Randomized Clinical Trials of Dual versus Triple therapy | |||||||
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Study | Year | Patients | Blinding | Intervention | Primary outcomes | 2nd outcomes | Â |
WOEST | 2013 | 563 | Open-label design | Double therapy:  Warfarin/VKA + Clopidogrel 75 mg daily Triple therapy:  VKA + Clopidogrel 75 mg + ASA 80–100 mg daily | Any bleeding (1 yr):  19.4% versus 44.4% (HR 0.36; 95% CI 0.26–0.50; P < 0.0001; NNT 4) | Death, MI, TVR, stroke or stent thrombosis (ST):  11.1% versus 17.6% (HR 0.60; 95% CI 0.38–0.94; P = 0.025; NNT 15) | Figure 5 |
PIONEER AF-PCI | 2016 | 2214 | Open-label design | Double therapy:  Rivaroxaban 10–15 mg daily + P2Y12 inhibitor for 12 months (n = 709)  Riva. 2.5 mg BID + DAPT for 1, 6, or 12mo (n = 709) Triple therapy:  VKA + DAPT × 1,6, or12 mo (n = 706) | Clinically relevant bleeding (CRB):  16.8% versus 18.0% versus 26.7%; P < 0.001 | Death, MI, TVR, stroke, or ST:  No significant results of the rate of major adverse CV events (MACE) | Figure 6 |
RE-DUAL PCI | 2017 | 2725 | Open-label design | Double therapy:  Dabigatran 110 mg bid + P2Y12 inhibitor (N = 981)  Dabi. 150 mg bid + P2Y12 inhibitor (N = 763) Triple therapy:  VKA plus DAPT (N = 981) | Major/CRB bleed:  Dabi. (110) versus TAT:   15.4% versus 26.9%; p < 0.001  Abi. (150) versus TAT:   20.2% versus 25.7%; p = 0.002 | Death, MI, TVR, stroke, or ST:  No significant results of the MACE, with a slight NS increase in the ischemic event in the dabi. arms | Figure 7 |
ENTRUST-AF-PCI | 2019 | 1506 | Open-label design | Double therapy:  Edoxaban 60 mg daily plus clopidogrel 75 mg daily for 12 months Triple therapy  VKA plus DAPT (clopidogrel 75 mg ASA 100 mg once daily) | Major/CRB bleed:  17% versus 20%;with p = 0·001 for non-inferiority (only) | Death, MI, TVR, stroke, or ST:  No significant difference in the MACEA and ischemic outcomes | Figure 8 |
AUGUSTUS | 2019 | 4614 | Open-label design | 1st randomization:  Apixaban 5 mg b.i.d versus VKA 2nd randomization:  ASA versus Placebo   *4 Groups compared:    Api. 5 mg + P2Y12 inhibitor w/o ASA (2#)    VKA + P2Y12 inhibitor w/o ASA (2#) | Major bleeding/CRB:  1st random.:   10.5% versus14.7%; p < 0.001  2nd random:   16.1% versus 9.0% p < 0.001 for non-inferiority only | MACE (death, MI, TVR, stroke or ST)  1st random.:   6.7% versus 7.1%    p = All NS; except for mortality& hospt  2nd random:   6.5% versus 7.3%    p = NS, and not tested in the ischemic event | Figure 9 |