Commentary on NICE guidelines for alteplase for the treatment of acute ischaemic stroke

Abstract

The decision by NICE was based on a rigorous examination of the randomised controlled trial (RCT) data, and it is reassuring to note that this was based, not on the main positive trial,2 but on independent systematic reviews of the totality of the data. For those not familiar with these data, the main concern has been that most of the evidence of the effectiveness of alteplase within the 3-hour time window is based on one study—the National Institute of Neurological Disorders and Stroke (NINDS) study.2 However, concerns about this study have been examined in an independent reanalysis of the NINDS data and the main findings confirmed.3 The large postmarketing surveillance audit of alteplase in Europe, SITS-MOST, has also been reassuring: provided that alteplase is delivered by doctors trained and experienced in the management of acute stroke, results …