Table 1.
Study characteristics
Augustus | Re‐Dual PCI | Pioneer AF‐PCI | Entrust AF PCI | |
---|---|---|---|---|
Patients (n) | 2307 | 1527 | 1393 | 1506 |
Study design | P2Y12 inhibitor + Apixaban or VKA + aspirin or placebo for 6 months | Dual therapy with dabigatran (150 mg) +P2Y12 inhibitor or triple therapy with warfarin + aspirin +P2Y12 inhibitor for 12 months | Group 1: Rivaroxaban (15 mg) + SAPT (P2Y12 inhibitor) for 12 months inhibitor) Group 3: VKA + DAPT (aspirin + P2Y12 inhibitor) | Edoxaban + SAPT (P2Y12 inhibitor) for 12 months or VKA + DAPT (P2Y12 inhibitor + aspirin) for 1 to 12 months |
Blinding | Placebo‐controlled | Open‐label | Open‐label | Open‐label |
Time to randomization | 14 days | 5 days | 3 days | 5 days |
Primary outcome | Major or CRNM bleeding at 6 months | Major or CRNM bleeding at 12 months | Clinically relevant bleeding at 12 months | Major or CRNM bleeding at 12 months |
Treatment effect for intervention vs control | HR 0.53, 95% CI 0.45‐0.63, P < .001 for superiority | HR 0.72,95% CI 0.58‐0.88, P = .002 for superiority (dabigatran 150 mg bid) | HR 0.59, 95% CI 0.47‐0.76, P < .001 for superiority | HR 0.83, 95% CI 0.65‐1.05, P = .001 for noninferiority, P = .1154 for superiority |
Year | 2019 | 2017 | 2016 | 2019 |
Follow‐up | 6 months | 14 months | 12 months | 12 months |