Table 1.
Study characteristics
| Trial name | Year of publication | No. of patients included | Trial design | Inclusion criteria | Primary outcome | Main efficacy outcome | Follow-up (months) | Time from PCI to randomization |
|---|---|---|---|---|---|---|---|---|
| AUGUSTUS [17] | 2019 | 4434 | 2:2 factorial design (apixaban 5 mg bid vs. VKA; aspirin vs. placebo) + P2Y12i) | NVAF and PCI or ACS | Major or CRNM bleeding (ISHT) | Composite of death, stroke, MI, stent thrombosis, and urgent revascularization | 6 | Up to 14 days |
| ENTRUST-AF PCI [18] | 2019 | 1505 | (Edoxaban 60 mg od + P2Y12i) vs. (VKA + aspirin + P2Y12i) | NVAF and PCI | Major or CRNM bleeding (ISHT) | Composite of CV death, stroke (mVARC2), systemic embolic events, MI, and stent thrombosis (ARC) | 12 | From 4 h to 5 days |
| PIONEER AF-PCI [13] | 2016 | 1393 | (Rivaroxaban 15 mg od + P2Y12i) vs. (rivaroxaban 2.5 mg bid + P2Y12i) vs. (VKA + aspirin + P2Y12i) | NVAF and PCI | Clinically significant bleeding (TIMI) | MACE (CV death, MI, stroke) | 12 | Up to 72 h |
| RE-DUAL PCI [14] | 2017 | 2725 | (Dabigatran 150 mg bid + P2Y12i) vs. (dabigatran 110 mg bid + P2Y12i) vs. (VKA + aspirin + P2Y12i) | NVAF and PCI | Major or CRNM bleeding (ISHT) | Composite of death, stroke, systemic embolic events, MI, unplanned revascularization | 14 | Up to 120 h |
ACS acute coronary syndrome, ARC academic research consortium, bid twice daily, CRNM clinically relevant non-major bleeding, CV cardiovascular, ISHT International Society of Thrombosis and Haemostasis, MACE major adverse cardiovascular events, MI myocardial infarction, mVARC2 modified Valve Academic Research Consortium-2, NVAF non-valvular atrial fibrillation, od once daily, P2Y12i P2Y12 inhibitor, PCI percutaneous coronary intervention, TIMI Thrombolysis in Myocardial Infarction trial, VKA vitamin K antagonist