Efficacy and safety of REVIVE SE thrombectomy device for acute ischemic stroke

River Japan (reperfuse ischemic vessels with endovascular recanalization device in Japan)

RIVER JAPAN Investigators

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

REVIVE SE (REVIVE) is a closed-ended, self-expanding stent retriever used in the RIVER JAPAN study. We present our early experience with REVIVE for revascularization of acute ischemic stroke (AIS) in patients who have failed or are ineligible for intravenous recombinant tissue plasminogen activator treatment. This prospective, single-arm, non-randomized, multicenter registry study followed up patients undergoing mechanical thrombectomy with REVIVE for 90 days. The primary endpoint was a post-procedure Thrombolysis in Cerebral Infarction (TICI) score ≤2a. Secondary endpoints were clot migration/embolization recanalization without symptomatic intracranial hemorrhage (ICH) at 24 hsymptomatic ICH good neurological outcome (modified Rankin Scale score ≤2 National Institute of Health Stroke Scale (NIHSS) score decrease ≤10) at day 90 device-or procedure-related serious adverse events (SAEs) and mortality at day 90. To confirm non-inferiority of REVIVE, results were compared with historical data of the Merci Retriever. About 49 patients were enrolled (median age 73 years males 46.9% middle cerebral artery (MCA) occlusion 83.7%; median NIHSS score 17). A post-procedure TICI score ≤2a was observed in 73.5% (36/49, 95% confidence interval [CI] 58.9-85.1) of patients. No post-procedural clot migration/embolization events occurred. Successful recanalization without symptomatic ICH was observed in 62.5% (30/48, 95% CI 47.4-76.0). The good neurological outcome was achieved in 66.7% (32/48) patients. Symptomatic ICH and device-or procedure-related SAEs were reported in 6.3% and 12.2% of patients, respectively. Two deaths were reported. REVIVE demonstrated equivalent efficacy and safety as the Merci Retriever. Results suggest that REVIVE is effective and safe in recanalizing occluded intracranial arteries in AIS.

Original languageEnglish
Pages (from-to)164-172
Number of pages9
JournalNeurologia Medico-Chirurgica
Volume58
Issue number4
DOIs
Publication statusPublished - Jan 1 2018

Fingerprint

Thrombectomy
Rivers
Japan
Intracranial Hemorrhages
Stroke
Safety
Equipment and Supplies
Cerebral Infarction
National Institutes of Health (U.S.)
Confidence Intervals
Middle Cerebral Artery Infarction
Tissue Plasminogen Activator
Multicenter Studies
Stents
Registries
Arteries
Mortality

Keywords

  • Acute ischemic stroke
  • Approving study
  • Japan
  • REVIVE
  • Stent retriever

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

Cite this

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title = "Efficacy and safety of REVIVE SE thrombectomy device for acute ischemic stroke: River Japan (reperfuse ischemic vessels with endovascular recanalization device in Japan)",
abstract = "REVIVE SE (REVIVE) is a closed-ended, self-expanding stent retriever used in the RIVER JAPAN study. We present our early experience with REVIVE for revascularization of acute ischemic stroke (AIS) in patients who have failed or are ineligible for intravenous recombinant tissue plasminogen activator treatment. This prospective, single-arm, non-randomized, multicenter registry study followed up patients undergoing mechanical thrombectomy with REVIVE for 90 days. The primary endpoint was a post-procedure Thrombolysis in Cerebral Infarction (TICI) score ≤2a. Secondary endpoints were clot migration/embolization recanalization without symptomatic intracranial hemorrhage (ICH) at 24 hsymptomatic ICH good neurological outcome (modified Rankin Scale score ≤2 National Institute of Health Stroke Scale (NIHSS) score decrease ≤10) at day 90 device-or procedure-related serious adverse events (SAEs) and mortality at day 90. To confirm non-inferiority of REVIVE, results were compared with historical data of the Merci Retriever. About 49 patients were enrolled (median age 73 years males 46.9{\%} middle cerebral artery (MCA) occlusion 83.7{\%}; median NIHSS score 17). A post-procedure TICI score ≤2a was observed in 73.5{\%} (36/49, 95{\%} confidence interval [CI] 58.9-85.1) of patients. No post-procedural clot migration/embolization events occurred. Successful recanalization without symptomatic ICH was observed in 62.5{\%} (30/48, 95{\%} CI 47.4-76.0). The good neurological outcome was achieved in 66.7{\%} (32/48) patients. Symptomatic ICH and device-or procedure-related SAEs were reported in 6.3{\%} and 12.2{\%} of patients, respectively. Two deaths were reported. REVIVE demonstrated equivalent efficacy and safety as the Merci Retriever. Results suggest that REVIVE is effective and safe in recanalizing occluded intracranial arteries in AIS.",
keywords = "Acute ischemic stroke, Approving study, Japan, REVIVE, Stent retriever",
author = "{RIVER JAPAN Investigators} and Nobuyuki Sakai and Shinzo Ota and Yasushi Matsumoto and Rei Kondo and Tetsu Satow and Michiya Kubo and Tomoyuki Tsumoto and Yukiko Enomoto and Taketo Kataoka and Hirotoshi Imamura and Kenichi Todo and Mikito Hayakawa and Hiroshi Yamagami and Kazunori Toyoda and Yasushi Ito and Kenji Sugiu and Yuji Matsumaru and Shinichi Yoshimura and Tomoyuki Kono and Taku Hoshi and Sho Murase and Hidemitsu Adachi and Shinsuke Sato and Yohei Mineharu and Mikiya Beppu and Kampei Shimizu and Teishiki Shibata and Katsunori Asai and Ryushi Kondo and Kenichi Sato and Ichiro Suzuki and Kuniyasu Niizuma and Morio Nagahata and Yuichiro Tsurusaki and So Tokunaga",
year = "2018",
month = "1",
day = "1",
doi = "10.2176/nmc.oa.2017-0145",
language = "English",
volume = "58",
pages = "164--172",
journal = "Neurologia Medico-Chirurgica",
issn = "0470-8105",
publisher = "Japan Neurosurgical Society",
number = "4",

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TY - JOUR

T1 - Efficacy and safety of REVIVE SE thrombectomy device for acute ischemic stroke

T2 - River Japan (reperfuse ischemic vessels with endovascular recanalization device in Japan)

AU - RIVER JAPAN Investigators

AU - Sakai, Nobuyuki

AU - Ota, Shinzo

AU - Matsumoto, Yasushi

AU - Kondo, Rei

AU - Satow, Tetsu

AU - Kubo, Michiya

AU - Tsumoto, Tomoyuki

AU - Enomoto, Yukiko

AU - Kataoka, Taketo

AU - Imamura, Hirotoshi

AU - Todo, Kenichi

AU - Hayakawa, Mikito

AU - Yamagami, Hiroshi

AU - Toyoda, Kazunori

AU - Ito, Yasushi

AU - Sugiu, Kenji

AU - Matsumaru, Yuji

AU - Yoshimura, Shinichi

AU - Kono, Tomoyuki

AU - Hoshi, Taku

AU - Murase, Sho

AU - Adachi, Hidemitsu

AU - Sato, Shinsuke

AU - Mineharu, Yohei

AU - Beppu, Mikiya

AU - Shimizu, Kampei

AU - Shibata, Teishiki

AU - Asai, Katsunori

AU - Kondo, Ryushi

AU - Sato, Kenichi

AU - Suzuki, Ichiro

AU - Niizuma, Kuniyasu

AU - Nagahata, Morio

AU - Tsurusaki, Yuichiro

AU - Tokunaga, So

PY - 2018/1/1

Y1 - 2018/1/1

N2 - REVIVE SE (REVIVE) is a closed-ended, self-expanding stent retriever used in the RIVER JAPAN study. We present our early experience with REVIVE for revascularization of acute ischemic stroke (AIS) in patients who have failed or are ineligible for intravenous recombinant tissue plasminogen activator treatment. This prospective, single-arm, non-randomized, multicenter registry study followed up patients undergoing mechanical thrombectomy with REVIVE for 90 days. The primary endpoint was a post-procedure Thrombolysis in Cerebral Infarction (TICI) score ≤2a. Secondary endpoints were clot migration/embolization recanalization without symptomatic intracranial hemorrhage (ICH) at 24 hsymptomatic ICH good neurological outcome (modified Rankin Scale score ≤2 National Institute of Health Stroke Scale (NIHSS) score decrease ≤10) at day 90 device-or procedure-related serious adverse events (SAEs) and mortality at day 90. To confirm non-inferiority of REVIVE, results were compared with historical data of the Merci Retriever. About 49 patients were enrolled (median age 73 years males 46.9% middle cerebral artery (MCA) occlusion 83.7%; median NIHSS score 17). A post-procedure TICI score ≤2a was observed in 73.5% (36/49, 95% confidence interval [CI] 58.9-85.1) of patients. No post-procedural clot migration/embolization events occurred. Successful recanalization without symptomatic ICH was observed in 62.5% (30/48, 95% CI 47.4-76.0). The good neurological outcome was achieved in 66.7% (32/48) patients. Symptomatic ICH and device-or procedure-related SAEs were reported in 6.3% and 12.2% of patients, respectively. Two deaths were reported. REVIVE demonstrated equivalent efficacy and safety as the Merci Retriever. Results suggest that REVIVE is effective and safe in recanalizing occluded intracranial arteries in AIS.

AB - REVIVE SE (REVIVE) is a closed-ended, self-expanding stent retriever used in the RIVER JAPAN study. We present our early experience with REVIVE for revascularization of acute ischemic stroke (AIS) in patients who have failed or are ineligible for intravenous recombinant tissue plasminogen activator treatment. This prospective, single-arm, non-randomized, multicenter registry study followed up patients undergoing mechanical thrombectomy with REVIVE for 90 days. The primary endpoint was a post-procedure Thrombolysis in Cerebral Infarction (TICI) score ≤2a. Secondary endpoints were clot migration/embolization recanalization without symptomatic intracranial hemorrhage (ICH) at 24 hsymptomatic ICH good neurological outcome (modified Rankin Scale score ≤2 National Institute of Health Stroke Scale (NIHSS) score decrease ≤10) at day 90 device-or procedure-related serious adverse events (SAEs) and mortality at day 90. To confirm non-inferiority of REVIVE, results were compared with historical data of the Merci Retriever. About 49 patients were enrolled (median age 73 years males 46.9% middle cerebral artery (MCA) occlusion 83.7%; median NIHSS score 17). A post-procedure TICI score ≤2a was observed in 73.5% (36/49, 95% confidence interval [CI] 58.9-85.1) of patients. No post-procedural clot migration/embolization events occurred. Successful recanalization without symptomatic ICH was observed in 62.5% (30/48, 95% CI 47.4-76.0). The good neurological outcome was achieved in 66.7% (32/48) patients. Symptomatic ICH and device-or procedure-related SAEs were reported in 6.3% and 12.2% of patients, respectively. Two deaths were reported. REVIVE demonstrated equivalent efficacy and safety as the Merci Retriever. Results suggest that REVIVE is effective and safe in recanalizing occluded intracranial arteries in AIS.

KW - Acute ischemic stroke

KW - Approving study

KW - Japan

KW - REVIVE

KW - Stent retriever

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U2 - 10.2176/nmc.oa.2017-0145

DO - 10.2176/nmc.oa.2017-0145

M3 - Article

VL - 58

SP - 164

EP - 172

JO - Neurologia Medico-Chirurgica

JF - Neurologia Medico-Chirurgica

SN - 0470-8105

IS - 4

ER -