Hospital System's Bleeding Risk Assessment Study Demonstrates Reduced Events and Costs

May 4, 2016—The Society for Cardiovascular Angiography and Interventions (SCAI) announced that the largest risk-directed study by a national hospital system demonstrated a 40% decline in bleeding events for percutaneous coronary intervention (PCI) patients and a significant reduction in pharmacy costs. This quality improvement project (QIP) study was presented as a late-breaking clinical trial at the SCAI 2016 scientific sessions in Orlando, Florida. Jerome E. Granato, MD, served as the study’s Lead Investigator. Dr. Granato is Vice President and Medical Director of the National Cardiovascular Service Line at Catholic Health Initiatives in Denver, Colorado.

According to SCAI, the QIP study aimed to reduce these bleeding events by using the National Cardiovascular Data Registry (NCDR) bleeding risk calculator and applying it to evidence-based bleeding avoidance strategies, including bivalirudin use.

In the SCAI announcement, Dr. Granato commented, “We found that some centers were using bivalirudin 100% of the time and others were not using it at all. Our goal was to determine the most appropriate time to use bivalirudin, which is why the bleeding risk calculator was so vital.” He concluded, “Our results showed that in a very large patient population and an expansive health system, we were able to change behaviors that resulted in better patient care and significant financial savings. We believe this process could easily be adopted by other health systems.”

As summarized by SCAI, the 2-year study (2013-2015) involved 8,713 PCI procedures from 21 hospitals, in 11 states, with more than 200 operators. The baseline Q1 2013 risk-adjusted bleeding event rate was 6.3%. Investigators used the bleeding risk calculator (Q2 2014) during the intraprocedural “time-out” and, based on the score, divided patients into high, intermediate, or low bleeding risk groups. Depending on the risk assessment, access site, and anticoagulant use, other interventions were used at the discretion of the operator.

During the 2-year period, incidence of bleeding decreased by 40% (6.3% to 3.78%). In addition, the cost of bleeding complications—typically approximately $8,000 per patient—was reduced by approximately $1 million for the entire hospital system.
 
Data showed that when physicians conducted the bleeding risk assessment before the procedure, they not only changed the use of the drug, they also adjusted their approach, going through the wrist instead of the groin with high-risk patients. 

The investigators monitored compliance by recording patients who received bivalirudin, their risk calculator scores, and the percentage who fell into each risk category. That information was relayed back to the hospitals and resulted in greater adherence to the process, noted SCAI.