Post-PCI Bleeding Risk Higher in Women, Linked with Mortality

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Women suffer more bleeding events following percutaneous coronary intervention (PCI) than men, regardless of age, body mass index (BMI), or type of antithrombotic therapy, according to a study published online August 8, 2013, ahead of print in the American Heart Journal. When bleeding does occur, both men and women are at increased risk of 1-year mortality.

Researchers led by Gjin Ndrepepa, MD, of the Deutsches Herzzentrum Munchen (Munich, Germany), propensity matched 3,351 women and 3,351 men who underwent PCI while enrolled in 7 randomized clinical trials from June 2000 to May 2011. Bleeding within 30 days was defined by the Bleeding Academic Research Consortium (BARC) criteria.

Bleeding occurred more frequently overall in women than in men (OR 1.55; 95% CI 1.34-1.79; P < 0.001), as did severe and access site bleeds (table 1).

Table 1. Bleeding Within 30 Days Post-PCI

 

Women
(n = 3,351)

Men
(n = 3,351)

P Value

Overall

15.5%

10.6%

< 0.001

Severe

9.4%

6.5%

< 0.001

Access Site

10.1%

5.4%

< 0.001


A higher proportion of all bleeding events were access site-related in women (65.4%) compared with men (51.4%). There was no difference between sexes with regard to non-access site bleeding (5.4% vs. 5.2%; OR 1.04; 95% CI 0.84-1.29; P = 0.701).

After adjustment for potential confounders, female sex remained an independent predictor of overall bleeding and access site bleeding but not non-access site bleeding.

Table 2. Risk of Bleeding: Women vs. Men

 

Adjusted OR (95% CI)

P Value

Overall

1.61 (1.35-1.92)

< 0.001

Access Site

2.00 (1.59-2.50)

< 0.001

Non-Access Site

1.18 (0.91-1.54)

0.701


Mortality at 1 year was 3.7%. For both men and women, mortality was higher in those who bled than in those who did not (P < 0.001):

  • Women: 7.8% vs. 2.5%; OR 3.35; 95% CI 2.24-5.01
  • Men: 9.1% vs. 3.6%; OR 2.68; 95% CI 1.78-4.05

There was no difference in 1-year mortality between women and men who bled (OR 0.84; 95% CI 0.52-1.37; P = 0.487). Bleeding was independently associated with an increased risk of 1-year mortality (adjusted HR 2.18; 95% CI 1.68-2.84; P < 0.001), but there was no bleeding-by-sex interaction with regard to mortality (P = 0.439 for interaction).

Local Anatomic Differences at Fault?

Dr. Ndrepepa said in an e-mail communication with TCTMD that the intent of the study was to “equalize” men and women in terms of the other factors that can predispose to bleeding. Because propensity matching isolated the impact of sex, it now appears clear that other comorbidities and risk factors are not responsible for the increased risk of bleeding in women, he observed.

“Since only access site bleeding . . . differed significantly among men and women, the present study suggests that local anatomic differences at the access site may have a role in explaining heightened risk of . . . bleeding in women,” Dr. Ndrepepa said. Generally, the femoral artery in women is shorter and of smaller diameter than in men, which could raise the risk of mechanical injury thanks to difficulties with catheter manipulation and a smaller zone of safe vascular puncture, he added.

Radial artery access and vascular closure devices—both known to reduce access site events more generally—could be tools to limit bleeding in women, Dr. Ndrepepa said, but more research is required to understand whether these strategies are equally effective in women and men.

Study Details

The included studies were: ISAR-REACT, ISAR-SWEET, ISAR-SMART, ISAR-REACT-2, ISAR-REACT-3, ISAR-REACT 3A, and ISAR-REACT-4.

 


Source:
Ndrepepa G, Schulz S, Neumann F-J, et al. Bleeding after percutaneous coronary intervention in women and men matched for age, body mass index, and type of antithrombotic therapy. Am Heart J. 2013;Epub ahead of print.

 

 

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Post-PCI Bleeding Risk Higher in Women, Linked with Mortality

Women suffer more bleeding events following percutaneous coronary intervention (PCI) than men, regardless of age, body mass index (BMI), or type of antithrombotic therapy, according to a study published online August 8, 2013, ahead of print in the American Heart
Disclosures
  • Dr. Ndrepepa reports no relevant conflicts of interest.

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