TCT: RIFLE aims to make radial approach standard for STEMI

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transradial PCI, stenting, interventional cardiology - 20.06 Kb
A 5-F introducer sheath was inserted into the radial artery, and a guide wire and a 5-F Simon II catheter were introduced into the ascending aorta. Source: Korean J Radiol 2006;7(1):7–13.

SAN FRANCISCO—The use of the radial approach during PCI can help reduce bleeding complications as well as cardiovascular death in STEMI patients, according to the results of the RIFLE STEACS trial presented Nov. 10 during a late-breaking clinical trial session at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) meeting. Trial presenter Enrico Romagnoli, MD, PhD, even went as far as to say that the radial access site should become the recommended access site for these patients undergoing PCI.

Because bleeding complications in patients with acute coronary syndromes (ACS) are a significant predictor of mortality, Romagnoli of the Policlinico Casilino in Rome, and colleagues set out to understand whether the radial approach for ST elevation acute coronary syndrome (STEACS) treatment reached better outcomes when it was compared with the transfemoral approach.

“The main reason to use the radial approach is because it reduces access site-related bleeding,” Romagnoli offered during a press conference. The researchers enrolled 1,001 patients to the RIFLE STEACS trial, a prospective, randomized trial of radial vs. femoral vascular access in STEMI patients.

Results showed that patients who underwent a procedure with radial access showed better results and lower adverse events compared to those who underwent a procedure with the femoral approach. For example, the net adverse cardiac event rate (NACE) was 21 percent in the femoral arm compared with 13.6 percent in the radial arm. Additionally, the rate of bleeding was also significantly lower in the radial arm compared with the femoral arm, 7.8 percent vs. 12.2 percent.

“It’s a new message,” Romagnoli offered. “We expected bleeding to be reduced with transradial access, however, we also found a significant reduction in major cardiovascular events.”

While rates of MI, target lesion revascularization and cerebrovascular incident rates were similar, use of the radial approach significantly reduced cardiac death compared with the femoral approach, 5.2 percent vs. 9.2 percent, respectively.

“Bleeding was significantly decreased,” Romagnoli said.  The rates of access bleeding were 2.6 vs. 6.8 percent respectively for the radial and femoral approaches. Non-access site bleeding was similar between the two groups,” Romagnoli offered.  These rates were 5.2 percent for the radial approach vs. 5.4 percent for the femoral approach.

“The radial approach is an independent predictor of better outcomes together with all other well known predictors of outcomes,” Romagnoli said. “Radial access in patients with STEMI is associated with significant clinical benefit in terms of both bleeding and cardiac mortality.”

Romagnoli advocated that the radial approach become the recommended access site for STEMI patients undergoing procedure.

“This trial confirms smaller studies that have been done as well as confirming that strategies to reduce bleeding complications are associated with improved mortality in extremely high-risk patient populations including those with STEMI,” Sunil V. Rao, MD, director of the cardiac cath lab at the Durham VA Medical Center in Durham, N.C., offered.

Additionally, Rao noted that there were two major messages coming from the RIFLE STEACS trial: that it is no longer appropriate to question the association between bleeding complications and mortality; and that radial access in STEMI patients undergoing primary PCI should be the preferred access route.

However, Rao did note that the challenges in the future will center on how the strategy can be implemented into practice.

“There are significant hurdles in the United States,” Rao noted. “Currently the use of radial access in patients is only about 11 percent. Having said that, though, if the RIFLE STEACS trials are consistent with the other studies, which show that radial access is associated with reduced mortality in primary PCI, then we should take on this challenge head on.

“It’s a hurdle, but it’s not insurmountable,” Rao noted.

With the radial approach, operator experience and the learning curve remains important, Rao said. He cautioned: “If you have never done a radial before … you should not start doing it tomorrow [because of the results of this trial].” Rao said that it will be important