The most common noncardiac complication of percutaneous coronary intervention (PCI) is bleeding. Bleeding following PCI is associated with short- and long-term death, nonfatal myocardial infarction, stroke, blood transfusion, prolonged hospital stay, and increased hospital costs.
According to researchers, post-PCI bleeding is predictable with the use of tools such as the bleeding risk algorithm derived from the CathPCI Registry®. The researchers also noted that bleeding risk is modifiable using bleeding avoidance strategies such as bivalirudin anticoagulation, arterial closure devices, and radial artery access.
To describe the association between bleeding events and in-hospital mortality after PCI, the researchers recently conducted an analysis of data from 3,386,688 procedures in the CathPCI Registry. The procedures in the analysis were performed between 2004 and 2011. The researchers also sought to estimate the adjusted population attributable risk (the proportion of mortality risk associated with bleeding events), risk difference, and number needed to harm (NNH) for bleeding-related in-hospital mortality after PCI. Analysis results were reported in JAMA [2013;309(10):1022-1029].
The primary outcome measure of the analysis was in-hospital mortality. Of the original 3,386,688 procedures, 274,043 were excluded. The overall PCI population was predominantly middle-age (64 years) and male (67%), with a high incidence of previous myocardial infarction (29%) and previous PCI (39%).
In 14% of cases, patients presented with ST-segment elevation myocardial infarction (STEMI), non-STEMI or stable angina in 52%, and no acute coronary syndrome in 34%. 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 artery access in 4.0% of cases.
In the total analytic cohort, there were 57,246 major bleeding events and 22,165 in-hospital deaths. Compared with patients without major bleeding, in-hospital mortality was higher in patients with major bleeding (0.57% vs 5.58%; P<.001).
Bleeding risk was stratified into 3 levels: (1) low (<1%) in 1,046,665 procedures (31%); (2) intermediate (1%-3%) in 1,713,785 procedures (51%); and (3) high (>3%) in 623,678 procedures (18%). The association between major bleeding and in-hospital mortality persisted across all risk strata: low: 1.62% versus 0.17%, risk difference, 1.45%, NNH=69, P<.001; intermediate: 3.27% versus 0.71%, risk difference, 2.56%, NNH=39, P<.001; and high: 8.16% versus 3.45%, risk difference, 4.71%, NNH=21, P<.001.
The NNH varied between 16 and 117, depending on bleeding risk and bleeding site. NNH was lowest in patients at high risk for bleeding risk (NNH=21) or those with non–access-site bleeding (NNH=16). NNH values were lowest in patients ≥75 years of age, STEMI, or low glomerular filtration rate.
Limitations cited by the researchers included use of data that was not randomized, creating the possibility that variables outside of those used in the propensity matching analysis may have affected in-hospital mortality used in this analysis, and the possible unreliability of data on the adjunctive use of cardiovascular medications such as aspirin, thienopyridines, beta-blockers, statins, and angiotensin-converting enzyme inhibitors.
In conclusion, the researchers stated, “In a large registry of patients undergoing PCI, postprocedural bleeding events were associated with increased risk of in-hospital mortality, with an estimated 12.1% of deaths related to bleeding complications.”