Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results

Abstract

Background and Purpose: The purpose of the COMPLETE (International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device) registry was to evaluate the generalizability of the safety and efficacy of the Penumbra System (Penumbra, Inc, Alameda) in a real-world setting. Methods: COMPLETE was a global, prospective, postmarket, multicenter registry. Patients with large vessel occlusion–acute ischemic stroke who underwent mechanical thrombectomy using the Penumbra System with or without the 3D Revascularization Device as frontline approach were enrolled at 42 centers (29 United States, 13 Europe) from July 2018 to October 2019. Primary efficacy end points were successful postprocedure angiographic revascularization (modified Thrombolysis in Cerebral Infarction ≥2b) and 90-day functional outcome (modified Rankin Scale score 0–2). The primary safety end point was 90-day all-cause mortality. An imaging core lab determined modified Thrombolysis in Cerebral Infarction scores, Alberta Stroke Program Early CT Scores, clot location, and occurrence of intracranial hemorrhage at 24 hours. Independent medical reviewers adjudicated safety end points. Results: Six hundred fifty patients were enrolled (median age 70 years, 54.0% female, 49.2% given intravenous recombinant tissue plasminogen activator before thrombectomy). Rate of modified Thrombolysis in Cerebral Infarction 2b to 3 postprocedure was 87.8% (95% CI, 85.3%–90.4%). First pass and postprocedure rates of modified Thrombolysis in Cerebral Infarction 2c to 3 were 41.5% and 66.2%, respectively. At 90 days, 55.8% (95% CI, 51.9%–59.7%) had modified Rankin Scale score 0 to 2, and all-cause mortality was 15.5% (95% CI, 12.8%–18.3%). Conclusions: Using Penumbra System for frontline mechanical thrombectomy treatment of patients with large vessel occlusion–acute ischemic stroke in a real-world setting was associated with angiographic, clinical, and safety outcomes that were comparable to prior randomized clinical trials with stringent site and operator selection criteria. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03464565.

Impact of interhospital transfer vs. direct admission on acute ischemic stroke patients: A subset analysis of the COMPLETE registry

“…Patients were considered enrolled once informed consent was obtained per Institutional Review Board/Ethics Committee and Penumbra System had been inserted into the body. Additional details on the COMPLETE Registry are reported separately ( 13 ).…”

Hyperacute immune responses associate with immediate neuropathology and motor dysfunction in large vessel occlusions

“…Recent advancement in stroke intervention has established endovascular therapy (EVT) as the standard of care for acute ischemic stroke due to large vessel occlusion (LVO). While 90% of LVO patients achieve near complete reperfusion after EVT, at least 40% still suffer a substantial disability 1 . Ischemia and reperfusion can lead to continued injury and dysfunction at the arteriolar and capillary levels even after recanalization.…”

“…While 90% of LVO patients achieve near complete reperfusion after EVT, at least 40% still suffer a substantial disability. 1 Ischemia and reperfusion can lead to continued injury and dysfunction at the arteriolar and capillary levels even after recanalization. Moreover, continued infarct growth is also attributed to the activation of several mechanisms and inflammatory pathways.…”

Mediation of Successful Reperfusion Effect through Infarct Growth and Cerebral Edema: A Pooled, Patient‐Level Analysis of EXTEND‐IA Trials and SELECT Prospective Cohort

“…Since pivotal trials established endovascular thrombectomy (EVT) efficacy and safety, 1–7 EVT has become the standard of care for selected inpatients with large vessel occlusion in both early (within 6 hours) and late (6–24 hours) windows 8 . Advances in device technologies and procedural techniques have also contributed to increasingly successful reperfusion, now approaching 90% 9–11 . However, only half of the patients receiving EVT achieve functional independence despite high procedural success rates, 9–11 demonstrating an opportunity to further optimize thrombectomy outcomes.…”

“…8 Advances in device technologies and procedural techniques have also contributed to increasingly successful reperfusion, now approaching 90%. [9][10][11] However, only half of the patients receiving EVT achieve functional independence despite high procedural success rates, [9][10][11] demonstrating an opportunity to further optimize thrombectomy outcomes.…”