Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke A Randomized Clinical Trial

Autor: Fransen, P.S.S., Berkhemer, O.A., Lingsma, H.F., Beumer, D., Berg, L.A. van den, Yoo, A.J., Schonewille, W.J., Vos, J.A., Nederkoorn, P.J., Wermer, M.J.H., Walderveen, M.A.A. van, Staals, J., Hofmeijer, J., Oostayen, J.A. van, Nijeholt, G.J.L.A., Boiten, J., Brouwer, P.A., Emmer, B.J., Bruijn, S.F. de, Dijk, L.C. van, Kappelle, L.J., R.H. lo, Dijk, E.J. van, Vries, J. de, Kort, P.L.M. de, Berg, J.S.P. van den, Hasselt, B.A.A.M. van, Aerden, L.A.M., Dallinga, R.J., Visser, M.C., Bot, J.C.J., Vroomen, P.C., Eshghi, O., Schreuder, T.H.C.M.L., Heijboer, R.J.J., Keizer, K., Tielbeek, A.V., Hertog, H.M. den, Gerrits, D.G., Berg-Vos, R.M. van den, Karas, G.B., Steyerberg, E.W., Flach, H.Z., Marquering, H.A., Sprengers, M.E.S., Jenniskens, S.F.M., Beenen, L.F.M., Berg, R. van den, Koudstaal, P.J., Zwam, W.H. van, Roos, Y.B.W.E.M., Oostenbrugge, R.J. van, Majoie, C.B.L.M., Lugt, A. van der, Dippel, D.W.J., Multictr Randomized Clin Trial End
Přispěvatelé: Other departments, Radiology and Nuclear Medicine, ACS - Amsterdam Cardiovascular Sciences, ANS - Neurovascular Disorders, Graduate School, Neurology, Biomedical Engineering and Physics, Other Research, MUMC+: MA AIOS Neurologie (9), RS: CARIM - R3.03 - Cerebral small vessel disease, Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: CARIM - R3.11 - Imaging, Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Clinical Neurophysiology, Faculty of Science and Technology, Radiology and nuclear medicine, Amsterdam Neuroscience - Neurovascular Disorders, Radiology & Nuclear Medicine, Public Health
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Male
Time Factors
ANGIOGRAPHIC REPERFUSION
030204 cardiovascular system & hematology
THERAPY
law.invention
Brain Ischemia
0302 clinical medicine
Randomized controlled trial
Modified Rankin Scale
law
Interquartile range
Non-U.S. Gov't
610 Medicine & health
Stroke
OUTCOMES
Research Support
Non-U.S. Gov't

Endovascular Procedures
Atrial fibrillation
Middle Aged
THROMBECTOMY
Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3]
Multicenter Study
Treatment Outcome
Anesthesia
Tissue Plasminogen Activator
Randomized Controlled Trial
Female
IMAGING SELECTION
INTERVENTION
medicine.medical_specialty
Research Support
METIS-320854
03 medical and health sciences
Reperfusion therapy
Fibrinolytic Agents
SDG 3 - Good Health and Well-being
medicine
Journal Article
Humans
Aged
Intention-to-treat analysis
COMPLEXITY
business.industry
Other Research Radboud Institute for Health Sciences [Radboudumc 0]
medicine.disease
Surgery
INTRAVENOUS T-PA
IR-103531
ENDOVASCULAR TREATMENT
Reperfusion
Neurology (clinical)
business
030217 neurology & neurosurgery
Fibrinolytic agent
Zdroj: JAMA Neurology, 73(2), 190-196
Fransen, P S S, Berkhemer, O A, Lingsma, H F, Beumer, D, van den Berg, L A, Yoo, A J, Schonewille, W J, Vos, J A, Nederkoorn, P J, Wermer, M J H, van Walderveen, M A A, Staals, J, Hofmeijer, J, van Oostayen, J A, Nijeholt, G J L A, Boiten, J, Brouwer, P A, Emmer, B J, de Bruijn, S F, van Dijk, L C, Kappelle, L J, Lo, R H, van Dijk, E J, de Vries, J, de Kort, P L M, van den Berg, J S P, van Hasselt, B A A M, Aerden, L A M, Dallinga, R J, Visser, M C, Bot, J C J, Vroomen, P C, Eshghi, O, Schreuder, T H C M L, Heijboer, R J J, Keizer, K, Tielbeek, A V, den Hertog, H M, Gerrits, D G, van den Berg-Vos, R M, Karas, G B, Steyerberg, E W, Flach, H Z, Marquering, H A, Sprengers, M E S, Jenniskens, S F M, Beenen, L F M, van den Berg, R, Koudstaal, P J, van Zwam, W H, Roos, Y B W E M, van Oostenbrugge, R J, Majoie, C B L M, van der Lugt, A & Dippel, D W J 2016, ' Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke A Randomized Clinical Trial ', JAMA Neurology, vol. 73, no. 2, pp. 190-196 . https://doi.org/10.1001/jamaneurol.2015.3886
JAMA Neurology, 73(2), 190-196. American Medical Association
JAMA Neurology, 73(2), 190. American Medical Association
Jama Neurology, 73, 190-6
Jama Neurology, 73, 2, pp. 190-6
Jama neurology, 73(2), 190-196. AMER MEDICAL ASSOC
ISSN: 2168-6157
2168-6149
DOI: 10.1001/jamaneurol.2015.3886
Popis: Item does not contain fulltext IMPORTANCE: Intra-arterial treatment (IAT) for acute ischemic stroke caused by intracranial arterial occlusion leads to improved functional outcome in patients treated within 6 hours after onset. The influence of treatment delay on treatment effect is not yet known. OBJECTIVE: To evaluate the influence of time from stroke onset to the start of treatment and from stroke onset to reperfusion on the effect of IAT. DESIGN, SETTING, AND PARTICIPANTS: The Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands (MR CLEAN) was a multicenter, randomized clinical open-label trial of IAT vs no IAT in 500 patients. The time to the start of treatment was defined as the time from onset of symptoms to groin puncture (TOG). The time from onset of treatment to reperfusion (TOR) was defined as the time to reopening the vessel occlusion or the end of the procedure in cases for which reperfusion was not achieved. Data were collected from December 3, 2010, to June 3, 2014, and analyzed (intention to treat) from July 1, 2014, to September 19, 2015. MAIN OUTCOMES AND MEASURES: Main outcome was the modified Rankin Scale (mRS) score for functional outcome (range, 0 [no symptoms] to 6 [death]). Multiple ordinal logistic regression analysis estimated the effect of treatment and tested for the interaction of time to randomization, TOG, and TOR with treatment. The effect of treatment as a risk difference on reaching independence (mRS score, 0-2) was computed as a function of TOG and TOR. Calculations were adjusted for age, National Institutes of Health Stroke Scale score, previous stroke, atrial fibrillation, diabetes mellitus, and intracranial arterial terminus occlusion. RESULTS: Among 500 patients (58% male; median age, 67 years), the median TOG was 260 (interquartile range [IQR], 210-311) minutes; median TOR, 340 (IQR, 274-395) minutes. An interaction between TOR and treatment (P = .04) existed, but not between TOG and treatment (P = .26). The adjusted risk difference (95% CI) was 25.9% (8.3%-44.4%) when reperfusion was reached at 3 hours, 18.8% (6.6%-32.6%) at 4 hours, and 6.7% (0.4%-14.5%) at 6 hours. CONCLUSION AND RELEVANCE: For every hour of reperfusion delay, the initially large benefit of IAT decreases; the absolute risk difference for a good outcome is reduced by 6% per hour of delay. Patients with acute ischemic stroke require immediate diagnostic workup and IAT in case of intracranial arterial vessel occlusion. TRIAL REGISTRATION: trialregister.nl Identifier: NTR1804.
Databáze: OpenAIRE