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

Ford, Gary A.; Choy, Anna Maria; Deedwania, Prakash; Karalis, Dean G.; Lindholm, Carl-Johan LU ; Pluta, Wladyslaw; Frison, Lars and Olsson, Bertil LU (2007) In Stroke: a journal of cerebral circulation 38(11). p.2965-2971
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a DTI studied in the Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation trials, has been withdrawn, development of other DTIs continues.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... (More)
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a DTI studied in the Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation trials, has been withdrawn, development of other DTIs continues.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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
elderly, atrial fibrillation, stroke, direct thrombin inhibitors, ximelagatran
in
Stroke: a journal of cerebral circulation
volume
38
issue
11
pages
2965 - 2971
publisher
American Heart Association
external identifiers
  • wos:000250518300017
  • scopus:35648929863
ISSN
1524-4628
DOI
10.1161/STROKEAHA.107.488007
language
English
LU publication?
yes
id
aeb20698-7026-46b1-9885-608c859f4fd5 (old id 651757)
alternative location
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=17885258&dopt=Abstract
date added to LUP
2007-12-10 13:53:35
date last changed
2017-10-01 03:52:34
@article{aeb20698-7026-46b1-9885-608c859f4fd5,
  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 &gt;= 75 (n = 2804) and &lt;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 &lt; 0.001) patients. Raised alanine aminotransferase values (&gt;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.},
  author       = {Ford, Gary A. and Choy, Anna Maria and Deedwania, Prakash and Karalis, Dean G. and Lindholm, Carl-Johan and Pluta, Wladyslaw and Frison, Lars and Olsson, Bertil},
  issn         = {1524-4628},
  keyword      = {elderly,atrial fibrillation,stroke,direct thrombin inhibitors,ximelagatran},
  language     = {eng},
  number       = {11},
  pages        = {2965--2971},
  publisher    = {American Heart Association},
  series       = { Stroke: a journal of cerebral circulation},
  title        = {Direct thrombin inhibition and stroke prevention in elderly patients with atrial fibrillation - Experience from the SPORTIF III and V trials},
  url          = {http://dx.doi.org/10.1161/STROKEAHA.107.488007},
  volume       = {38},
  year         = {2007},
}