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Tinzaparin in Acute Ischaemic Stroke (TAIST): a Randomised Aspirin-Controlled Trial

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Tinzaparin in Acute Ischaemic Stroke (TAIST): a Randomised Aspirin-Controlled Trial ARTICLES Tinzaparin in acute ischaemic stroke (TAIST): a randomised aspirin-controlled trial Philip M W Bath, Ewa Lindenstrom, Gudrun Boysen, Peter De Deyn, Pal Friis, Didier Leys, Reijo Marttila, Jan-Edwin Olsson, Desmond O’Neill, Jean-Marc Orgogozo, Bernd Ringelstein, Jan-Jacob van der Sande, Alexander G G Turpie, for the TAIST Investigators Summary Interpretation Treatment with tinzaparin, at high or medium dose, within 48 h of acute ischaemic stroke did not improve Background Low-molecular-weight heparins and functional outcome compared with aspirin. Although high- heparinoids are superior to unfractionated heparin in the dose tinzaparin was superior in preventing deep-vein prevention and treatment of venous thromboembolism, but thrombosis, it was associated with a higher rate of their safety and efficacy in acute ischaemic stroke are symptomatic intracranial haemorrhage. inadequately defined. Lancet 2001; 358: 702–10 Methods This randomised, double-blind, aspirin-controlled See Commentary page 683 trial tested the safety and efficacy of treatment with high- dose tinzaparin (175 anti-Xa IU/kg daily; 487 patients), Introduction medium-dose tinzaparin (100 anti-Xa IU/kg daily; 508 Acute ischaemic stroke is characterised in most cases by patients), or aspirin (300 mg daily; 491 patients) started large-vessel thromboembolic occlusion or small-vessel within 48 h of acute ischaemic stroke and given for up to occlusion, and may be complicated by local thrombus 10 days. Primary intracerebral haemorrhage was excluded extension, peripheral venous thromboembolism, and by computed tomography. Outcome was assessed, with ischaemic cardiac events. Anticoagulation with heparin treatment allocation concealed, by the modified Rankin might reduce the likelihood of these events and improve scale at 6 months (independence [scores 0–2] vs functional outcome. Although unfractionated heparin is dependence or death [scores 3–6]). commonly recommended and used in the management of acute ischaemic stroke,1–3 randomised controlled trials Findings Of 1486 randomised patients, two did not receive have not found it to be safe or effective in improving treatment and 46 were lost to follow-up. The proportions functional outcome.4–6 However, studies in other independent at 6 months were similar in the groups vascular disorders, especially in the prevention and assigned high-dose tinzaparin (194/468 [41·5%]), medium- treatment of deep-vein thrombosis and pulmonary dose tinzaparin (206/486 [42·4%]), or aspirin (205/482 embolism, have found that low-molecular-weight [42·5%]). There was no difference in effect in any (LMW) heparins are superior to unfractionated heparin predefined subgroup, including patients with presumed in terms of both efficacy and safety.7–9 Clinical cardioembolic stroke. Other outcome measures were differences between LMW and unfractionated heparins similar between the treatment groups (disability, case- are likely to result from differences in their fatality, and neurological deterioration rates). During the in- pharmacokinetic profile and activity:10 LMW heparins hospital treatment period no patient assigned high-dose have higher and more consistent bioavailability, a longer tinzaparin developed a symptomatic deep-vein thrombosis half-life, less protein binding, and dose-independent compared with nine assigned aspirin. Conversely, seven clearance, thereby producing a more predictable patients assigned high-dose tinzaparin developed anticoagulant response. LMW heparins also have less symptomatic intracerebral haemorrhage compared with one antiplatelet activity than unfractionated heparin and do in the aspirin group. not increase vascular permeability, resulting in less bleeding. Finally, LMW heparins have greater anti- Centre for Vascular Research, University of Nottingham, factor-Xa activity than unfractionated heparin, which Nottingham, UK (Prof P M W Bath FRCP); Leo Pharmaceutical preferentially inhibits anti-factor-IIa through activation Products, Ballerup, Denmark (E Lindenstrom MD); Department of of antithrombin. Neurology, Bispebjerg Hospital, Copenhagen, Denmark Ten randomised controlled trials of LMW heparins or (G Boysen MD); Department of Neurology, AZ Middelheim, heparinoids in acute ischaemic stroke have been University of Antwerp, Antwerp, Belgium (P De Deyn MD); Vest- reported,10 although only three of these11–13 were designed Agder Sentralsykehus, Kristiansand, Norway (P Friis MD); Clinique to test the hypothesis that these drugs decrease the risk Neurologique, CHRU de Lille, Lille, France (D Leys MD); Department of Neurology, Turku University Central Hospital, Turku, Finland of death and disability after stroke. Only the small (R Marttila MD); Institutionen för Neurologi, Universitetssjukhuset, Fraxiparine in Ischaemic Stroke (FISS) study of Linköping, Sweden (J-E Olsson MD); Department of Age Related nadroparin, with 312 patients, found positive results on 11 Health Care, Adelaide and Meath Hospital, Dublin, Ireland its primary outcome but this finding was not confirmed 13 (D O’Neill FRCPI); Department of Neurology, University of Bordeaux, in the larger FISS bis trial (767 patients). The Trial of Bordeaux, France (J-M Orgogozo MD); Klinik für Neurologie, Org 10172 in Acute Stroke Treatment (TOAST) Universität Münster, Münster, Germany (B Ringelstein MD); reported, in a post-hoc analysis, that danaparoid Slotervaartziekenhuis, Amsterdam, Netherlands increased the odds of a favourable outcome in patients (J-J van der Sande MD); Hamilton General Hospital, Hamilton, with stroke secondary to presumed large-artery Canada (A G G Turpie FRCP) (atherosclerotic) disease.12 A systematic review of these Correspondence to: Prof Philip M W Bath, Division of Stroke ten trials found that LMW heparins lowered the Medicine, Centre for Vascular Research, University of Nottingham, frequency of deep-vein thrombosis and pulmonary City Hospital Campus, Nottingham NG5 1PB, UK embolism but increased the risk of significant bleeding;14 (e-mail: [email protected]) there was a non-significant decrease in the combined 702 THE LANCET • Vol 358 • September 1, 2001 For personal use. Only reproduce with permission from The Lancet Publishing Group. ARTICLES outcome of death and disability with LMW heparins, an pregnancy (positive pregnancy test) or breastfeeding; effect that became significant in an exploratory analysis previous participation in TAIST; or participation in of the trials in which treatment could be started beyond another trial within the previous 2 weeks. 24 h after the onset of stroke.14 Tinzaparin sodium is a LMW heparin (peak molecular Design and procedures mass about 4500 Da) prepared by enzymatic Patients were assessed at baseline and, with concealment degradation of porcine mucosal heparin. It is licensed for of treatment allocation, at days 1, 4, 7, and 10 of the prevention and treatment of deep-vein thrombosis treatment, and at 3 and 6 months of follow-up. The and pulmonary embolism. One small pilot trial of primary outcome was independence, assessed as the tinzaparin in acute ischaemic stroke showed that the proportion with a score on the modified Rankin scale15 of drug reduced the frequency of deep-vein thrombosis 0, 1, or 2 at 6-month follow-up. Prespecified secondary (Leo Pharmaceutical Products, unpublished). We report and tertiary 6-month outcomes included median score here the findings of a randomised aspirin-controlled trial on the modified Rankin scale, proportion of patients assessing the safety and efficacy of tinzaparin in achieving a modified Rankin score of 0 or 1, proportion improving functional outcome after acute ischaemic of patients achieving a Barthel index of more than 90,15 stroke. death, and SF-36 health survey scales. Prespecified secondary 3-month outcomes included median score on Methods the modified Rankin scale, and proportion of patients Participants achieving a modified Rankin score of 0–2 and Barthel TAIST was a prospective randomised, multicentre, index of more than 90. Outcomes assessed at the end of double-blind, aspirin-controlled trial that took place treatment included proportion of patients with from July, 1997, in ten countries in Europe (Belgium, neurological deterioration (a decrease in score on the Denmark, Finland, France, Germany, Ireland, the Scandinavian neurological stroke scale of at least 5 Netherlands, Norway, Sweden, and the UK) and points or decrease in the consciousness part of Canada. Recruitment was completed in June 1999, and Scandinavian neurological stroke scale of more than 2 follow-up in January 2000. The study was run according points), having a recurrent stroke (classified as to the principles of the Declaration of Helsinki and the ischaemic, haemorrhagic, or unknown type), International Conference on Harmonisation of Good symptomatic deep-vein thrombosis (confirmed by Clinical Practice. Study approval by national (UK) and venography or ultrasonography), or pulmonary local research ethics committees (all centres) was embolism (confirmed by high-probability ventilation- obtained. An independent and masked adjudication perfusion scan, pulmonary angiography, or necropsy), committee classified events for a separate and and death. Hospital-related events included discharge independent safety-monitoring committee. The trial was disposition and length of stay. The primary outcome was supervised by an advisory committee. analysed by prespecified subgroups: sex, age (<80 years, Patients admitted to hospital with a clinical syndrome 80–90 years), stroke severity
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