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PARADISE
Preventing Amputations Using Drug-Eluting Stents
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Trial assessed major amputation and mortality after below-the-knee percutaneous transluminal angioplasty with drug-eluting stents among patients with critical limb ischemia.
Design: prospective, nonrandomized
Patients: 106
Centers: single-center
Country: United States
RESULTS: Patients experienced a 6% three-year cumulative amputation incidence. Survival rates were 71%, and amputation-free survival was 68%; 12% of patients who died had a preceding major amputation. Fifteen percent of patients experienced target limb revascularization. Among the 35% of patients who underwent repeat angiography, 12% had binary restenosis. Rutherford category, age, creatinine level and dialysis significantly predicted death, but not amputation.
Published in: J Am Coll Cardiol. 2010;55:1580-1589.
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