Bleeding Avoidance Strategies and Hospital Variation Post-PCI
Does differential use of bleeding avoidance strategies (BAS) explain the variation in bleeding across institutions?
The investigators used the National Cardiovascular Data Registry (NCDR) CathPCI Registry to estimate hospital-level bleeding rates from 2,459,686 procedures at 1,358 sites. They estimated the random-effect variance after adjusting for patient risk and various combinations of BAS (transradial access, bivalirudin, vascular closure device use).
There were a total of 125,361 bleeding events (5.1%). Patients who bled were less likely to have had radial access (5.0% vs. 11.2%, p < 0.001), bivalirudin therapy (43.8% vs. 59.4%), and vascular closure device use (32.9% vs. 42.4%, p < 0.001) than those without bleeding. The rate of bleeding varied significantly across hospitals (median 5.0%; interquartile range, 2.7%-6.6%), which persisted after incorporating patient-level risk (median 5.1%; interquartile range, 4.0%-4.4%). Patient factors accounted for 20% of the overall hospital-level variation, and radial access plus bivalirudin use accounted for an additional 7.8% of the overall hospital-level variation.
Less than one-third of the observed variation in bleeding across hospitals in the United States can be explained by patient factors or differential use of BAS.
Bleeding after percutaneous coronary intervention (PCI) has increasingly been advocated as a performance measure, and this study highlights why it should not be one. Bleeding in the NCDR is a composite event, and while some types of bleeding events are clearly causally related to mortality (e.g., retroperitoneal bleeding), others may simply reflect reverse causality (e.g., asymptomatic drop in hemoglobin in a patient undergoing a long procedure) or may simply be associations of uncertain significance. Furthermore, ascertainment bias can markedly impact the incidence of bleeding, and simply not checking hemoglobin routinely post-PCI can reduce the observed incidence of bleeding and improve the ‘performance’ of the institution. This study suggests that the use of BAS explains <10% of the observed variation in bleeding across institutions, and invokes the need for further investigation before operators and hospitals start getting ranked on this outcome.
Keywords: Antithrombins, CathPCI Registry, Hemoglobins, Hemorrhage, Hirudins, Outcome Assessment (Health Care), Peptide Fragments, Percutaneous Coronary Intervention, Risk, Vascular Closure Devices
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