September 21, 2016
2 min read

Randomized trial, registry may provide answers on optimal revascularization approach for CLI

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LAS VEGAS BEST-CLI, a randomized controlled trial of patients with critical limb ischemia supplemented by a registry, may finally answer the question of the optimal revascularization approach for that population, Kenneth Rosenfield, MD, MHCDS, FACC, MSCAI, said during a presentation at VIVA 16.

Treatment for critical limb ischemia (CLI) is currently underused and highly variable, with rates of amputation and attempted revascularization differing greatly by region and by center, according to Rosenfield, section head of vascular medicine and intervention at Massachusetts General Hospital and Cardiology Today’s Intervention Editorial Board member.

Kenneth Rosenfield MD, MHCDS, FACC, FSCAI
Kenneth Rosenfield

The variation is so great, that according to the Vascular Quality Initiative, some centers choose surgical revascularization for patients with CLI 100% of the time and some choose endovascular revascularization for such patients 100% of the time, according to Rosenfield.

“There should never be that much variation in treatment in any space,” he said. “In the coronary space, it’s much more narrowed in terms of variability.”

Part of the variability can be explained by a lack of definitive data that show that one of surgical or endovascular revascularization is superior to the other, Rosenfield said.

The BEST-CLI trial will attempt to provide such data. Rosenfield is a co-principal investigator of the NIH-funded trial. He is also president of the Society for Cardiovascular Angiography and Interventions.

BEST-CLI will assess outcomes, quality of life and cost in 2,100 patients with CLI at 140 centers in the United States and Canada. All patients are candidates for either surgical or endovascular revascularization. The patients are divided into two cohorts: those with a single-segment great saphenous vein (n = 1,620) and those without one (n = 480). This will enable endovascular therapy to be compared with infrainguinal bypass with or without an optimal conduit, Rosenfield said.

The study, which has enrolled approximately one-third of its target patients, will also validate the Society of Vascular Surgeons’ Wifi wound classification, he said.

The BEST-CLI investigators and VIVA Physicians are collaborating on the vCLI registry, which will include up to 5,000 patients who were screened for the BEST-CLI trial but were not enrolled, according to Rosenfield.

“This will capture a real-world cohort of patients with CLI in a complementary fashion: the randomized group and those who don’t randomize for whatever reason,” he said. “This will provide a better context for interpreting the results of the randomized trial. It will give us the most complete picture of the CLI world and how [CLI] is managed in the real world.”

More than 700 patients have been enrolled to date, Rosenfield said. – by Erik Swain


Rosenfield K. CLI Strategies. Presented at: VIVA 16; Sept. 18-22, 2016; Las Vegas.

Disclosure: Rosenfield reports financial ties with Abbott Vascular, Abiomed, Angiodynamics, Atrium Medical, Bard Peripheral Vascular, Boston Scientific, Cardinal Health, Contego Medical, Cook Medical, CR Bard, Ekos, Embolitech, Endospan, Eximo, Intact Vascular, Janacare, MD Insider, PQ Bypass, Primacea, Silk Road Medical, Surmodics, VIVA Physicians, Vortex Medical and WL Gore and Associates.