David T Martin1, Malcolm M Bersohn2, Albert L Waldo3, Mark S Wathen4, Wassim K Choucair5, Gregory Y H Lip6, John Ip7, Richard Holcomb8, Joseph G Akar9, Jonathan L Halperin10. 1. Lahey Hospital and Medical Center, Burlington, MA, USA. 2. Veterans Administration and University of California Los Angeles School of Medicine, Los Angeles, CA, USA. 3. Case Western Reserve University School of Medicine, Cleveland, OH, USA. 4. Tennessee Heart, Cookeville, TN, USA. 5. Endovascular Heart Institute, San Antonio, TX, USA. 6. University of Birmingham Centre for Cardiovascular Sciences, City Hospital, UK. 7. Sparrow Research Foundation, Lansing, MI, USA. 8. Minneapolis, MN, USA. 9. Yale University School of Medicine, New Haven, CT, USA. 10. Icahn School of Medicine at Mount Sinai, New York, NY, USA jonathan.halperin@mssm.edu.
Abstract
AIMS: Atrial tachyarrhythmias (ATs) detected by implanted devices are often atrial fibrillation or flutter (AF) associated with stroke. We hypothesized that introduction and termination of anticoagulation based upon AT monitoring would reduce both stroke and bleeding. METHODS AND RESULTS: We randomized 2718 patients withdual-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 ). Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Atrial tachyarrhythmias (ATs) detected by implanted devices are often atrial fibrillation or flutter (AF) associated with stroke. We hypothesized that introduction and termination of anticoagulation based upon AT monitoring would reduce both stroke and bleeding. 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 ). Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Lichy Han; Mariam Askari; Russ B Altman; Susan K Schmitt; Jun Fan; Jason P Bentley; Sanjiv M Narayan; Mintu P Turakhia Journal: Circ Cardiovasc Qual Outcomes Date: 2019-10-15
Authors: Alexander C Perino; Jun Fan; Mariam Askari; Paul A Heidenreich; Edmund Keung; Merritt H Raitt; Jonathan P Piccini; Paul D Ziegler; Mintu P Turakhia Journal: Circulation Date: 2019-03-17 Impact factor: 29.690
Authors: Rod Passman; Peter Leong-Sit; Adin-Cristian Andrei; Anna Huskin; Todd T Tomson; Richard Bernstein; Ethan Ellis; Jonathan W Waks; Peter Zimetbaum Journal: J Cardiovasc Electrophysiol Date: 2015-11-23
Authors: Hooman Kamel; Madeleine Hunter; Yeseon P Moon; Shadi Yaghi; Ken Cheung; Marco R Di Tullio; Peter M Okin; Ralph L Sacco; Elsayed Z Soliman; Mitchell S V Elkind Journal: Stroke Date: 2015-09-22 Impact factor: 7.914
Authors: Daniel A Steinhaus; Peter J Zimetbaum; Rod S Passman; Peter Leong-Sit; Matthew R Reynolds Journal: J Cardiovasc Electrophysiol Date: 2016-10-04