TY - JOUR
T1 - Optimal medical therapy with or without percutaneous coronary intervention in women with stable coronary disease
T2 - A pre-specified subset analysis of the Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation (COURAGE) trial
AU - Acharjee, Subroto
AU - Teo, Koon K.
AU - Jacobs, Alice K.
AU - Hartigan, Pamela M.
AU - Barn, Kulpreet
AU - Gosselin, Gilbert
AU - Tanguay, Jean Francois
AU - Maron, David J.
AU - Kostuk, William J.
AU - Chaitman, Bernard R.
AU - Mancini, G. B.John
AU - Spertus, John A.
AU - Dada, Marcin R.
AU - Bates, Eric R.
AU - Booth, David C.
AU - Weintraub, William S.
AU - O'Rourke, Robert A.
AU - Boden, William E.
N1 - Publisher Copyright:
© 2015 Published by Elsevier Inc.
PY - 2016/3/1
Y1 - 2016/3/1
N2 - 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.
AB - 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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U2 - 10.1016/j.ahj.2015.07.020
DO - 10.1016/j.ahj.2015.07.020
M3 - Article
C2 - 26920603
AN - SCOPUS:84960393105
SN - 0002-8703
VL - 173
SP - 108
EP - 117
JO - American Heart Journal
JF - American Heart Journal
ER -