title: Cool excimer laser-assisted angioplasty (CELA) and tibial balloon angioplasty (TBA) in management of infragenicular arterial occlusion in critical lower limb ischemia (CLI).
abstract: We aim to compare cool excimer laser-assisted angioplasty (CELA) versus tibial balloon angioplasty (TBA) in patients with critical limb ischemia (CLI) with tibial artery occlusive disease. The primary end point is sustained clinical improvement (SCI) and amputation-free survival (AFS). The secondary end points are binary restenosis, target extremity revascularization (TER), and cost-effectiveness. From June 2005 to October 2010, 1506 patients were referred with peripheral vascular disease and 572 with CLI. A total of 80 patients underwent 89 endovascular revascularizations (EVRs) for tibial occlusions, 47 using TBA and 42 using CELA. All patients were Rutherford category 4 to 6. Three-year SCI was enhanced with CELA (81%) compared to TBA (63.8%; P = .013). Three-year AFS significantly improved with CELA (95.2%) versus TBA (89.4%; P = .0165). Three-year freedom from TER was significantly improved with CELA (92.9%) versus 78.7% TBA (P = .026). Three-year freedom from MACE was comparable in both the groups (P = .455). Patients with CELA had significantly improved quality time without symptoms of disease or toxicity of treatment (Q-TWiST) at 3 years (10.5 months; P = .048) with incremental cost of €2073.19 per quality-adjusted life year gained. Tibial EVR provides exceptional outcome in CLI. The CELA has superior SCI, AFS, and freedom from TER, with improved Q-TWiST and cost-effectiveness.
authors: Western Vascular Institute, University College Hospital Galway, Galway, Ireland. sherif.sultan@hse.ie
authors: Sherif
authors: S
authors: Sultan
authors: Wael
authors: W
authors: Tawfick
authors: Niamh
authors: N
authors: Hynes
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation* / Q000401:mortality; D017222:Angioplasty, Balloon, Laser-Assisted / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation* / Q000401:mortality; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000191:economics / Q000401:mortality / Q000628:therapy*; D016009:Chi-Square Distribution; D003362:Cost-Benefit Analysis; D016638:Critical Illness; D018572:Disease-Free Survival; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000191:economics / Q000401:mortality / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D054018:Lasers, Excimer / Q000627:therapeutic use*; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012008:Recurrence; D012307:Risk Factors; D016909:Tibial Arteries; D013997:Time Factors; D016896:Treatment Outcome