Direct thrombin inhibition and stroke prevention in elderly patients with atrial fibrillation: experience from the SPORTIF III and V trials

Gary A. Ford, Anna-Maria Choy, Prakash Deedwania, Dean G. Karalis, Carl-Johan Lindholm, Wladyslaw Pluta, Lars Frison, S. Bertil Olsson

    Research output: Contribution to journalArticle

    23 Citations (Scopus)

    Abstract

    Background and Purpose— Warfarin prevents stroke in atrial fibrillation (AF); however, concerns regarding international normalized ratio control and hemorrhage limit its use in the elderly. The oral direct thrombin inhibitors (DTIs) are potential alternatives to warfarin, offering fixed dosing without drug and dietary interactions and the need for international normalized ratio monitoring. Although ximelagatran, a DTI studied in the Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation trials, has been withdrawn, development of other DTIs continues. We report our experience in elderly high-risk AF patients on ximelagatran compared with warfarin therapy. Methods— Data from patients with AF and stroke risk factors randomized in Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation III and V trials to ximelagatran or warfarin were analyzed for stroke/systemic emboli, bleeding, and raised alanine aminotransferase levels in those =75 (n=2804) and <75 (n=4525) years. Results— Ximelagatran was as effective as warfarin in reducing stroke/systemic emboli in the elderly (2.23%/y with ximelagatran vs 2.27%/y with warfarin) as in younger patients (1.25%/y vs 1.28%/y). Total bleeds were significantly lower with ximelagatran compared with warfarin in elderly (40% vs 45%, P=0.01) and younger (27% vs 35%, P<0.001) patients. Raised alanine aminotransferase values (>3-fold elevation) among ximelagatran patients were more common in older (7.5% old vs 5.3% young) patients, particularly women (9.5% elderly women vs 6.1% elderly men). Conclusions— In high-risk elderly AF patients, ximelagatran is as effective as warfarin with less bleeding, but alanine aminotransferase elevations are common, particularly in elderly women. Oral DTIs for stroke prevention show promise in elderly patients.
    Original languageEnglish
    Pages (from-to)2965-2971
    Number of pages7
    JournalStroke
    Volume38
    Issue number11
    DOIs
    Publication statusPublished - Nov 2007

    Keywords

    • Atrial fibrillation
    • Elderly
    • Direct thrombin inhibitors
    • Stroke
    • Ximelagatran

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