Radial Access for Angioplasty Slashes Morbidity, Mortality

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Radial Access for Primary PCI Now Preferred

This trial confirms previous smaller studies that have been done, and confirms trials showing that strategies that reduce bleeding complications are associated with improved mortality in very-high-risk patients such as those with ST-segment elevation MI.

There are two big messages that come out of this study. The first is that it’s no longer appropriate to question the association between bleeding complications and mortality. Second, a strategy of radial access in patients undergoing primary percutaneous coronary intervention (PCI) should be the preferred access route.

The challenge for the future, particularly in the United States, is how do we implement this strategy? I think there are significant hurdles in the United States; currently the use of radial access in all patients is only around 11%. Having said that, RIFLE STEACS is consistent with other studies showing that radial access is associated with reduced mortality in primary PCI. The U.S. interventional community should take this challenge head-on. It’s a hurdle, but it’s not insurmountable.

The learning-curve issue is important. If you’ve never done a radial procedure before, you should not use this study to start doing it tomorrow. It’s very clear that cardiologists need to start with elective cases, build up a certain level of experience, and then start tackling STEMI cases.

The level at which you start doing radial access for STEMI cases is going to vary depending on the operator, but you really need to make sure that you’re practicing in the best way possible to reduce patient risk.

Another issue is that it’s very clear that the learning curve will probably be higher in the United States, where the average volume per operator for PCI in general is lower than outside the United States.

Most importantly, the radial approach needs to be incorporated into the training guidelines, particularly in the United States. The guidelines only mention that radial experience should be gained. I think it’s time, especially given the results that we’ve heard today, to start including the radial approach not only in training guidelines but in treatment guidelines.

Dr. Sunil V. Rao is an interventional cardiologist at Duke University, Durham, N.C. He made these remarks as a discussant at a press briefing on Dr. Romagnoli’s study. Dr. Rao has received honoraria or fees for consulting, speaking or research from the Cordis Corp., Ikaria, the Medicines Co., Boehringer Ingelheim, Abbott Vascular, Terumo Medical Corp., and AstraZeneca.



SAN FRANCISCO – Transradial access for angioplasty to treat ST elevation acute coronary syndrome significantly reduced the risk of morbidity and mortality by 40%, compared with a transfemoral approach in a multicenter randomized controlled trial in 1,001 patients.

In the first 30 days after treatment, 14% in the radial access group and 21% in the femoral access group met the primary composite endpoint of cardiac death, MI, stroke, target lesion revascularization, or bleeding not related to coronary artery bypass graft (CABG), Dr. Enrico Romagnoli reported at Transcatheter Cardiovascular Therapeutics 2011, which was sponsored by the Cardiovascular Research Foundation.

He and his associates conducted the prospective RIFLE STEACS trial (Radial Versus Femoral Investigation in ST Elevation Acute Coronary Syndrome) at four high-volume clinical sites in Italy between January 2009 and July 2011.

Results for both the primary composite endpoint and the individual components of that endpoint showed significantly lower morbidity and mortality using the radial approach instead of the femoral approach in these patients.

"The radial approach should thus no more be considered a valid alternative to the femoral one, but become the recommended access site" when treating ST elevation acute coronary syndrome (STEACS), said Dr. Romagnoli, an interventional cardiologist at Policlinico Casilino, Rome.

It’s time for U.S. interventional radiologists to catch up with the rest of the world in offering the radial approach to patients undergoing angioplasty for ST elevation acute coronary syndrome, several commentators said at a press briefing held at the meeting.

"In most parts of the world outside the United States, radial is the dominant access," noted Dr. John A. Ormiston, an interventional cardiologist at the University of Auckland (New Zealand), and medical director of Mercy Angiography, Auckland. "In our records, probably 90% of all procedures are now radial. We’re not surprised about this data. The more we hear about this, the more the U.S. has to do it."

"The radial approach should thus no more be considered a valid alternative to the femoral one, but become the recommended access site."

Patients prefer the radial approach and seek treatment from physicians who offer it instead of the femoral approach, he said. "That’s one thing that will drive the U.S. change."

Dr. Pieter R. Stella of University Medical Center in Utrecht, the Netherlands, cautioned that physicians who choose the transradial approach for angioplasty should use it in all cases, not just in a select group, for the safest practices and best outcomes.

Among components of the composite endpoint in the study, rates of major adverse cardiac and cerebrovascular events were 7% in the radial group and 11% in the femoral group. Bleeding occurred in 8% of the radial group and 12% of the femoral group (Bleeding Academic Research Consortium types 2-5).

Cardiac death rates were 5% in the radial group and 9% in the femoral group. "This is the strongest message of this study," Dr. Romagnoli said.

All of these differences between groups were statistically significant.

The groups did not differ significantly in 30-day rates of MI (1.2% in the radial group vs. 1.4% in the femoral group), target lesion revascularization (1.2% vs. 1.8%, respectively), or cerebrovascular accident (0.8% vs. 0.5%, respectively).

The differences in bleeding were driven by a significantly lower rate of access site–related bleeding in the radial group (3% of patients), compared with the femoral group (7%). Rates of bleeding not related to the access site were 5% in each group.

"We all know that bleeding and hemorrhagic events are an important predictor of mortality in acute coronary syndrome. A radial approach virtually eliminates vascular access-site bleeding. Thus, the systematic use of a radial approach in patients with acute ST elevation MI – who are patients at high risk of bleeding from the aggressive antiplatelets and antithrombotics they receive – could improve the clinical outcome, in particular by reducing mortality," Dr. Romagnoli said in an interview.

In an analysis of predictors of the primary composite outcome, radial access was the only factor that significantly reduced risk, by 40%, he said. Four other factors each doubled the risk for the composite outcome: female gender; chronic kidney disease; Killip class; presence of culprit lesions in the left anterior descending coronary artery, and left ventricular ejection fraction less than 50%.

The study was sponsored by the independent investigators. Dr. Romagnoli said he had no relevant conflicts of interest. Dr. Ormiston has received honoraria or fees for consulting or speaking from Abbott Vascular and Boston Scientific Corp. Dr. Stella has received honoraria or fees for consulting or speaking from Eurocor and SMT Medical. Dr. Rao has received honoraria or fees for consulting, speaking or research from the Cordis Corp., Ikaria, the Medicines Co., Boehringer Ingelheim, Abbott Vascular, Terumo Medical Corp., and AstraZeneca.

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