Subroto Acharjee1, Koon K Teo2, Alice K Jacobs3, Pamela M Hartigan4, Kulpreet Barn5, Gilbert Gosselin6, Jean-Francois Tanguay6, David J Maron7, William J Kostuk8, Bernard R Chaitman9, G B John Mancini10, John A Spertus11, Marcin R Dada12, Eric R Bates13, David C Booth14, William S Weintraub15, Robert A O'Rourke16, William E Boden17. 1. Einstein Medical Center Philadelphia, Philadelphia, PA. 2. Hamilton General Hospital/Master University, Hamilton, Canada. 3. Boston Medical Center, Boston, MA. 4. VA Connecticut Healthcare System, West Haven, CT. 5. Geisinger Medical Center, Danville, PA. 6. Montreal Heart Institute/Université de Montréal, Montreal, QC, Canada. 7. Vanderbilt University Medical Center, Nashville, TN. 8. London Health Science Centre, London, ON, Canada. 9. Saint Louis University School of Medicine, St. Louis, MT. 10. Vancouver Hospital and Health Science Centre, Vancouver, BC, Canada. 11. Mid America Heart Institute, Kansas City, MO. 12. Hartford Hosp, Hartford, CT. 13. University of Michigan, Ann Arbor, MI. 14. University of Kentucky Med Center, Lexington, KY. 15. Christiana Healthcare System and Center for Outcomes Research, Newark, DE. 16. South Texas Veterans Health Care System-Audie Murphy Campus, San Antonio, TX. 17. Stratton VA Medical Center, Albany Medical College, Albany, NY. Electronic address: william.boden@va.gov.
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 toPCI 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.
RCT Entities:
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.
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Authors: Robert E Heinl; Devinder S Dhindsa; Elliot N Mahlof; William M Schultz; Johnathan C Ricketts; Tina Varghese; Amirhossein Esmaeeli; Marc P Allard-Ratick; Anthony J Millard; Heval M Kelli; Pratik B Sandesara; Danny J Eapen; Laurence Sperling Journal: Can J Cardiol Date: 2016-07-22 Impact factor: 5.223
Authors: Harmony R Reynolds; Leslee J Shaw; James K Min; John A Spertus; Bernard R Chaitman; Daniel S Berman; Michael H Picard; Raymond Y Kwong; C Noel Bairey-Merz; Derek D Cyr; Renato D Lopes; Jose Luis Lopez-Sendon; Claes Held; Hanna Szwed; Roxy Senior; Gilbert Gosselin; Rajesh Gopalan Nair; Ahmed Elghamaz; Olga Bockeria; Jiyan Chen; Alexander M Chernyavskiy; Balram Bhargava; Jonathan D Newman; Sasa B Hinic; Joanna Jaroch; Angela Hoye; Jeffrey Berger; William E Boden; Sean M O'Brien; David J Maron; Judith S Hochman Journal: JAMA Cardiol Date: 2020-07-01 Impact factor: 14.676