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Table 2 Summary table of RCTs studying DAT versus TAT

From: Is triple antithrombotic therapy a safe option in patients with AF who receive drug-eluting stents?: a review article

Randomized Clinical Trials of Dual versus Triple therapy

Study

Year

Patients

Blinding

Intervention

Primary outcomes

2nd outcomes

 

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