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. 2020 Jan 8;36(2):271–279. doi: 10.1002/joa3.12292

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