Clinical Trial Examines Best Method for Cardiac Catheterization in Women

CINCINNATI—UC Health cardiologists are conducting a clinical trial to determine the best method for cardiac catheterization and coronary angioplasty in women: feeding the catheter through the femoral artery (transfemoral) in the groin or through the radial artery (transradial) in the wrist.

Angioplasty involves mechanically widening narrowed or obstructed arteries using an empty and collapsed balloon on a guide wire, known as a balloon catheter, which is passed into the narrowed locations and then inflated to a fixed size using water pressures, opening up the vessel.

This study, called Study of Access Site for Enhancement of Percutaneous Coronary Intervention (PCI) for Women, or SAFE-PCI for Women, is being conducted nationally to standardize and collect cardiovascular data on this procedure.

"The Duke Clinical Research Institute is working in collaboration with the American College of Cardiology Foundation to develop a clinical investigator network based upon the data

collection and information activities of the National Cardiovascular Data Registries,” says Imran Arif, MD, associate professor in the division of cardiovascular diseases at the University of Cincinnati (UC) and principal investigator at UC.

"We are one of at least 50 sites involved. The trial is randomized and will involve around 3,000 female patients nationally who are undergoing emergent or elective angioplasty or angiography to evaluate possible heart and vascular issues.”

Arif says transradial angioplasty is something that other countries have been doing for years. Over the last two years, around 11 percent of physicians in the U.S. have begun using this technique, but this number is still far behind the rest of world, where 50 to 70 percent of these procedures are being done via the wrist approach.

"Radial artery catheterization has previously been shown to decrease vascular complications, bleeding and involve less pain and faster recovery for patients with much less time in the bed after the procedure,” Arif says. "By reducing the bleeding complications, there is a possibility of improving mortality in patients with heart attack using this approach, as shown in recent studies. However, this study will compare the data for this type of catheterization access versus transfemoral access to see if there is truly an outstanding benefit, particularly in a female population.”

In addition to weighing the efficacy of the wrist over the femoral approach, researchers are looking to determine the effect on procedure time, radiation doses and contrast volume as well as resource use, patient preferences, quality of life, vascular complications or repeat procedures.

The enrollment period for participants will be 24 months, with about a 20-day follow-up after the patient undergoes the angioplasty procedure.

"This trial has the potential to improve outcomes for patients and provides an avenue for safer angioplasty in women,” Arif says. "Also, by determining the most efficient form of access, we may be able to lessen hospital stays with same-day discharge, saving money for the system and the patient and improving patient satisfaction.”