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

Zaidat OO, Fifi JT, Nanda A, Atchie B, Woodward K, Dörfler A, Tomasello A, Tekle W, Singh IP, Matouk C, Thalwitzer J, Jargiełło T, Skrypnik D, Beuing O, Berge J, Katz JM, Biondi A, Bonovich D, Sheth SA, Yoo AJ, Hassan AE (2022)

Publication Type: Journal article

Publication year: 2022

Journal

Book Volume: 53

Pages Range: 769-778

Journal Issue: 3

DOI: 10.1161/STROKEAHA.121.034268

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-type 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.

Authors with CRIS profile

Involved external institutions

North Shore University Hospital United States (USA) (US) Eden Medical Center United States (USA) (US) Icahn School of Medicine at Mount Sinai United States (USA) (US) University of Texas Health Science Center at Houston (UTHealth) United States (USA) (US) SSM Health St. Clare Hospital United States (USA) (US) Hôpital Jean-Minjoz France (FR) Fort Sanders Regional Medical Center United States (USA) (US) Mercy Health United States (USA) (US) Yale New Haven Hospital United States (USA) (US) Universitätsklinikum Magdeburg A.ö.R. Germany (DE) University of Texas Rio Grande Valley (UTRGV) United States (USA) (US) Centre Hospitalier Universitaire de Bordeaux / CHU Bordeaux France (FR) City Clinical Hospital named after I.V. Davydovsky of Moscow Healthcare Department Russian Federation (RU) Klinikum Chemnitz Germany (DE) Texas Stroke Institute United States (USA) (US) Vall d'Hebron University Hospital / Hospital Universitari Vall d'Hebron Spain (ES)

How to cite

APA:

Zaidat, O.O., Fifi, J.T., Nanda, A., Atchie, B., Woodward, K., Dörfler, A.,... Hassan, A.E. (2022). Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results. Stroke, 53(3), 769-778. https://dx.doi.org/10.1161/STROKEAHA.121.034268

MLA:

Zaidat, Osama O., et al. "Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results." Stroke 53.3 (2022): 769-778.

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