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

Abstract

BackgroundClinical 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 ResultsAdults 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.ConclusionsBoth 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.

Editor's Choice – Follow-up of Patients After Revascularisation for Peripheral Arterial Diseases: A Consensus Document From the European Society of Cardiology Working Group on Aorta and Peripheral Vascular Diseases and the European Society for Vascular Surgery

“…60 Very few studies describe long-term results after infrapopliteal EVT; 5-year primary patency ranges from 38% in one study on balloon angioplasty, 61 to 9% with bare metal stents and 12% with drug-eluting stents in another trial. 62 Importantly, 5-year freedom from major amputation (range 66e81%) was definitely higher than primary patency in both trials.…”

SCAI appropriate use criteria for peripheral arterial interventions: An update

“…The PADI (Percutaneous transluminal Angioplasty versus Drug eluting stents for Infra‐popliteal lesions) trial was designed to compare the performance of paclitaxel‐eluting DESs and PTA‐BMS of infra‐popliteal lesions in a population consisting solely of CLI patients . Recently, the 5‐year follow‐up data were published confirming the long‐term advantage of coronary paclitaxel DES over a PTA with provisional BMS stenting (PTA‐BMS) for RC class ≥4 patients with infra‐popliteal lesions.…”

Drug-Eluting Balloons and Drug-Eluting Stents in the Treatment of Peripheral Vascular Disease

“…At 4 years, patency rate was higher in the DES group, though results were not statistically significant. 67 The YUKON trial similarly compared sirolimus-eluting DES to BMS. At long-term follow-up, event-free survival and amputation rates were improved in the DES group.…”