1 / 28

Novel Oral Anticoagulants: Benefits and risks

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.

earl
Download Presentation

Novel Oral Anticoagulants: Benefits and risks

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Novel Oral Anticoagulants: Benefits and risks • Matthew Moles, MD • December 4, 2012 • University of Colorado

  2. 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

  3. Rivaroxaban Dabigatran

  4. NOACs and Afib

  5. 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)

  6. Non-inferiority margin 1.46

  7. 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

  8. Non-inferiority margin 1.46

  9. NOACs and DVT/PE

  10. December 6, 2009

  11. 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

  12. NIM 2.75

  13. December 2010

  14. 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

  15. NIM 2.0

  16. NOACs and Overall Risks

  17. Fatal bleeding: 1 fewer death per 1000 pts GI bleeding: 1 increased bleed per 1000 pts

  18. 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

More Related