1. 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.
- Author
-
Acharjee S, Teo KK, Jacobs AK, Hartigan PM, Barn K, Gosselin G, Tanguay JF, Maron DJ, Kostuk WJ, Chaitman BR, Mancini GB, Spertus JA, Dada MR, Bates ER, Booth DC, Weintraub WS, O'Rourke RA, and Boden WE
- 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
- 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., 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., 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., 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., 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., (Copyright © 2015. Published by Elsevier Inc.)
- Published
- 2016
- Full Text
- View/download PDF