Sex-based differences in outcomes after percutaneous coronary intervention for acute myocardial infarction: a report from TRANSLATE-ACS

Connie N Hess, Lisa A McCoy, Hesha J Duggirala, Dale R Tavris, Kathryn O'Callaghan, Pamela S Douglas, Eric D Peterson, Tracy Y Wang, Connie N Hess, Lisa A McCoy, Hesha J Duggirala, Dale R Tavris, Kathryn O'Callaghan, Pamela S Douglas, Eric D Peterson, Tracy Y Wang

Abstract

Background: Data regarding sex-based outcomes after percutaneous coronary intervention (PCI) for myocardial infarction are mixed. We sought to examine whether sex differences in outcomes exist in contemporary practice.

Methods and results: We examined acute myocardial infarction patients undergoing PCI between April 2010 and October 2012 at 210 US hospitals participating in the Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) observational study. Outcomes included 1-year risk of major adverse cardiac events and bleeding according to Global Utilization of Strategies To Open Occluded Arteries (GUSTO) and Bleeding Academic Research Consortium (BARC) definitions. Among 6218 patients, 27.5% (n=1712) were female. Compared with men, women were older, had more comorbidities, and had lower functional status. Use of multivessel PCI and drug-eluting stents was similar between sexes, while women received less prasugrel. Unadjusted cumulative incidence of 1-year major adverse cardiac events was higher for women than for men (15.7% versus 13.6%, P=0.02), but female sex was no longer associated with higher incidence of major adverse cardiac events after multivariable adjustment (hazard ratio 0.98, 95% CI 0.83 to 1.15). Female sex was associated with higher risks of post-PCI GUSTO bleeding (9.1% versus 5.7%, P<0.0001) and postdischarge BARC bleeding (39.6% versus 27.9%, P<0.0001). Differences persisted after adjustment (GUSTO: hazard ratio 1.32, 95% CI 1.06 to 1.64; BARC: incidence rate ratio 1.42, 95% CI 1.27 to 1.56).

Conclusions: Female and male myocardial infarction patients undergoing PCI differ regarding demographic, clinical, and treatment profiles. These differences appear to explain the higher observed major adverse cardiac event rate but not higher adjusted bleeding risk for women versus men.

Trial registration: ClinicalTrials.gov NCT01088503.

Keywords: acute myocardial infarction; major adverse cardiac events; percutaneous coronary intervention; sex‐based outcomes.

Figures

Figure 1.
Figure 1.
Unadjusted cumulative incidence of major adverse cardiac events according to sex. The Kaplan–Meier curve for 1‐year post‐PCI MACE is shown. MACE indicates major adverse cardiac events; PCI, percutaneous coronary intervention.
Figure 2.
Figure 2.
Unadjusted cumulative incidence of ischemic outcomes according to sex. Shown are Kaplan–Meier curves for 1‐year post‐PCI: (A) all‐cause mortality; (B) MI; (C) stroke; and (D) unplanned repeat revascularization. MI indicates myocardial infarction; PCI, percutaneous coronary intervention.
Figure 3.
Figure 3.
Cumulative incidence of GUSTO bleeding according to sex. Kaplan–Meier curves for: (A) any GUSTO bleeding; and (B) moderate or severe GUSTO bleeding at 1 year post‐PCI are shown. GUSTO indicates Global Use of Strategies to Open Occluded Coronary Arteries; PCI, percutaneous coronary intervention.
Figure 4.
Figure 4.
Distribution of Bleeding Academic Research Consortium (BARC) bleeding according to sex. Bleeding events according to BARC definitions for women vs men are shown. The most severe BARC was counted per patient. *P value <0.0001; †P value <0.001; ‡P value <0.01 for pairwise comparisons.
Figure 5.
Figure 5.
MACE and bleeding outcomes by sex among subgroup populations. HRs for composite of: (A) MACE; and (B) any GUSTO bleeding events are shown for pre‐specified subgroups. P values correspond to the test for interaction between sex and the specific subgroup of interest. P values <0.05 indicate that the effect of sex differs significantly between levels of the subgroup, while P values ≥0.05 indicate no significant difference in the effect of sex by levels of the subgroup. ADP indicates adenosine diphosphate; CrCl, creatinine clearance; DES, drug‐eluting stent; GUSTO, Global Use of Strategies to Open Occluded Coronary Arteries; HR, hazard ratio; LCL, lower 95% confidence limit; MACE, major adverse cardiac events; NSTEMI, non–ST‐segment elevation myocardial infarction; STEMI, ST‐segment elevation myocardial infarction; UCL, upper 95% confidence limit.

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