A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke

被引：5016

作者：

Berkhemer, O. A. ^{[1
,8
]}

Fransen, P. S. S. ^{[8
,9
]}

Beumer, D. ^{[8
,11
,12
]}

van den Berg, L. A. ^{[2
]}

Lingsma, H. F. ^{[10
]}

Yoo, A. J. ^{[44
]}

Schonewille, W. J. ^{[14
]}

Vos, J. A. ^{[15
]}

Nederkoorn, P. J. ^{[2
]}

Wermer, M. J. H. ^{[16
]}

van Walderveen, M. A. A. ^{[17
]}

Staals, J. ^{[11
,12
]}

Hofmeijer, J. ^{[18
]}

van Oostayen, J. A. ^{[19
]}

Nijeholt, G. J. Lycklama A. ^{[20
]}

Boiten, J. ^{[21
]}

Brouwer, P. A. ^{[9
]}

Emmer, B. J. ^{[9
]}

de Bruijn, S. F. ^{[22
]}

van Dijk, L. C. ^{[23
]}

Kappelle, L. J. ^{[24
,25
]}

Lo, R. H. ^{[26
]}

Van Dijk, E. J. ^{[27
]}

de Vries, J. ^{[28
]}

de Kort, P. L. M. ^{[30
]}

van Rooij, W. J. J. ^{[31
]}

van den Berg, J. S. P. ^{[32
]}

van Hasselt, B. A. A. M. ^{[33
]}

Aerden, L. A. M. ^{[34
]}

Dallinga, R. J. ^{[35
]}

Visser, M. C. ^{[4
]}

Bot, J. C. J. ^{[5
]}

Vroomen, P. C. ^{[36
]}

Eshghi, O. ^{[37
]}

Schreuder, T. H. C. M. L. ^{[38
]}

Heijboer, R. J. J. ^{[39
]}

Keizer, K. ^{[40
]}

Tielbeek, A. V. ^{[41
]}

den Hertog, H. M. ^{[42
]}

Gerrits, D. G. ^{[43
]}

van den Berg-Vos, R. M. ^{[6
]}

Karas, G. B. ^{[7
]}

Steyerberg, E. W. ^{[10
]}

Flach, H. Z. ^{[33
]}

Marquering, H. A. ^{[1
,3
]}

Sprengers, M. E. S. ^{[1
]}

Jenniskens, S. F. M. ^{[29
]}

Beenen, L. F. M. ^{[1
]}

van den Berg, R. ^{[1
]}

Koudstaal, P. J. ^{[8
]}

机构：

[1] Univ Amsterdam, Acad Med Ctr, Dept Radiol, NL-1105 AZ Amsterdam, Netherlands

[2] Univ Amsterdam, Acad Med Ctr, Dept Neurol, NL-1105 AZ Amsterdam, Netherlands

[3] Univ Amsterdam, Acad Med Ctr, Dept Biomed Engn & Phys, NL-1105 AZ Amsterdam, Netherlands

[4] Vrije Univ Amsterdam Med Ctr, Dept Neurol, Amsterdam, Netherlands

[5] Vrije Univ Amsterdam Med Ctr, Dept Radiol, Amsterdam, Netherlands

[6] Sint Lucas Andreas Hosp, Dept Neurol, Amsterdam, Netherlands

[7] Sint Lucas Andreas Hosp, Dept Radiol, Amsterdam, Netherlands

[8] Erasmus Univ, Med Ctr, Dept Neurol, Rotterdam, Netherlands

[9] Erasmus Univ, Med Ctr, Dept Radiol, Rotterdam, Netherlands

[10] Erasmus Univ, Med Ctr, Dept Publ Hlth, Rotterdam, Netherlands

[11] Maastricht Univ, Med Ctr, Dept Neurol, Maastricht, Netherlands

[12] Cardiovasc Res Inst Maastricht, Maastricht, Netherlands

[13] Maastricht Univ, Med Ctr, Dept Radiol, Maastricht, Netherlands

[14] St Antonius Hosp, Dept Neurol, Nieuwegein, Netherlands

[15] St Antonius Hosp, Dept Radiol, Nieuwegein, Netherlands

[16] Leiden Univ, Med Ctr, Dept Neurol, Leiden, Netherlands

[17] Leiden Univ, Med Ctr, Dept Radiol, Leiden, Netherlands

[18] Rijnstate Hosp, Dept Neurol, Arnhem, Netherlands

[19] Rijnstate Hosp, Dept Radiol, Arnhem, Netherlands

[20] MC Haaglanden, Dept Radiol, The Hague, Netherlands

[21] MC Haaglanden, Dept Neurol, The Hague, Netherlands

[22] HAGA Hosp, Dept Neurol, The Hague, Netherlands

[23] HAGA Hosp, Dept Radiol, The Hague, Netherlands

[24] Univ Med Ctr Utrecht, Dept Neurol, Utrecht, Netherlands

[25] Univ Med Ctr Utrecht, Dept Neurol, Utrecht, Netherlands

[26] Univ Med Ctr Utrecht, Dept Radiol, Utrecht, Netherlands

[27] Radboud Univ Nijmegen, Med Ctr, Dept Neurol, NL-6525 ED Nijmegen, Netherlands

[28] Radboud Univ Nijmegen, Med Ctr, Dept Neurosurg, NL-6525 ED Nijmegen, Netherlands

[29] Radboud Univ Nijmegen, Med Ctr, Dept Radiol, NL-6525 ED Nijmegen, Netherlands

[30] Sint Elisabeth Hosp, Dept Neurol, Tilburg, Netherlands

[31] Sint Elisabeth Hosp, Dept Radiol, Tilburg, Netherlands

[32] Isala Klin, Dept Neurol, Zwolle, Netherlands

[33] Isala Klin, Dept Radiol, Zwolle, Netherlands

[34] Reinier Graaf Gasthuis, Dept Neurol, Delft, Netherlands

[35] Reinier Graaf Gasthuis, Dept Radiol, Delft, Netherlands

[36] Univ Groningen, Univ Med Ctr Groningen, Dept Neurol, NL-9713 AV Groningen, Netherlands

[37] Univ Groningen, Univ Med Ctr Groningen, Dept Radiol, NL-9713 AV Groningen, Netherlands

[38] Atrium Med Ctr, Dept Neurol, Heerlen, Netherlands

[39] Atrium Med Ctr, Dept Radiol, Heerlen, Netherlands

[40] Catharina Hosp, Dept Neurol, Eindhoven, Netherlands

[41] Catharina Hosp, Dept Radiol, Eindhoven, Netherlands

[42] Med Spectrum Twente, Dept Neurol, Enschede, Netherlands

[43] Med Spectrum Twente, Dept Radiol, Enschede, Netherlands

[44] Massachusetts Gen Hosp, Dept Radiol, Boston, MA 02114 USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2015年 / 372卷 / 01期

关键词：

ENDOVASCULAR TREATMENT; CEREBRAL INFARCT; RECANALIZATION; OCCLUSIONS; THERAPY; SCORE;

D O I：

10.1056/NEJMoa1411587

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking. METHODS We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis). RESULTS We enrolled 500 patients at 16 medical centers in the Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention (32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage. CONCLUSIONS In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe. (Funded by the Dutch Heart Foundation and others; MR CLEAN Netherlands Trial Registry number, NTR1804, and Current Controlled Trials number, ISRCTN10888758.)

引用

页码：11 / 20

页数：10

共 29 条

[1]

[Anonymous], 2014, LANCET

[2] Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy [J].

Barber, PA ;

Demchuk, AM ;

Zhang, JJ ;

Buchan, AM .

LANCET, 2000, 355 (9216) :1670-1674

[3]

Beumer D, 2013, CEREBROVASC DIS, V35, P66

[4] Automated Cerebral Infarct Volume Measurement in Follow-up Noncontrast CT Scans of Patients with Acute Ischemic Stroke [J].

Boers, A. M. ;

Marquering, H. A. ;

Jochem, J. J. ;

Besselink, N. J. ;

Berkhemer, O. A. ;

van der Lugt, A. ;

Beenen, L. F. ;

Majoie, C. B. .

AMERICAN JOURNAL OF NEURORADIOLOGY, 2013, 34 (08) :1522-1527

[5] Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke [J].

Broderick, Joseph P. ;

Palesch, Yuko Y. ;

Demchuk, Andrew M. ;

Yeatts, Sharon D. ;

Khatri, Pooja ;

Hill, Michael D. ;

Jauch, Edward C. ;

Jovin, Tudor G. ;

Yan, Bernard ;

Silver, Frank L. ;

von Kummer, Ruediger ;

Molina, Carlos A. ;

Demaerschalk, Bart M. ;

Budzik, Ronald ;

Clark, Wayne M. ;

Zaidat, Osama O. ;

Malisch, Tim W. ;

Goyal, Mayank ;

Schonewille, Wouter J. ;

Mazighi, Mikael ;

Engelter, Stefan T. ;

Anderson, Craig ;

Spilker, Judith ;

Carrozzella, Janice ;

Ryckborst, Karla J. ;

Janis, L. Scott ;

Martin, Renee H. ;

Foster, Lydia D. ;

Tomsick, Thomas A. .

NEW ENGLAND JOURNAL OF MEDICINE, 2013, 368 (10) :893-903

[6]

Christou I, 2001, INT ANGIOL, V20, P208

[7]

Ciccone A, 2013, NEW ENGL J MED, V368, P904, DOI [10.1056/NEJMoa1213701, 10.1056/NEJMc1304759]

[8] Endovascular Treatment of Acute Intracerebral Artery Occlusions with the Solitaire Stent: Single-Centre Experience with 108 Recanalization Procedures [J].

Dorn, F. ;

Stehle, S. ;

Lockau, H. ;

Zimmer, C. ;

Liebig, T. .

CEREBROVASCULAR DISEASES, 2012, 34 (01) :70-77

[9] Hemorrhagic transformation within 36 hours of a cerebral infarct - Relationships with early clinical deterioration and 3-month outcome in the European Cooperative Acute Stroke Study I (ECASS I) cohort [J].

Fiorelli, M ;

Bastianello, S ;

von Kummer, R ;

del Zoppo, GJ ;

Larrue, V ;

Lesaffre, E ;

Ringleb, AP ;

Lorenzano, S ;

Manelfe, C ;

Bozzao, L .

STROKE, 1999, 30 (11) :2280-2284

[10] MR CLEAN, a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands: study protocol for a randomized controlled trial [J].

Fransen, Puck S. S. ;

Beumer, Debbie ;

Berkhemer, Olvert A. ;

van den Berg, Lucie A. ;

Lingsma, Hester ;

van der Lugt, Aad ;

van Zwam, Wim H. ;

van Oostenbrugge, Robert J. ;

Roos, Yvo B. W. E. M. ;

Majoie, Charles B. ;

Dippel, Diederik W. J. .

TRIALS, 2014, 15

← 1 2 3 →