Table 1.
AUGUSTUS (PCI subgroup, n = 3498) | AUGUSTUS (n = 1097, medically managed subgroup) | ENTRUST-AF-PCI (n = 1506) | PIONEER-AF PCI (n = 2124) | RE-DUAL PCI (n = 2725) | Bai et al.50 (2022) (n = 100) |
Liu et al.51 (2021) (n = 106) |
|
---|---|---|---|---|---|---|---|
Age, mean, y | 70.7 | 69.6 | 70 | 70.2 | 70.8 | 58.0 | 78.5 |
Female, % | 25.8 | 39.0 | 25.6 | 26.1 | 24.0 | 37.0 | 40.6 |
CHAD2DS2VASc, mean | 3.9 | 4.1 | 4 | 4 | 3.6 | 3 | 4.7 |
HAS-BLED, mean | 2.6 | 2.5 | 3 | 3 | 2.7 | 2 | 3.9 |
ACS, % | 50.0 | 100 | 51.6 | 51 | 50.5 | 100 | 58.5 |
NSTE-ACS/STEMI, % | — | — | — | 39.2/11.5 | 39.5/14.8 | — | — |
DES, % | — | 0 | — | 67.7 | 84.1 | 100 | 100 |
Days from index event to randomization | < 14 (mean 6.0) | < 14 (mean 8.5) | ≤ 5 (mean 1.9) | ≤ 3 | ≤ 5 | — | ≤ 3 |
P2Y12i at baseline | |||||||
Clopidogrel, % | 91.0 | 97.7 | 92.4 | 94.7 | 88.0 | — | — |
Prasugrel/ticagrelor, % | 1.5/7.5 | 0.2/2.1 | 0/7 | 1.2/4.1 | -/10.7 | — | — |
Dual therapy | |||||||
OAC | Apixaban 5 mg BID or warfarin (INR 2-3) | Edoxaban 60 mg daily | Rivaroxaban 15 mg daily | Dabigatran 110 mg or 150 mg BID | Rivaroxaban 15 mg daily | Rivaroxaban 15 mg daily | |
P2Y12i | Clopidogrel or ticagrelor or prasugrel | Clopidogrel or ticagrelor or prasugrel | Clopidogrel or ticagrelor or prasugrel | Clopidogrel or ticagrelor | Clopidogrel | Ticagrelor | |
Triple therapy | |||||||
OAC | Apixaban 5 mg BID or warfarin (INR 2-3) | Warfarin (INR 2-3) | Warfarin (INR 2-3) | Warfarin (INR 2-3) | Warfarin (INR 2-3) | Warfarin (INR 1.6-2.5) | |
P2Y12i | Clopidogrel or ticagrelor or prasugrel | Clopidogrel or ticagrelor or prasugrel | Clopidogrel or ticagrelor or prasugrel | Clopidogrel or ticagrelor | Clopidogrel | Clopidogrel | |
Outcome definitions | |||||||
MACE | Death, MI, stroke, stent thrombosis (definite or probable), or urgent revascularization | Death, MI, stroke, stent thrombosis (definite), or systemic embolism | CV death, MI, or stroke | Death, MI, stroke, systemic embolism | Death, MI, stroke, stent thrombosis, unplanned revascularization | CV death, MI, stroke, or stent thrombosis | |
Major bleeding | ISTH | BARC (3 or 5) | ISTH | ISTH | TIMI | TIMI | |
Stent thrombosis | Reported: Definite/probable | Reported: Definite/probable | Reported | Reported: Definite | Reported | Reported | |
Follow-up duration, mo | 6 | 12 | 12 | 14 | 12 | 12 |
ACS, acute coronary syndrome; AUGUSTUS, Apixaban Versus Warfarin in Patients With AF and ACS or PCI; BARC, Bleeding Academic Research Consortium; BID, twice a day; CHA2DS2-VASc, Congestive Heart Failure, Hypertension, Age [≥ 75 years] [doubled], Diabetes Mellitus, Stroke/Transient Ischemic Attack [doubled], Vascular Disease, Age [65-74] Years, Sex Category [female]); CV, cardiovascular; DES, drug-eluting stent; ENTRUST-AF-PCI, Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention; HAS-BLED, Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly (> 65 Years), Drugs/Alcohol Concomitantly; INR, international normalized ratio; MACE, major adverse cardiovascular events; OAC, oral anticoagulant; MI, myocardial infarction; ISTH, International Society on Thrombosis and Haemostasis; NSTE-ACS, non-ST-elevation ACS; PCI, percutaneous coronary intervention; PIONEER-AF PCI, Exploration of Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo a PCI; P2Y12i, P2Y12 inhibitor; RE-DUAL PCI, Randomized Evaluation of Dual Therapy With Dabigatran vs Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting; STEMI, ST-elevation myocardial infarction; TIMI, thrombolysis in myocardial infarction.