-
Multicenter Study Clinical Trial
Tirofiban for Stroke without Large or Medium-Sized Vessel Occlusion.
- Wenjie Zi, Jiaxing Song, Weilin Kong, Jiacheng Huang, Changwei Guo, Wencheng He, Yinquan Yu, Bo Zhang, Wanjie Geng, Xiaolin Tan, Yaoyu Tian, Zongtao Liu, Minghua Cao, Daoyou Cheng, Bo Li, Wenguo Huang, Junsheng Liu, Pengfei Wang, Zhou Yu, Hao Liang, Shuang Yang, Mingshan Tang, Wenhua Liu, Xianjun Huang, Shugai Liu, Yufeng Tang, Youlin Wu, Li Yao, Zhu Shi, Pengcheng He, Haojin Zhao, Zhuo Chen, Jun Luo, Yue Wan, Qiang Shi, Maorong Wang, De Yang, Xianglin Chen, Fang Huang, Jinlin Mu, Hao Li, Zhimin Li, Jingbang Zheng, Shunli Xie, Tieying Cai, Yuqi Peng, Weihua Xie, Zhongming Qiu, Chang Liu, Chengsong Yue, Linyu Li, Yan Tian, Dahong Yang, Jian Miao, Jie Yang, Jinrong Hu, Raul G Nogueira, Duolao Wang, Jeffrey L Saver, Fengli Li, Qingwu Yang, and RESCUE BT2 Investigators.
- From the Department of Neurology, Xinqiao Hospital and the Second Affiliated Hospital, Army Medical University (Third Military Medical University) (W.Z., J.S., W.K., J.H., C.G., Z.Q., C.Y., L.L., Yan Tian, Dahong Yang, J.Y., J.H., F.L., Q.Y.), Guangyang Bay Laboratory, Chongqing Institute for Brain and Intelligence (W.Z., F.L., Q.Y.), the Department of Neurology, People's Hospital of Chongqing Banan District (M.T.), the Department of Neurology, Chongqing University Fuling Hospital (De Yang), No. 2 Department of Internal Medicine, Chongqing Sanbo Chang'an Hospital (J.Z.), the Department of Neurology, Youyang County People's Hospital (S.X., T.C.), and the Department of Neurology, Second Affiliated Hospital of Chongqing Medical University (C.L.), Chongqing, the Department of Neurology, Guiping People's Hospital, Guiping (W.H.), the Department of Neurology, Bazhong Hospital of Traditional Chinese Medicine (Y.Y.), the Department of Neurology, Bazhong Central Hospital (B.L.), the Department of Neurology, People's Hospital of Pingchang (J.L.), and the Department of Neurology, Nanjiang Hospital of Traditional Chinese Medicine (J.M.), Bazhong, the Department of Neurology, Suining First People's Hospital, Suining (B.Z), the Department of Neurology, Taihe County People's Hospital (W.G.), and the Department of Neurology, Taihe County Hospital of Traditional Chinese Medicine (Z.L.), Fuyang, the Department of Neurology, Meishan Second People's Hospital, Meishan (X.T.), the Department of Neurology, Qian Xi Nan People's Hospital, Qian Xi Nan (Yaoyu Tian), the Department of Neurology, Jingdezhen No. 1 People's Hospital, Jingdezhen (M.C.), the Department of Neurology, Xingyi People's Hospital, Xingyi (D.C.), the Department of Encephalopathy, Maoming Hospital of Traditional Chinese Medicine, Maoming (W.H.), the Department of Neurology, Weihai Municipal Hospital, Weihai (P.W.), the Department of Neurology, Liangshan First People's Hospital, Xichang (Z.Y.), the Department of Neurology, People's Hospital of Luyi, Zhoukou (H.L.), the Department of Neurology, People's Hospital of Zunyi City Bo Zhou District, Zunyi (S.Y.), the Department of Neurology, Wuhan Hospital of Traditional Chinese and Western Medicine (W.L.), and the Department of Neurology, Third People's Hospital of Hubei Province, (Y.W.), Wuhan, the Department of Neurology, First Affiliated Hospital of Wannan Medical College, Wuhu (X.H.), the Department of Cerebrovascular Diseases, Guangyuan Central Hospital, Guangyuan (S.L), the Department of Neurology, Mianyang Central Hospital (Y. Tang), the Department of Cerebrovascular Diseases, Sichuan Mianyang 404 Hospital (J.L.), the Department of Neurology, People's Hospital of Zitong County (M.W.), and the Department of Neurology, Sichuan Science City Hospital (Y.P.), Mianyang, the Department of Neurology, Chongzhou People's Hospital, Chengdu (Y.W.), the Department of Neurology, Xian XD Group Hospital, Xi'an (L.Y.), the Department of Neurology, Southern Medical University-affiliated Dongguan People's Hospital, Dongguan (Z.S.), the Department of Neurology, People's Hospital of Nanbu County (P.H.), and the Department of Neurology, Affiliated Hospital of North Sichuan Medical College (Z.L.), Nanchong, the Department of Neurology, Second People's Hospital of Mengjin District, Luoyang (H.Z.), the Department of Neurology, Mianzhu People's Hospital, Deyang (Z.C.), the Department of Neurology, Zigong First People's Hospital, Zigong (Q.S.), the Department of Neurology, Sixth Affiliated Hospital of Guangzhou Medical University, Qingyuan People's Hospital, Qingyuan (X.C.), the Department of Cerebrovascular Diseases, People's Hospital of Yuxi City, Yuxi (F.H.), the Department of Neurology, First People's Hospital of Yibin, Yibin (H.L.), the Department of Neurology, People's Hospital of Mengzi, Hani-Yi Autonomous Prefecture of Honghe, Mengzi (W.X.); and the Department of Neurology, Xianyang Hospital of Yan'an University, Xianyang (J.M.) - all in China; University of Pittsburgh Medical Center Stroke Institute, Departments of Neurology and Neurosurgery, University of Pittsburgh School of Medicine, Pittsburgh (R.G.N.); the Global Health Trials Unit, Liverpool School of Tropical Medicine, Liverpool, United Kingdom (D.W.); and the Department of Neurology, David Geffen School of Medicine at UCLA, Los Angeles (J.L.S.).
- N. Engl. J. Med. 2023 Jun 1; 388 (22): 202520362025-2036.
BackgroundThe effects of the glycoprotein IIb/IIIa receptor inhibitor tirofiban in patients with acute ischemic stroke but who have no evidence of complete occlusion of large or medium-sized vessels have not been extensively studied.MethodsIn a multicenter trial in China, we enrolled patients with ischemic stroke without occlusion of large or medium-sized vessels and with a National Institutes of Health Stroke Scale score of 5 or more and at least one moderately to severely weak limb. Eligible patients had any of four clinical presentations: ineligible for thrombolysis or thrombectomy and within 24 hours after the patient was last known to be well; progression of stroke symptoms 24 to 96 hours after onset; early neurologic deterioration after thrombolysis; or thrombolysis with no improvement at 4 to 24 hours. Patients were assigned to receive intravenous tirofiban (plus oral placebo) or oral aspirin (100 mg per day, plus intravenous placebo) for 2 days; all patients then received oral aspirin until day 90. The primary efficacy end point was an excellent outcome, defined as a score of 0 or 1 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. Secondary end points included functional independence at 90 days and a quality-of-life score. The primary safety end points were death and symptomatic intracranial hemorrhage.ResultsA total of 606 patients were assigned to the tirofiban group and 571 to the aspirin group. Most patients had small infarctions that were presumed to be atherosclerotic. The percentage of patients with a score of 0 or 1 on the modified Rankin scale at 90 days was 29.1% with tirofiban and 22.2% with aspirin (adjusted risk ratio, 1.26; 95% confidence interval, 1.04 to 1.53, P = 0.02). Results for secondary end points were generally not consistent with the results of the primary analysis. Mortality was similar in the two groups. The incidence of symptomatic intracranial hemorrhage was 1.0% in the tirofiban group and 0% in the aspirin group.ConclusionsIn this trial involving heterogeneous groups of patients with stroke of recent onset or progression of stroke symptoms and nonoccluded large and medium-sized cerebral vessels, intravenous tirofiban was associated with a greater likelihood of an excellent outcome than low-dose aspirin. Incidences of intracranial hemorrhages were low but slightly higher with tirofiban. (Funded by the National Natural Science Foundation of China; RESCUE BT2 Chinese Clinical Trial Registry number, ChiCTR2000029502.).Copyright © 2023 Massachusetts Medical Society.
Notes
Knowledge, pearl, summary or comment to share?You can also include formatting, links, images and footnotes in your notes
- Simple formatting can be added to notes, such as
*italics*
,_underline_
or**bold**
. - Superscript can be denoted by
<sup>text</sup>
and subscript<sub>text</sub>
. - Numbered or bulleted lists can be created using either numbered lines
1. 2. 3.
, hyphens-
or asterisks*
. - Links can be included with:
[my link to pubmed](http://pubmed.com)
- Images can be included with:
![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
- For footnotes use
[^1](This is a footnote.)
inline. - Or use an inline reference
[^1]
to refer to a longer footnote elseweher in the document[^1]: This is a long footnote.
.