Surgery or balloon angioplasty for peripheral vascular disease: a randomized clinical trial. Principal investigators and their Associates of Veterans Administration Cooperative Study Number 199. Balloon angioplasty versus bypass grafting in the era of coronary stenting.
Surgical revascularization and angioplasty (PTA) are effective therapies for patients with peripheral arterial disease, but there are no data on long-term survival, limb salvage, and hemodynamic status from a randomized study of such patients. A multicenter, prospective trial compared PTA with bypass surgery (BP) in 263 men who had iliac, femoral, or popliteal artery obstruction.
                Lesions in the iliac versus the femoropopliteal artery and rest pain versus claudication were separately randomized to the two treatment interventions. One hundred twenty-six patients underwent BP, 129 patients underwent PTA, and eight patients were not treated for lower extremity ischemia.
                Three operative deaths occurred in the BP group and none in the PTA group. For the entire study, average annual mortality was higher in the BP group, but survival was not significantly different on life-table analysis (P = .08). Primary success favored BP, while limb salvage favored PTA, but differences were not statistically significant (P = .08 and .35, respectively). Patients with iliac disease or claudication fared better, but there was no statistical difference in response to PTA or BP.
                Patients in both treatment groups had prompt and sustained increases in hemodynamics and quality of life. This study of patients randomly assigned to BP or PTA shows no significant difference in outcomes during a median follow-up of 4 years. Patients with multivessel coronary artery disease are candidates for either angioplasty and stenting or coronary artery bypass grafting. A prospective randomized study designed to compare the both methods included only a minority of the eligible patients.
                To compare coronary artery bypass grafting to angioplasty plus stenting in patients with multivessel disease who declined randomization to a multicenter study (the ARTS).
                During 1997-98 we prospectively followed 96 consecutive patients who were eligible according to the ARTS criteria but refused randomization. Of these patients, 50 underwent angioplasty + stenting and 46 underwent coronary bypass surgery. We compared the incidence of major adverse cardiac and cerebral events, chest pain recurrence, quality of life and procedural cost during the first 6 months.
                All procedures were completed successfully without mortality or cerebral events. The rate of Q-wave myocardial infarction was 2% in the AS group vs. 0% in the CABG group (not significant). Minor complications occurred in 7 patients (14%) in the AS group and in 21 patients (45%) in the CABG group (P < 0.01). At 6 months follow-up the incidence of major cardiac and cerebral events was similar in both groups (11% and 4% in the AS and CABG groups respectively, P = NS). Seventeen patients (36%) in the AS group required repeat revascularization compared to only 3 (7%) in the CABG group (P = 0.002). Nevertheless, quality of life was better, hospitalization was shorter and the cost was lower during the first 6 months after angioplasty.
                Angioplasty with stenting compared to coronary bypass surgery in patients with multivessel disease resulted in similar short-term major complications. However, 36% of patients undergoing angioplasty may need further revascularization procedures during the first 6 months.
These limited results suggest that angioplasty may have had a short term benefit, but this may not have been sustained.