）中，替格瑞洛降低了心血管死亡、心肌梗死（MI）或中风的发生率。MI 可发生在不同的情况下且严重程度不同；因此，了解预防的 MI 事件的类型和大小具有临床重要意义。
方法和结果 由盲法临床事件委员会对 MI 进行裁定，并根据亚型和心肌肌钙蛋白峰值相对于正常值上限的升高倍数进行分类。在中位随访 33 个月期间，21162 例随机患者中有 898 例发生了 1042 例 MI。大多数 MI（76%）为自发性（1 型），需求性 MI（2 型）和支架血栓形成（4b 型）分别占 13%和 9%；猝死（3 型）、经皮冠状动脉介入治疗相关（4a 型）和冠状动脉旁路移植术相关（5 型）各占不到 1%。一半的 MI（520 例，50%）肌钙蛋白峰值≥10 倍正常值上限，21%的 MI（220 例）肌钙蛋白峰值≥100 倍正常值上限。总共 21%（224 例）为 ST 段抬高型 MI（STEMI）。总体而言，替格瑞洛降低了 MI 发生率（4.47%比 5.25%，风险比 0.83，95%置信区间 0.72-0.95，P=0.0055）。这种获益在各亚型中一致，包括肌钙蛋白峰值≥100 倍正常值上限的 MI 减少了 31%（风险比 0.69，95%置信区间 0.53-0.92，P=0.0096）和 ST 段抬高型 MI 减少了 40%（风险比 0.60，95%置信区间 0.46-0.78，P=0.0002）。
结论 在稳定的既往心肌梗死门诊患者中，大多数复发性 MI 为自发性，且与高生物标志物升高有关。替格瑞洛在各亚型和大小的 MI 中均一致降低 MI，包括大 MI 和 ST 段抬高型 MI。
https://www.clinicaltrials.gov。
NCT01225562。
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