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خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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Trials comparing direct oral anticoagulants versus warfarin in atrial fibrillation

Trials comparing direct oral anticoagulants versus warfarin in atrial fibrillation
Trial N Baseline characteristics of trial participants Trial details Median follow-up
Mean CHADS2 score Percent on aspirin Study drug (DOAC) and dose Comparison Mean percent time in INR range
RE-LY 18,113 2.1 40% Dabigatran 110 mg twice daily or 150 mg twice daily Warfarin (target INR 2.0 to 3.0) 64% 2 years
ROCKET-AF 14,264 3.5 36% Rivaroxaban 20 mg once daily* Warfarin (target INR 2.0 to 3.0) 55% 1.9 years
ARISTOTLE 18,201 2.1 31% Apixaban 5 mg twice daily Warfarin (target INR 2.0 to 3.0) 62% 1.8 years
ENGAGE AF-TIMI 48 21,105 2.8 29% EdoxabanΔ 30 mg once daily or 60 mg once daily Warfarin (target INR 2.0 to 3.0) 65% 2.8 years
Trial Event rates◊ for key outcomes
Death Stroke or systemic embolic event Hemorrhagic stroke Major bleeding§
DOAC Warfarin Relative effect (95% CI) DOAC Warfarin Relative effect (95% CI) DOAC Warfarin Relative effect (95% CI) DOAC Warfarin Relative effect (95% CI)
RE-LY 110 mg 3.75 4.13 RR 0.91 (0.8-1.03) 1.53 1.69 RR 0.91 (0.74-1.11) 0.12 0.38 RR 0.31 (0.17-0.56) 2.71 3.36 RR 0.80 (0.69-0.93)
150 mg 3.64 4.13 RR 0.88 (0.77-1.00) 1.11 1.69 RR 0.66 (0.53-0.82) 0.10 0.38 RR 0.26 (0.14-0.49) 3.11 3.36 RR 0.93 (0.81-1.07)
ROCKET-AF 4.5 4.9 HR 0.92 (0.82-1.03) 2.1 2.4 HR 0.88 (0.75-1.03) 0.26 0.44 HR 0.59 (0.37-0.93)¥ 3.6 3.4 HR 1.04 (0.9-1.2)¥
ARISTOTLE 3.52 3.94 HR 0.89 (0.80-0.998) 1.27 1.60 HR 0.79 (0.66-0.95) 0.24 0.47 HR 0.51 (0.35-0.75) 2.13 3.09 HR 0.69 (0.6-0.8)
ENGAGE AF-TIMI 48 30 mg 3.80 4.35 HR 0.87 (0.79-0.96) 2.04 1.80 HR 1.13 (0.96-1.34) 0.16 0.47 HR 0.33 (0.22-0.50) 1.61 3.43 HR 0.47 (0.41-0.55)
ENGAGE AF-TIMI 48 60 mg 3.99 4.35 HR 0.92 (0.83-1.01) 1.57 1.80 HR 0.87 (0.73-1.04) 0.26 0.47 HR 0.54 (0.38-0.77) 2.75 3.43 HR 0.80 (0.71-0.91)
Combined results‡ 6.90 7.68 RR 0.90 (0.85-0.95) 3.11 3.79 RR 0.81 (0.73-0.91) 0.44 0.90 RR 0.49 (0.38-0.64) 5.26 6.17 RR 0.86 (0.73-1.0)
DOAC: direct oral anticoagulant; AF: atrial fibrillation; N: number of trial participants; CHADS2: score to estimate risk of stroke with 1 point assigned for each of the following clinical features: history of congestive heart failure, hypertension, age ≥75 years, or diabetes mellitus, and 2 points assigned for prior stroke or transient ischemic attack; INR: international normalized ratio; HR: hazard ratio; RR: relative risk.
* Dose of rivaroxaban was adjusted to 15 mg once daily for renal insufficiency (creatinine clearance 30 to 49 mL/minute [0.5 to 0.82 mL/second]).
¶ Dose of apixaban was adjusted to 2.5 mg twice daily for patients with two or more of: age ≥80 years, body weight ≤60 kg, or renal insufficiency (serum creatinine level ≥1.5 mg/dL [133 micromol/L]).
Δ For patients in either dose group, the dose of edoxaban was reduced by 50% if any of the following characteristics were present: estimated creatinine clearance 30 to 50 mL/minute, body weight ≤60 kg, or concomitant use of verapamil, quinidine, or dronedarone.
◊ For the individual trials, the annual event rate (expressed as %/year) is presented for each outcome. For the meta-analysis, the table provides the absolute event rates (%) during the total study duration, which varied between studies (median follow-up 1.8 to 2.8 years).
§ Major bleeding was variably defined. In RE-LY, it was defined as a reduction in hemoglobin of at least 2 g/dL [20 g/L], transfusion of ≥2 units of blood, or symptomatic bleeding in a critical area or organ. In ROCKET-AF, ARISTOTLE, and ENGAGE AF-TIMI 48, it was defined as fatal bleeding, bleeding at a critical site, or overt bleeding plus fall in hemoglobin of at least 2 g/dL [20 g/L] or transfusion of ≥2 units of blood.
¥ For ROCKET-AF, the results for hemorrhagic stroke and for bleeding are based on an as-treated safety population.
‡ These combined results include data for dabigatran 150 mg twice daily, rivaroxaban 20 mg once daily, apixaban 5 mg twice daily, and edoxaban 60 mg once daily.
Data from:
  1. Connolly SJ, Ezekowitz MD, Eikelbloom YS, et al. Dabigatran versus warfarin in patients with atrial fibrillation; N Engl J Med 2009; 361:1139.
  2. Patel MR, Mahaffey KE, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation; N Engl J Med 2011; 365:883.
  3. Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation; N Engl J Med 2011; 365:981.
  4. Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013; 369:2093.
  5. Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 2014; 383:955.
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