Fransen, Puck S. S., Berkhemer, Olvert A., Lingsma, Hester F., Beumer, Debbie, van den Berg, Lucie A., Yoo, Albert J., Schonewille, Wouter J., Vos, Jan Albert, Nederkoorn, Paul J., Wermer, Marieke J. H., van Walderveen, Marianne A. A., Staals, Julie, Hofmeijer, Jeannette, van Oostayen, Jacques A., Nijeholt, Geert J. Lycklama a, Boiten, Jelis, Brouwer, Patrick A. ORCID: 0000-0003-0041-2833, Emmer, Bart J., de Bruijn, Sebastiaan F., van Dijk, Lukas C., Kappelle, L. Jaap, Lo, Rob H., van Dijk, Ewoud J., de Vries, Joost, de Kort, Paul L. M., van den Berg, J. S. Peter, van Hasselt, Boudewijn A. A. M., Aerden, Leo A. M., Dallinga, Rene J., Visser, Marieke C., Bot, Joseph C. J., Vroomen, Patrick C., Eshghi, Omid, Schreuder, Tobien H. C. M. L., Heijboer, Roel J. J., Keizer, Koos, Tielbeek, Alexander V., den Hertog, Heleen M., Gerrits, Dick G., van den Berg-Vos, Renske M., Karas, Giorgos B., Steyerberg, Ewout W., Flach, H. Zwenneke, Marquering, Henk A., Sprengers, Marieke E. S., Jenniskens, Sjoerd F. M., Beenen, Ludo F. M., van den Berg, Rene, Koudstaal, Peter J., van Zwam, Wim H., Roos, Yvo B. W. E. M., van Oostenbrugge, Robert J., Majoie, Charles B. L. M., van der Lugt, Aad and Dippel, Diederik W. J. (2016). Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke A Randomized Clinical Trial. JAMA Neurol., 73 (2). S. 190 - 197. CHICAGO: AMER MEDICAL ASSOC. ISSN 2168-6157

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Abstract

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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Fransen, Puck S. S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berkhemer, Olvert A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lingsma, Hester F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beumer, DebbieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van den Berg, Lucie A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Yoo, Albert J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schonewille, Wouter J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vos, Jan AlbertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nederkoorn, Paul J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wermer, Marieke J. H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Walderveen, Marianne A. A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Staals, JulieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hofmeijer, JeannetteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Oostayen, Jacques A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nijeholt, Geert J. Lycklama aUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boiten, JelisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brouwer, Patrick A.UNSPECIFIEDorcid.org/0000-0003-0041-2833UNSPECIFIED
Emmer, Bart J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Bruijn, Sebastiaan F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Dijk, Lukas C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kappelle, L. JaapUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lo, Rob H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Dijk, Ewoud J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Vries, JoostUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Kort, Paul L. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van den Berg, J. S. PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Hasselt, Boudewijn A. A. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aerden, Leo A. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dallinga, Rene J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Visser, Marieke C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bot, Joseph C. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vroomen, Patrick C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eshghi, OmidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schreuder, Tobien H. C. M. L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heijboer, Roel J. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Keizer, KoosUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tielbeek, Alexander V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
den Hertog, Heleen M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gerrits, Dick G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van den Berg-Vos, Renske M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Karas, Giorgos B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Steyerberg, Ewout W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Flach, H. ZwennekeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Marquering, Henk A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sprengers, Marieke E. S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jenniskens, Sjoerd F. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beenen, Ludo F. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van den Berg, ReneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koudstaal, Peter J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Zwam, Wim H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roos, Yvo B. W. E. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Oostenbrugge, Robert J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Majoie, Charles B. L. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van der Lugt, AadUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dippel, Diederik W. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-286350
DOI: 10.1001/jamaneurol.2015.3886
Journal or Publication Title: JAMA Neurol.
Volume: 73
Number: 2
Page Range: S. 190 - 197
Date: 2016
Publisher: AMER MEDICAL ASSOC
Place of Publication: CHICAGO
ISSN: 2168-6157
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
INTRAVENOUS T-PA; ENDOVASCULAR TREATMENT; ANGIOGRAPHIC REPERFUSION; THROMBECTOMY; THERAPY; INTERVENTION; COMPLEXITY; OUTCOMESMultiple languages
Clinical NeurologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/28635

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