Precision Medicine Improves Use of Bleeding Avoidance Strategies and Reduces Bleeding in Patients Undergoing Percutaneous Coronary Intervention

KANSAS CITY, Mo. (March 27, 2015) — Bleeding is one of the most common complications for patients undergoing percutaneous coronary intervention (PCI), resulting in increased mortality, morbidity, and costs. Ironically, studies have observed a “risk-treatment paradox,” in which the highest-risk PCI patients with the most to gain from treatment are treated less often with bleeding avoidance strategies than lower-risk patients. 

Researchers at Saint Luke’s Mid America Heart Institute asked the question whether prospectively determining and informing physicians of an individual patient’s bleeding risk would increase the proper application of bleeding avoidance strategies and result in reduced odds of bleeding.

In the study, researchers utilized a validated risk model developed by the American College of Cardiology’s National Cardiovascular Data Registry (NCDR) CathPCI Registry. Patients’ personalized risks were calculated with the Patient Risk Information Services Manager (ePRISM) which was designed to translate multivariable risk models utilizing each patient’s specific clinical risk factors at the point of care. Multiple risk factors were included in the prediction model, including patients’ age, sex, previous heart failure, and previous percutaneous coronary intervention, to generate personalized estimates of risk for each  patient. ePRISM created streamlined decision support tools which were presented to physicians before the PCI procedure and generated personalized consent forms, which have been shown to improve patients’ care experience.

After analyzing more than 7,000 patients at nine large PCI centers in the United States and evaluating the outcomes following the utilization of the ePRISM tool, researchers determined that by providing patients’ individualized estimates of risk prior to PCI, bleeding avoidance strategies were preferentially increased in those at higher risk of bleeding and the odds of bleeding were reduced by 44 percent.

“This data illustrates the value of developing methods to integrate individualized risk analysis into clinical care, which alerts physicians to each patient’s potential benefits from treatment,” said John A. Spertus, M.D., director of Saint Luke’s Mid America Heart Institute’s Cardiovascular Outcomes Research program. “This study demonstrates the potential utilization of precision medicine to enable more patient-centered, evidence-based, cost-effective care with better, safer outcomes, which is exactly the challenge recently issued by the Institute of Medicine to U.S. health care.”

Bleeding avoidance strategies include the use of bivalirudin, radial percutaneous intervention, and vascular closure devices.

“This concept of generating personalized estimates of outcomes and tailoring treatment to a patient’s personal risk can be applied to numerous medical treatments and embodies the vision of precision medicine that was highlighted in President Obama’s State of the Union address,” said Dr. Spertus.

The ePRISM patient predictor tool was developed by researchers at Saint Luke’s Mid America Heart Institute and is used for all patients undergoing PCI within the Saint Luke’s Health System.

The article can be read in full at http://www.bmj.com/content/350/bmj.h1302, and will appear in the April 4, 2015, issue of the BMJ. The authors are J.A. Spertus, Carole Decker, Elizabeth Gialde, Philip G. Jones, Edward J. McNulty, Richard Bach, and Adnan K. Chhatriwalla.

About Saint Luke’s Mid America Heart Institute
Saint Luke’s Mid America Heart Institute, a member of Saint Luke’s Health System and a teaching affiliate of the University of Missouri-Kansas City, is one of the preeminent cardiovascular programs in the country. Its legacy of innovation began more than 25 years ago when it opened as the nation’s first heart hospital. Since then, the Heart Institute has earned a world-wide reputation for excellence in the treatment of heart disease, including interventional cardiology, cardiovascular surgery, imaging, heart failure, transplant, heart disease prevention, women’s heart disease, electrophysiology, outcomes research, and health economics. With more than 50 full-time board-certified cardiovascular specialists on staff, the Heart Institute offers one of the largest heart failure/heart transplant programs in the country, has the largest experience with transcatheter aortic valve replacement in the Midwest, and is a global teaching site for the newest approaches to opening challenging blocked arteries using minimally invasive techniques.