Saint Luke's research identifies therapies to reduce risk of bleeding with common cardiac procedure

June 1, 2010

KANSAS CITY, Mo. (June 1, 2010) — Each year more than 1.5 million Americans receive percutaneous coronary intervention (PCI) or angioplasty to open blockages in their coronary arteries. While generally safe, the risk of post-procedure bleeding remains the most common non-cardiac side effect, occurring in about 2 percent of patients and resulting in higher costs of care and increasing the risk of early and late death.

In a study released in the June 2 issue of the Journal of the American Medical Association (JAMA), researchers at Saint Luke's Mid America Heart Institute identified opportunities to improve the safety of PCI by calculating patients' risk of bleeding using a personalized predictive model they developed. Proven strategies that mitigate bleeding can then be administered to patients based on their risk.

“PCI is an invasive procedure performed while patients are on potent blood thinners,” explained cardiologist Steven Marso, M.D., lead author of the JAMA study. “However, bleeding associated with PCI is the most common complication and results in added expense, increased length of hospitalization and greater risk of death. It's important to recognize that the risk of bleeding is modifiable.”

Typically PCI is performed by threading a slender balloon-tipped tube or catheter from an artery in the groin to a blockage in an artery in the heart. The balloon is then inflated, compressing the blockage and widening the narrowed coronary artery so that blood can flow more easily, sometimes supported by an expandable metal stent. Bleeding can occur at the site where the catheter is inserted as well as in places such as the gastrointestinal tract.

In a previous study evaluating more than 300,000 patients, Dr. Marso and colleagues at Saint Luke's developed a clinical model to predict risk of bleeding in PCI patients. Using risk scores calculated by the model, patients can be subsequently categorized by low, intermediate or high-risk for bleeding.

Bleeding avoidance therapies include use of a specific blood thinner, bivalirudin (Angiomax®, The Medicines Company, Parsippany, NJ); vascular closure devices which seal the puncture site where the catheter is inserted, and inserting the catheter through the artery in the wrist (transradially) instead of the leg.

In the current study, more than 1.5 million procedures performed from 2004 – 2008 at 955 hospitals throughout the U.S. were examined. All the centers voluntarily participate in the American College of Cardiology's National Cardiovascular Data Registry® CathPCI registry. Patients receiving bivalirudin and/or vascular closure devices were compared with patients who received none.

Intermediate and high-risk patients who received bivalirudin and vascular closure devices benefited most in terms of reduced rates of bleeding. High-risk patients who received neither therapy were almost three times more likely to bleed after PCI compared with high-risk patients who received the combination of both therapies.

Especially noteworthy, the researchers found that while high-risk patients were most likely to benefit from the use of bivalirudin and vascular closure devices, they were least likely to receive this combination, while patients least likely to bleed received it most often. According to Dr. Marso, this finding points toward an opportunity to redirect these therapies, improve the safety of PCI, and potentially lead to reduced length of stay and lower costs of care.

“Saint Luke's pioneered the application of bleeding risk prediction to our PCI patients and is actively working with other centers interested in applying it to their patients,” said Dr. Marso. “This kind of personalized medicine is an important step forward in delivering high quality, targeted therapy to patients, resulting in improved safety and effectiveness.”

Publication title: “Association Between Use of Bleeding Avoidance Strategies and Risk of Periprocedural Bleeding Among Patients Undergoing Percutaneous Coronary Intervention”
Authors: Steven P. Marso, MD; Amit P. Amin, MD; John A. House, MS; Kevin F. Kennedy, MS; John A. Spertus, MD, MPH; Sunil V. Rao, MD; David J. Cohen, MD, MSc; John C. Messenger, MD; John S. Rumsfeld, MD, PhD for the National Cardiovascular Data Registry®
Publication: JAMA (Journal of the American Medical Association)
Publication date: June 2, 2010 (publication embargo: 3:00 p.m. CST, June 1, 2010