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Optimal medical therapy with or without percutaneous coronary intervention in women with stable coronary disease: A pre-specified subset analysis of the Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation (COURAGE) trial.
- Source :
-
American heart journal [Am Heart J] 2016 Mar; Vol. 173, pp. 108-17. Date of Electronic Publication: 2015 Jul 26. - Publication Year :
- 2016
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Abstract
- Objectives: To determine whether sex-based differences exist in clinical effectiveness of percutaneous coronary intervention (PCI) when added to optimal medical therapy (OMT) in patients with stable coronary artery disease.<br />Background: A prior pre-specified unadjusted analysis from COURAGE showed that women randomized to PCI had a lower rate of death or myocardial infarction during a median 4.6-year follow-up with a trend for interaction with respect to sex.<br />Methods: We analyzed outcomes in 338 women (15%) and 1949 men (85%) randomized to PCI plus OMT versus OMT alone after adjustment for relevant baseline characteristics.<br />Results: There was no difference in treatment effect by sex for the primary end point (death or myocardial infarction; HR, 0.89; 95% CI, 0.77-1.03 for women and HR, 1.02, 95% CI 0.96-1.10 for men; P for interaction = .07). Although the event rate was low, a trend for interaction by sex was nonetheless noted for hospitalization for heart failure, with only women, but not men, assigned to PCI experiencing significantly fewer events as compared to their counterparts receiving OMT alone (HR, 0.59; 95% CI, 0.40-0.84, P < .001 for women and HR, 0.86; 95% CI, 0.74-1.01, P = .47 for men; P for interaction = .02). Both sexes randomized to PCI experienced significantly reduced need for subsequent revascularization (HR, 0.72; 95% CI, 0.62-0.83, P < .001 for women; HR, 0.84; 95% CI, 0.79-0.89, P < .001 for men; P for interaction = .02) with evidence of a sex-based differential treatment effect.<br />Conclusion: In this adjusted analysis of the COURAGE trial, there were no significant differences in treatment effect on major outcomes between men and women. However, women assigned to PCI demonstrated a greater benefit as compared to men, with a reduction in heart failure hospitalization and need for future revascularization. These exploratory observations require further prospective study.<br /> (Copyright © 2015. Published by Elsevier Inc.)
- Subjects :
- Aged
Canada epidemiology
Cause of Death trends
Coronary Angiography
Coronary Artery Disease diagnosis
Coronary Artery Disease mortality
Dose-Response Relationship, Drug
Electrocardiography
Female
Follow-Up Studies
Humans
Male
Middle Aged
Prognosis
Prospective Studies
Retrospective Studies
Sex Factors
Survival Rate trends
Time Factors
Treatment Outcome
United States epidemiology
Cardiovascular Agents administration & dosage
Coronary Artery Disease therapy
Percutaneous Coronary Intervention
Risk Assessment
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6744
- Volume :
- 173
- Database :
- MEDLINE
- Journal :
- American heart journal
- Publication Type :
- Academic Journal
- Accession number :
- 26920603
- Full Text :
- https://doi.org/10.1016/j.ahj.2015.07.020