Long-Term Follow-up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

Background: clinical outcomes reported after treatment of infrapopliteal lesions with drug-eluting stents (dess) have been more favorable compared with percutaneous transluminal angioplasty with a bailout bare metal stent (pta-bms) through midterm follow-up in patients with critical limb ischemia. in the present study,long-term results of treatment of infrapopliteal lesions with dess are presented.methods and results: adults with critical limb ischemia (rutherford category ≥4) and infrapopliteal lesions were randomized to receive pta-bms or dess with paclitaxel. long-term follow-up consisted of annual assessments up to 5 years after treatment or until a clinical end point was reached. clinical end points were major amputation (above ankle level),infrapopliteal surgical or endovascular reintervention,and death. preserved primary patency (≤50% restenosis) of treated lesions was an additional morphological end point,assessed by duplex sonography. in total,74 limbs (73 patients) were treated with dess and 66 limbs (64 patients) were treated with pta-bms. the estimated 5-year major amputation rate was lower in the des arm (19.3% versus 34.0% for pta-bms; p=0.091). the 5-year rates of amputation- and event-free survival (survival free from major amputation or reintervention) were significantly higher in the des arm compared with pta-bms (31.8% versus 20.4%,p=0.043; and 26.2% versus 15.3%,p=0.041,respectively). survival rates were comparable. the limited available morphological results showed higher preserved patency rates after dess than after pta-bms at 1,3,and 4 years of follow-up.conclusions: both clinical and morphological long-term results after treatment of infrapopliteal lesions in patients with critical limb ischemia are improved with des compared with pta-bms.clinical trial registration: url: http://www.clinicaltrials.gov. unique identifier: nct00471289. © 2017 the authors. published on behalf of the american heart association,inc.,by wiley.