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Title: Alteplase Can Be Used 3 to 4.5 Hours Post-Stroke, Not Just Within 3 Hours
URL: http://www.pslgroup.com/dg/22C20E.htm
Doctor's Guide
September 15, 2008

NEW YORK -- September 15, 2008 -- Alteplase is safe and effective between 3 and 4.5 hours post-stroke, as well as within the conventional 3-hour treatment window, according to a study published early online and in an upcoming edition of The Lancet.

The Safe Implementation of Thrombolysis in Stroke International Stroke Thrombolysis Register (SITS-ISTR) study, led by Nils Wahlgren, Karolinska University Hospital, Stockholm, Sweden, compared stroke patients given intravenous alteplase 3 to 4.5 hours post-stroke (n = 664 patients) with 11,865 patients given the drug within 3 hours.

In the 3- to 4.5-hour group, treatment started a mean of 55 minutes later (195 vs 140 min), average age of patients was 3 years younger (65 vs 68 y), and stroke severity slightly lower than in the within 3-hour group.

The researchers found that outcome measures were similar for the 3- to 4.5-hour group versus the 3-hour group; mortality (12.7% vs 12.2%, respectively), brain haemorrhage (2.2% vs 1.6%), and proportion of patients retaining independence (58.0% vs 56.3%).

"Our results show that the rates of symptomatic intracerebral haemorrhage, mortality, and independence at 3 months follow-up in routine clinical practice are similar between patients for whom treatment was started between 3 and 4.5 [hours] and for those treated within 3 [hours] after ischaemic stroke onset. Our findings lend support to those of the meta-analysis suggesting a potentially longer timeframe for intravenous [use of alteplase] of 4.5 [hours]," the authors wrote.

In an accompanying comment, Georgios Tsivgoulis, MD, and Andrei Alexandrov, MD, Comprehensive Stroke Center, University of Alabama at Birmingham Hospital, Birmingham, Alabama, said: "Extension of the timeframe of systemic thrombolysis seems to be a safe option for patients with acute stroke. ... We are looking forward to moving away from rigid timeframes to treatment based on imaging that can assess brain pathophysiology and tissue viability."

SOURCE: The Lancet

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