Kunadian Vijay, Baber Usman, Pivato Carlo A, Cao Davide, Dangas George, Sartori Samantha, Zhang Zhongjie, Angiolillo Dominick J, Briguori Carlo, Cohen David J, Collier Timothy, Dudek Dariusz, Gibson Michael, Gil Robert, Huber Kurt, Kaul Upendra, Kornowski Ran, Krucoff Mitchell W, Dehghani Payam, Mehta Shamir, Moliterno David J, Ohman E Magnus, Escaned Javier, Sardella Gennaro, Sharma Samin K, Shlofmitz Richard, Weisz Giora, Witzenbichler Bernhard, Džavík Vladimír, Gurbel Paul, Hamm Christian W, Henry Timothy, Kastrati Adnan, Marx Steven O, Oldroyd Keith, Steg P Gabriel, Pocock Stuart, Mehran Roxana
Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.
Department of Cardiology, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
JACC Cardiovasc Interv. 2022 Oct 10;15(19):1948-1960. doi: 10.1016/j.jcin.2022.07.039.
There is a paucity of data regarding the safety and efficacy of different antiplatelet regimens according to standardized body mass index (BMI) categories.
The aim of this study was to investigate bleeding and ischemic outcomes according to BMI in the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial.
The TWILIGHT trial randomized high-risk patients to ticagrelor plus aspirin or ticagrelor plus placebo at 3 months after percutaneous coronary intervention. In this secondary analysis, patients were stratified by standard BMI categories, as recommended by the European Society of Cardiology Working Group on Thrombosis (normal weight [BMI 18.5-24.99 kg/m], overweight [BMI 25-29.99 kg/m], and obese [BMI ≥30 kg/m]) and by median BMI, as prespecified in the protocol.
Among 7,038 patients randomized and with available BMI, 1,807 (25.7%) were normal weight, 2,927 (41.6%) were overweight, and 2,304 (32.7%) were obese. In normal-weight, overweight, and obese patients, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced the primary endpoint of Bleeding Academic Research Consortium type 2, 3, or 5 bleeding (normal weight: HR: 0.48 [95% CI: 0.32-0.73]; overweight: HR: 0.57 [95% CI: 0.41-0.78]; obese: HR: 0.63 [95% CI: 0.44-0.91]; P for interaction = 0.627), without any increase in the composite ischemic endpoint of all-cause death, myocardial infarction, or stroke (normal weight: HR: 1.36 [95% CI: 0.84-2.19]; overweight: HR: 0.92 [95% CI: 0.63-1.35]; obese: HR: 0.84 [95% CI: 0.56-1.25]; P for interaction = 0.290). These findings were consistent with the prespecified analysis by median BMI.
Among high-risk patients undergoing percutaneous coronary intervention, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced bleeding events without any increase in ischemic risk across different BMI categories.
关于根据标准化体重指数（BMI）类别划分的不同抗血小板治疗方案的安全性和有效性的数据匮乏。
本研究的目的是在TWILIGHT（替格瑞洛在冠状动脉介入术后高危患者中联合阿司匹林或单药治疗）试验中，根据BMI调查出血和缺血事件的结局。
TWILIGHT试验将高危患者在经皮冠状动脉介入术后3个月随机分为替格瑞洛联合阿司匹林组或替格瑞洛联合安慰剂组。在这项二次分析中，患者按照欧洲心脏病学会血栓形成工作组推荐的标准BMI类别（正常体重[BMI 18.5 - 24.99kg/m²]、超重[BMI 25 - 29.99kg/m²]和肥胖[BMI≥30kg/m²]）以及方案中预先规定的BMI中位数进行分层。
在7038例随机分组且有可用BMI数据的患者中，1807例（25.7%）为正常体重，2927例（41.6%）为超重，2304例（32.7%）为肥胖。在正常体重、超重和肥胖患者中，与替格瑞洛联合阿司匹林相比，替格瑞洛单药治疗降低了出血学术研究联盟2、3或5型出血的主要终点（正常体重：HR：0.48[95%CI：0.32 - 0.73]；超重：HR：0.57[95%CI：0.41 - 0.78]；肥胖：HR：0.63[95%CI：0.44 - 0.9l]；交互作用P = 0.627），且全因死亡、心肌梗死或卒中的复合缺血终点未增加（正常体重：HR：1.36[95%CI：0.84 - 2.19]；超重：HR：0.92[95%CI：0.63 - 1.35]；肥胖：HR：0.84[95%CI：0.56 - 1.25]；交互作用P = 0.290）。这些发现与按BMI中位数进行的预先规定分析一致。
在接受经皮冠状动脉介入治疗的高危患者中，与替格瑞洛联合阿司匹林相比，替格瑞洛单药治疗减少了出血事件，且在不同BMI类别中缺血风险未增加。
