Study Highlights Gender Differences in Bleeding Risk After PCI

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Women are at higher risk of bleeding after percutaneous coronary intervention (PCI) than men, according to a study published online March 19, 2013, ahead of print in the Journal of the American College of Cardiology. The study also confirms a previously described “risk-treatment paradox” whereby patients at highest risk for bleeding are least likely to receive accepted bleeding avoidance therapies no matter what their gender.

Researchers led by Stacie L. Daugherty, MD, MSPH, of University of Colorado School of Medicine (Aurora, CO), analyzed use of bleeding avoidance strategies from the National Cardiovascular Data Registry’s CathPCI Registry of 570,777 men and women who underwent PCI between July 2009 and March 2011.

Bleeding avoidance strategies included:

  • Vascular closure device alone
  • Bivalirudin alone
  • Bivalirudin and a vascular closure device
  • Radial access alone
  • Radial access and bivalirudin

More Women at High Risk

The mean estimated bleeding risk was higher for women than men (8.0% vs. 4.0%; P < 0.01). In addition, women were more likely to be categorized as either high (54.1% vs. 23.3%) or intermediate (38.9% vs. 30.7%) risk for bleeding compared with men, while men were significantly more likely to be categorized as low risk (46.0% vs. 7.0%; P < 0.01 for each comparison). In adjusted bleeding outcomes models, women were more than twice as likely to bleed compared with men (OR 2.23, 95% CI 2.17-2.30).


Overall, 7.8% of women and 3.7% of men experienced a bleeding event after PCI (P < 0.01). Post-PCI transfusions and hemoglobin decreases greater than 3 g/dL were the leading contributors to bleeding in both men and women.

Bleeding avoidance strategies were used with similar frequency in women and men (75.4% vs. 75.7%; P = 0.01). When they were not used, women were twice as likely as men to experience bleeding (12.5% vs. 6.2%; P < 0.01).

Compared with men, women were more likely to receive bivalirudin (31.0% vs. 27.5%; P < 0.01) and less likely to undergo a radial approach (3.0% vs. 3.5%; P < 0.05) or have a closure device deployed (16.4% vs. 18.6%; P < 0.01).

The interaction of gender and risk category for receiving any bleeding avoidance strategy was significant, with the largest gender differences in bleeding avoidance strategies among highest risk women and men (71.4% vs. 63.9%). There was no significant interaction between gender and specific bleeding avoidance strategies except in the combined radial approach plus bivalirudin group, where the relative risk reduction was greater in women (P = 0.02 for interaction).

Bleeding avoidance strategies of any type were used the least often in both women and men at highest risk for bleeding compared with those in the lower risk tertiles (men: 63.9% high vs. 76.4% intermediate and 81.2% low; women: 71.4% high vs. 79.7% intermediate and 82.4% low; P < 0.01 for both comparisons).

Women and men had similar adjusted risk reductions of bleeding when any bleeding avoidance strategy was used (OR 0.60 vs. 0.62). Both genders had lower absolute bleeding risks with such strategies; however, the absolute reduction in risk was higher in women vs. men (6.3% vs. 3.2%; P < 0.01).

‘Tip of the Iceberg’

“A lot of this type of data has been historical in nature, so this is a much more contemporary look at the landscape of PCI and the outcomes of women,” study co-author Sunil V. Rao, MD, of the Duke Clinical Research Institute (Durham, NC), said in a telephone interview with TCTMD.

Dr. Rao added that the data support other studies showing that accepted bleeding avoidance strategies tend to be underused in women and underscores the need for operators to “be more cognizant of subsets of patients that are at increased risk for bleeding and to try to overcome this ‘risk-treatment paradox’. . . patients who are least likely to benefit from a bleeding reduction strategy are most likely to get one.”

He said education of operators with regard to the higher bleeding risk in women is an important key to optimizing PCI outcomes but another is finding out why women have a higher risk of bleeding than men in the first place.

“It’s not really clear,” Dr. Rao continued. “Is there something different about the way they metabolize drugs? Is there something different about their vascular structure that predisposes them to bleeding? In one sense, [this study] is just the very tip of what probably is a very large iceberg.”

While the study was not powered to examine differences in efficacy between the various bleeding strategies, he pointed out, “it’s not clear to me from this or any other study that these strategies are all the same. We have seen some differences but a lot more research needs to be done to look for interactions between some of these therapies and access site specifically. For example, if you use bivalirudin with radial, do you get the same benefit [as femoral]?”

Some answers to those questions may be forthcoming from the SAFE-PCI for Women trial, which is currently underway and involves a comparison of radial and femoral PCI in over 3,000 women.


Daugherty SL, Thompson LE, Kim S, et al. 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. J Am Coll Cardiol. 2013;Epub ahead of print.



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  • Dr. Daugherty reports no relevant conflicts of interest.
  • Dr. Rao reports serving as a consultant for Terumo and The Medicines Company.