Bordeaux PharmacoEpi, INSERM CIC1401, Université de Bordeaux, 33076, Bordeaux, France.
AstraZeneca, 92400, Courbevoie, France.
Br J Clin Pharmacol. 2017 Sep;83(9):2056-2065. doi: 10.1111/bcp.13291. Epub 2017 May 5.
The present study aims to describe real-life outcomes in stable patients after-myocardial infarction (MI) similar to those in the PEGASUS-TIMI 54 trial (PEGASUS), which found long-term benefits of ticagrelor in patients with a history of MI.
One-year event-free post-MI patients were identified in the French claims database representative 1/97 sample (2005-2010) and followed for up to 3 years. A PEGASUS-like (PL) population included patients with age ≥ 65 years, or age ≥ 50 and diabetes, renal dysfunction or prior MI, without stroke, end-stage renal failure or oral anticoagulation. Outcomes were: a composite of all-cause death or hospital admission for MI or stroke; individual events; major bleeding.
There were 1585 post-MI patients totalling 3926 person-years including 865 PL patients (2114 PY); 68% were male; mean age was 66 (standard deviation 15) in post-MI, 74 (10) in PL. Outcomes per 100 person-years [95% confidence interval] were, respectively, in post-MI and PL 6.3 [5.6-7.1] and 7.8 [6.7-8.9] for the composite outcome; 5.1 [4.4-5.8] and 6.5 [5.5-7.6] for death; 1.0 [0.7-1.3] and 1.0 [0.6-1.4] for MI; 0.6 [0.4-0.9] and 0.9 [0.5-1.2] for stroke; 1.3 [0.9-1.6] and 1.4 [0.9-1.9] for major bleeding. Event rates were stable over the 3 study years. Placebo patients in the PEGASUS-TIMI54 Study were younger, more often male and had lower event rates, especially for all-cause death and major bleeding.
Patients selected using the criteria described in PEGASUS were older with more comorbidities, resulting in higher all-cause death and bleeding rates, but similar MI recurrence rates.
本研究旨在描述心肌梗死后(MI)稳定患者的真实临床结局,这些结局类似于 PEGASUS-TIMI 54 试验(PEGASUS)中的结果,该试验发现替格瑞洛对有 MI 病史的患者具有长期益处。
在法国索赔数据库中,我们选择了 1/97 样本(2005-2010 年)中具有 1 年无事件 MI 后生存的患者,并对其进行了长达 3 年的随访。PEGASUS 样(PL)人群包括年龄≥65 岁,或年龄≥50 岁且合并糖尿病、肾功能不全或既往 MI,无卒中、终末期肾病或口服抗凝治疗的患者。结局为:全因死亡或因 MI 或卒中住院的复合结局;单个事件;大出血。
共有 1585 例 MI 患者,总计 3926 人年,其中 865 例为 PL 患者(2114 人年);68%为男性;MI 后平均年龄为 66(15)岁,PL 为 74(10)岁。每 100 人年(95%置信区间)的结局分别为:MI 后和 PL 组的复合结局发生率为 6.3[5.6-7.1]和 7.8[6.7-8.9];死亡率为 5.1[4.4-5.8]和 6.5[5.5-7.6];MI 发生率为 1.0[0.7-1.3]和 1.0[0.6-1.4];卒中发生率为 0.6[0.4-0.9]和 0.9[0.5-1.2];大出血发生率为 1.3[0.9-1.6]和 1.4[0.9-1.9]。3 年研究期间,事件发生率保持稳定。PEGASUS-TIMI54 研究中的安慰剂患者更年轻,更多为男性,且事件发生率更低,尤其是全因死亡率和大出血发生率。
使用 PEGASUS 中描述的标准选择的患者年龄更大,合并症更多,导致全因死亡和出血发生率更高,但 MI 复发率相似。