Prospective risk stratification before percutaneous coronary intervention (PCI) may increase the use of avoidance strategies and led to a 44 percent decrease in the odds for bleeding, according to a study published March 24 in BMJ.

Using data from the ACC’s CathPCI Registry, researchers looked at records from 10,937 patients between March 24, 2010, and May 5, 2011. Their goal was to compare use of bleeding avoidance strategies before the availability of a consent form that included individualized estimates of bleeding risks and after the intervention was implemented.  Avoidance strategies included medication (bivalirudin), radial access and vascular closure devices.

The study design was a pre- and post-implementation comparison from patients from nine hospitals in the U.S. A total of 7,408 procedures conducted before the availability of the consent form were compared with 3,529 procedures performed after the form became available. These findings were then compared with the PCIs that took place at more than 1,000 hospitals that did not have access to the novel risk-estimation tool.  

Results showed that use of bleeding avoidance strategies increased from 81.4 percent to 88.7 percent after conducting individualized bleeding estimates, with increased use of bivalirudin significantly greater in patients at high risk of bleeding, where the benefit of this drug is greatest. Bleeding complications decreased from 1.7 percent to 1.0 percent after implementation.

For high-risk patients, bleeding complications decreased significantly more at the intervention sites than at the control settings. Similarly, the overall bleeding rates at the intervention sites improved significantly more than those at the control sites (44 percent vs. 9 percent).

Notably, the use of bleeding avoidance strategies varied considerably from hospital to hospital, ranging from 31 percent to 98 percent in the post-implementation period. Specific approaches also varied: bivalirudin use ranged from 1 percent to 98 percent; radial access, from 1 percent to 51 percent; and use of a vascular closure device, from 3 percent to 70 percent.

“To our knowledge, this is the first demonstration that by supporting tailored treatment in patients at the greatest risk for adverse outcomes, we can improve the safety of medical care,” said John A. Spertus, MD, MPH, FACC, the study’s lead author and director of health outcomes research at Saint Luke's Mid America Heart Institute and Professor, the Daniel J. Lauer Missouri Endowed Chair in metabolism and vascular disease research at the University of Missouri-Kansas City. “What’s more, the variability of care observed in this study suggests an important opportunity to further improve the quality of PCI intervention care.”

Keywords: Consent Forms, Goals, Hirudins, Outcome Assessment, Health Care, Peptide Fragments, Percutaneous Coronary Intervention, Prospective Studies, Registries, Research, Research Personnel, Vascular Diseases, National Cardiovascular Data Registries, CathPCI Registry

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