HOLLYWOOD, FLA. — Drug-eluting stents placed in tibial arteries had 73% patency at 2 years' follow-up and led to an 86% limb salvage rate after 26 months in a series of 52 patients.
“Drug-eluting tibial stents are a viable option for the endovascular treatment of limb-threatening ischemia,” Dr. William D. McMillan said at ISET 2009, an international symposium on endovascular therapy.
This is the largest reported series of patients receiving drug-eluting stents in tibial lesions, with the longest follow-up, said Dr. McMillan, noting the “acceptable” long-term patency and “reasonable” limb salvage rates.
The patients, who received one or two paclitaxel-eluting stents in tibial lesions, were part of a series of 240 consecutive patients who underwent endovascular treatment for tibial occlusions during June 2004-June 2008. In this series, all tibial lesions were first treated with balloon angioplasty; a stent was placed if angioplasty failed to produce satisfactory patency. Drug-eluting stents were used if the lesion was smaller than 3 cm, to avoid placing them end to end, said Dr. McMillan, a vascular surgeon in Minneapolis. Bare-metal stents were used for longer lesions, up to 6-8 cm. Lesions longer than that were treated with open surgery.
Dr. McMillan and his associates began using drug-eluting stents because of concern about the rate of hyperplasia with bare-metal stents, especially in tibial arteries. For this series, they used the paclitaxel-eluting coronary stent (Taxus) for consistency, and to simplify their interpretation of patency outcomes, said Dr. McMillan, who reported having no financial conflicts.
The patients (65% male, average age 73 years), received a total of 62 paclitaxel-eluting stents. Comorbidities were common: 87% had hypertension, 63% had diabetes, 48% smoked, and 19% were on dialysis. Their Rutherford class ranged from 4 to 6. In addition, 42% had gangrene, 40% had a nonhealing foot or leg ulcer, and 18% had pain in the limb at rest. The specific vessel involved was the posterior tibial in 32% of patients, peroneal in 31%, tibioperoneal in 24%, and anterior tibial in 13%.
Forty-eight (92%) of the patients required concurrent endovascular treatment of a more proximal lesion, most often in the superficial femoral and popliteal arteries.
After stenting, patients were routinely followed with duplex ultrasound and by their ankle-brachial index. Eighteen underwent peripheral arteriography during follow-up. Median follow-up was 14 months, with a range of 1-48 months. Overall patient survival during 2 years following treatment was 65%, a “surprisingly poor” rate, Dr. McMillan said.
Drug-eluting stents are a viable option for patients who have limb-threatening ischemia. DR. MCMILLAN