Preventing leg amputations in critical limb ischemia with below-the-knee drug-eluting stents: the PaRADISE (PReventing Amputations using Drug eluting StEnts) trial.

OBJECTIVES

We investigated the efficacy and safety of using balloon expandable drug-eluting stents (DES) to prevent amputations in patients with below-the-knee critical limb ischemia.

BACKGROUND

Critical limb ischemia patients have a 1-year amputation rate of 30% and a mortality rate of 25%. Most patients with critical limb ischemia have severe below-the-knee arterial disease that limits the use of bypass surgery or balloon angioplasty.

METHODS

In all, 106 patients (118 limbs) were treated with DES in this prospective, nonrandomized trial. No patients were excluded because of comorbidities or unfavorable anatomy. Primary end points were major amputation and mortality, each stratified by Rutherford category.

RESULTS

The mean patient age was 74 +/- 9 years. There were 228 DES implanted (83% Cypher [Cordis, Johnson & Johnson, Warren, New Jersey], 17% Taxus [Boston Scientific, Maple Grove, Minnesota]). The number of stents per limb was 1.9 +/- 0.9, and 35% of limbs received overlapping DES (length of 60 +/- 13 mm). There were no procedural deaths, and 96% of patients were discharged within 24 h. The 3-year cumulative incidence of amputation was 6 +/- 2%, survival was 71 +/- 5%, and amputation-free-survival was 68 +/- 5%. Only 12% of patients who died had a preceding major amputation. Rutherford category, age, creatinine level, and dialysis (p <or= 0.001 to 0.04) were predictors of death but not amputation. Target limb revascularization occurred in 15% of patients, and repeat angiography in 35% of patients revealed a binary restenosis in 12%.

CONCLUSIONS

Treating below-the-knee critical limb ischemia with DES is an effective and safe means of preventing major amputation and relieving symptoms. Procedural complications and limb revascularization rates were low. Limb salvage and survival rates in patients treated with DES exceed those of historic controls.