Percutaneous transluminal angioplasty versus operation for peripheral arteriosclerosis. Report of a prospective randomized trial in a selected group of patients.

A prospective, randomized comparison of percutaneous transluminal angioplasty (PTA) with surgery in the treatment of occlusive disease of the iliac, superficial femoral, or popliteal arteries began in 1983. Radiologists and vascular surgeons independently assessed index lesions on arteriograms to decide whether their respective treatments were appropriate. Of 263 male patients randomized, 255 received vascular intervention (surgery, 126 patients; PTA, 129 patients). The groups were comparable when stratified for systemic risk factors and anatomic distribution of disease. Because eligibility criteria required that all lesions randomized for treatment be suitable for PTA, the severity of disease was less than that of the general population having vascular disease. Claudication was the principal indication for intervention. The immediate failure rate for PTA was 15.5% (20 of 129 patients). Surgery was performed with one in-hospital death (0.8%) and 17 complications (13.5%). There were two late deaths ascribable to surgical complications and none to PTA. At 4.5 years, 50 deaths (20%) (28 from surgery; 22 with PTA) and 24 major amputations of legs included in the study (13 with surgery; 11 with PTA) have occurred. The baseline ankle-brachial indexes (ABIs) of 0.51 +/- 0.02, respectively, after treatment and was not different between the groups through 36 months (surgery, 0.28 +/- 0.04; PTA, 0.30 +/- 0.05). The 17 patients undergoing surgery after unsuccessful PTA had a mean ABI increase of 0.32 +/- 0.07; the durability of hemodynamic improvement was similar in both groups of patients.

RCT Entities:   Population Interventions Outcomes