Bleeding Avoidance Strategies and Hospital Variation Post-PCI

Study Questions:

Does differential use of bleeding avoidance strategies (BAS) explain the variation in bleeding across institutions?

Methods:

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).

Results:

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.

Conclusions:

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.

Perspective:

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.

Clinical Topics: Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention

Keywords: Antithrombins, CathPCI Registry, Hemoglobins, Hemorrhage, Hirudins, Outcome Assessment (Health Care), Peptide Fragments, Percutaneous Coronary Intervention, Risk, Vascular Closure Devices


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