Table 4.
NOAC Trials for Patients With Atrial Fibrillation Undergoing PCI
| First Author | Trial Name (N) | NOAC | Target Patients | Intervention Group | Control Group | Primary Endpoint | Results |
|---|---|---|---|---|---|---|---|
| Gibson et al54 | PIONEER AF-PCI (2,124) | Rivaroxaban 2.5 mg BD Rivaroxaban 15 mg OD |
ACS/PCI CCS/PCI |
NOAC (2.5 mg BD) plus DAPT for 12 mo NOAC (15 mg OD) plus SAPT for 12 mo |
Warfarin plus DAPT for 1, 6, 12 mo | Clinically relevant bleeding at 12 mo | Rivaroxaban 2.5 mg BD (HR: 0.63, 95% CI: 0.50-0.80) P < 0.001 for superiority Rivaroxaban 15 mg OD (HR: 0.59, 95% CI: 0.47-0.76) P < 0.001 for superiority |
| Cannon et al89 | RE-DUAL PCI (2,725) | Dabigatran 110 mg BD Dabigatran 150 mg BD |
ACS/PCI CCS/PCI |
NOAC plus SAPT for 12 mo | Warfarin plus DAPT for 1 (BMS) or 3 (DES) mo | Major or CRNM bleeding for 14 mo | Dabigatran 110 BD (HR: 0.52, 95% CI: 0.42-0.63) P < 0.001 for superiority Dabigatran 150 BD (HR: 0.72, 95% CI: 0.58-0.88) P = 0.002 for superiority |
| Lopes et al49 | AUGUSTUS (4,614) | Apixaban 5 mg BD | ACS/PCI CCS/PCI ACS/medical |
NOAC or warfarin plus SAPT for 6 mo | NOAC or warfarin plus DAPT for 6 mo | Major or CRNM bleeding at 6 mo | (HR: 0.69, 95% CI: 0.58-0.81) P < 0.001 for superiority |
| Vranckx et al90 | ENTRUST-AF PCI (1,506) | Edoxaban 60 mg OD | ACS/PCI CCS/PCI |
NOAC plus SAPT for 12 mo | Warfarin plus DAPT for 12 mo | Major or CRNM bleeding at 12 mo | (HR: 0.83, 95% CI: 0.65-1.05) P = 0.001 for noninferiority P = 0.1145 for superiority |
ACS = acute coronary syndrome; AUGUSTUS = Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary Intervention; BD = twice daily; BMS = bare metal stent; CCS = chronic coronary syndrome; CRNM = clinical relevant non-major; DAPT = dual antiplatelet therapy; DES = drug-eluting stent; ENTRUST-AF-PCI = Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention; OD = once daily; PCI = percutaneous coronary intervention; PIONEER AF-PCI = Open-Label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects with Atrial Fibrillation who Undergo Percutaneous Coronary Intervention; RE-DUAL PCI = Randomized Evaluation of Dual Antithrombotic Therapy with Dabigatran versus Triple Therapy with Warfarin in Patients with Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention; SAPT = single antiplatelet therapy; other abbreviation as in Table 3.