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Novel Oral Anticoagulants: Benefits and risks. Matthew Moles, MD December 4, 2012 University of Colorado. Objectives. Become familiar with the mechanism of action of dabigatran and rivaroxaban Review the data behind the use of NOACs in Afib and DVT/PE.

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novel oral anticoagulants benefits and risks
Novel Oral Anticoagulants: Benefits and risks
  • Matthew Moles, MD
  • December 4, 2012
  • University of Colorado
objectives
Objectives
  • Become familiar with the mechanism of action of dabigatran and rivaroxaban
  • Review the data behind the use of NOACs in Afib and DVT/PE.
  • Evaluate the overall risks across all studies
slide3

Rivaroxaban

Dabigatran

re ly
RE-LY
  • N = 18,113, Follow-up median 2 years, CHADS2 median 2.1, open-label
  • Inclusion: Afib on EKG w/in last 6 months, plus at least one: CVA, TIA, LVEF < 40%, NYHA class II or great HF symptoms w/in 6 months and age of at least ≥75 or 65-74 plus DM, HTN, or CAD
  • Exclusion: severe heart-valve disorder, stroke w/in 14 days or severe stroke w/in 6 months, increased risk of bleeding, CrCl < 30, liver dx, prenancy
  • Randomized to 110 or 150 mg of dabigitran BID vs unblinded warfarin (ASA <100 mg or other antiplatelet agents allowed)
  • Primary outcome: stroke or systemic embolization
  • Safety outcome: major hemorrhage (reduction of Hgb by 2 g/dL, 2 units of PRBCs, or symptomatic bleeding in critical area)
rocket af
ROCKET-AF
  • N = 14,264, Follow-up median 1.6 yrs, CHADS2 median 3, double-blind
  • Inclusion: Non-valvular Afib by EKG w/ hx of stroke, TIA, or embolism or with at least a CHADS2 ≥ 2
  • Randomized to rivaroxaban 20 mg daily or 15 mg daily depending on CrCl vs warfarin
  • Primary outcome: stroke and embolism
  • Safety end point: major and non-major clinically relevant bleeding
re cover
RE-COVER
  • N = 2564, Follow-up 6 months, double-blind
  • Inclusion: DVT or PE with planned tx for 6 months
  • Exclusion: Symptoms longer than 6 months, PE with HD instability or use of TPA, indication for warfarin, unstable heart disease, high risk of bleeding, transaminases, life expectancy < 6 months, CrCl < 30, pregnancy
  • Randomized to 150 mg dabigatran BID vs warfarin
  • Primary outcome: symptomatic VTE or death 2/2 VTE
einstein dvt
EINSTEIN-DVT
  • N = 3449, most tx for 6 months, open-label
  • Inclusion: DVT w/o PE
  • Exclusion: CrCl <30, liver disease, active bleeding or high risk for bleeding, HTN, contraindication to anticoagulation, or received UFH/LMWH for > 48 hrs
  • Randomized to rivaroxaban at 15 mg BID for 3 weeks then 20 mg daily for 3, 6, or 12 months vs warfarin
  • Primary outcome: symptomatic recurrent VTE
slide27

Fatal bleeding: 1 fewer death per 1000 pts

GI bleeding: 1 increased bleed per 1000 pts

summary
Summary
  • Non-inferior for prevention of stroke/embolism in Afib
  • Non-inferior for treatment of DVT/PE
  • NNT for clinical benefit are large
  • Probable reduced hemorrhagic stroke rate
  • Reduced rate of fatal bleeding events
  • Increased incidence of GI bleeds
  • Perhaps increased incidence of MIs with dabigatran
  • Cost of drug/year $3000