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(Stroke. 2005;36:1432.)
© 2005 American Heart Association, Inc.
Original Contributions |
From University of California, San Francisco, Department of Neurology (W.S.S.), San Francisco, Calif; the Department of Neurology (G.S.), University of Southern California, Los Angeles; the Department of Neurology (S.S., J.L.S.) and the Department of Emergency Medicine (S.S.), University of California, Los Angeles; the Division of Interventional Neuroradiology (Y.P.G.), Weill Cornell Medical College, New York, NY; Oregon Health Science University (H.L.L., G.M.N.), Portland; Saint Lukes Hospital (T.G., M.M.R.), Kansas City, Mo; Hartford Hospital (I.E.S.), Hartford, Conn; Department of Radiology (R.T.H.), University of California, San Francisco; Riverside Methodist Hospital (R.F.B.), Columbus, Ohio; and the Department of Radiology (M.P.M.), Stanford University, Palo Alto, Calif.
Correspondence to Wade S. Smith, MD, PhD, University of California, San Francisco, Department of Neurology, 505 Parnassus Avenue, San Francisco, CA 94143-0114. E-mail smithw{at}neurology.ucsf.edu
Background and Purpose The only Food and Drug Administration (FDA)-approved treatment for acute ischemic stroke is tissue plasminogen activator (tPA) given intravenously within 3 hours of symptom onset. An alternative strategy for opening intracranial vessels during stroke is mechanical embolectomy, especially for patients ineligible for intravenous tPA.
Methods We investigated the safety and efficacy of a novel embolectomy device (Merci Retriever) to open occluded intracranial large vessels within 8 hours of the onset of stroke symptoms in a prospective, nonrandomized, multicenter trial. All patients were ineligible for intravenous tPA. Primary outcomes were recanalization and safety, and secondary outcomes were neurological outcome at 90 days in recanalized versus nonrecanalized patients.
Results Recanalization was achieved in 46% (69/151) of patients on intention to treat analysis, and in 48% (68/141) of patients in whom the device was deployed. This rate is significantly higher than that expected using an historical control of 18% (P<0.0001). Clinically significant procedural complications occurred in 10 of 141 (7.1%) patients. Symptomatic intracranial hemorrhages was observed in 11 of 141 (7.8%) patients. Good neurological outcomes (modified Rankin score
2) were more frequent at 90 days in patients with successful recanalization compared with patients with unsuccessful recanalization (46% versus 10%; relative risk [RR], 4.4; 95% CI, 2.1 to 9.3; P<0.0001), and mortality was less (32% versus 54%; RR, 0.59; 95% CI, 0.39 to 0.89; P=0.01).
Conclusions A novel endovascular embolectomy device can significantly restore vascular patency during acute ischemic stroke within 8 hours of stroke symptom onset and provides an alternative intervention for patients who are otherwise ineligible for thrombolytics.
Key Words: angiography embolism embolectomy ischemia reperfusion stroke, acute thrombectomy treatment outcome
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