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Lancet Neurol. 2007 Feb;6(2):115-24.

Medium intensity oral anticoagulants versus aspirin after cerebral ischaemia of arterial origin (ESPRIT): a randomised controlled trial.

Collaborators (276)

Banga JD, Boiten J, van der Bom JG, Boon AE, Dippel DW, Donders RC, Eefting FD, Franke CL, Frenken CW, Frijns CJ, van Gemert HM, van Gijn J, de Jaegere PP, Kamp O, Kappelle LJ, Koudstaal PJ, Kwa VI, de Leeuw FE, Linn FH, van der Meer WK, Mosterd A, Pop GA, Raaymakers TW, van Schooneveld MJ, Stam J, Verheugt FW, van der Worp HB, Zijlstra F, Boekweit MP, Van Buuren M, Greebe P, Mooibroek GE, Slabbers DC, Algra A, Beijer IS, van den Bergh WM, Biessels GJ, De Schryver EL, van Dijk GW, Donders RC, Dorhout-Mees SM, Ferrier CH, Frijns CJ, van Gijn J, Gorter JW, Halkes PH, Hofmeijer J, Hop JW, Kappelle LJ, Klijn CJ, de Leeuw FE, Linn FH, Manschot SM, Nieuwkamp DJ, van Oers CA, Pruissen DM, Raaymakers TW, Ruigrok YM, Schaafsma JD, Slooter AJ, Tjeerdsma HC, Wermer MJ, van Wijk I, van der Worp HB, Collins R, Donnan GA, Rosendaal FR, Vermeulen M, Warlow CP, Wheatly K, Algra A, van Gijn J, Greebe P, Kappelle LJ, Koudstaal PJ, Aichner F, Algra A, Bogousslavsky J, Chamorro A, Chen CP, De Schryver EL, Ferro JM, van Gijn J, Hankey GJ, Hertzberger LI, Koudstaal PJ, Leys D, Ricci S, Ringelstein EB, Vanhooren G, Venables GS, Biessels GJ, De Schryver EL, Ferrier CH, Gorter JW, Halkes PH, Ruigrok YM, Aichner F, Fazekas F, Kleinert G, Depondt C, Derijck O, Dobbelaere K, Foncke E, Simons P, Vanhooren G, Verhoeven K, Girot M, Henon H, Leys D, Lucas C, Arquizan C, Calvet D, Mas JL, Decavel D, Ringelstein EB, Schilling M, Muhs A, Postert T, Caso V, Paciaroni M, Grazia Celani M, Ricci S, Righetti E, Guccione A, Sterzi R, Cenciarelli S, Girelli L, Aisa G, Freddo M, Polidori MC, Cavallini A, Marcheselli S, Micieli G, Rimondi B, Landini G, Gandolfo C, Biessels GJ, De Schryver EL, Ferrier CH, Frijns CJ, Gorter JW, Halkes PH, Kappelle LJ, Ruigrok YM, Hertzberger LI, Nanninga-van den Neste VM, Stam J, Bakker SL, Dippel DW, van Kooten F, Koudstaal PJ, Berntsen PJ, Feenstra B, den Hartog GW, Boon AM, Doelman JC, Lieuwens WH, Sips HJ, Visscher F, Brouwers PJ, Nihom J, Poels PJ, Prick JJ, Franke CL, Koehler PJ, Jöbsis GJ, Kwa VI, van der Sande JJ, ten Houten R, Veering MM, Bernsen PL, Boringa JB, van Gemert HM, Raaymakers TW, van der Meulen WD, Tans JT, Wagner GL, Blankenvoort JB, Christiaans MH, Kuiper H, Mallo GN, Keyser AJ, de Leeuw FE, Klaver MM, Prick JJ, Bouwsma C, Kienstra GE, Rutgers AW, Snoek JW, Bulens C, Vermeij FH, Baal MG, van der Steen A, van der Wielen-Jongen JC, Feikema WJ, Lohmann HJ, Sie LT, Driesen JJ, Verhey JC, van Dijk GW, Mulleners WM, Lindeboom SF, Nijmeijer HW, Geervliet JP, Tans RJ, Verweij RD, Linssen WH, Vanneste JA, Weinstein HC, Bakker SL, Zijlmans JC, Sie TH, Bertelsmann FW, Lanting P, Herderschêe D, Leyten QH, Heerema J, Saxena R, Böttger HR, Driessen-Kletter MF, Alting van Geusau RB, De Schryver EL, Glimmerveen WF, Donders RC, Henriques I, Rebocho L, Calado S, Viana Baptista M, Grilo Goncalves JA, Canhao P, Ferro JM, Chamorro A, Obach V, Vila N, Hambraeus J, Nilsson SA, Nordmark O, Terent A, Bogousslavsky J, Devuyst G, Michel P, Vuadens P, Mehrzad A, Curless R, Venables GS, Kalra L, Perez I, Bates D, Cartledge N, Dorman P, Rodgers H, Lees KR, Watt M, Enevoldson P, Humphrey P, Brown MM, Brown MM, Coward L, Featherstone R, Werring D, Young G, Bath P, Weaver C, Dennis M, Lindley R, Jenkins C, Overstall PW, Potter J, Eames P, Hankey GJ, Zhang WW, Chang HM, Chen CP, Wong MC, Verro P.

Abstract

BACKGROUND:

Oral anticoagulants are better than aspirin for secondary prevention after myocardial infarction and after cerebral ischaemia in combination with non-rheumatic atrial fibrillation. The European/Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT) aimed to determine whether oral anticoagulation with medium intensity is more effective than aspirin in preventing future vascular events in patients with transient ischaemic attack or minor stroke of presumed arterial origin.

METHODS:

In this international, multicentre trial, patients were randomly assigned within 6 months after a transient ischaemic attack or minor stroke of presumed arterial origin either anticoagulants (target INR range 2.0-3.0; n=536) or aspirin (30-325 mg daily; n=532). The primary outcome was the composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever occurred first. In a post hoc analysis anticoagulants were compared with the combination of aspirin and dipyridamole (200 mg twice daily). Treatment was open, but auditing of outcome events was blinded. Primary analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN73824458) and with ClinicalTrials.gov (NCT00161070).

FINDINGS:

The anticoagulants versus aspirin comparison of ESPRIT was prematurely ended because ESPRIT reported previously that the combination of aspirin and dipyridamole was more effective than aspirin alone. Mean follow-up was 4.6 years (SD 2.2). The mean achieved INR was 2.57 (SD 0.86). A primary outcome event occurred in 99 (19%) patients on anticoagulants and in 98 (18%) patients on aspirin (hazard ratio [HR] 1.02, 95% CI 0.77-1.35). The HR for ischaemic events was 0.73 (0.52-1.01) and for major bleeding complications 2.56 (1.48-4.43). The HR for the primary outcome event comparing anticoagulants with the combination treatment of aspirin and dipyridamole was 1.31 (0.98-1.75).

INTERPRETATION:

Oral anticoagulants (target INR range 2.0-3.0) are not more effective than aspirin for secondary prevention after transient ischaemic attack or minor stroke of arterial origin. A possible protective effect against ischaemic events is offset by increased bleeding complications.

PMID:
17239798
DOI:
10.1016/S1474-4422(06)70685-8
[Indexed for MEDLINE]

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