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Managing Patients Who Cannot Take Anticoagulants

Managing Patients Who Cannot Take Anticoagulants. 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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Managing Patients Who Cannot Take Anticoagulants

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  1. Managing Patients Who Cannot Take Anticoagulants Kenneth W. Mahaffey, MD, FACCProfessor of Medicine, Cardiology Faculty Associate Director, DCRIDirector, DCRI MegaTrials & CEC Duke Clinical Research Institute Durham, NC

  2. 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

  3. Hemostasis and Thrombosis Red Blood Cells • Pathobiology is complex • Understanding relationships is important • Antiplatelet therapy • Anticoagulant therapy Platelet aggregate Fibrin Atherosclerotic Plaque

  4. Antithrombotic Therapy for AF Overview:Antiplatelet Agents Compared with Placebo or Control Study, Year RRR (95% CI) AFASAK I, 1989; 1990 SPAF I, 1991 EAFT, 1993 ESPS II, 1997 LASAF, 1997 Daily Alternate day UK-TIA, 1999 300 mg daily 1,200 mg daily JAST, 2006 Aspirin trials (n = 7) SAFT, 2003 ESPS II, 1997 Dipyridamole Combination All antiplatelet trials (n = 10) 100% 50% 0% -50% -100% Favors Antiplatelet Favors Placebo or Control Hart RG, et al. Ann Intern Med. 2007;146:857-867.

  5. Contraindications to Oral Anticoagulation 1,409 / 10,124 (14%) with a contraindication

  6. ACTIVE A: Primary Outcome (Stroke, MI, Non-CNS Systemic Embolism, Vascular Death) 0.4 HR = 0.89 (0.81-0.98) p = 0.014 0.3 Placebo + Aspirin Cumulative Hazard Rates 0.2 Clopidogrel + Aspirin 0.1 0.0 1 3 0 2 Years 4 No. at Risk C + A 3772 3456 3180 2522 1179 ASA 3782 3426 3103 2460 1156 Connolly SJ, et al. N Engl J Med. 2009;361:1139-1151.

  7. AVERROES Trial Design 36 countries, 522 centres Apixaban 5 mg twice daily AF and ≥ 1 risk factor and demonstrated or expected unsuitable for VKA 2.5 mg twice daily in select patients 5,599 patients R Double-Blind ASA (81-324 mg/d) Primary Outcome: Stroke or Systemic Embolic Event Connolly SJ, et al. N Engl J Med. 2011;364:806-817.

  8. AVERROES: Primary EndpointStroke or Systemic Embolic Event HR = 0.45 95% CI = 0.32-0.62 P < 0.001 0.05 ASA CumulativeRisk 0.03 Apixaban 0.01 0.0 0 3 6 9 12 18 21 Months Connolly SJ, et al. N Engl J Med. 2011;364:806-817.

  9. Recommendations for prevention of thromboembolism in non-valvular AF ESC Guidelines AF, EHJ 2012

  10. Summary • Few patients have true contraindications to anticoagulant therapy • ASA vs. placebo • Modest reduction in thromboembolic events • Modest increase in bleeding • ASA + clopidogrel vs. ASA • Reduces thromboembolic events • Increases bleeding • Apixaban is a potentially attractive alternative in patients with VKA contraindications

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