Abstract | AIMS: METHODS AND RESULTS: We randomized 2718 patients with dual-chamber and biventricular defibrillators to start and stop anticoagulation based on remote rhythm monitoring vs. usual office-based follow-up with anticoagulation determined by standard clinical criteria. The primary analysis compared the composite endpoint of stroke, systemic embolism, and major bleeding with the two strategies. The trial was stopped after 2 years median follow-up based on futility of finding a difference in primary endpoints between groups. A total of 945 patients (34.8%) developed AT, 264 meeting study anticoagulation criteria. Adjudicated atrial electrograms confirmed AF in 91%; median time to initiate anticoagulation was 3 vs. 54 days in the intervention and control groups, respectively (P < 0.001). Primary events (2.4 vs. 2.3 per 100 patient-years) did not differ between groups (HR 1.06; 95% CI 0.75-1.51; P = 0.732). Major bleeding occurred at 1.6 vs. 1.2 per 100 patient-years (HR 1.39; 95% CI 0.89-2.17; P = 0.145). In patients with AT, thromboembolism rates were 1.0 vs. 1.6 per 100 patient-years (relative risk -35.3%; 95% CI -70.8 to 35.3%; P = 0.251). Although AT burden was associated with thromboembolism, there was no temporal relationship between AT and stroke. CONCLUSION: In patients with implanted defibrillators, the strategy of early initiation and interruption of anticoagulation based on remotely detected AT did not prevent thromboembolism and bleeding. CLINICAL TRIAL REGISTRATION: IMPACT ClinicalTrials.gov identifier: NCT00559988 ( http://clinicaltrials.gov/ct2/show/NCT00559988?term=NCT00559988&rank=1 ).
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Authors | David T Martin, Malcolm M Bersohn, Albert L Waldo, Mark S Wathen, Wassim K Choucair, Gregory Y H Lip, John Ip, Richard Holcomb, Joseph G Akar, Jonathan L Halperin, IMPACT Investigators |
Journal | European heart journal
(Eur Heart J)
Vol. 36
Issue 26
Pg. 1660-8
(Jul 07 2015)
ISSN: 1522-9645 [Electronic] England |
PMID | 25908774
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: [email protected]. |
Chemical References |
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Topics |
- Aged
- Anticoagulants
(therapeutic use)
- Atrial Fibrillation
(therapy)
- Cardiac Resynchronization Therapy Devices
- Defibrillators, Implantable
- Female
- Humans
- Male
- Middle Aged
- Monitoring, Ambulatory
(methods)
- Single-Blind Method
- Stroke
(prevention & control)
- Telemedicine
(methods)
- Thromboembolism
(prevention & control)
- Treatment Outcome
- Wireless Technology
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