Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre‐Specified Analysis of the GLOBAL LEADERS Trial

Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease

卷:10

Kurt Huber¹  Yoshinobu Onuma²  Dik Heg³  Eugene P. Mc Fadden⁴  Lorenz Räber⁵  Marco Valgimigli⁵  Stephan Windecker⁵  Ayodele Odutayo⁶  Peter Jüni⁶  Roberto Diletti⁷  Philippe Gabriel Steg⁸  Luc Janssens⁹  Patrick W. Serruys¹⁰  Pascal Vranckx¹¹  Edouard Benit¹¹  Christian Hamm¹²  Maurizio Ferrario¹³ 

[1] 3rd Department of Medicine, Cardiology and Intensive Care Medicine Medical Faculty Wilhelminen Hospital and Sigmund Freud University Vienna Austria;

[2] Cardialysis Rotterdam The Netherlands;

[3] Clinical Trials Unit University of Bern Switzerland;

[4] Cork University Hospital Cork Ireland;

[5] Department of Cardiology University of BernInselspital Bern Switzerland;

[6] Department of Medicine and Institute of Health Policy, Management and Evaluation Applied Health Research CentreLi Ka Shing Knowledge Institute of St. Michael’s HospitalUniversity of Toronto Canada;

[7] Erasmus Medical Center Rotterdam The Netherlands;

[8] INSERM U‐1148 FACT (French Alliance for Cardiovascular Trials) Hôpital BichatAssistance Publique–Hôpitaux de ParisUniversité de Paris France;

[9] Imeldaziekenhuis Bonheiden Belgium;

[10] Imperial College London London United Kingdom;

[11] Jessa Ziekenhuis Faculty of Medicine and Life Sciences at the Hasselt University Hasselt Belgium;

[12] Kerckhoff Heart and Thorax Center Bad Nauheim Germany;

[13] UOC Cardiologia Fondazione IRCCS Policlinico San Matteo Pavia Italy;

关键词: acute coronary syndrome;    all‐comers;    antiplatelet therapy;    coronary;    intervention;    stable coronary artery disease;   

DOI  :  10.1161/JAHA.119.015560

来源: DOAJ

【 摘 要 】

Background The optimal duration of dual antiplatelet therapy after coronary drug‐eluting stent placement in adults with stable coronary artery disease (SCAD) versus acute coronary syndromes (ACS) remains uncertain. Methods and Results This was a prespecified subgroup analysis of the GLOBAL LEADERS trial. Participants were randomly assigned 1:1 to the experimental or reference strategy, stratified by ACS (experimental, n=3750; reference, n=3737) versus SCAD (experimental, n=4230; reference, n=4251). The experimental strategy was 75 to 100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy. The reference strategy was 75 to 100 mg aspirin daily plus either 75 mg clopidogrel daily (for SCAD) or 90 mg ticagrelor twice daily (for ACS) for 12 months, followed by aspirin monotherapy for 12 months. The primary end point at 2 years was a composite of all‐cause mortality or non‐fatal centrally adjudicated new Q‐wave myocardial infarction. The key secondary safety end point was site‐reported Bleeding Academic Research Consortium grade 3 or 5 bleeding. The primary end point occurred in 147 (3.92%) versus 169 (4.52%) patients with ACS (rate ratio [RR], 0.86; 95% CI, 0.69–1.08; P=0.189), and in 157 (3.71%) versus 180 (4.23%) patients with SCAD (RR, 0.87; 95% CI, 0.71–1.08; P=0.221) with experimental and reference strategy, respectively (P‐interaction=0.926). Bleeding Academic Research Consortium grade 3 or 5 bleeding occurred in 73 (1.95%) versus 100 (2.68%) patients with ACS (RR, 0.73; 95% CI, 0.54–0.98; P=0.037), and in 90 (2.13%) versus 69 (1.62%) patients with SCAD (RR, 1.32; 95% CI, 0.97–1.81; P=0.081; P‐interaction=0.007). Conclusions While there was no evidence for differences in efficacy between treatment strategies by subgroup, the experimental strategy appeared to reduce bleeding risk in patients with ACS but not in patients with SCAD. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.

【 授权许可】

Unknown