Bleeding and Ischemic Outcomes With Ticagrelor Monotherapy According to Body Mass Index,JACC: Cardiovascular Interventions

当前位置： X-MOL 学术 › JACC Cardiovasc. Inte. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Bleeding and Ischemic Outcomes With Ticagrelor Monotherapy According to Body Mass Index
JACC: Cardiovascular Interventions ( IF 11.7 ) Pub Date : 2022-10-03 , DOI: 10.1016/j.jcin.2022.07.039
Vijay Kunadian ₁ , Usman Baber ₂ , Carlo A Pivato ₃ , Davide Cao ₄ , George Dangas ₅ , Samantha Sartori ₅ , Zhongjie Zhang ₅ , Dominick J Angiolillo ₆ , Carlo Briguori ₇ , David J Cohen ₈ , Timothy Collier ₉ , Dariusz Dudek ₁₀ , Michael Gibson ₁₁ , Robert Gil ₁₂ , Kurt Huber ₁₃ , Upendra Kaul ₁₄ , Ran Kornowski ₁₅ , Mitchell W Krucoff ₁₆ , Payam Dehghani ₁₇ , Shamir Mehta ₁₈ , David J Moliterno ₁₉ , E Magnus Ohman ₁₆ , Javier Escaned ₂₀ , Gennaro Sardella ₂₁ , Samin K Sharma ₅ , Richard Shlofmitz ₂₂ , Giora Weisz ₂₃ , Bernhard Witzenbichler ₂₄ , Vladimír Džavík ₂₅ , Paul Gurbel ₂₆ , Christian W Hamm ₂₇ , Timothy Henry ₂₈ , Adnan Kastrati ₂₉ , Steven O Marx ₃₀ , Keith Oldroyd ₃₁ , P Gabriel Steg ₃₂ , Stuart Pocock ₉ , Roxana Mehran ₅

Affiliation

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.
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy.
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, USA.
Mediterranea Cardiocentro, Naples, Italy.
Cardiovascular Research Foundation, New York, New York, USA; St. Francis Hospital, Roslyn, Roslyn, New York, USA.
Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Jagiellonian University Medical College, Krakow, Poland.
Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Center of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.
3rd Department Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud University, Medical Faculty, Vienna, Austria.
Batra Hospital and Medical Research Centre, New Delhi, India.
Rabin Medical Center, Petach Tikva, Israel.
Duke University Medical Center-Duke Clinical Research Institute, Durham, North Carolina, USA.
Prairie Vascular Research, Regina, Saskatchewan, Canada.
Hamilton Health Sciences, Hamilton, Ontario, Canada.
University of Kentucky, Lexington, Kentucky, USA.
Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Madrid, Spain.
Policlinico Umberto I University, Rome, Italy.
St. Francis Hospital, Roslyn, Roslyn, New York, USA.
NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA.
Helios Amper-Klinikum, Dachau, Germany.
Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.
Sinai Hospital of Baltimore System, Baltimore, Maryland, USA.
Kerckhoff Clinic, Bad Nauheim, Germany.
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital, Cincinnati, Ohio, USA.
Deutsches Herzzentrum München, Munich, Germany.
Columbia University Medical Center, New York, New York, USA.
The West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom.
Université de Paris and Assistance Publique-Hôpitaux de Paris, Paris, France.

Background

There is a paucity of data regarding the safety and efficacy of different antiplatelet regimens according to standardized body mass index (BMI) categories.

Objectives

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.

Methods

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/m²], overweight [BMI 25-29.99 kg/m²], and obese [BMI ≥30 kg/m²]) and by median BMI, as prespecified in the protocol.

Results

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.

Conclusions

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.

中文翻译：

根据体重指数，替格瑞洛单药治疗的出血和缺血结果

背景

根据标准化体重指数 (BMI) 类别，关于不同抗血小板方案的安全性和有效性的数据很少。

目标

本研究的目的是在 TWILIGHT（替格瑞洛联合阿司匹林或单独用于冠脉介入治疗后的高危患者）试验中根据 BMI 调查出血和缺血结果。

方法

TWILIGHT 试验在经皮冠状动脉介入治疗后 3 个月将高危患者随机分配至替格瑞洛联合阿司匹林或替格瑞洛联合安慰剂组。在该次要分析中，按照欧洲心脏病学会血栓形成工作组的建议（正常体重 [BMI 18.5-24.99 kg/m ² ]、超重 [BMI 25-29.99 kg/m ² ]），按照标准 BMI 类别对患者进行分层, 和肥胖 [BMI ≥ 30 kg/m ² ]) 和中位数 BMI，如协议中预先规定的那样。

结果

在 7,038 名随机分组且有可用 BMI 的患者中，1,807 名（25.7%）体重正常，2,927 名（41.6%）超重，2,304 名（32.7%）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，替格瑞洛单药治疗可减少出血学术研究联盟 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：0.44-0.91]；交互作用P = 0.627)，复合缺血性终点无任何增加全因死亡、心肌梗死或中风（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]；P交互作用 = 0.290）。这些发现与预先设定的中位 BMI 分析一致。