The stroke drug alteplase is safe and effective between three and 4.5 hours post-stroke, as well as within the conventional 3-hour treatment window. This is the conclusion of authors of an Article published early Online and in an upcoming edition of The Lancet, written by Prof Nils Wahlgren, Karolinska University Hospital, Stockholm, Sweden, and colleagues.
The SITS-ISTR study compared stroke patients given intravenous alteplase 3-4.5 hours post-stroke (664 patients) with 11865 given the drug within three hours. In the 3-4.5h group, treatment started a mean of 55 mins later (195 v 140 min), average age of patients was three years younger (65 v 68 years) and stroke severity slightly lower than in the within 3h group. The researchers found that outcome measures were similar for 3-4.5h versus within 3h: mortality (12.7% vs 12.2%), brain haemorrhage (2.2% vs 1.6%), and proportion of patients retaining independence (58.0% vs 56.3%).
The authors conclude: "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 h and for those treated within 3 h 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 h."
In an accompanying Comment, Dr Georgios Tsivgoulis and Dr Andrei Alexandrov Comprehensive Stroke Center, University of Alabama at Birmingham Hospital, Birmingham, Alabama, USA, say: "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."
For Prof Nils Wahlgren, Karolinska University Hospital, Stockholm, Sweden please contact Katarina Sternudd , Press OfficeT) +46 8 524 838 95 / +46 70-2243895 E) nils.wahlgren@karolinska.se / katarina.sternudd@ki.se
Dr Andrei Alexandrov, Comprehensive Stroke Center, University of Alabama at Birmingham Hospital, Birmingham, Alabama, USA E) avalexandrov@att.net
Full study: http://press.thelancet.com/Alteplasefinal.pdf
Journal
The Lancet