Results of the RIFLE STEACS clinical trial reported at TCT 2011

Results of the Radial versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome (RIFLE STEACS) trial were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

Bleeding complications in patients with acute coronary syndrome (ACS) are a significant predictor of mortality and recent data suggest that in these patients, the radial approach could be associated with improved mortality and morbidity.

Researchers in this trial sought to determine whether transradial access for ST elevation Acute Coronary Syndrome (STEACS) treatment is associated with better outcomes when compared to transfemoral approach

The study was a prospective, randomized, parallel group, multi-center trial. Before arterial stick for percutaneous access, all STEACS patients eligible for acute revascularization were randomized (1:1 ratio) to radial or femoral access. 1,001 STEMI patients were enrolled between January 2009 and July 2011 in four high-volume clinical sites in Italy.

The primary endpoint of the study was the rate at 30 days of net adverse clinical events (NACE), a composite of cardiac death, myocardial infarction, stroke, target lesion revascularization or non-coronary artery bypass graft (non-CABG)-related major bleeding. Secondary endpoints were individual components of NACE.

At 30 days, the rate of NACE was significantly lower in the radial group when compared to the femoral group, 13.6% vs. 21.0% respectively. This difference was determined by a reduction of both the major adverse cardiac and cerebrovascular events (MACCE), 7.2% vs. 11.4%, and of bleeding, 7.8% vs. 12.2%. In particular, the rate of cardiac death at 30 days was 9.2% in the femoral group and 5.2% in the radial group.

"Radial access in patients with ST elevation acute coronary syndrome is associated with significant clinical benefits, in terms of both lower morbidity and mortality," said Enrico Romagnoli, MD, PhD, a member of the Interventional Cardiology Unit at Policlinico Casilino in Rome, Italy.

"The radial approach should no longer just be considered a valid alternative to the femoral one, but become the recommended access site for ST elevation acute coronary syndrome," concluded Dr. Romagnoli.

Provided by Cardiovascular Research Foundation