Trial Supports Radial Over Femoral Access in STEMI Patients
November 15, 2011 — A randomized clinical trial examining angioplasty approaches in patients with ST elevation acute coronary syndrome (STEACS) suggests the transradial approach should be the recommended access route. The results of the trial found transradial access preferable to the femoral approach.
Outcomes of the Radial versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome (RIFLE STEACS) trial were presented at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. TCT is sponsored by the Cardiovascular Research Foundation.
Bleeding complications in patients with ACS are a significant predictor of mortality. 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 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). NACE is 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 percent vs. 21 percent respectively. This difference was determined by a reduction of both the major adverse cardiac and cerebrovascular events (MACCE) (7.2 percent vs. 11.4 percent) and of bleeding (7.8 percent vs. 12.2 percent). In particular, the rate of cardiac death at 30 days was 9.2 percent in the femoral group and 5.2 percent 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, M.D., Ph.D., 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 Romagnoli.
The RIFLE STEACS trial is a spontaneous clinical study and thus independent of commercial funding. Romagnoli reported no financial relationship with any company.
For more information: www.crf.org