Patterns of Use and Comparative Effectiveness of Bleeding Avoidance Strategies in Men and Women Following Percutaneous Coronary Interventions: An Observational Study From the National Cardiovascular Data Registry®

Study Questions:

What is the use and effectiveness of bleeding avoidance strategies (BAS) in men and women?

Methods:

The authors assessed in-hospital bleeding rates and the use of BAS (vascular closure devices, bivalirudin, radial approach, and their combinations) among 570,777 men (67.5%) and women (32.5%) undergoing percutaneous coronary intervention (PCI) in the National Cardiovascular Data Registry’s CathPCI Registry between 7/1/2009 and 3/31/2011. The relative risk of bleeding for each BAS compared with no BAS was determined in women and men using multivariable logistic regressions adjusted for clinical characteristics and the propensity for receiving BAS. Finally, the absolute risk differences in bleeding associated with BAS were compared.

Results:

The use of any BAS was slightly lower in women (75.4% vs. 75.7%, p = 0.01). In the absence of BAS, women had significantly higher rates of bleeding than men (12.5% vs. 6.2%, p < 0.01). There was no interaction between gender and the anti-bleeding efficacy of BAS with similar adjusted risk reductions of bleeding when any BAS was used (women: odds ratio [OR], 0.60; 95% confidence interval [CI], 0.57-0.63; men: OR, 0.62; 95% CI, 0.59-0.65). The absolute risk difference in bleeding risk with BAS was greater in women compared with men (6.3% vs. 3.2%, p < 0.01).

Conclusions:

The authors concluded that women have a higher risk of bleeding compared with men, and have a greater absolute benefit of BAS.

Perspective:

The higher risk of bleeding and vascular complications in women compared with men has been highlighted in multiple studies. This study corroborates prior work demonstrating the benefit of bivalirudin and other BAS in women undergoing PCI. The risk of bleeding in women, even when these strategies are used, is higher than in men, and invokes the need for further research. Nevertheless, the benefits of BAS observed in this study were striking, and these measures should be considered routinely in all patients.

Keywords: Hemorrhage, Percutaneous Coronary Intervention


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