Key Results
Key Result 1
The primary event rate did not differ between the intervention and control groups (2.4 vs. 2.3/100 patient-years, respectively; HR 1.06).
IMPACT Clinical Trial
The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with ICD and CRT-D Devices
Martin et al., European Heart Journal 2015
Study Design
- Prospective, multicenter, single-blinded, and randomized trial
- Investigates the clinical benefit of the combined use of BIOTRONIK Home Monitoring technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in subjects with implanted dual-chamber defibrillators or cardiac resynchronization devices
- A technical roll-out phase of 200 subjects at 30 clinical sites was conducted prior to the start of the large pivotal trial. The pivotal trial included 2,718 subjects and 104 active clinical sites worldwide
Key Result 2
Major bleeding rates were 1.6 and 1.2/100 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).
Key Result 3
Although AT burden was associated with thromboembolism, there was no temporal relationship between AT and stroke.
Clinical Relevance
- Early initiation of anticoagulation based on device-detected ATdid not improve outcomes, in part because of temporal dissociation between AF and stroke, and possibly because of stroke mechanisms independent of AF
- Additional studies are needed to elucidate stroke mechanisms in patients with advanced heart disease to inform anticoagulation decision for AF detected by implanted cardiac rhythm management devices
- The results do not support urgent initiation or any later withdrawal of anticoagulation in response to incident AFor its termination, and argue instead for anticoagulation based on more comprehensive, individualized assessment of risk and benefit
Study Details
Study Objective
- Investigation of the clinical benefit of the combined use of BIOTRONIK Home Monitoring technology and a predefined anticoagulation plan (group 1: intervention) compared to conventional device evaluation and physician-directed anticoagulation (group 2: control) in subjects with implanted dual-chamber defibrillators or cardiac resynchronization devices
Primary Endpoint
- First occurrence of stroke, systemic embolism, or major bleed between the intervention group and the control group
Major Secondary Endpoints
- Total mortality rate
- Ischemic and hemorrhagic stroke event rates
- Fatal or disabling and non-disabling stroke event rates
- Rates of major bleeding events
- AF burden
- Cardio-embolic and non-cardio-embolic stroke rates
- Quality of Life (QoL)
- Mean Heart Rate (HR) reduction
Clinical Sites
- 104 U.S. and international sites
Sample Size
- 2,718 subjects (1:1 randomization)
Main Inclusion Criteria
- Candidates for implantation of or already implanted with a BIOTRONIK Lumax HF-T or DR-T device
- Documented P-wave mean amplitude ≥ 1.0 mV (sinus rhythm) or ≥ 0.5 mV (AF) at enrollment, if previously implanted
- Class I or II CRT-D or ICD implant indication
- CHADS2 risk score ≥ 1
- Able and willing to follow anticoagulation therapy if the indication develops during the course of the trial
- Able to utilize the HM system throughout the study
- Ability to provide informed consent
- Geographically stable and expected ability to return for regular follow-up visits for 36 months
Main Exclusion Criteria
- Patients who do not fulfill all inclusion criteria
- Permanent AF: AF documented for more than 30 days with failed cardioversion, or longstanding AF documented for more than 6 months or symptomatic AF with poorly controlled rapid ventricular rates.
- History of stroke, transient ischemic attack (TIA) or systemic embolism and documented AF or AFL
- Currently requiring anticoagulant therapy for any indication
- Patients who underwent successful AF ablation (sinus rhythm restored) and have not completed a minimum of 3 months of OAC therapy
- Known, current contraindication to use of eligible OAC
- Long QT or Brugada syndrome as the sole indication for device implantation
- Pregnant, nursing or planned pregnancy during the duration of the study
Devices
- BIOTRONIK Lumax family of dual-chamber ICD or CRT-D devices (DR-T and HF-T) or future legally marketed BIOTRONIK dual-chamber ICD or CRT-D with Home Monitoring and IEGM-online technology
Follow-Up
- On-site device evaluations at least every 3 or 6 months after randomization (±30 days) until the study is closed, or until the subject decides to discontinue participation
Study Duration
- February 2008 – June 2013
Reference no.
- NCT00559988
Principal Investigators
- Jonathan L. Halperin, MD Mount Sinai Medical Center, New York, USA
- John Ip, MD Thoracic & Cardiovascular Healthcare Foundation, Lansing, USA