Table 1.
Trial Name | Study Design and Location | Study Duration | Test Drug (n)/Control (N) | Mean Age | CHA2DS2-VASc Score | Arrhythmia | Stroke or Systemic Embolism | Ischemic Stroke HR (95% CI) |
Major Bleeding HR (95% CI) |
Cardiovascular Death HR (95% CI) |
All-Cause Mortality HR (95% CI) |
---|---|---|---|---|---|---|---|---|---|---|---|
NOAH-AFNET6 trial. Kirchhof et al. (2023) [15] | Investigator-initiated, DB, double-dummy, RCT. Multicenter. | 5 years | Edoxaban (1270)/Placebo (1266) | 77.5 ± 6.7 | 4 ± 1 (Median) |
AHRE * | 0.65 (0.39 to 1.07) | 0.79 (0.45 to 1.39) | 2.10 (1.30 to 3.38) | 0.90 (CI, 0.62 to 1.31) | 1.16 (0.88 to 1.53) |
ARTESIA trial. Healey et al. (2023) [16] | DB, double-dummy randomized trial. Multicenter | 6 years | Apixaban (2015)/Aspirin (1997) | 76.8 ± 7.6 | 3.9 ± 1.1 (Mean) | SCAF # | 0.63 (0.45 to 0.88) | 0.62 (0.43 to 0.91) | 1.36 (1.01 to 1.82) | 0.96 (0.73 to 1.25) | 1.04 (0.90 to 1.21) |
NOAH-AFNET 6—Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial High-Rate Episodes Trial [15], ARTESIA—Apixaban for the Reduction of Thrombo-Embolism in Patients with Device-Detected Subclinical Atrial Fibrillation Trial [16], n—number of patients, HR—hazard ratio, CI—confidence interval, RCT—randomized controlled trial, DB—double-blind, AHRE—atrial high-rate episode, SCAF—subclinical atrial fibrillation. *—AHREs included in this study are the atrial tachyarrhythmia episodes detected at least 2 months after implantation of the device, with an atrial rate of ≥170 beats per minute and had to last ≥6 min; no upper limit for the duration. #—SCAFs included in this study are the device-detected AF episodes, with at least one episode lasting ≥6 min but not longer than 24 h.