Whether institutions employ anti-bleeding strategies for percutaneous coronary intervention (PCI) does not fully account for hospital-wide variation in bleeding rates, a multi-center study suggested.
Patients were less likely to bleed with radial access (5.0% versus 11.2% for femoral, P<0.001), when treated with bivalirudin (Angiomax, 43.8% versus 59.4% without, P<0.001), and with use of a vascular closure device (32.9% versus 42.4% without, P<0.001).
Institutions with increased use of anti-bleeding strategies — those above the median of 86.6% implementation — saw lower odds of bleeding events (odds ratio 0.90, 95% confidence interval 0.88-0.93), Amit N. Vora, MD, MPH, of Duke University Medical Center in Durham, N.C., and colleagues reported in the April 25 issue of JACC: Cardiovascular Interventions.
But the three patient factors accounted for 20% of the variation, while the combination of radial access and bivalirudin therapy contributed another 7.8%, leaving the remaining contributors to between-center variation in bleeding risk unknown.
Even though only a “modest proportion” of the variation was attributable to differential use of bleeding avoidance strategies, the researchers maintained that “a strategy to broadly use bleeding avoidance strategies in all patients (i.e., overcoming the risk-treatment paradox) is a reasonable strategy to reduce overall variation in hospital bleeding rates.”
“Further analyses are required to determine the remaining approximately 70% causes of variation in PCI bleeding seen among hospitals,” the authors noted. That much of the variation remains unknown highlights the “significant limitation in the use of bleeding rates as a performance measure under the current data collection structure” as well.
“As such, the stringent use of bleeding rate measures to determine reimbursement rates or to penalize institutions by payers and regulators may be premature at this time, given the significant variability in bleeding that is not well understood at this time offers providers no clear path to improve patient outcomes,” Vora’s group emphasized.
Eric R. Bates, MD, of University of Michigan Medical Center in Ann Arbor, agreed that bleeding rate was “another poor candidate” for a PCI performance measure.
However, he took issue with the fact that the authors failed to acknowledge the failure of radial artery access itself — independent of bivalirudin — to impact hospital-level bleeding rates.
Bates suggested this was “perhaps because of the cognitive dissonance associated with their previous ideological position on radial artery access superiority,” he wrote in an accompanying editorial.
The lack of strong evidence for its radial access benefits means some bleeding avoidance strategies themselves may be up for debate, Bates suggested.
“Although bleeding events are decreased with radial artery access, there is enough equipoise on major adverse clinical events in the literature to challenge the European Society of Cardiology Class 1A recommendation on radial artery access that appears to be based on one meta-analysis,” he wrote.
“U.S. interventionalists have been criticized for being slow to adopt radial artery access. And yet, the radialists need to avoid hubris and prove to the skeptics that they are not wearing the emperor’s new clothes when they promote the superiority of radial artery access over femoral artery access for all patients,” Bates argued.
Nonetheless, “most of us will agree that radial artery access decreases access site complications in the subgroup of patients at increased risk for femoral artery complications,” Bates admitted.
“However, it remains quite possible that operator/laboratory experience and expertise, and patient variables, rather than access site, determine clinical outcomes,” he cautioned.
Vora’s study used data on 2,459,686 procedures in the CathPCI Registry, part of the American College of Cardiology National Cardiovascular Data Registry. The median bleeding rate was 5.0% across hospitals.
Limitations included the potential variation in the accuracy of reported events, including an underreporting of minor bleeding episodes. The researchers also noted that the CathPCI Registry did not record post-discharge bleeding events.
The study was supported by the American College of Cardiology.
Vora and Bates reported no relevant conflicts of interest.
JACC: Cardiovascular Interventions
Vora AN, et al “The impact of bleeding avoidance strategies on hospital-level variation in bleeding rates following percutaneous coronary intervention” JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2016.01.033.
JACC: Cardiovascular Interventions
Bates ER “Bleeding avoidance strategies, performance measures, and the emperor’s new clothes” JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2016.02.040.