title: Treatment of chronic SFA in-stent occlusion with combined laser atherectomy and drug-eluting balloon angioplasty in patients with critical limb ischemia: a single-center, prospective, randomized study.
abstract: OBJECTIVE
  To compare the safety and efficacy of laser debulking (LD) and drug-eluting balloon (DEB) angioplasty to treatment with DEB angioplasty alone in patients affected by critical limb ischemia (CLI) and superficial femoral artery (SFA) chronic stent occlusion in a prospective, randomized study.
  
  
  METHODS
  Among 448 CLI patients treated from December 2009 to March 2011, 48 patients (39 men; mean age 72.7±7.8 years) with chronic SFA in-stent occlusion were randomly assigned to treatment using LD+DEB (n=24) or DEB angioplasty alone (n=24). Patency at 12 months was the primary outcome measure; secondary outcomes were target lesion revascularization (TLR) and clinical success at 12 months.
  
  
  RESULTS
  In the LD+DEB group, the patency rates at 6 and 12 months (91.7% and 66.7%, respectively) were significantly higher (p=0.01) than in the DEB only patients (58.3% and 37.5%, respectively). TLR at 12 months was 16.7% in the LD+DEB group and 50% in the DEB only group (p=0.01). Two (8%) patients needed major amputations in the LD+DEB group vs. 11 (46%) in the DEB only group at 12 months (p=0.003).
  
  
  CONCLUSIONS
  In this small initial experience, combined treatment with LD and DEB angioplasty is correlated with better outcomes in CLI patients with occluded SFA stents.
authors: Department of Diagnostic Imaging, Molecular Imaging, Interventional Radiology, Radiotherapy, and Nuclear Medicine, "IRCCS Policlinico di Tor Vergata," Rome, Italy.
authors: Roberto
authors: R
authors: Gandini
authors: Costantino
authors: C
authors: Del Giudice
authors: Stefano
authors: S
authors: Merolla
authors: Daniele
authors: D
authors: Morosetti
authors: Enrico
authors: E
authors: Pampana
authors: Giovanni
authors: G
authors: Simonetti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002908:Chronic Disease; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D016638:Critical Illness; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D007834:Lasers; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011859:Radiography; D012008:Recurrence; D019233:Retreatment; D012307:Risk Factors; D012384:Rome; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D020099:Coated Materials, Biocompatible