Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results
Osama O. Zaidat, Johanna T. Fifi, Ashish Nanda, Benjamin Atchie, Keith Woodward, Arnd Doerfler, Alejandro Tomasello, Wondwossen Tekle, Inder Paul Singh, Charles Matouk, Jörg Thalwitzer, Tomasz Jargiełło, Dmitry Skrypnik, Oliver Beuing, Jérôme Berge, Jeffrey M. Katz, Alessandra Biondi, David Bonovich, Sunil A. Sheth, Albert J. Yoo, Ameer E. Hassan, Michel Piotin, Raphaël Blanc, Jean-Philippe Desilles, Gabriele Ciccio, Stanislas Smajda, Jérôme Berge, Gaultier Marnat, Xavier Barreau, Patrice Ménégon, Florent Gariel, Arnd Dörfler, Tobias Engelhorn, Philipp Gölitz, Manuel Schmidt, Stefan Lang, Iris Mühlen, Julie Rösch, Michael Knott, Hannes Lücking, Philip Hoelter, Peter Schramm, Alexander Neumann, Thomas Eckey, Tobias Boppel, Jörg Thalwitzer, Mike Krah, Jens Schwarze, Bettina Manikowski, Philipp Ladig, Nathanael Albert, Carmen Otto, Anne Lemme, Silvio Brandt, Georg Bohner, Justus Kleine, Eberhard Siebert, Hans-Christian Bauknecht, Edzard Wiener, Oliver Beuing, Aneta Donitza, Tomasz Jargiełło, Michał Górnik, Krzysztof Pyra, Tomasz Roman, Maciej Szajner, Remigiusz Ficek, Katarzyna Prus, Sylwia Stachowicz, Joanna Wojczal, Michał Sojka, Kinga Buraczyńska, Piotr Luchowski, Dmitry Skrypnik, Kirill Anisimov, Ekaterina Sukhanova, Eugene Shloydo, Kirill Kravchenko, Konstantin Golikov, Aleksey Sergeev, Anna Udovichenko, Roman Georgiev, Eduard Gasparyan, Svyatoslav Malov, Eugeny Ploschenkov, Alejandro Tomasello Weitz, Marc Ribó, David Hernández, David Rodriguez-Luna, Álvaro García-Tornel, Marta Rubiera, Jesús Juega, Marian Muchada, Noelia Rodríguez Villatoro, Sandra Boned Riera, Jorge Pagola, Matías Deck Román, Carlos Piñana Plaza, Joaquín Zamarro Parra, Guillermo Parrilla
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.