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September 1, 2017Journal of Internal MedicineOpen Access

Standard and reduced doses of dabigatran, rivaroxaban and apixaban for stroke prevention in atrial fibrillation: a nationwide cohort study

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Why the study?

Does the choice of NOAC (dabigatran, rivaroxaban, apixaban) at standard or reduced doses affect the risk of stroke/thromboembolism and bleeding in oral anticoagulant-naïve patients with atrial fibrillation?

Population

31,522 oral anticoagulant-naïve patients with atrial fibrillation initiating NOAC treatment in Denmark

Comparison

Dabigatran, rivaroxaban, or apixaban at standard… vs Direct comparisons between dabigatran…

Design

Cohort

Follow-up

1 year

Key result

Standard and reduced dose NOACs showed similar stroke risks in AF patients, but standard-dose rivaroxaban had a higher major bleeding risk (2.78%) compared to dabigatran (ARD -0.93%).

Authors

LSLaila StærkTGThomas Alexander GerdsGLGregory Y.H. Lip

Discussion

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Overview

Supports caution with standard-dose rivaroxaban for bleeding risk in AF; leaves open optimal NOAC selection pending randomized data.

Key Points

  • This research aims to compare the effectiveness and safety of standard and reduced doses of NOACs in patients with atrial fibrillation.
  • Used Danish nationwide registries to include all oral anticoagulant-naïve AF patients initiating NOAC treatment from 2012 to 2016.
  • Applied multiple Cox regressions to analyze stroke and bleeding risks.
  • Calculated average treatment effects as 1-year standardized differences.
  • 1-year standardized absolute risks of stroke/thromboembolism were 1.73-1.98% for standard doses and 2.51-2.78% for reduced doses.
  • Rivaroxaban had a major bleeding risk of 2.78% (95% CI 2.42-3.17%) compared to dabigatran (-0.93%, 95% CI -1.45% to -0.38%) and apixaban (-0.54%, 95% CI -0.99% to -0.05%).
  • Dabigatran showed a lower intracranial bleeding risk compared to rivaroxaban and apixaban.

Study Design

Type

Cohort (n=31,522)

Multicenter

Yes

Structured PICO

Does the choice of NOAC (dabigatran, rivaroxaban, apixaban) at standard or reduced doses affect the risk of stroke/thromboembolism and bleeding in oral anticoagulant-naïve patients with atrial fibrillation?

P
Population
31,522 oral anticoagulant-naïve patients with atrial fibrillation initiating NOAC treatment, evaluated for 1-year stroke and bleeding risks.
E
Exposure
Dabigatran, rivaroxaban, or apixaban at standard or reduced doses
C
Comparator
Direct comparisons between dabigatran, rivaroxaban, and apixaban at corresponding standard and reduced doses
O
Outcome
1-year standardized absolute risks of stroke/thromboembolism, major bleeding, and intracranial bleedinghard clinical

Main Result

Absolute Risk Reduction: -0.93 (95% CI -1.45–-0.38)

Absolute Risk Reduction: -0.93%

In a nationwide cohort of AF patients, standard and reduced doses of dabigatran, rivaroxaban, and apixaban showed similar effectiveness for stroke prevention, but rivaroxaban was associated with higher major bleeding risk.

Cite This Study

Stærk et al. (2017) conducted a cohort in Atrial fibrillation (n=31,522). Non-vitamin K antagonist oral anticoagulants (dabigatran, rivaroxaban, apixaban) vs. Active comparators (head-to-head NOAC comparisons) was evaluated on Major bleeding (dabigatran vs rivaroxaban standard dose) (Absolute risk difference -0.93%, 95% CI -1.45 to -0.38). Standard and reduced dose NOACs showed similar stroke risks in AF patients, but standard-dose rivaroxaban had a higher major bleeding risk (2.78%) compared to dabigatran (ARD -0.93%).

synapsesocial.com/papers/6a22488ad0d1b96d67ab4f17https://doi.org/10.1111/joim.12683
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