November 11, 2011

November 10, 2011 (San Francisco, California) — Patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI via the radial artery have a significantly lower risk of bleeding and major adverse cardiac and cerebrovascular events (MACCE), including a significantly lower risk of cardiac death at 30 days, compared with patients treated with conventional PCI using the femoral artery, a randomized trial suggests.

Investigators, led by Dr Enrico Romagnoli (Policlinico Casilino, Rome, Italy), say the findings show that the radial-access approach should no longer be considered a substitute for the femoral approach, but instead should become the primary recommended access site for STEMI and other acute coronary syndromes (ACS).

The results, presented today here at TCT 2011 during the late-breaking clinical trials session, earned praise from interventional cardiologists, especially those who had already adopted the radial-access approach. Dr Sunil Rao (Durham Veterans Affairs Medical Center, NC), who was not involved in the trial, said the study confirms earlier studies and shows that "strategies to reduce bleeding complications are associated with improved mortality in extremely high-risk patients, such as those with STEMI." Speaking with the media, Rao, like Romagnoli, said he believes a "strategy of radial access in patients undergoing primary PCI should be the preferred access route."


The Radial versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome (RIFLE STEACS) study included 1001 patients with STEMI randomized to radial- or femoral-access PCI. The primary composite end point included bleeding and MACCE, a composite known as the net adverse clinical event (NACE) rate.

At 30 days, the overall NACE rate was 21.0% in the femoral-access PCI group and 13.6% in the radial-access group, a statistically significant difference (p=0.003). The MACCE rate--a composite of cardiac death, myocardial infarction, target lesion revascularization, and stroke--was also significantly reduced: 11.4% in the femoral-access group and 7.2% in the radial-access group (p=0.029). The reduction in MACCE was driven by a significant reduction in cardiac death, which was 5.2% in the radial-access group and 9.2% in the femoral-access group (p=0.20).

"This is a strong message of the study, an important reduction [in cardiac death]," said Romagnoli. He added that the radial approach was an independent predictor of improved outcomes.

Not surprisingly, bleeding rates were also significantly reduced in the radial-access group compared with the femoral approach: 7.8% vs 12.2%, respectively (p=0.026). The reduction in bleeding complications was driven almost entirely by a 47% reduction in access-site bleeds.

Experience Still Needed

Dr Sanjit Jolly (McMaster University, Hamilton, ON), who was not affiliated with the study, told heartwire that the magnitude of reduction in cardiac death was much larger--about a 40% relative reduction in risk--than investigators had expected. Jolly said the RIFLE STEACS study is applicable to operators experienced in radial and femoral PCI, and who are comfortable performing interventions with either route. "What I think we need to be careful with is if clinicians aren't doing very much radial access PCI, who don't have the expertise, the results can't be applied to them," said Jolly. "We don't want every person who does STEMI but who has never done radial PCI to all of a sudden start doing this. They need to be trained first."

Currently, there is no consensus on how many cases are needed for a clinician to become proficient in radial-access PCI. Initially, it was thought that operators would be fairly capable after 50 cases, but most no longer believe this to be true. Rao agreed with Jolly that physicians not comfortable with radial-access PCI shouldn't begin with STEMI patients, as one of the competing issues are door-to-balloon times, and inexperienced operators, if they struggled with accessing the radial artery, would be unable to open the artery fast enough.

"The radial approach needs to be incorporated into the training guidelines, particularly in the United States," said Rao. "It is only mentioned in the COCATS [Core Cardiology Training Symposium] guidelines that radial experience should be gained. That's all that's mentioned. But I think it's time, given the results we heard today, to start including the radial approach not only in the training guidelines, but also in the treatment guidelines as well."