IMPACT

IMPACT

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

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Study Design

  • Prospective, multicenter, single-blinded, and randomized trial
  • Investigated 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.

Disclaimer

The IMPACT study was closed prematurely on June 12, 2013 by the Steering Committee and BIOTRONIK due to futility to affect the primary endpoint.

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).

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.
Reference No.
  • NCT00559988
Study Objective
  • To investigate 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.
1° Endpoints
  • First occurrence of stroke, systemic embolism, or major bleed between the Intervention and Control groups
2° Endpoints
  • Total mortality rate between the Intervention and Control groups
  • Ischemic and hemorrhagic stroke event rates between the Intervention and Control groups
  • Fatal or disabling and non-disabling stroke event rates between the Intervention and Control groups
  • Rates of major bleeding events between the Intervention and Control groups
  • AF burden between the Intervention and Control groups
  • Cardio-embolic and non-cardio-embolic stroke rates between the Intervention and Control groups
  • Quality of Life (QoL) between the Intervention and Control groups
  • Mean Heart Rate (HR) reduction between the Intervention and Control groups
Clinical Sites
  • 104 U.S. and international sites
Sample Size
  • 2,718 subjects (1:1 randomization)
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
Principal Investigators
  • Jonathan L. Halperin, MD Mount Sinai Medical Center, New York, NY
  • John Ip, MD Thoracic & Cardiovascular Healthcare Foundation, Lansing, MI

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Tachycardia Therapy

Tachycardia Therapy

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