Reintervention as a clinical trial endpoint after peripheral arterial bypass surgery

Background. Graft patency is usually the primary endpoint in studies of per ipheral arterial bypass surgery, but gives only a limited indication of cli nical outcome. The aim of this study was to evaluate reintervention as a st udy endpoint after femorodistal bypass surgery. Methods: The database from a multicentre, prospectively planned study of 51 7 patients undergoing femorodistal bypass for severe ischaemia was used to investigate the predictive value of technical endpoints. Clinical symptoms, graft patency, vascular interventions and clinical outcomes were recorded for 12 months after operation. Results: Complete follow-up data were obtained on 498 patients (96 per cent ). Success in terms of patients' need for reintervention agreed with clinic al outcome in 90 (95 per cent confidence interval (c.i.) 87-93) per cent of cases. Primary and secondary patency agreed with the clinical outcome in 8 0 (95 per cent c.i. 77-84) and 81 (95 per cent c.i. 78-85) per cent of pati ents respectively. However, the best agreement with clinical outcome was ob tained from the composite endpoint of 'patient alive without reintervention ': 92 (95 per cent c.i. 90-94) per cent. Conclusion: Recording the number of patients who did not need reinterventio n for 12 months after femorodistal bypass gave a more accurate assessment o f the number with clinical improvement than was obtained by recording bypas s graft patency. Inclusion of patient survival in a composite endpoint incr eased the clinical relevance of this endpoint in patients with severe ischa emia who had femorodistal bypass surgery.