Ticagrelor With or Without Aspirin in High -Risk Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention
Ticagrelor With or Without Aspirin in High -Risk Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention
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DOI：
10.1016/j.jacc.2020.03.008
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发表时间：
2020-05-19
影响因子：
24
通讯作者：
Mehran, Roxana
中科院分区：
文献类型：
--
作者：
Angiolill, Dominick J.;Baber, Usman;Mehran, Roxana
背景P2 Y（12）抑制剂替格瑞洛单药治疗在短期双重抗血小板治疗后可以减少经皮冠状动脉介入治疗（PCI）后的出血而不增加缺血性损害。这种方法对糖尿病（DM）患者的影响仍然未知。目的本研究的目的是检查替格瑞洛单药治疗与替格瑞洛加阿司匹林在接受PCI的DM患者中的效果。方法这是对TWILIGHT（冠状动脉介入治疗后高危患者中的替格瑞洛联合阿司匹林或单独使用）试验中DM队列的预先指定分析。在替格瑞洛加阿司匹林3个月后，患者维持替格瑞洛并随机接受阿司匹林或安慰剂治疗1年。主要终点为出血学术研究联盟2、3或5级出血。复合缺血性终点为全因死亡、心肌梗死或stroke.Results，DM患者占随机队列的37%（n = 2，620），其特征为更频繁的合并症和更高的多支血管疾病患病率。在随机接受替格瑞洛+安慰剂与替格瑞洛+阿司匹林的DM患者中，出血学术研究联盟2、3或5级出血的发生率分别为4.5%和6.7%（风险比：0.65; 95%置信区间：0.47至0.91; p = 0.012）。与替格瑞洛加阿司匹林相比，替格瑞洛单药治疗与缺血性事件增加无关（4.6% vs. 5.9%;风险比：0.77; 95%置信区间：0.55 - 1.09; p = 0.14）。在整个试验人群中，有没有显着的相互作用DM状态和治疗组的主要出血或缺血endpoints. Conclusions相比，替格瑞洛加阿司匹林，替格瑞洛单药治疗在降低临床相关出血的风险，而不增加缺血事件的影响是一致的患者或无DM接受PCI。（替格瑞洛与阿司匹林或单独用于冠状动脉介入治疗后的高危患者[TWILIGHT]; NCT 02270242）（J Am科尔Cardiol 2020;75：2403-13）（c）2020年，美国心脏病学会基金会。
BACKGROUND P2Y(12) inhibitor monotherapy with ticagrelor after a brief period of dual antiplatelet therapy can reduce bleeding without increasing ischemic harm after percutaneous coronary intervention (PCI). The impact of this approach among patients with diabetes mellitus (DM) remains unknown.OBJECTIVES The purpose of this study was to examine the effect of ticagrelor monotherapy versus ticagrelor plus aspirin among patients with DM undergoing PCI.METHODS This was a pre-specified analysis of the DM cohort in the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial. After 3 months of ticagrelor plus aspirin, patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. The primary endpoint was Bleeding Academic Research Consortium 2, 3, or 5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke.RESULTS Patients with DM comprised 37% (n = 2,620) of the randomized cohort and were characterized by more frequent comorbidities and a higher prevalence of multivessel disease. The incidence of Bleeding Academic Research Consortium 2, 3, or 5 bleeding was 4.5% and 6.7% among patients with DM randomized to ticagrelor plus placebo versus ticagrelor plus aspirin (hazard ratio: 0.65; 95% confidence interval: 0.47 to 0.91; p = 0.012). Ticagrelor monotherapy was not associated with an increase in ischemic events compared with ticagrelor plus aspirin (4.6% vs. 5.9%; hazard ratio: 0.77; 95% confidence interval: 0.55 to 1.09; p = 0.14). In the overall trial population, there was no significant interaction between DM status and treatment group for the primary bleeding or ischemic endpoints.CONCLUSIONS Compared with ticagrelor plus aspirin, the effect of ticagrelor monotherapy in reducing the risk of clinically relevant bleeding without any increase in ischemic events was consistent among patients with or without DM undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242) (J Am Coll Cardiol 2020;75:2403-13) (c) 2020 by the American College of Cardiology Foundation.