Arrhythmias & electrophysiology
Clinical outcomes in elderly atrial fibrillation patients at increased bleeding risk treated with very low dose vs. regular-dose non-vitamin K antagonist oral anticoagulants: a nationwide cohort study
Authors' conclusion
Use of VLD NOACs was associated with a greater risk of arterial and venous thrombosis, death as well as the composite outcomes, when compared with that of RD NOAC in high-risk elderly AF patients at increased bleeding risk.
Study context
- Population
- Atrial fibrillation (AF) patients aged ≥80 years with CHADS2 score ≥2, similar to ELDERCARE-AF, Taiwan National Health Insurance Research Database (NHIRD), 2012–2019
- Participants
- 7,294 vs 4,151
- Exposure
- Very low dose NOACs vs regular-dose NOACs
- Very low dosage (VLD)n = 7,294
- Regular-dosage (RD)n = 4,151reference
Methodological detailsnationwide, propensity-score stabilized weighting, Main result consistent in on-treatment analysis and accounting for death as a competing risk
- Nationwide
- Propensity-score stabilized weighting
- Main result consistent in on-treatment analysis and accounting for death as a competing risk
Main finding
As reported in the abstract
Ischemic stroke/systemic embolism and major bleeding
- VLD NOAC associated with comparable risk of ischemic stroke/systemic embolism and major bleeding vs RD NOACs
- After propensity-score stabilized weighting (PSSW)
Observational data: associations, not effects.
Further findings
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| MALEs requiring lower limb revascularization or amputation · after PSSW | 1.54 (1.09–2.18) | P = 0.014 | |
| Venous thrombosis · after PSSW | 3.75 (1.56–8.97) | P = 0.003 | |
| All-cause mortality · after PSSW | 1.21 (1.15–1.29) | P < 0.001 | |
| 0.10.31310Hazard ratio (log scale) |
Net clinical outcomes
- VLD NOACs showed worse outcomes in most net clinical outcome (NCO) benefits
NCOs in high-risk subgroups
- Advantage of NCOs for RD over VLD persisted in most high-risk subgroups
- P for interaction > 0.05
Safety
Major bleeding
- Comparable risk of major bleeding, VLD vs RD
- After PSSW
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Clinical outcomes in elderly atrial fibrillation patients at increased bleeding risk treated with very low dose vs. regular-dose non-vitamin K antagonist oral anticoagulants: a nationwide cohort study. Eur Heart J Cardiovasc Pharmacother. Published 14 August 2023. doi:10.
Summarised from the published abstract; every number is checked against it