Two-Year Outcome after Endovascular Treatment for Acute Ischemic Stroke
BACKGROUND: Several trials involving patients with acute ischemic stroke have shown better functional outcomes with endovascular treatment than with conventional treatment at 90 days after initiation of treatment. However, results on long-term clinical outcomes are lacking.
METHODS: We assessed clinical outcomes 2 years after patients were randomly assigned to receive either endovascular treatment (intervention group) or conventional treatment (control group) for acute ischemic stroke. The primary outcome was the score on the modified Rankin scale at 2 years; this scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). Secondary outcomes included all-cause mortality and the quality of life at 2 years, as measured by means of a health utility index that is based on the European Quality of Life-5 Dimensions questionnaire (scores range from -0.329 to 1, with higher scores indicating better health).
RESULTS: Of the 500 patients who underwent randomization in the original trial, 2-year data for this extended follow-up trial were available for 391 patients (78.2%) and information on death was available for 459 patients (91.8%). The distribution of outcomes on the modified Rankin scale favored endovascular treatment over conventional treatment (adjusted common odds ratio, 1.68; 95% confidence interval [CI], 1.15 to 2.45; P=0.007). There was no significant difference between the treatment groups in the percentage of patients who had an excellent outcome (i.e., a modified Rankin scale score of 0 or 1). The mean quality-of-life score was 0.48 among patients randomly assigned to endovascular treatment as compared with 0.38 among patients randomly assigned to conventional treatment (mean difference, 0.10; 95% CI, 0.03 to 0.16; P=0.006). The cumulative 2-year mortality rate was 26.0% in the intervention group and 31.0% in the control group (adjusted hazard ratio, 0.9; 95% CI, 0.6 to 1.2; P=0.46).
CONCLUSIONS: In this extended follow-up trial, the beneficial effect of endovascular treatment on functional outcome at 2 years in patients with acute ischemic stroke was similar to that reported at 90 days in the original trial. (Funded by the Netherlands Organization for Health Research and Development and others; MR CLEAN Current Controlled Trials number, ISRCTN10888758 , and Netherlands Trial Register number, NTR1804 , and MR CLEAN extended follow-up trial Netherlands Trial Register number, NTR5073 .).
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Medienart: |
E-Artikel |
Erscheinungsjahr: |
2017 |
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Erschienen: |
2017 |
Enthalten in: |
Zur Gesamtaufnahme - volume:376 |
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Enthalten in: |
The New England journal of medicine - 376(2017), 14 vom: 06. Apr., Seite 1341-1349 |
Sprache: |
Englisch |
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Beteiligte Personen: |
van den Berg, Lucie A [VerfasserIn] |
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Links: |
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Themen: |
Journal Article |
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Anmerkungen: |
Date Completed 27.04.2017 Date Revised 11.03.2022 published: Print NTR: NTR1804, NTR5073 ISRCTN: ISRCTN10888758 CommentIn: N Engl J Med. ;376(26):2597. - PMID 28691785 Citation Status MEDLINE |
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doi: |
10.1056/NEJMoa1612136 |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
NLM270676724 |
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500 | |a published: Print | ||
500 | |a NTR: NTR1804, NTR5073 | ||
500 | |a ISRCTN: ISRCTN10888758 | ||
500 | |a CommentIn: N Engl J Med. ;376(26):2597. - PMID 28691785 | ||
500 | |a Citation Status MEDLINE | ||
520 | |a BACKGROUND: Several trials involving patients with acute ischemic stroke have shown better functional outcomes with endovascular treatment than with conventional treatment at 90 days after initiation of treatment. However, results on long-term clinical outcomes are lacking | ||
520 | |a METHODS: We assessed clinical outcomes 2 years after patients were randomly assigned to receive either endovascular treatment (intervention group) or conventional treatment (control group) for acute ischemic stroke. The primary outcome was the score on the modified Rankin scale at 2 years; this scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). Secondary outcomes included all-cause mortality and the quality of life at 2 years, as measured by means of a health utility index that is based on the European Quality of Life-5 Dimensions questionnaire (scores range from -0.329 to 1, with higher scores indicating better health) | ||
520 | |a RESULTS: Of the 500 patients who underwent randomization in the original trial, 2-year data for this extended follow-up trial were available for 391 patients (78.2%) and information on death was available for 459 patients (91.8%). The distribution of outcomes on the modified Rankin scale favored endovascular treatment over conventional treatment (adjusted common odds ratio, 1.68; 95% confidence interval [CI], 1.15 to 2.45; P=0.007). There was no significant difference between the treatment groups in the percentage of patients who had an excellent outcome (i.e., a modified Rankin scale score of 0 or 1). The mean quality-of-life score was 0.48 among patients randomly assigned to endovascular treatment as compared with 0.38 among patients randomly assigned to conventional treatment (mean difference, 0.10; 95% CI, 0.03 to 0.16; P=0.006). The cumulative 2-year mortality rate was 26.0% in the intervention group and 31.0% in the control group (adjusted hazard ratio, 0.9; 95% CI, 0.6 to 1.2; P=0.46) | ||
520 | |a CONCLUSIONS: In this extended follow-up trial, the beneficial effect of endovascular treatment on functional outcome at 2 years in patients with acute ischemic stroke was similar to that reported at 90 days in the original trial. (Funded by the Netherlands Organization for Health Research and Development and others; MR CLEAN Current Controlled Trials number, ISRCTN10888758 , and Netherlands Trial Register number, NTR1804 , and MR CLEAN extended follow-up trial Netherlands Trial Register number, NTR5073 .) | ||
650 | 4 | |a Journal Article | |
650 | 4 | |a Multicenter Study | |
650 | 4 | |a Randomized Controlled Trial | |
650 | 4 | |a Research Support, Non-U.S. Gov't | |
700 | 1 | |a Dijkgraaf, Marcel G W |e verfasserin |4 aut | |
700 | 1 | |a Berkhemer, Olvert A |e verfasserin |4 aut | |
700 | 1 | |a Fransen, Puck S S |e verfasserin |4 aut | |
700 | 1 | |a Beumer, Debbie |e verfasserin |4 aut | |
700 | 1 | |a Lingsma, Hester F |e verfasserin |4 aut | |
700 | 1 | |a Majoie, Charles B L M |e verfasserin |4 aut | |
700 | 1 | |a Dippel, Diederik W J |e verfasserin |4 aut | |
700 | 1 | |a van der Lugt, Aad |e verfasserin |4 aut | |
700 | 1 | |a van Oostenbrugge, Robert J |e verfasserin |4 aut | |
700 | 1 | |a van Zwam, Wim H |e verfasserin |4 aut | |
700 | 1 | |a Roos, Yvo B W E M |e verfasserin |4 aut | |
700 | 0 | |a MR CLEAN Investigators |e verfasserin |4 aut | |
700 | 1 | |a Yoo, Albert J |e investigator |4 oth | |
700 | 1 | |a Schonewille, Wouter J |e investigator |4 oth | |
700 | 1 | |a Vos, Jan Albert |e investigator |4 oth | |
700 | 1 | |a Nederkoorn, Paul J |e investigator |4 oth | |
700 | 1 | |a Wermer, Marieke J H |e investigator |4 oth | |
700 | 1 | |a van Walderveen, Marianne A A |e investigator |4 oth | |
700 | 1 | |a Staals, Julie |e investigator |4 oth | |
700 | 1 | |a Hofmeijer, Jeannette |e investigator |4 oth | |
700 | 1 | |a van Oostayen, Jacques A |e investigator |4 oth | |
700 | 1 | |a Lycklama à Nijeholt, Geert J |e investigator |4 oth | |
700 | 1 | |a Boiten, Jelis |e investigator |4 oth | |
700 | 1 | |a Brouwer, Patrick A |e investigator |4 oth | |
700 | 1 | |a Emmer, Bart J |e investigator |4 oth | |
700 | 1 | |a de Bruijn, Sebastiaan F |e investigator |4 oth | |
700 | 1 | |a van Dijk, Lukas C |e investigator |4 oth | |
700 | 1 | |a Kappelle, L Jaap |e investigator |4 oth | |
700 | 1 | |a Lo, Rob H |e investigator |4 oth | |
700 | 1 | |a van Dijk, Ewoud J |e investigator |4 oth | |
700 | 1 | |a de Vries, Joost |e investigator |4 oth | |
700 | 1 | |a de Kort, Paul L M |e investigator |4 oth | |
700 | 1 | |a van den Berg, Jan S P |e investigator |4 oth | |
700 | 1 | |a van Hasselt, Boudewijn A A M |e investigator |4 oth | |
700 | 1 | |a Aerden, Leo A M |e investigator |4 oth | |
700 | 1 | |a Dallinga, René J |e investigator |4 oth | |
700 | 1 | |a Visser, Marieke C |e investigator |4 oth | |
700 | 1 | |a Bot, Joseph C J |e investigator |4 oth | |
700 | 1 | |a Vroomen, Patrick C |e investigator |4 oth | |
700 | 1 | |a Eshghi, Omid |e investigator |4 oth | |
700 | 1 | |a Schreuder, Tobien H C M L |e investigator |4 oth | |
700 | 1 | |a Heijboer, Roel J J |e investigator |4 oth | |
700 | 1 | |a Keizer, Koos |e investigator |4 oth | |
700 | 1 | |a Tielbeek, Alexander V |e investigator |4 oth | |
700 | 1 | |a den Hertog, Heleen M |e investigator |4 oth | |
700 | 1 | |a Gerrits, Dick G |e investigator |4 oth | |
700 | 1 | |a van den Berg-Vos, Renske M |e investigator |4 oth | |
700 | 1 | |a Karas, Giorgos B |e investigator |4 oth | |
700 | 1 | |a Steyerberg, Ewout W |e investigator |4 oth | |
700 | 1 | |a Flach, H Zwenneke |e investigator |4 oth | |
700 | 1 | |a Marquering, Henk A |e investigator |4 oth | |
700 | 1 | |a Sprengers, Marieke E S |e investigator |4 oth | |
700 | 1 | |a Jenniskens, Sjoerd F M |e investigator |4 oth | |
700 | 1 | |a Beenen, Ludo F M |e investigator |4 oth | |
700 | 1 | |a van den Berg, René |e investigator |4 oth | |
700 | 1 | |a Koudstaal, Peter J |e investigator |4 oth | |
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