Table 1.
Randomized clinical trials of combined antithrombotic therapies in patients with AF with ACS or PCI/Stenting
| PIONEER‐AF PCI 23 | RE‐DUAL PCI 20 | ENTRUST‐AF PCI 22 | AUGUSTUS 24 | |
|---|---|---|---|---|
| Objective | Rivaroxaban + P2Y12 inhibitor or DAPT versus VKA + DAPT in patients with NVAF undergoing PCI | Dabigatran + P2Y12 inhibitor versus VKA + DAPT in patients with NVAF undergoing PCI | Edoxaban + P2Y12 inhibitor versus VKA + DAPT in patients with NVAF undergoing PCI | Apixaban + ASA/placebo versus VKA + ASA/placebo in patients with NVAF and ACS or PCI |
| Population size | 2124 | 2725 | 1506 | 4600 |
| Treatments |
Rivaroxaban 15 mg once daily + P2Y12 inhibitor, rivaroxaban 2.5 mg once daily + P2Y12 inhibitor + ASA, then rivaroxaban 15 mg once daily + ASA, VKA + P2Y12 inhibitor + ASA, then VKA + ASA |
Dabigatran 120 mg or 110 mg twice daily + P2Y12 inhibitor, VKA + P2Y12 inhibitor + ASA |
Edoxaban 60 mg once daily or 30 mg once daily + P2Y12 inhibitor, VKA + P2Y12 inhibitor + aspirin |
Apixaban 5 mg or 2.5 mg twice daily + ASA/placebo VKA + ASA/placebo |
| Duration | 12 mo | 6‐30 mo | 12 mo | 6 mo |
| Primary outcome | Clinically significant bleeding | Major or clinically relevant nonmajor bleeding event | Major or clinically relevant nonmajor bleeding | Major or clinically relevant nonmajor bleeding |
| Main secondary composite end point | The composite of death from cardiovascular causes, myocardial infarction, or stroke | The composite of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization (PCI or coronary artery bypass grafting). | The composite of cardiovascular death, stroke, systemic embolic events, myocardial infarction, and definite stent thrombosis | The composite of death or hospitalization; the composite of death or ischemic events (stroke, myocardial infarction, stent thrombosis [definite or probable], or urgent revascularization) |
| Analysis period | Treatment‐emergent period | Time to first event | Day 1 to 12 mo | Time to first event |
Abbreviations: ACS, acute coronary syndrome; ASA, acetylsalicylic acid; DAPT, dual antiplatelet therapy; NVAF, nonvalvular atrial fibrillation; PCI, percutaneous coronary intervention; TTR, time in therapeutic range; VKA, vitamin K antagonists.