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

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 t...

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Autores principales:	Pascal Vranckx, Marco Valgimigli, Ayodele Odutayo, Patrick W. Serruys, Christian Hamm, Philippe Gabriel Steg, Dik Heg, Eugene P. Mc Fadden, Yoshinobu Onuma, Edouard Benit, Luc Janssens, Roberto Diletti, Maurizio Ferrario, Kurt Huber, Lorenz Räber, Stephan Windecker, Peter Jüni
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	acute coronary syndrome all‐comers antiplatelet therapy coronary intervention stable coronary artery disease Diseases of the circulatory (Cardiovascular) system RC666-701
Acceso en línea:	https://doaj.org/article/3f8d273488474e0287631cc521cf8542
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spelling	oai:doaj.org-article:3f8d273488474e0287631cc521cf85422021-11-23T11:36:34ZEfficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre‐Specified Analysis of the GLOBAL LEADERS Trial10.1161/JAHA.119.0155602047-9980https://doaj.org/article/3f8d273488474e0287631cc521cf85422021-09-01T00:00:00Zhttps://www.ahajournals.org/doi/10.1161/JAHA.119.015560https://doaj.org/toc/2047-9980Background 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.Pascal VranckxMarco ValgimigliAyodele OdutayoPatrick W. SerruysChristian HammPhilippe Gabriel StegDik HegEugene P. Mc FaddenYoshinobu OnumaEdouard BenitLuc JanssensRoberto DilettiMaurizio FerrarioKurt HuberLorenz RäberStephan WindeckerPeter JüniWileyarticleacute coronary syndromeall‐comersantiplatelet therapycoronaryinterventionstable coronary artery diseaseDiseases of the circulatory (Cardiovascular) systemRC666-701ENJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 10, Iss 18 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	acute coronary syndrome all‐comers antiplatelet therapy coronary intervention stable coronary artery disease Diseases of the circulatory (Cardiovascular) system RC666-701
spellingShingle	acute coronary syndrome all‐comers antiplatelet therapy coronary intervention stable coronary artery disease Diseases of the circulatory (Cardiovascular) system RC666-701 Pascal Vranckx Marco Valgimigli Ayodele Odutayo Patrick W. Serruys Christian Hamm Philippe Gabriel Steg Dik Heg Eugene P. Mc Fadden Yoshinobu Onuma Edouard Benit Luc Janssens Roberto Diletti Maurizio Ferrario Kurt Huber Lorenz Räber Stephan Windecker Peter Jüni Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre‐Specified Analysis of the GLOBAL LEADERS Trial
description	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.
format	article
author	Pascal Vranckx Marco Valgimigli Ayodele Odutayo Patrick W. Serruys Christian Hamm Philippe Gabriel Steg Dik Heg Eugene P. Mc Fadden Yoshinobu Onuma Edouard Benit Luc Janssens Roberto Diletti Maurizio Ferrario Kurt Huber Lorenz Räber Stephan Windecker Peter Jüni
author_facet	Pascal Vranckx Marco Valgimigli Ayodele Odutayo Patrick W. Serruys Christian Hamm Philippe Gabriel Steg Dik Heg Eugene P. Mc Fadden Yoshinobu Onuma Edouard Benit Luc Janssens Roberto Diletti Maurizio Ferrario Kurt Huber Lorenz Räber Stephan Windecker Peter Jüni
author_sort	Pascal Vranckx
title	Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre‐Specified Analysis of the GLOBAL LEADERS Trial
title_short	Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre‐Specified Analysis of the GLOBAL LEADERS Trial
title_full	Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre‐Specified Analysis of the GLOBAL LEADERS Trial
title_fullStr	Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre‐Specified Analysis of the GLOBAL LEADERS Trial
title_full_unstemmed	Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre‐Specified Analysis of the GLOBAL LEADERS Trial
title_sort	efficacy and safety of ticagrelor monotherapy by clinical presentation: pre‐specified analysis of the global leaders trial
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/3f8d273488474e0287631cc521cf8542
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Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre‐Specified Analysis of the GLOBAL LEADERS Trial

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