Ospedale Fabrizio Spaziani, Cardiology, Frosinone, Italy (M.M.).
University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany (F.N., D.T.).
Ann Intern Med. 2020 Sep 15;173(6):436-444. doi: 10.7326/M20-1806. Epub 2020 Jul 21.
The efficacy and safety of a reduced dose of prasugrel versus a standard dose of ticagrelor in elderly patients or those with a low body weight presenting with an acute coronary syndrome (ACS) are unknown.
To investigate the effect of an age- and weight-adapted dose of prasugrel versus a standard dose of ticagrelor in patients with ACS. (ClinicalTrials.gov: NCT01944800).
Prespecified analysis of the multicenter, randomized ISAR-REACT 5 trial.
23 centers in Germany and Italy.
3997 patients with ACS planned for invasive management.
Participants were randomly assigned to receive a standard dose of ticagrelor or prasugrel (reduced dose in the elderly or low-weight group and standard dose in the neither elderly nor low-weight group).
The efficacy end point was a composite of death, myocardial infarction, or stroke, and the safety end point was bleeding, both at 12 months.
In the elderly or low-weight group, the efficacy end point occurred in 12.7% of patients assigned to receive prasugrel and 14.6% of those assigned to receive ticagrelor (hazard ratio [HR], 0.82 [95% CI, 0.60 to 1.14]); in the neither elderly nor low-weight group, the efficacy end point occurred in 4.8% of patients assigned to receive prasugrel and 7.3% of those assigned to receive ticagrelor (HR, 0.65 [CI, 0.48 to 0.88]; for interaction > 0.2). In the elderly or low-weight group, Bleeding Academic Research Consortium type 3 to 5 bleeding occurred in 8.1% of patients assigned to receive prasugrel and 10.6% of those assigned to receive ticagrelor (HR, 0.72 [0.46 to 1.12]), and in 3.7% and 3.8%, respectively, of patients in the neither elderly nor low-weight group (HR, 0.98 [CI, 0.65 to 1.47]; for interaction > 0.2).
The study is a subgroup analysis.
In elderly or low-weight patients with ACS, a reduced dose of prasugrel compared with the standard dose of ticagrelor is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk for bleeding.
German Center for Cardiovascular Research and Deutsches Herzzentrum München.
对于患有急性冠脉综合征（ACS）的老年患者或体重较低的患者，普拉格雷的低剂量与替格瑞洛的标准剂量相比，其疗效和安全性尚不清楚。
旨在探究适合年龄和体重的普拉格雷剂量与 ACS 患者的标准剂量替格瑞洛相比的效果。（ClinicalTrials.gov：NCT01944800）。
多中心、随机 ISAR-REACT 5 试验的预设分析。
德国和意大利的 23 个中心。
计划进行有创性治疗的 3997 例 ACS 患者。
参与者被随机分配接受标准剂量替格瑞洛或普拉格雷（老年或低体重组接受低剂量，非老年且非低体重组接受标准剂量）。
主要终点是 12 个月时的死亡、心肌梗死或中风的复合终点，次要终点是出血。
在老年或低体重组中，接受普拉格雷治疗的患者中有 12.7%出现了主要终点事件，而接受替格瑞洛治疗的患者中有 14.6%出现了该事件（风险比 [HR]，0.82 [95%CI，0.60 至 1.14]）；在非老年且非低体重组中，接受普拉格雷治疗的患者中有 4.8%出现了主要终点事件，而接受替格瑞洛治疗的患者中有 7.3%出现了该事件（HR，0.65 [CI，0.48 至 0.88]；交互作用检验>0.2）。在老年或低体重组中，接受普拉格雷治疗的患者中有 8.1%发生了 Bleeding Academic Research Consortium 3 至 5 级出血，而接受替格瑞洛治疗的患者中有 10.6%发生了该事件（HR，0.72 [0.46 至 1.12]），而在非老年且非低体重组中，分别有 3.7%和 3.8%的患者发生了该事件（HR，0.98 [CI，0.65 至 1.47]；交互作用检验>0.2）。
该研究是亚组分析。
对于 ACS 的老年或低体重患者，与标准剂量替格瑞洛相比，普拉格雷的低剂量与维持抗缺血效果相关，同时降低了这些患者的出血风险。
德国心血管研究中心和慕尼黑德国心脏中心。
