Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap)

Zaidat, Osama O.; Bozorgchami, Hormozd; Ribó, Marc; Saver, Jeffrey L.; Mattle, Heinrich; Chapot, René; Narata, Ana Paula; Ochsenbein, F.; Jadhav, Ashutosh P.; Grossberg, Jonathan A; Riedel, Christian; Tomasello, Alejandro; Clark, Wayne M.; Nordmeyer, Henning; Lin, Eugene C.; Nogueira, Raul G; Yoo, Albert J.; Jovin, Tudor G; Siddiqui, Adnan H.; Bernard, Thierry; Claffey, Mairsil; Andersson, Tommy

doi:10.1161/strokeaha.117.020125

Cited by 122 publications

(113 citation statements)

References 24 publications

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“…At least four trials have explicitly incorporated a reperfusion outcome MCID into study design, power calculations, and interpretation. All were noninferiority trials and used MCID values of 8–15%, all substantially higher than the expert-determined 3.1–5% value identified in the current study ( 10 , 11 , 19 , 20 ). None of the trial reports indicate how its more generous MCID values were derived.…”

Section: Discussionmentioning

confidence: 63%

The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment

Lin

Saver

2020

Front. Neurol.

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Section: Discussionmentioning

confidence: 63%

The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment

Lin

Saver

2020

Front. Neurol.

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“…Just as stent retrievers represented an evolutionary leap in the treatment of ELVO over the Merci device,43 44 more recently a newer generation of devices, including Embotrap (Ceronovus), have been developed with the aim of facilitating the removal of more resistant thrombi but the real world efficacy compared with traditional stent retrievers is as yet untested. In a recent prospective trial, the failure rate (TICI 0–2a) after three passes was still 20%, suggesting a persisting need for an efficient bailout technique 45. Registry data suggest that use of balloon guide catheters does lessen the need for rescue treatments 46…”

Section: Discussionmentioning

confidence: 99%

A systematic review and meta-analysis of observational evidence for the use of bailout self-expandable stents following failed anterior circulation stroke thrombectomy

Wareham

Flood

Phan³

et al. 2018

J NeuroIntervent Surg

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BackgroundThe crucial role of thrombectomy in the management of emergent large vessel occlusive stroke is not disputed but there is a technical failure rate in a significant minority of patients whose outcomes are often poor. Our objective was to perform a systematic review and meta-analysis to assess the safety and efficacy of permanent self-expandable stent deployment as a bailout procedure in cases of failed anterior circulation thrombectomy.MethodsTwo independent reviewers searched the Pubmed (Medline) database for studies reporting outcomes following failed endovascular thrombectomy with subsequent rescue therapy employing self-expandable stents.ResultsEight studies (one prospective, seven retrospective) originating from Europe, Asia, and America comprising 160 patients met the inclusion criteria. Estimated baseline National Institutes of Health Stroke Scale score was 17.1 (95% CI 15.7 to 18.4). Following failed thrombetcomy and stent deployment, the rate of favorable outcome (modified Rankin Scale score 0–2) was 43% (95% CI 34% to 53%). Pooled mortality was 21% (95% CI 13% to 33%). Successful recanalization (Thrombolysis in Cerebral Infarction (TICI) 2b–3 or Thrombolysis in Myocardial Infarction (TIMI) 2–3) was 71% (95% CI 63% to 77%). Symptomatic intracerebral hemorrhage was seen in 12% (95% CI 7% to 18%). The Solitaire stent (Medtronic) was the most commonly deployed stent following failed thrombectomy attempts (66%; 95% CI 31% to 89%). Pre- or post-stent angioplasty was performed in 39%of patients (95% CI 29% to 48%). Glycoprotein IIb/IIIa inhibitors were used in 89% (95% CI 71% to 97%). 95% of patients received postprocedural antiplatelet therapy.ConclusionA rescue stent procedure seems reasonable as a last resort following failed thrombectomy but currently the level of evidence is limited. Prospective registries may aid in guiding future recommendations.

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“…First described in the analysis of the North American Solitaire Acute Stroke (NASA) Registry database, FPE served as an independent predictor of good clinical outcome after stent retriever thrombectomy (modified Rankin Scale score 0-2 in 61% in FPE vs. 35% in non-FPE cohort; P = 0.013) (2,3). The benefit of FPE on clinical outcome was subsequently confirmed by the Analysis of Revascularization in Ischemic Stroke With EmboTrap (ARISE II) study of the EmboTrap thrombectomy device (4).…”

Section: Introductionmentioning

confidence: 91%

First Pass Effect in Patients Treated With the Trevo Stent-Retriever: A TRACK Registry Study Analysis

et al. 2020

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Results: The rate of FPE in TRACK was 23% (140/609). There was no association between patient demographics and FPE, including age (p = 0.36), sex (p = 0.50), race (p = 0.50), location of occlusion (p = 0.26), baseline NIHSS (p = 0.62), or past medical history. There was no difference in the use of a balloon-guide catheter or general anesthesia (49 and 57% with FPE vs. 47 and 64%, p = 0.63 and p = 0.14, respectively). Clinical outcomes were significantly associated with FPE; 63 vs. 44% in non-FPE patients achieved mRS 0-2 at 90 days (p = 0.0004). Conclusion: Our study showed that achieving complete recanalization with a single thrombectomy pass using the Trevo device was highly beneficial. The most common clinical factors that are used to determine eligibility for endovascular therapy, such as NIHSS severity, location of occlusion or patient age were not predictive of the ability to achieve FPE.

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Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap)

Abstract: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02488915.

Cited by 122 publications

References 24 publications

The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment

The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment

A systematic review and meta-analysis of observational evidence for the use of bailout self-expandable stents following failed anterior circulation stroke thrombectomy

First Pass Effect in Patients Treated With the Trevo Stent-Retriever: A TRACK Registry Study Analysis

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