A quality improvement project led to a 40 percent, risk-adjusted decrease in bleeding rates following PCIs during a 21-month period. The initiative also decreased costs by approximately $1 million.
Lead researcher Jerome E. Granato, MD, vice president and medical director of the national cardiovascular service line at Catholic Health Initiatives, presented the results of the study during a late-breaking clinical trial session at the Society for Cardiovascular Angiography and Interventions scientific sessions on May 4 in Orlando.
Catholic Health Initiatives operates 103 hospitals in 11 states. Its cardiovascular service line oversees cardiology and cardiac surgery cases for tens of thousands of patients in 11 health systems, three medical schools and a research institute. Each year, Catholic Health Initiatives performs more than 15,000 coronary interventions and 10,000 open heart procedures.
“As you might suspect for an organization of this size, there is considerable variability in the way that care is delivered,” Granato said at a news conference. “In looking at that variability, we noticed that there was considerable opportunity to provide additional value to our patients.”
In this study, the researchers obtained data from the National Cardiovascular Data Registry (NCDR) involving 8,713 PCI procedures from 21 hospitals that Catholic Health Initiatives operates in 11 states. More than 200 operators performed the procedures.
Granato said there was considerable variation in how physicians prescribed bivalirudin, an anticoagulant. He added that was no correlation between the use of bivalirudin and the physicians’ ability to prevent bleeding complications.
Based on that analysis, the researchers developed a standardized approach for the use of bivalirudin. They used the NCDR’s bleeding risk calculator to determine how to use bivalirudin. The researchers then implemented a bleeding risk calculator and stratified patients into low-, intermediate- and high-risk groups based on their scores.
For patients in the low-risk group for bleeding, the researchers discouraged the use of bivalirudin and encouraged the use of heparin. For patients in the intermediate-risk group, they allowed the physicians to prescribe bivalirudin or heparin. For patients in the high-risk group, they encouraged the use of bivalirudin and transradial access.
The researchers also discouraged the use of glycoprotein IIb/IIIa inhibitors in all patients.
The operators were able to access the scores and employ interventions such as prescribing anticoagulants. Physicians also received monthly surveillance and feedback.
During a 21-month period from 2013 to 2015, the use of bivalirudin significantly declined, which was associated with a savings of approximately $1 million per year.
At baseline in 2013, the risk-adjusted bleeding event rate was 6.3 percent. After two years, the risk-adjusted bleeding event rate was 3.78 percent, which represented a 40 percent decrease from baseline.
“Risk-directed therapeutic decision making works,” Granato said. “We were able to reduce bivalirudin and bleeding events, providing better care to our patients. This resulted in a significant reduction in the cost of care, both in direct costs with respect to pharmacy costs but indirect costs of complications, bed availability and the like.”
He added that physicians changed their approach to treating patients when they had access to their bleeding risk. During the study, transradial access nearly doubled to approximately 54 percent.
“We were able to significantly modify physician behavior,” Granato said. “We did so by involving them in the formation of this study early on, providing them with regular feedback of their performance on a monthly basis and letting everyone know how they were doing, why were doing it and what the next steps were.”