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How Much AF is Too Much AF? Do I Initiate Anticoagulation Based on AF Detected on Device Monitoring?. Kenneth W. Mahaffey, MD, FACC Professor of Medicine, Cardiology Faculty Associate Director, DCRI Director, DCRI MegaTrials & CEC Duke Clinical Research Institute Durham, NC.
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How Much AF is Too Much AF?Do I Initiate Anticoagulation Based on AF Detected on Device Monitoring? Kenneth W. Mahaffey, MD, FACCProfessor of Medicine, CardiologyFaculty Associate Director, DCRIDirector, DCRI MegaTrials & CEC Duke Clinical Research Institute Durham, NC
DisclosuresConsultant Fees/HonorariaAdolor; Amgen; AstraZeneca; Bayer HealthCare; Biotronik, Inc.; Boehringer Ingelheim; Bristol-Myers Squibb; Daiichi Sankyo, Inc.; Eli Lilly; Elsevier; Exeter Group; Forest; Genentech; Gilead; GlaxoSmithKline; Haemonetics; Johnson and Johnson; Medtronic; Merck and Co., Inc.; Novartis; Orexigen Therapeutics; Ortho-McNeil; Pfizer Inc; sanofi-aventis U.S. Inc.; Sun Pharma; Springer Publishing; WebMD Research/Research GrantsAbbott Vascular; Amgen; Amylin; AstraZeneca; Baxter; Bayer HealthCare; Boehringer Ingelheim; Bristol-Myers Squibb; Cordis; Daiichi Sankyo, Inc.; Edwards Lifesciences; Eli Lilly; GlaxoSmithKline; Guidant; Ikaria; INC Research; Johnson and Johnson; Kai Pharmaceuticals; Luitpold; Merck and Co., Inc.; Portola Pharmaceuticals; Pozen; Regado Biosciences; Roche; sanofi-aventis U.S. Inc.; Schering Plough; The Medicines Company
Screening for AF:Key Issues • Predicting AF • Screening • Finding • Quantifying • Determining risk • Treating • Modifying outcomes
ASSERT TrialStroke or Systemic Embolism 0.10 # at Risk Year 0.5 1.0 1.5 2.0 2.5 + 261 249 238 218 178 122 - 2,319 2,145 2,070 1,922 1,556 1,197 0.08 HR = 2.49 95% CI, 1.28-4.85 P = 0.007 Device-Detected Atrial TachyarrhythmiaDetected 0-3 months 0.06 Cumulative Hazard Rates 0.04 0.02 No Asymptomatic Atrial TachycardiaDetected 0-3 months 0.0 2.5 0 0.5 1.0 1.5 2.0 T0 at 3-month visit Years of Follow-up Healy JS, et al. N Engl J Med. 2012;366:120-129.
TRENDS TrialAF Burden & Thromboembolic Events Glotzer TV, et al. Circ Arrhythm Electrophysiol. 2009;474-480.
IMPACT TrialDevice Monitoring Guided Anticoagulation • Patient Population: • N = 2,718 • Dual-chamber ICD or CRT-D device • CHADS2 ≥ 1 • Primary endpoint = composite of stroke, systemic embolism and major bleeding • Hypothesis: • Initiation and withdrawal of anticoagulant therapy guided by ambulatory monitoring will improve clinical outcomes • Phase A (N = 227) completed 2009 • Phase B ongoing Group 1 (Intervention) Conventional follow-up + HM-guided anticoagulation Randomize 1:1 Conventional follow-up + physician-directed anticoagulation Group 2 (Control) 30m 6m 12m 24m 18m 36m Ip J, et al. Am Heart J. 2009;158:364-370.
Summary • Type of AF or AF burden should not influence stroke prevention treatment strategy • Antithrombotic therapy for patients with AF should be guided by risk stratification based on validated prediction tools • Patients with history of AF in sinus rhythm are not necessarily low risk