Controlled reperfusion versus conventional treatment of the acutely ischemic limb: results of a randomized, open-label, multicenter trial.

BACKGROUND Amputation rates and mortality in patients with severe acute limb ischemia remain high. The protective effect of controlled reperfusion (CR) on tissue damage because of local and systemic reperfusion injury is unclear. METHODS AND RESULTS A total of 174 patients from 14 centers were randomized between conventional treatment (CT) by thrombembolectomy and normal blood reperfusion and thrombembolectomy followed by CR. The primary end point was amputation-free survival (AFS) after 4 weeks (CT, 82.4%; CR, 82.6%). Secondary end points were AFS (CT, 62.4%; CR, 63.1%) and overall survival (CT, 71.6%; CR, 76.3%) after 1 year. Analysis of the prognostic effects of preoperative factors revealed a strong adverse effect of bilateral involvement on AFS. In the subgroup with unilateral ischemia (n=160), age >80 years and central localization of the occlusion had independent negative prognostic effects on AFS. In the per-protocol population of 104 patients with unilateral ischemia, treatment per protocol, and successful revascularization, amputation or death within 4 weeks occurred in only 8% as compared with 33% in patients not fulfilling these criteria. No differences between treatment groups CT and CR were found, neither overall nor in the per-protocol population nor in patient subgroups defined by other pre- and intraoperative factors. CONCLUSIONS Similar AFS in patients with CT or with CR was observed in this large randomized multicenter trial. CLINICAL TRIAL REGISTRATION URL http://www.drks.de. Unique identifier: DRKS00000579.