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

Marlon I Spreen, Jasper M Martens, Bob Knippenberg, Lukas C van Dijk, Jean-Paul P M de Vries, Jan Albert Vos, Gert Jan de Borst, Evert-Jan P A Vonken, Okker D Bijlstra, Jan J Wever, Randolph G Statius van Eps, Willem P Th M Mali, Hendrik van Overhagen, Marlon I Spreen, Jasper M Martens, Bob Knippenberg, Lukas C van Dijk, Jean-Paul P M de Vries, Jan Albert Vos, Gert Jan de Borst, Evert-Jan P A Vonken, Okker D Bijlstra, Jan J Wever, Randolph G Statius van Eps, Willem P Th M Mali, Hendrik van Overhagen

Abstract

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.

Keywords: critical limb ischemia; drug‐eluting stent; endovascular treatment; peripheral artery disease.

© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Figures

Figure 1
Figure 1
Flow diagram of inclusion. *Four patients included for 2 limbs, with 1 limb in each arm. BMS indicates bare metal stent; DES, drug‐eluting stent; PTA, percutaneous transluminal angioplasty.
Figure 2
Figure 2
Clinical outcome per patient at 1 year (a), 2 years (b), 3 years (c), 4 years (d), and 5 years (e) of follow‐up. Amp indicates amputation; DES, drug‐eluting stent; FU, follow‐up; PTA, percutaneous transluminal angioplasty; reint, reintervention.
Figure 3
Figure 3
A, Kaplan–Meier curves representing estimated 5‐year cumulative incidence rates after PTA‐BMS and DES. A, Major amputation per limb. B, Amputation‐free survival per patient. C, Event‐free survival per patient. D, Survival per patient. BMS indicates bare metal stent; DES, drug‐eluting stent; PTA, percutaneous transluminal angioplasty.

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