Interventional radiologists have found that a subgroup of patients with critical limb ischemia, the most severe form of peripheral arterial disease (PAD), may avoid amputation through the use of drug-eluting stents on the smaller arteries below the knee, according to a study released at this week’s Society of Interventional Radiology's (SIR) Annual Scientific Meeting in Tampa, Fla.
"Drug-eluting stents are an emerging technology that offer hope to PAD patients with critical limb ischemia and freedom from major amputations. The placement of drug-eluting stents in the infrapopliteal leg arteries is safe and effective and can significantly impact care,” said Robert A. Lookstein, MD, an interventional radiologist and associate director of the division of interventional radiology at Mount Sinai Medical Center in New York.
In the U.S., drug-eluting stents are currently FDA-approved for the coronary arteries but not for infrapopliteal arteries.
Over a four-year period, Lookstein and colleagues studied 53 patients (32 men, 21 women) ranging in age from 43 to 93 who underwent implantation of 94 drug-eluting stents (80 sirolimus-eluting, 12 everolimus-eluting, and 2 paclitaxel-eluting) to treat a suboptimal angioplasty result in an infrapopliteal artery.
According to the study, the initial technical success rate was 100 percent, with all treated lesions having less than 10 percent residual angiographic stenosis at completion of the procedure, where the mean number of stents placed per patient was 1.62 with the stent diameter ranging from 2.5 to 4 millimeters.
Angiographic, clinical and noninvasive vascular examination results were collected prospectively at regular intervals. Primary patency for the study at 12 months was 81.8 percent, said Lookstein. Patients were followed for an average of 17 months where it was found that freedom from major amputation at follow-up was 90.6 percent for the entire group and 100 percent for patients with ischemic pain at rest and lower-extremity ischemia associated with minor tissue loss, according to the authors.
Surgical bypass remains the mainstream therapy for blocked infrapopliteal arteries, but there are a growing number of patients who are unable to undergo this treatment because of their medical problems, said Lookstein.
"Our study reinforces the fact that when it comes to treating cardiovascular disease, there is a wide range of safe and effective treatments," concluded Lookstein. Multicenter randomized trials are necessary to support such promising results of the value of infrapopliteal drug-eluting stents in critical limb ischemia treatments, he added.