Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke

被引：1358

作者：

Broderick, Joseph P. ^{[1
,2
]}

Palesch, Yuko Y. ^{[3
]}

Demchuk, Andrew M. ^{[5
,6
]}

Yeatts, Sharon D. ^{[3
]}

Khatri, Pooja ^{[1
,2
]}

Hill, Michael D. ^{[5
,6
]}

Jauch, Edward C. ^{[4
]}

Jovin, Tudor G. ^{[7
]}

Yan, Bernard ^{[8
]}

Silver, Frank L. ^{[9
,10
]}

von Kummer, Ruediger ^{[11
]}

Molina, Carlos A. ^{[12
]}

Demaerschalk, Bart M. ^{[13
]}

Budzik, Ronald ^{[14
]}

Clark, Wayne M. ^{[15
]}

Zaidat, Osama O. ^{[16
]}

Malisch, Tim W. ^{[17
]}

Goyal, Mayank ^{[5
,6
]}

Schonewille, Wouter J. ^{[18
,19
]}

Mazighi, Mikael ^{[20
,21
]}

Engelter, Stefan T. ^{[22
]}

Anderson, Craig ^{[23
]}

Spilker, Judith ^{[1
,2
]}

Carrozzella, Janice ^{[1
,2
]}

Ryckborst, Karla J. ^{[5
,6
]}

Janis, L. Scott ^{[24
]}

Martin, Renee H.

Foster, Lydia D. ^{[3
]}

Tomsick, Thomas A. ^{[1
,2
]}

机构：

[1] Univ Cincinnati, Acad Hlth Ctr, Inst Neurosci, Dept Neurol, Cincinnati, OH 45267 USA

[2] Univ Cincinnati, Acad Hlth Ctr, Inst Neurosci, Dept Rehabil Med & Radiol, Cincinnati, OH 45267 USA

[3] Med Univ S Carolina, Dept Publ Hlth Sci, Charleston, SC USA

[4] Med Univ S Carolina, Div Emergency Med, Charleston, SC USA

[5] Univ Calgary, Hotchkiss Brain Inst, Seaman Family Magnet Resonance Res Ctr, Dept Clin Neurosci, Calgary, AB, Canada

[6] Univ Calgary, Hotchkiss Brain Inst, Seaman Family Magnet Resonance Res Ctr, Dept Radiol, Calgary, AB, Canada

[7] Univ Pittsburgh, Med Ctr, Stroke Inst, Pittsburgh, PA USA

[8] Univ Melbourne, Royal Melbourne Hosp, Melbourne Brain Ctr, Melbourne, Vic 3050, Australia

[9] Univ Toronto, Dept Med, Div Neurol, Toronto, ON, Canada

[10] Univ Hlth Network, Toronto, ON, Canada

[11] Dresden Univ, Stroke Ctr, Univ Hosp, Dept Neuroradiol, Dresden, Germany

[12] Hosp Univ Vall dHebron, Dept Neurol, Neurovasc Unit, Barcelona, Spain

[13] Mayo Clin, Dept Neurol, Phoenix, AZ USA

[14] Riverside Methodist Hosp, OhioHlth Neurosci Inst, Columbus, OH 43214 USA

[15] Oregon Hlth & Sci Univ, Oregon Stroke Ctr, Portland, OR 97201 USA

[16] Med Coll Wisconsin, Dept Radiol, Milwaukee, WI 53226 USA

[17] Alexian Bros Med Ctr, Elk Grove Village, IL USA

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

[19] St Antonius Hosp, Nieuwegein, Netherlands

[20] Hop Xavier Bichat, Dept Neurol, Paris, France

[21] Hop Xavier Bichat, Stroke Ctr, Paris, France

[22] Univ Basel Hosp, Dept Neurol, CH-4031 Basel, Switzerland

[23] Univ Sydney, Royal Prince Alfred Hosp, George Inst Global Hlth, Sydney, NSW 2006, Australia

[24] NINDS, NIH, Bethesda, MD 20892 USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2013年 / 368卷 / 10期

基金：

美国国家卫生研究院;

关键词：

ACUTE ISCHEMIC-STROKE; PERCUTANEOUS CORONARY INTERVENTION; TISSUE-PLASMINOGEN ACTIVATOR; MYOCARDIAL-INFARCTION; CLINICAL-TRIALS; POOLED ANALYSIS; MERCI TRIAL; III TRIAL; MANAGEMENT; TIME;

D O I：

10.1056/NEJMoa1214300

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND Endovascular therapy is increasingly used after the administration of intravenous tissue plasminogen activator (t-PA) for patients with moderate-to-severe acute ischemic stroke, but whether a combined approach is more effective than intravenous t-PA alone is uncertain. METHODS We randomly assigned eligible patients who had received intravenous t-PA within 3 hours after symptom onset to receive additional endovascular therapy or intravenous t-PA alone, in a 2: 1 ratio. The primary outcome measure was a modified Rankin scale score of 2 or less (indicating functional independence) at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). RESULTS The study was stopped early because of futility after 656 participants had undergone randomization (434 patients to endovascular therapy and 222 to intravenous t-PA alone). The proportion of participants with a modified Rankin score of 2 or less at 90 days did not differ significantly according to treatment (40.8% with endovascular therapy and 38.7% with intravenous t-PA; absolute adjusted difference, 1.5 percentage points; 95% confidence interval [CI], -6.1 to 9.1, with adjustment for the National Institutes of Health Stroke Scale [NIHSS] score [8-19, indicating moderately severe stroke, or >= 20, indicating severe stroke]), nor were there significant differences for the predefined subgroups of patients with an NIHSS score of 20 or higher (6.8 percentage points; 95% CI, -4.4 to 18.1) and those with a score of 19 or lower (-1.0 percentage point; 95% CI, -10.8 to 8.8). Findings in the endovascular-therapy and intravenous t-PA groups were similar for mortality at 90 days (19.1% and 21.6%, respectively; P = 0.52) and the proportion of patients with symptomatic intracerebral hemorrhage within 30 hours after initiation of t-PA (6.2% and 5.9%, respectively; P = 0.83). CONCLUSIONS The trial showed similar safety outcomes and no significant difference in functional independence with endovascular therapy after intravenous t-PA, as compared with intravenous t-PA alone. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00359424.)

引用

页码：893 / 903

页数：11