Systemic THrombolysis Randomization IN Endovascular Stroke Therapy (SHRINE) Collaboration: a patient-level pooled analysis of the SKIP and DEVT Trials

作者全名："Nogueira, Raul G.; Kimura, Kazumi; Matsumaru, Yuji; Suzuki, Kentaro; Qiu, Zhongming; Zi, Wenjie; Moran, Timothy P.; Li, Fengli; Sang, Hongfei; Luo, Weidong; Liu, Shuai; Yuan, Junjie; Song, Jiaxing; Huang, Jiacheng; Takeuchi, Masataka; Morimoto, Masafumi; Otsuka, Toshiaki; Yang, Qingwu"

作者地址："[Nogueira, Raul G.] Univ Pittsburgh, Dept Neurol & Neurosurg, Med Ctr Hlth Syst, Pittsburgh, PA 15219 USA; [Kimura, Kazumi; Suzuki, Kentaro] Nippon Med Sch, Dept Neurol, Tokyo, Japan; [Matsumaru, Yuji] Univ Tsukuba, Fac Med, Div Stroke Prevent & Treatment, Tsukuba, Ibaraki, Japan; [Qiu, Zhongming; Zi, Wenjie; Li, Fengli; Sang, Hongfei; Luo, Weidong; Liu, Shuai; Yuan, Junjie; Song, Jiaxing; Huang, Jiacheng; Yang, Qingwu] Army Med Univ, Mil Med Univ 3, Xinqiao Hosp, Dept Neurol, Chongqing, Peoples R China; [Qiu, Zhongming; Zi, Wenjie; Li, Fengli; Sang, Hongfei; Luo, Weidong; Liu, Shuai; Yuan, Junjie; Song, Jiaxing; Huang, Jiacheng; Yang, Qingwu] Army Med Univ, Mil Med Univ 3, Affiliated Hosp 2, Chongqing, Peoples R China; [Qiu, Zhongming] 903th Hosp PLA, Dept Neurol, Hangzhou, Zhejiang, Peoples R China; [Zi, Wenjie] Chongqing Med Univ, Dept Neurol, Affiliated Hosp 2, Chongqing, Peoples R China; [Moran, Timothy P.] Emory Univ, Dept Emergency Med, Sch Med, Atlanta, GA USA; [Takeuchi, Masataka] Seisho Hosp, Dept Neurosurg, Kanagawa, Japan; [Morimoto, Masafumi] Yokohama Shintoshi Neurosurg Hosp, Dept Neurosurg, Yokohama, Kanagawa, Japan; [Otsuka, Toshiaki] Nippon Med Sch, Dept Hyg & Publ Hlth, Bunkyo Ku, Tokyo, Japan"

通信作者："Nogueira, RG (通讯作者)，Univ Pittsburgh, Dept Neurol & Neurosurg, Med Ctr Hlth Syst, Pittsburgh, PA 15219 USA."

来源：JOURNAL OF NEUROINTERVENTIONAL SURGERY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001006740400001

JCR分区：Q1

影响因子：4.5

年份：2023

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：Stroke; Thrombolysis; Thrombectomy

摘要："ObjectiveTo evaluate the non-inferiority of endovascular treatment (EVT) alone versus intravenous thrombolysis (IVT) followed by EVT and to assess its heterogeneity across prespecified subgroups. MethodsWe pooled data from two trials (SKIP in Japan; DEVT in China). Individual patient data were pooled to assess outcomes and heterogeneity of treatment effect. The primary outcome was functional independence (modified Rankin Scale score 0-2) at 90 days. Safety outcomes included symptomatic intracranial hemorrhage (sICH) and 90-day mortality. ResultsWe included 438 patients (217 EVT alone; 221 combined IVT+EVT). The meta-analysis failed to demonstrate the non-inferiority of EVT alone over combined IVT+EVT in achieving 90-day functional independence (56.7% vs 51.6%; adjusted common odds ratio (cOR)=1.27, 95% CI 0.84 to 1.92, p(non-inferiority)=0.06). Effect sizes favoring EVT alone were present with stroke onset to puncture time longer than 180 min (cOR=2.28, 95% CI 1.18 to 4.38, p(interaction <= 180 vs >180 min)=0.02) and intracranial internal carotid artery ICA occlusions (for ICA cOR=3.04, 95% CI 1.10 to 8.43, p(interaction ICA vs MCA)=0.08). The rates of sICH (6.5% vs 9.0%; cOR=0.77, 95% CI 0.37 to 1.61) and 90-day mortality (12.9% vs 13.6%; cOR=1.05, 95% CI 0.58 to 1.89) were comparable. ConclusionsThe cumulative data of these two recent Asian trials failed to unequivocally demonstrate the non-inferiority of EVT alone over combined IVT+EVT. However, our study suggests a potential role for more individualized decision-making. Specifically, Asian patients with stroke onset to EVT longer than 180 min, as well as those with intracranial ICA occlusions and those with atrial fibrillation might have better outcomes with EVT alone than with combined IVT+EVT."

基金机构："Japanese Society for Neuroendovascular Therapy; National Natural Science Foundation of China [81525008, 81901236, 81801157]; Chongqing Major Disease Prevention and Control Technology Research Project [2019ZX001]; Clinical Medical Research Talent Training Program of Army Medical University [2019XLC2008, 2019XLC3016]; Major Clinical Innovation Technology Project of the Second Affiliated Hospital of Army Medical University [2018JSLC0017]"

基金资助正文："Funding for the SKIP trial was provided by the Japanese Society for Neuroendovascular Therapy. The DEVT trial was supported by grants 81525008, 81901236, 81801157 from the National Natural Science Foundation of China, 2019ZX001 from the Chongqing Major Disease Prevention and Control Technology Research Project, 2019XLC2008 2019XLC3016 from the Clinical Medical Research Talent Training Program of Army Medical University, and 2018JSLC0017 from the Major Clinical Innovation Technology Project of the Second Affiliated Hospital of Army Medical University."