Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results
Author:
Zaidat Osama O.1ORCID, Fifi Johanna T.2ORCID, Nanda Ashish3, Atchie Benjamin4ORCID, Woodward Keith5, Doerfler Arnd6ORCID, Tomasello Alejandro7ORCID, Tekle Wondwossen8ORCID, Singh Inder Paul9, Matouk Charles10ORCID, Thalwitzer Jörg11ORCID, Jargiełło Tomasz12, Skrypnik Dmitry13ORCID, Beuing Oliver14ORCID, Berge Jérôme15ORCID, Katz Jeffrey M.16ORCID, Biondi Alessandra17ORCID, Bonovich David18, Sheth Sunil A.19ORCID, Yoo Albert J.20ORCID, Hassan Ameer E.121ORCID, Piotin Michel, Blanc Raphaël, Desilles Jean-Philippe, Ciccio Gabriele, Smajda Stanislas, Marnat Gaultier, Barreau Xavier, Ménégon Patrice, Gariel Florent, Engelhorn Tobias, Gölitz Philipp, Schmidt Manuel, Lang Stefan, Mühlen Iris, Rösch Julie, Knott Michael, Lücking Hannes, Hoelter Philip, Schramm Peter, Neumann Alexander, Eckey Thomas, Boppel Tobias, Krah Mike, Schwarze Jens, Manikowski Bettina, Ladig Philipp, Albert Nathanael, Otto Carmen, Lemme Anne, Brandt Silvio, Bohner Georg, Kleine Justus, Siebert Eberhard, Bauknecht Hans-Christian, Wiener Edzard, Donitza Aneta, Górnik Michał, Pyra Krzysztof, Roman Tomasz, Szajner Maciej, Ficek Remigiusz, Prus(Sub-I) Katarzyna, Stachowicz Sylwia, Wojczal Joanna, Sojka Michał, Buraczyńska Kinga, Luchowski Piotr, Anisimov Kirill, Sukhanova Ekaterina, Shloydo Eugene, Kravchenko Kirill, Golikov Konstantin, Sergeev Aleksey, Udovichenko Anna, Georgiev Roman, Gasparyan Eduard, Malov Svyatoslav, Ploschenkov Eugeny, Ribó Marc, Hernández David, Rodriguez-Luna David, García-Tornel Álvaro, Rubiera Marta, Juega Jesús, Muchada Marian, Rodríguez Villatoro Noelia, Boned Riera Sandra, Pagola Jorge, Deck Román Matías, Piñana Plaza Carlos, Zamarro Parra Joaquín, Parrilla Reverter Guillermo, Espinosa de Rueda Ruiz Mariano, García-Villalba Navaridas Blanca, Díaz Pérez José, Hellinger Frank, Gandhi Ravi, Bellew Michael, Bellon Richard, Frei Do, Kaminsky Ian, Arias Eric, Woo Henry, Teron Molina Ina, Patel Anand, Libman Richard, Arora Rohan, Hixson Harry, Graham Cole, Moftakhar Roham, Diaz Orlando, Klucznik Richard, Alexander Michael, Jackson Robert, Padrick Matthew, Dumitrascu Oana, Schlick Konrad, Olivas Edgar, Song Shlee, Barnard Zachary, Kornbluth Penelope, John Madarang Ernest, Reeves Alan, Shoriah Hazem, Yaeger Kurt, Majidi Shahram, DeLacey Reade, Keller Christopher, Shigematsu Tomoyoshi, Yaniv Gal, Oxley Thomas, Georgiadis Alexandros, Herber Ryan, Bahrassa Farhad, Johnson Michele, Hawk Harris, Quarfordt Steven, Nichols Michael, Calvert Justin, Starke Robert, Yavagal Dileep, Peterson Eric, Altschul Dorothea, Sattar Ahsan, Ali Aziz-Sultan Mohammed, Large Daniel, Patel Nirav, Chen Karen, Ziayee Habibullah, Du Rose, Frerichs Kai, Patel Akshal, Monteith Stephen, Loh Yince, Aref Mohammed, Tjoumakaris Stavropoula, Herial Nabeel, Jabbour Pacal, Rosenwasser Robert, Reid Gooch Michael, Zarzour Hekmat, Taqi Muhammad, Hoit Daniel, Arthur Adam, Elijovich Lucas, Nickele Christopher, Inoa Violiza, Goyal Nitin, Torabi Radmehr, Dornbos David, Peterson Jeremy, Maidan Lucian, Luh George, Kale Sushant, Alshekhlee Amer, Farid Hamed, Bress Aaron, Senturk Cagin, Milburn Jim, Vidal Gabriel, Gulotta Paul, Valle-Giler Edison, Turkel-Parrella David, S. Gordon David, Liff Jeremy, Arcot Karthik, Farkas Jeffrey, Adamczyk Peter, Lin Eugene, Ezzeldin Mohammad, Sultan-Qurraie Ali, Alenzi Badar, Teleb Mohamed, Abuawad Mazen, Viktoria Totoraitis Ruta, Richard Paul
Affiliation:
1. Mercy Health St. Vincent Medical Center, Toledo, OH (O.O.Z.). 2. Icahn School of Medicine at Mount Sinai, New York, NY (J.T.F.). 3. SSM St. Clare Healthcare, Fenton, MO (A.N.). 4. RIA Neurovascular, Englewood, CO (B.A.). 5. Fort Sanders Regional Medical Center, Knoxville, TN (K.W.). 6. Universitätsklinikum Erlangen, Germany (A.D.). 7. Hospital Universitari Vall d’Hebron, Barcelona, Spain (A.T.). 8. University of Texas Rio Grande Valley - Valley Baptist Health System, Harlingen (W.T.). 9. Mount Sinai Health System, New York, NY (I.P.S.). 10. Yale New Haven Hospital, New Haven, CT (C.M.). 11. Klinikum Chemnitz GmbH, Chemnitz, Germany (J.T.). 12. Samodzielny Publiczny Szpital Kliniczny nr 4, Lublin, Poland (T.J.). 13. Moscow City Clinical Hospital named after Davydovsky, Russia (D.S.). 14. Universitätsklinikum Magdeburg, Germany (O.B.). 15. CHU de Bordeaux- Hôpital Pellegrin, Bordeaux, France (J.B.). 16. North Shore University Hospital, Northwell Health, Manhasset, NY (J.M.K.). 17. J Minjoz University Hospital, Besançon, France (A.B.). 18. Eden Medical Center, Castro Valley, CA (D.B.). 19. Department of Neurology, UTHealth McGovern Medical School, Houston, TX (S.A.S.). 20. Texas Stroke Institute, Dallas-Fort Worth (A.J.Y.). 21. University of Texas Rio Grande Valley - Valley Baptist Medical Center, Harlingen (A.E.H.).
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.
Publisher
Ovid Technologies (Wolters Kluwer Health)
Subject
Advanced and Specialised Nursing,Cardiology and Cardiovascular Medicine,Clinical Neurology
Cited by
21 articles.
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