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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

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

slide2

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

slide3

Hemostasis and Thrombosis

Red Blood Cells

  • Pathobiology is complex
  • Understanding relationships is important
  • Antiplatelet therapy
  • Anticoagulant therapy

Platelet aggregate

Fibrin

Atherosclerotic Plaque

antithrombotic therapy for af overview antiplatelet agents compared with placebo or control
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.

contraindications to oral anticoagulation
Contraindications to Oral Anticoagulation

1,409 / 10,124 (14%) with a contraindication

active a primary outcome stroke mi non cns systemic embolism vascular death
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.

slide7

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.

averroes primary endpoint stroke or systemic embolic event
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.

slide9

Recommendations for prevention of thromboembolism in non-valvular AF

ESC Guidelines AF, EHJ 2012

summary
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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