NEW YORK (Reuters Health) – Drug-eluting stents can prevent leg amputations in patients with atherosclerosis and severe below-the-knee ischemia, according to a report in the April 13th Journal of the American College of Cardiology.
The approach “results in sustained limb salvage rates that significantly exceed previously published methods,” lead author Dr. Andrew J. Feiring from Columbia-St. Mary’s Medical Center, Milwaukee, Wisconsin, told Reuters Health by email. “Moreover, there is no mortality associated with the procedure and minimal morbidity.”
In attempts to avoid amputation, Dr. Feiring and colleagues implanted 228 balloon-expandable drug-eluting stents in 118 legs of 106 patients.
All procedures were technically successful, and all but 5 procedures (96%) established continuous flow to the ankle.
There was 1 major adverse event (failure to maintain superficial femoral artery patency resulting in amputation). In addition, there were 6 major amputations in the first year, but none thereafter.
More than 90% of patients had relief of rest pain, and all but 1 of 10 planned minor amputations healed.
At 3 years, the cumulative incidence of amputation was 6%, the survival rate was 71%, and amputation-free survival was 68%.
Of those alive at 3 years, 96% were free of major amputation. The mean survival among the 25 patients who died was 12.8 months.
The authors report that patients in this study fared better in most respects than patients who received surgery or percutaneous transluminal angioplasty in the previously reported BASIL study. The only superior outcome in that earlier study was amputation-free survival 3 years after bypass surgery.
In the current cohort, “stent failures (restenosis or occlusion) were < 6% and easily managed by repeat endovascular techniques,” Dr. Feiring said.
“Compared to the cost of bypass surgery and/or amputation, using drug-eluting stents to treat critical limb ischemia should result in a significant health care savings if our findings are confirmed,” he continued. “The cost…is less of an issue than previously. The cost of 2 (drug-eluting stents) is less than a single atherectomy catheter.”
“We are continuing the present study and will continue to monitor patient outcomes,” Dr. Feiring said. “We are at the point where the next logical step is to have Industry step forward…and conduct a randomized trial between balloon angioplasty and stenting in patients with critical limb ischemia. There are ongoing trials in Europe… but none currently in the U.S.”
J Am Coll Cardiol 2010;55:1580-1589.