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Rising U.S. Radial Access for Coronary Cath Predated RIVAL Results


 

FROM THE ANNUAL MEETING OF THE AMERICAN COLLEGE OF CARDIOLOGY

The only prespecified end point where radial access outperformed femoral access was in the secondary measure of major vascular access site complications: large hematomas, pseudoaneurysms requiring closure, arteriovenous fistula, and other vascular surgery related to the access site. In the radial group, this occurred in 1.4% of patients and in 3.7% of those in the femoral group, a statistically significant 63% relative risk reduction.

"By going radial you prevent complications at the access site," explained Dr. Jolly. These complications "don’t cause deaths," he admitted, "but they are important to patients. They can cause significant discomfort."

But others minimized the importance of access site complications.

"Access-site hematomas don’t impact mortality. Large bleeds are associated with mortality. Gastrointestinal bleeds, genitourinary bleeds, and intracranial bleeds really impact mortality," commented Dr. Gregg W. Stone, professor of medicine and director of cardiovascular research and education at Columbia. Dr. Stone noted that he performs 99% of his coronary interventions via the femoral route.

Aside from the basic findings, perhaps the most notable results focused on the importance of operator and center experience in performing radial catheterizations. One prespecified subgroup analysis split the participating centers into tertiles based on their annual volume of radial-access procedures: those that did at least 146 a year (the highest tertile), those that did 61-145 radial procedures annually (middle tertile), and those performing 60 or fewer annually. The highest tertile centers showed a statistically significant reduction in the study’s primary end point when using radial access.

Also, focusing on outcomes in patients with an ST elevation MI showed that in this subgroup radial access produced a statistically significant reduction in the primary end point, an effect that Dr. Jolly speculated related to individual operator experience. "Radial access in the ST elevation MI patients primarily was done by the high-volume operators because of the time pressure." Only the most experienced operators were comfortable treating these patients radially, he said. Another issue was that these patients are more heavily treated with antiplatelet drugs, which magnified the benefit from radial access in cutting bleeding complications.

The subgroup findings convinced some cardiologists that RIVAL, in sum, scored a triumph for radial access.

"At the least, radial access reduced bleeding, and at best it improved the hard outcomes of death and MI" at the high volume centers, noted Dr. Khandelwal. "Perhaps our goal should be to emulate the operators in the top tertile," he said in an interview.

But Dr. Stone had the take of a femoral-artery enthusiast. "I don’t think in and of itself these data will change practice. What might change practice," he conceded, "is patient comfort."

Dr. Jolly said that he has received consultant fees or honoraria from Boehringer-Ingelheim, GlaxoSmithKline, and Sanofi-Aventis, and research grants from Merck. Dr. McNulty said he had no disclosures. Dr. Leon said he has been an unpaid consultant to Abbott, Boston Scientific, and Medtronic. Dr. Stone said that he has been a consultant to Inspire MD, Reva, Osprey, Lilly, BMS/Sanofi, Medtronic, AstraZeneca, Vascular Solutions, Gilead, The Medicines Company, Abbott Vascular, Boston Scientific, Ortho-McNeil, Edwards, and Merck; he has an ownership or partnership role in MiCardia, Biostar I and II, FlowCardia, Embrella, Caliber, Medfocus I and II, Accelerator, and Access Closure; and he has received research funds from InfraReDx, TherOx, Atrium, and Volcano. Dr. Khandelwal said he had no disclosures.

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