title: Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial.
abstract: OBJECTIVE
  This study sought to report the results of a prospective randomized controlled trial comparing paclitaxel-coated balloons (PCB) versus drug-eluting stents (DES) in long infrapopliteal lesions.
  
  
  BACKGROUND
  DES have an established role in the treatment of short infrapopliteal lesions, whereas there is increasing evidence for the use of PCB in longer below-the-knee lesions.
  
  
  METHODS
  Inclusion criteria were patients with Rutherford classes 3 to 6 and angiographically documented infrapopliteal disease with a minimum lesion length of 70 mm. The primary endpoint was target lesion restenosis >50% assessed by digital angiography at 6 months. Secondary endpoints included immediate post-procedure stenosis and target lesion revascularization.
  
  
  RESULTS
  Fifty patients were randomized to undergo infrapopliteal PCB angioplasty (25 arteries in 25 limbs; PCB group) or primary DES placement (30 arteries in 27 limbs; DES group). Immediate residual post-procedure stenosis was significantly lower in DES (9.6 ± 2.2% vs. 24.8 ± 3.5% in PCB; p < 0.0001). At 6 months, 5 patients died (2 in PCB vs. 3 in DES; p = 1.00) and 3 suffered a major amputation (1 in PCB vs. 2 in DES; p = 1.00). In total, 44 angiograms were evaluable with quantitative vessel analysis. Binary (>50%) angiographic restenosis rate was significantly lower in DES (7 of 25 [28%] vs. 11 of 19 [57.9%] in PCB; p = 0.0457). There were no significant differences with regard to target lesion revascularization (2 of 26 [7.7%] in DES vs. 3 of 22 [13.6%] in PCB; p = 0.65). Positive vessel wall remodeling was observed in 3 cases in the PCB arm (3 of 19 [(15.8%)] vs. 0 of 19 [0%] in DES; p = 0.07).
  
  
  CONCLUSIONS
  Compared with PCB in long infrapopliteal lesions, DES are related with significantly lower residual immediate post-procedure stenosis and have shown significantly reduced vessel restenosis at 6 months. PCB may produce positive vessel remodeling. (Infrapopliteal Drug-Eluting Angioplasty Versus Stenting [IDEAS-I]; NCT01517997).
authors.affiliation: Interventional Radiology Department, Patras University Hospital, Patras, Greece.
authors.forename: Dimitris
authors.initials: D
authors.lastname: Siablis
authors.affiliation: Interventional Radiology Department, Patras University Hospital, Patras, Greece.
authors.forename: Panagiotis M
authors.initials: PM
authors.lastname: Kitrou
authors.affiliation: Interventional Radiology Department, Patras University Hospital, Patras, Greece.
authors.forename: Stavros
authors.initials: S
authors.lastname: Spiliopoulos
authors.affiliation: Interventional Radiology Department, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, London, United Kingdom.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Katsanos
authors.affiliation: Interventional Radiology Department, Patras University Hospital, Patras, Greece. Electronic address: karnaby@med.upatras.gr.
authors.forename: Dimitris
authors.initials: D
authors.lastname: Karnabatidis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D015901:Angiography, Digital Subtraction; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D054855:Drug-Eluting Stents; D005260:Female; D006115:Greece; D006801:Humans; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency; D066253:Vascular Remodeling
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: drug-eluting stents; infrapopliteal lesions; neointimal hyperplasia; paclitaxel-coated balloons; restenosis