PARADISE Trial Supports Use of Balloon-Expandable DES to Treat CLI

April 6, 2010—In the Journal of the American College of Cardiology, Andrew J. Feiring, MD, et al published findings from the PARADISE (Preventing Amputations Using Drug-Eluting Stents) trial, which is an investigation of the efficacy and safety of using balloon-expandable, drug-eluting stents (DES) to prevent amputations in patients with below-the-knee critical limb ischemia (CLI) (2010;55:1580–1589). The background of the study is the recognition that CLI patients have a 1-year amputation rate of 30% and a mortality rate of 25%. Most patients with CLI have severe below-the-knee arterial disease that limits the use of bypass surgery or balloon angioplasty.

The investigators reported that 106 patients (118 limbs) were treated with DES in this prospective, nonrandomized trial. No patients were excluded because of comorbidities or unfavorable anatomy. Primary endpoints were major amputation and mortality, each stratified by Rutherford category. The mean patient age was 74 ± 9 years. There were 228 DES implanted (83% Cypher [Cordis Corporation, Bridgewater, NJ] and 17% Taxus [Boston Scientific Corporation, Natick, MA]). The number of stents per limb was 1.9 ± 0.9, and 35% of limbs received overlapping DES (length of 60 ± 13 mm).

According to the investigators, there were no procedural deaths, and 96% of patients were discharged within 24 hours. 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 ≤ .001–.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%.

The investigators concluded that treating below-the-knee CLI with DES is a safe and effective 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.