LAS VEGAS — There has never been a randomized trial to determine what interventions may prevent progression from claudication to critical limb ischemia, but current evidence suggests one might be warranted, a speaker said at VIVA 19.
Matthew Menard, MD, associate professor of surgery at Harvard Medical School, co-director of endovascular surgery and program director of the Vascular and Endovascular Surgery Fellowship at the Brigham and Women's Hospital, said guidelines currently indicate that interventions for claudication are designed to improve walking performance and promote functional independence, but make no mention of preventing progression to CLI.
“We don’t treat claudication to prevent progression to CLI,” he said. “The concept is a bit heretical, but in my mind, if we did treat the claudicant to prevent progression to CLI, would patients feel better, walk better, walk more, be healthier and convert to CLI less frequently? Or would they convert to CLI and acute limb ischemia more frequently?”
He noted that 5% to 10% of patients with claudication progress to CLI within 5 years. In one study, he said, claudicants had an average annual decline in ankle-brachial index of 0.014 and an average annual decline in self-reported 6-minute walk distance of 9 yards per year, while 7% progressed to ischemic rest pain and 23% progressed to ischemic ulceration in 10 years. Outcomes were worst in patients with diabetes and ankle-brachial index < 0.5.
Menard also noted that TRA 2P-TIMI 50 and FOURIER trials found that patients with peripheral artery disease had lower rates of major adverse limb events when treated with vorapaxar (Zontivity, Deerfield) and evolocumab (Repatha, Amgen), respectively, compared with placebo.
A number of studies have suggested that the patients who are at highest risk for major adverse limb events are those who have had prior limb revascularization, he said.
“This suggests that restenosis is the new vascular epidemic,” he said.
No one has ever randomly assigned claudicants in a trial to determine if an intervention prevents progression to CLI, Menard said.
“That would be a great study to follow these patients over time to determine if we were helping or hurting them,” he said. “Likely there is a subset of patients who would benefit from more aggressive therapy.” – by Erik Swain
Menard M. Defining the CLI epidemic. Presented at: VIVA 19; Nov. 4-7, 2019; Las Vegas.
Disclosure: Menard reports he consulted for Janssen.