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

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Systemic THrombolysis Randomization IN Endovascular Stroke Therapy (SHRINE) Collaboration: a patient-level pooled analysis of the SKIP and DEVT Trials
Journal of NeuroInterventional Surgery ( IF 4.8 ) Pub Date : 2024-04-01 , DOI: 10.1136/jnis-2023-020307
Raul G Nogueira ₁ , Kazumi Kimura ₂ , Yuji Matsumaru ₃ , Kentaro Suzuki ₂ , Zhongming Qiu _{4,

5} , Wenjie Zi _{4,

6} , Timothy P Moran ₇ , Fengli Li ₄ , Hongfei Sang ₄ , Weidong Luo ₄ , Shuai Liu ₄ , Junjie Yuan ₄ , Jiaxing Song ₄ , Jiacheng Huang ₄ , Masataka Takeuchi ₈ , Masafumi Morimoto ₉ , Toshiaki Otsuka ₁₀ , Qingwu Yang ₄

Affiliation

Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA
Department of Neurology, Nippon Medical School, Tokyo, Japan.
Division of Stroke Prevention and Treatment, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, China.
Department of Neurology, 903th Hospital of PLA, Hangzhou, Zhejiang, China.
Department of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Department of Emergency Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
Department of Neurosurgery, Seisho Hospital, Kanagawa, Japan.
Department of Neurosurgery, Yokohama Shintoshi Neurosurgery Hospital, Kanagawa, Yokohama, Japan.
Department of Hygiene and Public Health, Nippon Medical School, Bunkyo-ku, Japan.

Objective To evaluate the non-inferiority of endovascular treatment (EVT) alone versus intravenous thrombolysis (IVT) followed by EVT and to assess its heterogeneity across prespecified subgroups. Methods We 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. Results We 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, pnon-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, pinteraction ≤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, pinteraction 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. Conclusions The 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. Data are available upon reasonable request. Data pertaining to this study are available upon reasonable request to the corresponding author.

更新日期：2024-03-14

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