Laser versus balloon angioplasty in endovascular management of infragenicular tibial arterial occlusion in critical limb ischemic TASC D: Six L Trial

We aim to compare cool excimer laser-assisted angioplasty versus tibial balloon angioplasty (TBA) in critical limb ischemia (CLI) patients, with tibial artery occlusive disease. From June 2005 to October 2010, 1506 patients were referred with peripheral vascular disease. 80 patients underwent 89 endorevascularizations for tibial occlusions; 47 using TBA and 42 using cool excimer laser-assisted angioplasty. All patients were Rutherford Category 4, 5, or 6, with TASC D lesions.Five-year sustained clinical improvement was enhanced with laser angioplasty (76%) compared to TBA (62%; P = 0.1004). Rate of revascularization performed due to progression of arteriosclerosis was significantly higher post-TBA (P = 0.006). Major adverse clinical events at 5 years were significantly more pronounced in TBA, 38% versus 66% (P = 0.001). Laser angioplasty patients had significantly improved quality time spent without symptoms of disease or toxicity of treatment (10.5 months; P = 0.048) with an incremental cost of €2073.19 per quality-adjusted life-year gained.Tibial endovascularization bestows an exceptional outcome in CLI TASC D lesions. Both laser angioplasty and TBA impart recuperated clinical and technical success rates and are superior to bypass surgery. Laser is cost-effective with superior quality time spent without symptoms of disease or toxicity of treatment and quality-adjusted life-years. It offers superior quality of life, with enhanced immediate clinical improvement, reduced binary restenosis, and target lesion revascularization rates. It boosts outstanding survival rates, free from major clinical events at 5 years.