Sex-related analysis of short- and long-term clinical outcomes and bleeding among patients treated with primary percutaneous coronary intervention: an evaluation of the RISK-PCI data.

Background: Unfavourable effect of female sex on short- and long-term clinical outcomes has been demonstrated in unselected ST-elevation acute myocardial infarction (STEMI) patients; the results are conflicting in patients who undergo primary percutaneous coronary intervention (PPCI). The objective of this substudy was to determine whether there are sex-related differences in the 30-day and 1-year clinical outcomes and bleeding after PPCI for STEMI.

Methods: We analyzed 2096 STEMI patients enrolled in the Risk Scoring Model to Predict Net Adverse Cardiovascular Outcomes After Primary Percutaneous Coronary Intervention (RISK-PCI) trial from February 2006 to December 2009. Composite efficacy end point comprised all-cause mortality, nonfatal infarction, and stroke. Safety end point was bleeding classified according to the Thrombolysis in Myocardial Infarction (TIMI) criteria. Net adverse cardiovascular events included composite efficacy end point and total bleeding.

Results: Women in our study were older and presented later than men. After adjustment for potential confounders, there was no difference between sexes with respect to the composite efficacy end point. A higher rate of total bleeding was observed in women (adjusted odds ratio [OR], 1.67; 95% confidence interval [CI], 1.07-2.61 at 30 days, adjusted OR, 1.63; 95% CI, 1.08-2.47 at 1 year) compared with men. Total bleeding was associated with increased mortality at 30 days (OR, 4.87; 95% CI, 2.79-8.47) and at 1 year (OR, 4.43; 95% CI, 2.79-7.02) after PPCI.

Conclusions: We did not find a significant sex-related difference with respect to the composite efficacy end point. Women had a higher rate of total bleeding which was associated with increased short- and long-term mortality. Specific measures aimed at preventing bleeding in women might improve the prognosis of PPCI patients.