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The Future of Intra-Arterial Thrombolysis for Acute Stroke Therapy: Fine Tune the Procedure or Go Back to the Drawing Board?

Released: 7-Feb-2013 7:00 PM EST
Source Newsroom: Cedars-Sinai
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Newswise — Media Advisory: Patrick D. Lyden, MD, chair of Cedars-Sinai’s Department of Neurology and director of the Stroke Program, is available to comment on breaking news from the International Stroke Conference and the New England Journal of Medicine.

Lyden, a pioneer in the use of clot-busting drugs (tissue plasminogen activator, or tPA) in acute stroke treatment, is co-moderator of a symposium (Feb. 7, 2:30 p.m.) at the International Stroke Conference in Honolulu on the Interventional Management of Stroke Trial III.

IMS III is a randomized, multicenter, open-label clinical trial examining whether a combined intravenous and intra-arterial approach to opening arteries is superior to standard IV clot-busting drug (Activase®) treatment alone. Lyden was chair of the trial’s safety board.

Additionally, the New England Journal of Medicine today published (online) two articles giving results of this and another intra-arterial thrombolysis study.

Thrombolytic drugs dissolve clots (thrombolysis) to open blocked arteries. Intravenous tPA was approved by the Food and Drug Administration in 1996 but must be administered within three hours of stroke onset for maximum potential effectiveness. Intra-arterial thrombolysis – delivering thrombolytics via a microcatheter directly to the area of blockage – has been studied as a way to expand the time window and possibly provide better results than IV therapy or IV therapy alone.

According to the journal articles, the IMS III study was stopped after 656 participants had been randomized because it was clear there was no significant difference between the two approaches.

The other study, SYNTHESIS Expansion, assigned 181 patients to receive intra-arterial treatment and 181 to intravenous tPA. The authors found that the endovascular therapy was not superior to the standard treatment.

“The finding that intra-vascular thrombolysis fails to provide significant benefit over IV tPA is highly significant for stroke clinicians and researchers because we desperately need effective treatment options for those patients who reach us outside the three-hour window or fail to respond to the standard treatment,” said Lyden, who was a leader of the pivotal studies that led to IV tPA’s approval by the FDA in 1996.

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