TY - JOUR
T1 - A Randomized Trial of Intravenous Alteplase before Endovascular Treatment for Stroke
AU - MR CLEAN–NO IV Investigators
AU - LeCouffe, Natalie E
AU - Kappelhof, Manon
AU - Treurniet, Kilian M
AU - Rinkel, Leon A
AU - Bruggeman, Agnetha E
AU - Berkhemer, Olvert A
AU - Wolff, Lennard
AU - van Voorst, Henk
AU - Tolhuisen, Manon L
AU - Dippel, Diederik W J
AU - van der Lugt, Aad
AU - van Es, Adriaan C G M
AU - Boiten, Jelis
AU - Lycklama À Nijeholt, Geert J
AU - Keizer, Koos
AU - Gons, Rob A R
AU - Yo, Lonneke S F
AU - van Oostenbrugge, Robert J
AU - van Zwam, Wim H
AU - Roozenbeek, Bob
AU - van der Worp, H Bart
AU - Lo, Rob T H
AU - van den Wijngaard, Ido R
AU - de Ridder, Inger R
AU - Costalat, Vincent
AU - Arquizan, Caroline
AU - Lemmens, Robin
AU - Demeestere, Jelle
AU - Hofmeijer, Jeannette
AU - Martens, Jasper M
AU - Schonewille, Wouter J
AU - Vos, Jan-Albert
AU - Uyttenboogaart, Maarten
AU - Bokkers, Reinoud P H
AU - van Tuijl, Julia H
AU - Kortman, Hans
AU - Schreuder, Floris H B M
AU - Boogaarts, Hieronymus D
AU - de Laat, Karlijn F
AU - van Dijk, Lukas C
AU - den Hertog, Heleen M
AU - van Hasselt, Boudewijn A A M
AU - Brouwers, Paul J A M
AU - Bulut, Tomas
AU - Remmers, Michel J M
AU - van Norden, Anouk
AU - Imani, Farshad
AU - Rozeman, Anouk D
AU - Elgersma, Otto E H
AU - Desfontaines, Philippe
AU - Brisbois, Denis
AU - Samson, Yves
AU - Clarençon, Frédéric
AU - Krietemeijer, Menno
AU - Postma, Alida A.
AU - van Doormaal, Pieter-Jan
AU - van den Berg, René
AU - van der Hoorn, Anouk
AU - Beenen, Ludo F.M.
AU - Nieboer, Daan
AU - Lingsma, Hester F.
AU - Emmer, Bart J.
AU - Coutinho, Jonathan M.
AU - Majoie, Charles B.L.M.
AU - Roos, Yvo B.W.E.M.
N1 - Copyright © 2021 Massachusetts Medical Society.
PY - 2021/11/11
Y1 - 2021/11/11
N2 - BACKGROUND: The value of administering intravenous alteplase before endovascular treatment (EVT) for acute ischemic stroke has not been studied extensively, particularly in non-Asian populations.METHODS: We performed an open-label, multicenter, randomized trial in Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT and who were eligible for intravenous alteplase and EVT. Patients were randomly assigned in a 1:1 ratio to receive EVT alone or intravenous alteplase followed by EVT (the standard of care). The primary end point was functional outcome on the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 90 days. We assessed the superiority of EVT alone over alteplase plus EVT, as well as noninferiority by a margin of 0.8 for the lower boundary of the 95% confidence interval for the odds ratio of the two trial groups. Death from any cause and symptomatic intracerebral hemorrhage were the main safety end points.RESULTS: The analysis included 539 patients. The median score on the modified Rankin scale at 90 days was 3 (interquartile range, 2 to 5) with EVT alone and 2 (interquartile range, 2 to 5) with alteplase plus EVT. The adjusted common odds ratio was 0.84 (95% confidence interval [CI], 0.62 to 1.15; P = 0.28), which showed neither superiority nor noninferiority of EVT alone. Mortality was 20.5% with EVT alone and 15.8% with alteplase plus EVT (adjusted odds ratio, 1.39; 95% CI, 0.84 to 2.30). Symptomatic intracerebral hemorrhage occurred in 5.9% and 5.3% of the patients in the respective groups (adjusted odds ratio, 1.30; 95% CI, 0.60 to 2.81).CONCLUSIONS: In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke. The incidence of symptomatic intracerebral hemorrhage was similar in the two groups. (Funded by the Collaboration for New Treatments of Acute Stroke consortium and others; MR CLEAN-NO IV ISRCTN number, ISRCTN80619088.).
AB - BACKGROUND: The value of administering intravenous alteplase before endovascular treatment (EVT) for acute ischemic stroke has not been studied extensively, particularly in non-Asian populations.METHODS: We performed an open-label, multicenter, randomized trial in Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT and who were eligible for intravenous alteplase and EVT. Patients were randomly assigned in a 1:1 ratio to receive EVT alone or intravenous alteplase followed by EVT (the standard of care). The primary end point was functional outcome on the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 90 days. We assessed the superiority of EVT alone over alteplase plus EVT, as well as noninferiority by a margin of 0.8 for the lower boundary of the 95% confidence interval for the odds ratio of the two trial groups. Death from any cause and symptomatic intracerebral hemorrhage were the main safety end points.RESULTS: The analysis included 539 patients. The median score on the modified Rankin scale at 90 days was 3 (interquartile range, 2 to 5) with EVT alone and 2 (interquartile range, 2 to 5) with alteplase plus EVT. The adjusted common odds ratio was 0.84 (95% confidence interval [CI], 0.62 to 1.15; P = 0.28), which showed neither superiority nor noninferiority of EVT alone. Mortality was 20.5% with EVT alone and 15.8% with alteplase plus EVT (adjusted odds ratio, 1.39; 95% CI, 0.84 to 2.30). Symptomatic intracerebral hemorrhage occurred in 5.9% and 5.3% of the patients in the respective groups (adjusted odds ratio, 1.30; 95% CI, 0.60 to 2.81).CONCLUSIONS: In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke. The incidence of symptomatic intracerebral hemorrhage was similar in the two groups. (Funded by the Collaboration for New Treatments of Acute Stroke consortium and others; MR CLEAN-NO IV ISRCTN number, ISRCTN80619088.).
KW - ACUTE ISCHEMIC-STROKE
KW - MECHANICAL THROMBECTOMY
KW - THROMBOLYSIS
KW - GUIDELINES
KW - THERAPY
KW - CARE
U2 - 10.1056/NEJMoa2107727
DO - 10.1056/NEJMoa2107727
M3 - Article
C2 - 34758251
VL - 385
SP - 1833
EP - 1844
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 20
ER -