Universität zu Köln

Pereira, Vitor M., Gralla, Jan, Davalos, Antoni, Bonafe, Alain, Castano, Carlos, Chapot, Rene, Liebeskind, David S., Nogueira, Raul G., Arnold, Marcel, Sztajzel, Roman, Liebig, Thomas, Goyal, Mayank, Besselmann, Michael, Moreno, Alfredo and Schroth, Gerhard (2013). Prospective, Multicenter, Single-Arm Study of Mechanical Thrombectomy Using Solitaire Flow Restoration in Acute Ischemic Stroke. Stroke, 44 (10). S. 2802 - 2808. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 0039-2499

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Abstract

Background and Purpose Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire Flow Restoration in patients with acute ischemic stroke. Methods Solitaire Flow Restoration Thrombectomy for Acute Revascularization was an international, multicenter, prospective, single-arm study of Solitaire Flow Restoration thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary end point was the revascularization rate (thrombolysis in cerebral infarction 2b) of the occluded vessel as determined by an independent core laboratory. The secondary end point was the rate of good functional outcome (defined as 90-day modified Rankin scale, 0-2). Results A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada, and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, and the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and procedure-related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic. Conclusions In this single-arm study, treatment with the Solitaire Flow Restoration device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Pereira, Vitor M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gralla, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Davalos, Antoni UNSPECIFIED UNSPECIFIED UNSPECIFIED Bonafe, Alain UNSPECIFIED UNSPECIFIED UNSPECIFIED Castano, Carlos UNSPECIFIED UNSPECIFIED UNSPECIFIED Chapot, Rene UNSPECIFIED UNSPECIFIED UNSPECIFIED Liebeskind, David S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nogueira, Raul G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Arnold, Marcel UNSPECIFIED UNSPECIFIED UNSPECIFIED Sztajzel, Roman UNSPECIFIED UNSPECIFIED UNSPECIFIED Liebig, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Goyal, Mayank UNSPECIFIED UNSPECIFIED UNSPECIFIED Besselmann, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Moreno, Alfredo UNSPECIFIED UNSPECIFIED UNSPECIFIED Schroth, Gerhard UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-475539
DOI:	10.1161/STROKEAHA.113.001232
Journal or Publication Title:	Stroke
Volume:	44
Number:	10
Page Range:	S. 2802 - 2808
Date:	2013
Publisher:	LIPPINCOTT WILLIAMS & WILKINS
Place of Publication:	PHILADELPHIA
ISSN:	0039-2499
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language MERCI TRIAL; REVASCULARIZATION; PROUROKINASE; SAFETY; TISSUE Multiple languages Clinical Neurology; Peripheral Vascular Disease Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/47553