CAT: ACTIVE-A & W
  A-fib Clopidogrel Trial w/
Irbesartan for prevention of
       Vascular Events
        ASA, Warfarin

...
Clinical Question
• What are the treatment options for
  reducing cerebrovascular complications in
  elderly patients with...
Source: ACTIVE-W
• Clopidogrel plus aspirin versus oral
  anticoagulation for atrial fibrillation in
  the Atrial fibrilla...
Validity?
•   Randomized                • Accountability:
•   Double Blinded              sponsored by
•   Multicenter tri...
7455 eligible
6706 randomized




3371          3335
Warfarin       ASA
           Clopidogrel


                   ASA 75...
Warfarin (n=3371)
               |      Clopidogrel+ASA (3335)


No 1o
               3206             3101
end
point


Pr...
Warfarin (n=3371)
              |      Clopidogrel+ASA (3335)


No
              3276              3271
stroke




Stroke ...
Warfarin (n=3371)
                                                      |      Clopidogrel+ASA (3335)

                   ...
Results
• Warfarin
                                   • Clopidogrel + ASA
• 4.9% of patients achieved
  a primary end poin...
Summary statement:
• Warfarin is superior to Clopidogrel (75mg)
  plus Aspirin (75-100mg) for patients with
  atrial fibri...
Source: ACTIVE-A
• Effect of Clopidogrel Added to Aspirin
  in Patients with Atrial Fibrillation
  (ACTIVE-A)
  The ACTIVE...
Validity?
•   Randomized                • Accountability:
•   Double Blinded              sponsored by
•   Multicenter tri...
7554 patients from
   33 countries,
    561 centers
    0.6% lost to
      followup




   3772       3782
   ASA        A...
Clopidogrel+ASA   placebo+ASA



No 1o
               2940           2858
end
point


Primary
end             832         ...
Clopidogrel+ASA   placebo+ASA



No
              3476           3374
stroke




Stroke         296           408
Clopidogrel+ASA   placebo+ASA



No major
                3521           3620
bleeding




Major            251           ...
Results
• Clopidogrel + ASA                • ASA alone
• 22.0% of patients                • 24.4% of patients
  achieved a...
Summary statement:
• Clopidogrel (75mg) plus aspirin
  (75-100mg) is an alternative to warfarin for
  patients with atrial...
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ACTIVE-A and W trials

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A-fib Clopidogrel Trial w/ Irbesartan for prevention of Vascular Events (ASA and Warfarin trials) in NEJM 2009 and Lancet 2006

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ACTIVE-A and W trials

  1. 1. CAT: ACTIVE-A & W A-fib Clopidogrel Trial w/ Irbesartan for prevention of Vascular Events ASA, Warfarin Clinton Pong
  2. 2. Clinical Question • What are the treatment options for reducing cerebrovascular complications in elderly patients with atrial fibrillation? http://cardiology.ucsf.edu/ep/debris/ecg.htm
  3. 3. Source: ACTIVE-W • Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial The ACTIVE Writing Group on behalf of the ACTIVE Investigators Lancet Volume 367, Issue 9526, 10 June 2006-16 June 2006, Pages 1903-1912
  4. 4. Validity? • Randomized • Accountability: • Double Blinded sponsored by • Multicenter trial – Sanofi-Aventis • Avapro (Irbesartan) • Similar • Plavix (Clopidogrel) • Intention to treat – Bristol-Myers Squibb analysis • Avapro (Irbesartan) • Coumadin (Warfarin) • Plavix (Clopidogrel)
  5. 5. 7455 eligible 6706 randomized 3371 3335 Warfarin ASA Clopidogrel ASA 75-100mg + Clopidogrel 75mg
  6. 6. Warfarin (n=3371) | Clopidogrel+ASA (3335) No 1o 3206 3101 end point Primary end 165 234 point
  7. 7. Warfarin (n=3371) | Clopidogrel+ASA (3335) No 3276 3271 stroke Stroke 59 100
  8. 8. Warfarin (n=3371) | Clopidogrel+ASA (3335) No major bleeding 3278 3234 Major bleeding 93 101 p=0.53 Warfarin (n=3371) | Clopidogrel+ASA (3335) No 2816 2691 bleeding Total 555 644 bleeding
  9. 9. Results • Warfarin • Clopidogrel + ASA • 4.9% of patients achieved a primary end point • 7.0% of patients achieved – ARR is 2.1% a primary end point – NNT to prevent CV events: • Stroke in 3.0% 48 • Stroke in 1.8% – ARR is 1.2% • Major bleeding not – NNT to prevent stroke is 84 statistically significant • Bleeding in 16.5% • Bleeding in 19.3% – ARR is 2.8% – NNH is 35
  10. 10. Summary statement: • Warfarin is superior to Clopidogrel (75mg) plus Aspirin (75-100mg) for patients with atrial fibrillation to prevent CV events. In addition, the bleeding risk is higher in the C+A group when compared to the warfarin group for all bleeding events, while there was no significant difference in severe bleeds.
  11. 11. Source: ACTIVE-A • Effect of Clopidogrel Added to Aspirin in Patients with Atrial Fibrillation (ACTIVE-A) The ACTIVE Investigators NEJM Volume 360:2066-2078 May 14, 2009 Number 20
  12. 12. Validity? • Randomized • Accountability: • Double Blinded sponsored by • Multicenter trial – Sanofi-Aventis • Avapro (Irbesartan) • Similar • Plavix (Clopidogrel) • Intention to treat – Bristol-Myers Squibb analysis • Avapro (Irbesartan) • Coumadin (Warfarin) • Plavix (Clopidogrel)
  13. 13. 7554 patients from 33 countries, 561 centers 0.6% lost to followup 3772 3782 ASA ASA Clopidogrel Placebo ASA 75-100mg + Clopidogrel 75mg
  14. 14. Clopidogrel+ASA placebo+ASA No 1o 2940 2858 end point Primary end 832 924 point
  15. 15. Clopidogrel+ASA placebo+ASA No 3476 3374 stroke Stroke 296 408
  16. 16. Clopidogrel+ASA placebo+ASA No major 3521 3620 bleeding Major 251 162 bleeding
  17. 17. Results • Clopidogrel + ASA • ASA alone • 22.0% of patients • 24.4% of patients achieved a primary end achieved a primary end point point – ARR is 2.4% • Stroke in 10.8% – NNT to prevent CV events: • Major bleeding in 4.3% 43 • Stroke in 7.8% – ARR is 2.9% – NNT to prevent stroke is 34 • Major bleeding in 6.7% – ARR is 2.4% – NNH is 42
  18. 18. Summary statement: • Clopidogrel (75mg) plus aspirin (75-100mg) is an alternative to warfarin for patients with atrial fibrillation to prevent CV events. However, this must be balanced with the consideration for major bleeding as the NNT is equal to the NNH.

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