Association Between Bleeding Events and In-Hospital Mortality After Percutaneous Coronary Intervention

Study Questions:

What is the association between bleeding events and in-hospital mortality after percutaneous coronary intervention (PCI)?

Methods:

Data from 3,386,688 procedures in the CathPCI Registry performed in the United States between 2004 and 2011 were analyzed. The population-attributable risk was calculated after adjustment for baseline demographic, clinical, and procedural variables. To calculate the number needed to harm (NNH) for bleeding-related mortality, a propensity-matched analysis was performed. The main outcome measure was in-hospital mortality.

Results:

There were 57,246 bleeding events (1.7%) and 22,165 in-hospital deaths (0.65%) in 3,386,688 PCI procedures. The adjusted population-attributable risk for mortality related to major bleeding was 12.1% (95% confidence interval [CI], 11.4%-12.7%) in the entire CathPCI cohort. The propensity-matched population consisted of 56,078 procedures with a major bleeding event and 224,312 in controls. In this matched cohort, major bleeding was associated with increased in-hospital mortality (5.26% vs. 1.87%; risk difference, 3.39% [95% CI, 3.20%-3.59%]; NNH = 29 [95% CI, 28-31]; p < 0.001). The association between major bleeding and in-hospital mortality was observed in all strata of preprocedural bleeding risk (low: 1.62% vs. 0.17%; risk difference, 1.45% [95% CI, 1.13%-1.77%], NNH = 69 [95% CI, 57-88], p < 0.001; intermediate: 3.27% vs. 0.71%; risk difference, 2.56% [95% CI, 2.33%-2.79%], NNH = 39 [95% CI, 36-43], p < 0.001; and high: 8.16% vs. 3.45%; risk difference, 4.71% [95% CI, 4.35%-5.07%], NNH = 21 [95% CI, 20-23], p < 0.001). Although both access-site and non–access-site bleeding were associated with increased in-hospital mortality (2.73% vs. 1.87%; risk difference, 0.86% [95% CI, 0.66%-1.05%], NNH = 117 [95% CI, 95-151], p < 0.001; and 8.25% vs. 1.87%; risk difference, 6.39% [95% CI, 6.04%-6.73%], NNH = 16 [95% CI, 15-17], p < 0.001, respectively), the NNH was lower for nonaccess bleeding.

Conclusions:

The authors concluded that postprocedural bleeding events were associated with increased risk of in-hospital mortality.

Perspective:

This study of more than 3.3 million PCI procedures reported that major bleeding was associated with significantly increased in-hospital mortality after PCI. Adjusted population-attributable risk estimates suggested that 12.1% of all in-hospital mortality after PCI may be related to bleeding complications and may therefore be modifiable, and NNH calculations suggest that the mortality risk associated with bleeding is greatest in patients at highest bleeding risk or with non–access site bleeding. It appears that bleeding avoidance strategies are of greatest benefit and, therefore, should be preferentially used in higher-risk patients to reduce the risk of major bleeding complications and bleeding-related mortality after PCI. These data also affirm the importance of using validated risk assessment tools to accurately estimate bleeding risk and guide treatment strategy for all patients undergoing PCI.

Keywords: Outcome Assessment, Health Care, Registries, Hospital Mortality, Demography, Cardiology, Confidence Intervals, Risk Assessment, Angioplasty, Hemorrhage, United States, Percutaneous Coronary Intervention


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