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

Abstract

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.

• Authors: Raul G Nogueira, Kazumi Kimura, Yuji Matsumaru, Kentaro Suzuki, Zhongming Qiu, Wenjie Zi, Timothy P Moran, Fengli Li, Hongfei Sang, Weidong Luo, Shuai Liu, Junjie Yuan, Jiaxing Song, Jiacheng Huang, Masataka Takeuchi, Masafumi Morimoto, Toshiaki Otsuka, Qingwu Yang
• Journal: Journal of neurointerventional surgery (J Neurointerv Surg) Vol. 16 Issue 4 Pg. 359-364 (Mar 14 2024) ISSN: 1759-8486 [Electronic] England
• PMID: 37290918 (Publication Type: Meta-Analysis, Journal Article)
• Copyright: © Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Fibrinolytic Agents

Topics

• Humans
• Arterial Occlusive Diseases
• Brain Ischemia (therapy)
• Endovascular Procedures (adverse effects)
• Fibrinolytic Agents (therapeutic use)
• Intracranial Hemorrhages
• Random Allocation
• Stroke (therapy)
• Thrombectomy
• Thrombolytic Therapy
• Treatment Outcome
• Clinical Trials as Topic