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JAMA Cardiol. 2019 Nov 6:1-10. doi: 10.1001/jamacardio.2019.4296. [Epub ahead of print]

Association of Sex With Outcomes in Patients Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the GLOBAL LEADERS Randomized Clinical Trial.

Author information

1
Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
2
Cardiology Unit, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.
3
Cardiology Division, Department of Internal Medicine, University of Campinas, Campinas, Brazil.
4
Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.
5
First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
6
Department of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.
7
Royal Bournemouth and Christchurch National Health Services Trust, Bournemouth, England.
8
Division of Interventional Cardiology, Cardio-Thoracic-Vascular Department, San Raffaele Scientific Institute, Milan, Italy.
9
GCS ES Axium Rambot, Aix en Provence, France.
10
St Vincent's and Northern Hospitals, Melbourne Medical School, The University of Melbourne, Victoria, Australia.
11
East Lancashire Hospitals National Health Services Trust, Blackburn, Lancashire, England.
12
Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim, Germany.
13
French Alliance for Cardiovascular Trials; Hôpital Bichat, AP-HP; Université Paris-Diderot; INSERM U-1148; Paris, France.
14
Royal Brompton Hospital, Imperial College, London, England.
15
Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Canada.
16
Department of Cardiology, Bern University Hospital, Bern, Switzerland.
17
Cardialysis Clinical Trials Management and Core Laboratories, Westblaak 98, Rotterdam, the Netherlands.
18
Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
19
National Heart and Lung Institute, Imperial College London, London, England.

Abstract

Importance:

Women experience worse ischemic and bleeding outcomes after percutaneous coronary intervention (PCI).

Objectives:

To assess the association of sex with patient outcomes at 2 years after contemporary PCI and with the efficacy and safety of 2 antiplatelet strategies.

Design, Setting, and Analysis:

This study is a prespecified subgroup analysis of the investigator-initiated, prospective, randomized GLOBAL LEADERS study evaluating 2 strategies of antiplatelet therapy after PCI in an unselected population including 130 secondary/tertiary care hospitals in different countries. The main study enrolled 15 991 unselected patients undergoing PCI between July 2013 and November 2015. Patients had an outpatient clinic visit at 30 days and 3, 6, 12, 18, and 24 months after the index procedure. Data were analyzed between January 1, 2019, and March 31, 2019.

Interventions:

Eligible patients were randomized to either the experimental or reference antiplatelet strategy. Experimental strategy consisted of 1 month of dual antiplatelet therapy (DAPT) followed by 23 months of ticagrelor monotherapy, while the reference strategy comprised of 12 months of DAPT followed by 12 months of aspirin monotherapy.

Main Outcomes and Measures:

The primary efficacy end point was the composite of all-cause mortality and new Q-wave myocardial infarction at 2 years. The secondary safety end point was Bleeding Academic Research Consortium type 3 or 5 bleeding.

Results:

Of the 15 968 patients included in this study, 3714 (23.3%) were women. The risk of the primary end point at 2 years was similar between women and men (adjusted hazard ratio [HR], 1.00; 95% CI, 0.83-1.20). Compared with men, women had higher risk of Bleeding Academic Research Consortium type 3 or 5 bleeding (adjusted HR, 1.32; 95% CI, 1.04-1.67) and hemorrhagic stroke at 2 years (adjusted HR, 4.76; 95% CI, 1.92-11.81). At 2 years, there was no between-sex difference in the efficacy and safety of the 2 antiplatelet strategies. At 1 year, compared with DAPT, ticagrelor monotherapy was associated with a lower risk of bleeding in men (HR, 0.72; 95% CI, 0.53-0.98) but not in women (HR, 1.23; 95% CI, 0.80-1.89; P for interaction = .045).

Conclusions and Relevance:

Compared with men, women experienced a higher risk of bleeding and hemorrhagic stroke after PCI. The effect of 2 antiplatelet strategies on death and Q-wave myocardial infarction following PCI did not differ between the sexes at 2 years.

Trial Registration:

ClinicalTrials.gov identifier: NCT01813435.

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