William L. Baker, PharmD; Jennifer A. Colby, PharmD; Vanita Tongbram, MBBS, MPH; Ripple Talati, PharmD; Isaac E. Silverman, MD; C. Michael White, PharmD; Jeffrey Kluger, MD; Craig I. Coleman, PharmD
Acute ischemic strokes are associated with poor outcomes and high health care burden. Evidence exists evaluating the use of neurothrombectomy devices in patients receiving currently recommended treatments that may have limited efficacy.
To describe the state of the evidence supporting use of neurothrombectomy devices in the treatment of acute ischemic stroke.
MEDLINE, SCOPUS, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Web of Science were searched, without language restrictions, from their inception through May 2010. The MEDLINE and Cochrane Central Register of Controlled Trials searches were updated through November 2010.
Two independent investigators screened citations for human studies of any design or case series or case reports of patients with an acute ischemic stroke that evaluated a neurothrombectomy device and reported at least 1 clinical effectiveness outcome or harm.
Using standardized protocols, 2 independent investigators extracted information about study characteristics and outcomes, and a third reviewer resolved disagreement.
87 articles met eligibility criteria, including 18 prospective single-group studies, 7 noncomparative retrospective studies, and 62 case series or case reports. Two U.S. Food and Drug Administration (FDA)–cleared devices, the MERCI Retriever (Concentric Medical, Mountain View, California) (40%) and the Penumbra System (Penumbra, Alameda, California) (9%), represented a large portion of the available data. All prospective and retrospective studies provided data on successful recanalization with widely varying rates (43% to 78% with the MERCI Retriever and 83% to 100% with the Penumbra System). Rates of harms, including symptomatic (16 studies; 0% to 10% with the MERCI Retriever and 0% to 11% with the Penumbra System) or asymptomatic (13 studies; 28% to 43% and 1% to 30%, respectively) intracranial hemorrhage and vessel perforation or dissection (11 studies; 0% to 7% and 0% to 5%, respectively), also varied by device. Predictors of harm included older age, history of stroke, and higher baseline stroke severity scores, whereas successful recanalization was the sole predictor of good outcomes.
Most available data are from single-group, noncomparative studies. In addition, the patient population most likely to benefit from these devices is undetermined.
Currently available neurothrombectomy devices offer intriguing treatment options in patients with acute ischemic stroke. Future trials should use a randomized design, with adequate power to show equivalency or noninferiority between competing strategies or devices, and strive to identify populations that are most likely to benefit from use of neurothrombectomy devices.
Agency for Healthcare Research and Quality.
Left. MERCI Retriever (Concentric Medical, Mountain View, California). Image used with permission from Concentric Medical. Right. Penumbra System (Penumbra, Alameda, California). Image used with permission from Penumbra.
Darker shading represents more frequent evaluation or larger number of patients evaluated. BI = Barthel Index; C = case report or case series; GOS = Glasgow Outcome Scale; mRS = modified Rankin Scale; NIHSS = National Institutes of Health Stroke Scale; P = prospective; R = retrospective.
* Death was included if patients were followed after hospital discharge.
Darker shading represents more frequent evaluation or larger number of patients evaluated. AICH = asymptomatic intracranial hemorrhage; C = case report or case series; P = prospective; R = retrospective; SICH = symptomatic intracranial hemorrhage.
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Baker WL, Colby JA, Tongbram V, Talati R, Silverman IE, White CM, et al. Neurothrombectomy Devices for the Treatment of Acute Ischemic Stroke: State of the Evidence. Ann Intern Med. ;154:243–252. doi: 10.7326/0003-4819-154-4-201102150-00306
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Published: Ann Intern Med. 2011;154(4):243-252.
High Value Care, Neurology, Stroke.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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