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PARADISE: Drug-eluting stents safe, effective treatment for critical limb ischemia
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Limb salvage and survival rates among patients with below-the-knee critical limb ischemia who were treated with drug-eluting stents exceeded those of historical controls, findings from the PaRADISE trial indicated.
Researchers from Columbia-St. Mary’s Medical Center and the Medical College of Wisconsin, both in Milwaukee, sequentially enrolled 106 patients with critical limb ischemia to study the safety and efficacy of balloon expandable drug-eluting stents in preventing amputations. Patients were not excluded for comorbidities, and all patients had below-the-knee intervention.
Primary endpoints included major amputation (above the ankle), all-cause mortality, tissue healing and relief of rest pain. Mean patient age was 74 years. Also, 118 limbs were treated with about 1.9 stents per limb, and 228 drug-eluting stents were implanted (83% Cypher, Cordis; 17% Taxus, Boston Scientific). The researchers performed routine follow-up at one, three and six months and every six months thereafter.
They found that PaRADISE 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.
Although the study design did not include a control arm, the researchers compared outcomes to historical data from the TASC II and BASIL trials. Amputation rates and symptom resolution were significantly lower among PaRADISE patients compared with TASC II benchmarks that indicated a 30% one-year major amputation rate and the 20% failure to resolve symptoms rate.
Although one-year (11%) and three-year (18%) amputation rates were low among patients in the BASIL study, the researchers said BASIL patients were low risk, with nearly 90% excluded for unsuitable anatomy or comorbidities and less than 25% with true critical limb ischemia. “Nevertheless, despite these differences, at three years, the PaRADISE study maintained a 13% limb survival advantage over the BASIL trial,” the researchers wrote.
Additionally, one-year all-cause mortality rates were lower among patients in the PaRADISE study (87%) compared with three-year mortality among those in the TASC II study, according to the researchers. Although mortality was similar among patients in the BASIL and PaRADISE studies, the PaRADISE cohort was older (35% vs. 25% aged older than 80 years); had worse renal function (creatinine 1.8 mg/dL vs. 1.3 mg/dL); and had greater variation in clinical status.
“These data support a drug-eluting stent–first approach when treating infrapopliteal critical limb ischemia,” the researchers wrote.
Feiring A. J Am Coll Cardiol. 2010;55:1580-1589.
