DES Seen As Effective for Critically Ischemic Limbs

LAS VEGAS -- Drug-eluting stents placed below the knee worked well to revascularize critically ischemic limbs in a study of 20 patients. Within a mean 10 months’ follow-up, wounds in 17 of the 20 patients in the study (85%) were healed after stenting, and 16 patients (80%) reported pain relief. Only two needed subsequent amputations.

"Stents are just emerging for below the knee. We certainly have one of the early, large-volume [series], with reasonable follow-up," said Dr. Michael Wilderman, a vascular surgeon at Hackensack (N.J.) University Medical Center.

Before they were stented, the patients had, on average, Rutherford stage 4.9 disease, indicating pain at rest and ischemic toe or foot ulcers. The majority had already lost some tissue, and seven (35%) had cellulitis.

Diabetes, hypertension, heart disease, and other comorbidities – plus an average age of 79 years – were found to make open repair too risky, according to Dr. Wilderman, who spoke at the annual meeting of the Society for Clinical Vascular Surgery.

The 25 lesions, in 22 limbs, were located in the below-knee popliteal artery, tibioperoneal trunk, anterior tibial artery, peroneal artery, and posterior tibial artery. Five lesions threatened distal reversed saphenous vein grafts.

The researchers placed everolimus-eluting stents (average diameter, 3 mm) using standard percutaneous techniques. The lesions they addressed were short, and thus could be adequately covered with a 3-cm stent.

Complications were minimal: One patient had a groin hematoma, and another had a puncture-site pseudoaneurysm.

"Initially, we were not planning to stent the first couple we did. We were just going to balloon and see what happens, because that’s what everyone else does," Dr. Wilderman said.

However, because the vessels did not look good angiographically, his team put a stent in and the patients did well. "We found that if we had a short, focal [lesion] that we could stent, we would just stent it," he explained.

Because drug-eluting stents work well for coronary arteries, and tibial arteries share similar histology and luminal diameters, it made sense to try them for below-the-knee ischemia, he said.

Asked for comment, Dr. George Meier, chief of vascular surgery at the University of Cincinnati, noted that coronary drug-eluting stents have been used off label below the knee before. "It’s something we occasionally do in recurrent lesions when we have nothing else to do. The difficulty is following it out long enough to see if it makes an impact," he said.

Dr. Wilderman and Dr. Meier reported that they had no relevant financial disclosures.