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

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• 作者：Subroto Acharjee ; MD^a ; Koon K. Teo ; MB ; BCH ; PHD^b ; Alice K. Jacobs ; MD^c ; Pamela M. Hartigan ; PHD^d ; Kulpreet Barn ; MD^e ; Gilbert Gosselin ; MD^f ; Jean-Francois Tanguay ; MD^f ; David J. Maron ; MD^g ; William J. Kostuk ; MD^h ; Bernard R. Chaitman ; MDⁱ ; G.B. John Mancini ; MD^j ; John A. Spertus ; MD ; MPH^k ; Marcin R. Dada ; MD^l ; Eric R. Bates ; MD^m ; David C. Booth ; MDⁿ ; William S. Weintraub ; MD^o ; Robert A. O&rsquo ; Rourke ; MD^p ; ^r ; William E. Boden ; MD^q ; ^{william.boden@va.gov" class="auth_mail" title="E-mail the corresponding author} ; on behalf of the COURAGE Trial Research Group
• 关键词：SD ; standard deviation ; IQR ; interquartile range ; HR ; hazard ratio ; CI ; confidence interval ; HF ; heart failure ; PCI ; percutaneous coronary intervention ; CABG ; coronary artery bypass grafting ; ACS ; acute coronary syndrome ; LVEF ; left ventricular ejection fraction ; HDL-C ; high density lipoprotein cholesterol ; LDL-C ; low-density lipoprotein cholesterol ; MI ; myocardial infarction. BMI ; body mass index ; CAD ; coronary artery disease ; SBP ; systolic blood pressure ; DBP ; diastolic blood pressure ; eGFR ; e
• 刊名：American Heart Journal
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：173
• 期：Complete
• 页码：108-117
• 全文大小：354 K

文摘

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.