title: Percutaneous Transluminal Angioplasty and Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI) Trial.
abstract: BACKGROUND
  Endovascular infrapopliteal treatment of patients with critical limb ischemia using percutaneous transluminal angioplasty (PTA) and bail-out bare metal stenting (BMS) is hampered by restenosis. In interventional cardiology, drug-eluting stents (DES) have shown better patency rates and are standard practice nowadays. An investigator-initiated, multicenter, randomized trial was conducted to assess whether DES also improve patency and clinical outcome of infrapopliteal lesions.
  
  
  RESULTS
  Adults with critical limb ischemia (Rutherford category ≥4) and infrapopliteal lesions were randomized to receive PTA±BMS or DES with paclitaxel. Primary end point was 6-month primary binary patency of treated lesions, defined as ≤50% stenosis on computed tomographic angiography. Stenosis >50%, retreatment, major amputation, and critical limb ischemia-related death were regarded as treatment failure. Severity of failure was assessed with an ordinal score, ranging from vessel stenosis through occlusion to the clinical failures. Seventy-four limbs (73 patients) were treated with DES and 66 limbs (64 patients) received PTA±BMS. Six-month patency rates were 48.0% for DES and 35.1% for PTA±BMS (P=0.096) in the modified-intention-to-treat and 51.9% and 35.1% (P=0.037) in the per-protocol analysis. The ordinal score showed significantly worse treatment failure for PTA±BMS versus DES (P=0.041). The observed major amputation rate remained lower in the DES group until 2 years post-treatment, with a trend toward significance (P=0.066). Less minor amputations occurred after DES until 6 months post-treatment (P=0.03).
  
  
  CONCLUSIONS
  In patients with critical limb ischemia caused by infrapopliteal lesions, DES provide better 6-month patency rates and less amputations after 6 and 12 months compared with PTA±BMS.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00471289.
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Marlon I
authors: MI
authors: Spreen
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Jasper M
authors: JM
authors: Martens
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Bettina E
authors: BE
authors: Hansen
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Bob
authors: B
authors: Knippenberg
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Elke
authors: E
authors: Verhey
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Lukas C
authors: LC
authors: van Dijk
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Jean-Paul P M
authors: JP
authors: de Vries
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Jan-Albert
authors: JA
authors: Vos
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Gert Jan
authors: GJ
authors: de Borst
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Evert-Jan P A
authors: EJ
authors: Vonken
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Jan J
authors: JJ
authors: Wever
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Randolph G
authors: RG
authors: Statius van Eps
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Willem P Th M
authors: WP
authors: Mali
authors: From the Departments of Radiology (M.I.S., J.M.M., L.C.v.D., H.v.O.) and Vascular Surgery (B.K., J.J.W., R.G.S.v.E.), Haga Teaching Hospital, The Hague, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands (B.E.H., E.V.); Departments of Vascular Surgery (J.-P.P.M.d.V.) and Radiology (J.-A.V.), Sint Antonius Hospital, Nieuwegein, The Netherlands; and Departments of Vascular Surgery (G.J.d.B.) and Radiology (E.-J.P.A.V., W.P.T.M.M.), University Medical Center Utrecht, Utrecht, The Netherlands. h.voverhagen@hagaziekenhuis.nl.
authors: Hans
authors: H
authors: van Overhagen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical / Q000706:statistics & numerical data; D017130:Angioplasty / Q000295:instrumentation*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data*; D005260:Female; D006083:Graft Occlusion, Vascular / Q000517:prevention & control; D006801:Humans; D007511:Ischemia / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel
keywords: angioplasty; drug-eluting stents; ischemia; peripheral arterial disease