RIFLE STEACS: Radial Approach Safer Than Femoral in STEMI

SAN FRANCISCO, CALIF.—In the treatment of patients with STEMI, radial access is associated with less bleeding events and mortality compared with the femoral approach, according to results of a late-breaking trial presented at TCT 2011.

For the prospective, multicenter RIFLE STEACS study, Enrico Romagnoli, MD, PhD, of Policlinico Casilino, Rome, Italy, and colleagues randomized 1,001 STEMI patients to either transradial (n=500) or transfemoral (n=501) PCI.  The researchers determined net adverse clinical events (NACE), defined as a composite of cardiac death, MI, target lesion revascularization, stroke or non-CABG-related bleeding, at 30-days post-procedure.

Radial access superior

Statistical analysis showed significant differences in NACE, MACCE and bleeding events between the 2 arms (see Figure). Within bleeding events, access site-related bleeding was significantly higher in the femoral arm (6.8% vs. 2.6%; P=.002), and accounted for 47% of all bleeding events in both arms. The radial group also had significantly less cardiac death (5.2% vs. 9.2%; P=.02), but there was no difference in MI, target lesion revascularization or stroke. Lastly, radial access was a predictor of lower 30-day NACE (OR 0.6; 95% CI 0.4-0.9; P=.012).

“Radial access in patients with STEMI is associated with significant clinical benefit, in terms of both bleeding and cardiac mortality,” Romagnoli said. “Radial approach should thus no longer be considered as a valid alternative to femoral, but become the recommended access site for STEMI.”

Panelist Sunil V. Rao, MD, of Duke University Medical Center, Durham, N.C., congratulated the trial investigators and said the findings confirm previous trials showing that strategies that reduce bleeding complications are associated with improved mortality in very high-risk patients, such as those with STEMI.

“There are two big messages that come out of this study: the first is that it is no longer appropriate to question the association between bleeding complications and mortality; and the second is that I think this clearly shows that radial access in patients undergoing primary PCI should be the preferred access route,” Rao said, cautioning that implementation will be an obstacle in the United States. “I think that the U.S. interventional community should take this challenge head on. It is a hurdle, but surmountable.”

Part of the difficulty in increasing the use of radial access in the United States will be overcoming the learning curve, Rao said. However, “It’s time, especially given these results, that we start including radial approach not only in the training guidelines, but in the treatment guidelines as well.”

Study details

Patients in the RIFLE STEACS trial averaged 65 years of age, with 26.7% female and 23.7% diabetic, while 11.7% had prior revascularization.