Objectives. This study sought to assess outcomes of men with double-vessel coronary artery disease randomly assigned to treatment by percutaneous transluminal coronary angioplasty (PTCA) or medical therapy, compared with previously reported outcomes for men with single-vessel disease. Background. We previously reported that PTCA provides better symptom relief and treadmill performance than medical therapy for men with stable angina pectoris due to single-vessel disease, Whether this advantage applies to patients with double-vessel disease is unknown. Methods. Male patients (n = 328) with stable angina pectoris and ischemia on treadmill testing were randomly assigned to PTCA or medical therapy; 101 patients had double-vessel disease, and 227 had single-vessel disease, Symptoms, treadmill performance, quality of life score, coronary stenosis and myocardial perfusion were compared at baseline and at 6 months. Patients were followed up for up to 6 years and underwent additional treadmill testing 2 to 3 years after randomization. Results. PTCA-treated and medically treated patients with double vessel disease experienced comparable improvement in exercise duration (+1.2 vs, +1.3 min, respectively, p = 0.89), freedom from angina (53% and 36%, respectively, p = 0.09) and improvement of overall quality of life score (+1.3 vs, +4.4, respectively, p = 0.32) at 6 months compared with baseline, This contrasts with greater advantages favoring PTCA by these criteria in patients with single-vessel disease (p = 0.0001 to 0.02), Trends present at 6 months persisted at late follow-up, Patients undergoing double-vessel dilation had less complete initial revascularization (45% vs, 83%) and greater average stenosis of worst lesions at 6 months (74% vs, 56%). Likewise, patients with double-vessel disease showed less improved myocardial perfusion imaging (59% vs, 75%). Conclusions. PTCA is beneficial in male patients with double vessel disease; however, we cannot demonstrate the same advantage over medical therapy seen in similar patients with single-vessel disease, Less complete revascularization and greater restenosis for patients having multiple dilations would account for these findings, Alternatively, a type 2 error might be operative, Technical advances since completion of this trial might improve these outcomes. These findings warrant further investigation in a larger trial. (C) 1997 by the American College of Cardiology.