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Major bleeding events are responsible for more than 1 in 10 of the in-hospital deaths that occur among patients undergoing percutaneous coronary intervention (PCI), according to a large registry study published in the March 13, 2013, issue of the Journal of the American Medical Association. 

Investigators led by Adnan K. Chhatriwalla, MD, of Saint Luke’s Mid America Heart Institute (Kansas City, MO), analyzed data on 3,386,688 PCI procedures from the nationwide CathPCI Registry between 2004 and 2011. Using the most recent CathPCI definitions, a bleeding event was defined as a suspected bleeding with transfusion, a decrease in hemoglobin level of greater than 3.0 g/dL, or a procedural intervention to correct the bleeding event.

Overall, there were 57,246 (1.69%) major bleeding events and 22,165 (0.65%) in-hospital deaths. In-hospital mortality was higher in patients with major bleeding complications compared with those without bleeding (5.58% vs. 0.57%; P < 0.001).

The adjusted population-attributable risk of in-hospital mortality related to major bleeding was 12.1%, and it was similar across risk strata from low (14.7%) to intermediate (11.9%) to high (11.5%).

Propensity Matching Supports Link

In a separate analysis, each patient with major bleeding (n = 56,078) was propensity-matched for both bleeding and mortality risk with 4 controls (n = 224,312). Bleeding patients showed higher in-hospital mortality overall as well as across bleeding risk levels and sites (table 1).

Table 1. In-Hospital Mortality in Propensity-Matched Cohort^a

^a All P values < 0.001.

With regard to major bleeding, the overall number needed to harm (NNH) to produce 1 in-hospital death was 29 and was lowest in patients at high risk for bleeding (NNH = 21) or with nonaccess site bleeding (NNH = 16). In addition, NNH values varied across multiple subgroups, being lowest in patients aged at least 75 years (n = 22), with STEMI (n = 26), or with a glomerular filtration rate below 30 mL/min (n = 20).

According to the authors, the results suggest that “[b]leeding can be reduced through use of established bleeding avoidance strategies, including bivalirudin anticoagulation, arterial closure devices, and radial artery access,” and that the magnitude of the reduction in proportional to the underlying bleeding risk.

Data from the CathPCI Registry indicate that such strategies are being used preferentially in patients at lowest bleeding risk, while the NNH results suggest they should be used in those at highest risk, Dr. Chhatriwalla and colleagues observe.

The findings also underline “the importance of using validated risk assessment tools to accurately estimate bleeding risk and guide treatment strategy for all patients undergoing PCI,” they conclude.

The authors acknowledge that the registry data are subject to several limitations including variable reporting of bleeding complications across participating institutions and the unavailability of information on the specific causes of death.

Study Details

The overall population was predominantly middle-aged (mean 64 years) and male (67%), with a high incidence of prior MI (29%) and previous PCI (39%). Patients presented with STEMI in 14% of cases and NSTEMI or unstable angina in 52%. Heparin anticoagulation was used in 52% of cases, bivalirudin in 48%, and glycoprotein IIb/IIIa inhibitors with heparin or bivalirudin in 34%. PCI was performed via radial access 4.0% of the time.

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