Clopidogrel 75 mg daily + warfarin

Versus

ASA 80-100 mg + clopidogrel 75 mg daily + warfarin

Any TIMI bleeding episode (minimal, minor, major) at 12 months

Clopidogrel + warfarin: 19.4%

ASA+clopidogrel + warfarin: 44.4% (p<0·0001)

• 69% had AF/flutter
• Most of the reduction in bleeding was in minimial and minor bleeding
• Not powered for efficacy (thrombotic events)
• Use of PPI: <40%

ASA 75-200 mg daily + clopidogrel 75 mg daily + warfarin (lowest recommended target INR)

for 6 weeks versus 6 months

Composite of death, MI, definite stent thrombosis, stroke, or major bleeding at 9 months

6 weeks triple therapy: 9.8% (30 events)

6 months triple therapy: 8.8% (27 events) (p=0.63)

• The trial was underpowered for its primary endpoint
• No differences in efficacy or safety were found
• Prevalence of AF: 84%
• Use of PPI: 37.2%

1. Rivaroxaban 15 mg daily + P2Y12 inhibitor (mainly clopidogrel)
2. Rivaroxaban 2.5 mg twice daily + DAPT (ASA + P2Y12 inhibitor, mainly clopidogrel). Step down to rivaroxaban 15mg daily + P2Y12 inhibitor
3. Traditional triple therapy: ASA + clopidogrel + warfarin

Clinically significant bleeding (composite of TIMI major, minor or requiring medical attention) at 12 months

1. Rivaroxaban 5 mg daily+clopidogrel: 16.8%
2. Rivaroxaban 2.5 mg BID + DAPT: 18.0%
3. Traditional triple therapy (ASA+clopidogrel+warfarin): 26.7% (p<0.001 versus both groups 1 and 2)

• Prevalence of AF: 100%
• Clopidogrel used as the P2Y12 inhibitor in >93% of patients
• Duration of triple therapy for groups and 3 were not randomized (1, 6 or 12 months)
• Most of the reduction in bleeding was in bleeding requiring medical attention with no difference in TIMI major or minor bleeding
• Not powered to detect differences in efficacy
• Use of PPI: <40%

Dabigatan 110 mg twice daily + P2Y12 inhibitor (clopidogrel 75 mg daily or ticagrelor 90 mg twice daily)

Dabigatan 150 mg twice daily + P2Y12 inhibitor (clopidogrel 75 mg daily or ticagrelor 90 mg twice daily)

Traditional triple therapy: ASA + clopidogrel + warfarin

Time to first major or clinically relevant non-major bleeding event

Dual therapy with dabigatran 110 mg twice daily: 15.4%
Triple therapy group: 26.9% (p<0.001)

Dual therapy with dabigatran 150 mg twice daily: 20.0%
Corresponding triple therapy group: 25.7% (p=0.002)

• Prevalence of AF: 100%
• Clopidogrel used as the P2Y12 inhibitor in 88% of patients (ticagrelor in 12% of patients); Not powered to detect differences in efficacy; Use of PPI: not provide