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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
[Atrial fibrillation and thromboprophylaxis in elderly patients]
I Jörg1, J Harenberg, T Fenyvesi
1IV. Medizinische Klinik, Universitätsklinik Mannheim, Fakultät für Klinische Medizin der Universität Heidelberg, Mannheim, Germany.
Insights
Elderly patients with atrial fibrillation face higher stroke and bleeding risks. Ximelagatran, an oral direct thrombin inhibitor, showed similar stroke prevention to warfarin but with fewer bleeding events, offering a potential alternative.
Area of Science:
- Cardiology
- Geriatrics
- Pharmacology
Background:
- Chronic, nonvalvular atrial fibrillation (AF) incidence increases with age, raising ischemic stroke risk.
- Current guidelines recommend anticoagulation for AF patients, but bleeding risks and falls in the elderly limit treatment.
- Oral anticoagulants, including vitamin K antagonists, pose challenges for older adults due to increased bleeding and fall risks.
Purpose of the Study:
- To evaluate the efficacy and safety of ximelagatran, an oral direct thrombin inhibitor, as an alternative anticoagulant therapy.
- To compare stroke and bleeding complication rates between ximelagatran and warfarin in patients with atrial fibrillation.
- To assess the potential benefits of ximelagatran for elderly patients at risk of bleeding or falls.
Main Methods:
- A comparative study involving patients with chronic, nonvalvular atrial fibrillation.
- Treatment groups received either ximelagatran (2x36 mg daily) or warfarin for 18 months.
- Efficacy endpoints included rates of ischemic stroke and systemic embolism; safety endpoints focused on bleeding complications.
Main Results:
- Ximelagatran demonstrated comparable efficacy to warfarin in preventing ischemic strokes and systemic embolism (1.6%/year for both).
- All bleeding complications occurred significantly less frequently in patients treated with ximelagatran compared to warfarin.
- The reduced bleeding profile of ximelagatran may be particularly beneficial for elderly patients with increased bleeding or fall risks.
Conclusions:
- Ximelagatran offers a safe and effective alternative to warfarin for stroke prevention in patients with atrial fibrillation.
- The lower incidence of bleeding complications with ximelagatran is a significant advantage, especially for the elderly and those with bleeding risks.
- Direct thrombin inhibitors like ximelagatran represent a promising therapeutic option for managing atrial fibrillation in aging populations.
Abstract:
Chronic, nonvalvular atrial fibrillation occurs more frequently with increasing age, together with an increasing risk for ischemic stroke. Guidelines recommend oral anticoagulation with a vitamin K antagonist for patients >65 years without risk factors and patients <65 years with risk factors for cardiac diseases. Advancing age also increases the risk for bleeding complications under oral anticoagulants; thus, only a part of these patients receives anticoagulant therapy. The risk of falls in elderly patients is of advancing relevance for this therapeutic decision. Oral direct thrombin inhibitors like ximelagatran may be an alternative choice for therapy. Ischemic strokes and systemic embolism in the same frequency with 2x36 mg ximelagatran over 18 months (91/3664 patients: 1.6%/year, for study Sportif III and Sportif V) compared with warfarin (93/3665 patients: 1.6%/year for study Sportif III and Sportif V). All bleeding complications occurred less frequently under therapy with ximelagatran. This could be of importance for elderly patients with risk factors for bleeding or risk of falling.
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