Abstract TP27: ADAPT Reperfusion With ACE64 and ACE68 is Safe and Effective in Large Vessel Occlusions of the Anterior Circulation - The PROMISE Registry Results

Abstract

Introduction: Safe and complete recanalization is important to reduce clot burden and determines functional prognosis of patients with cerebral infarction from large vessel occlusions (LVO). The aim of PROMISE is to evaluate the safe and effective use of the aspiration-based Penumbra System with the latest generation of ACE Reperfusion Catheters in a real world population with acute ischemic stroke from anterior circulation LVO, treated with the ADAPT technique in routine practice. Methods: The prospective, single-arm, multicenter PROMISE registry evaluated the Penumbra System with ACE64 and ACE68 catheters across 20 European centers. Criteria for inclusion include presentation of anterior circulation LVO within 6 hours of ictus, NIHSS ≥ 2, ASPECTS ≥ 6 and wherein intervention was proceeded with ADAPT as frontline. Primary endpoints include angiographic revascularization to TICI 2b-3, and clinical independence (mRS 0-2) at 90 days. Secondary endpoints include safety events, functional improvement at 7-10 days, procedural metrics and quality of life. Results: A total of 202 patients were enrolled for evaluation of this interim analysis. Table I details patient history and baseline characteristics. Prior to endovascular procedure, IV rtPA was administered in 61.9% of patients. A final revascularization mTICI 2b-3 was achieved in 96.5% (194/201), per investigator assessment. Of these, mTICI 3 was achieved in 68.2% (137/201). Mortality was observed in 15 of the 141 (10.6%) patients at this interim analysis. Patient follow-up data collection, including clinical outcome, will be completed by the end of 2017. Core lab adjudicated results will be available at time of presentation. Conclusion: Interim analysis of the PROMISE registry demonstrated safe and effective utility of the Penumbra System with the novel ACE64 and ACE68 Reperfusion Catheters using ADAPT as frontline treatment. All follow up visits and final results will be presented at the ISC conference.