Clinical ResearchSex-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
Section snippets
Methods
We analyzed data from 2096 patients enrolled in the Risk Scoring Model to Predict Net Adverse Cardiovascular Outcomes After Primary Percutaneous Coronary Intervention (RISK-PCI) trial between February 2006 and December 2009. The design and methods of the RISK-PCI trial have been previously published.25, 26 Briefly, the RISK-PCI is an observational, longitudinal, cohort, single-centre trial specifically designed to generate and validate an accurate risk model to predict major adverse
Patient characteristics
Baseline clinical characteristics by sex are shown in Supplemental Table S1. Women were older and had higher prevalence of cardiovascular risk factors (excepting smoking) compared with men. Moreover, women showed more unfavourable clinical, laboratory, and angiographic characteristics than men. Median hospitalization time was 8 (interquartile range, 7-10) days for women and 7 (interquartile range, 5-8) days for men, Mann-Whitney P = 0.03. In hospital, women were treated more frequently with
Discussion
The present study showed that women were older, presented later, and had more adverse risk profiles compared with men. After adjustment for baseline clinical and treatment differences, women had a higher rate of total bleeding at 30-day and 1-year follow-ups. Total bleeding was significantly associated with short- and long-term mortality after PPCI. The prespecified composite efficacy end point at 30 days and at 1-year follow-up was comparable across sexes. Men, however, had a trend toward more
Conclusion
Our results show that women were older, presented later, and had more adverse baseline risk profiles compared with men. However, the rate of adjusted short- and long-term composite efficacy outcome did not differ significantly between women and men. The rate of total bleeding was significantly higher in women at 30-day and at 1-year follow-up compared with men. Additionally, total bleeding was associated with higher cumulative mortality after PPCI in both women and men. This finding provides a
Acknowledgements
The authors thank the physicians and nurses of the Coronary Unit and Catheterization Laboratory participating in the primary PCI program.
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