Routine initiation of DOAC therapy in patients with device-detected subclinical AF yielded an ICER of €105,293 per QALY and is unlikely to be cost-effective.
Is direct oral anticoagulant (DOAC) therapy cost-effective compared to no anticoagulation in patients with device-detected subclinical atrial fibrillation?
Routine initiation of DOAC therapy in all patients with device-detected subclinical AF is unlikely to be cost-effective, though uncertainty remains for patients with very high CHA2DS2-VASc scores.
Effect estimate: ICER €105 293 per QALY
Importance: Anticoagulation for stroke prevention in subclinical, device-detected atrial fibrillation (AF) remains an area of clinical equipoise, and its cost-effectiveness is unknown. Objective: To evaluate the cost-effectiveness of direct oral anticoagulant (DOAC) therapy in patients with device-detected AF. Design, Setting, and Participants: This economic evaluation was a cost-effectiveness analysis using a Markov model comparing initiation of DOAC therapy vs no anticoagulation over a 10-year time horizon. Base-case analyses modeled 10 000 patients per strategy with device-detected subclinical AF, with baseline characteristics and risks of stroke, bleeding, and mortality reflecting those observed in randomized clinical trials. The evaluation was conducted from the health system perspective, with treatment and event costs derived from Nordic health care data. The modeling was conducted on March 10, 2026. Exposure: The associations of DOAC therapy with the risk and severity of clinical events were incorporated into the analysis, based on a meta-analysis of trials evaluating DOAC therapy in subclinical AF. Probabilistic sensitivity analysis also considered the 95% CIs in the reported treatment effect sizes. Main Outcomes and Measures: Incremental quality-adjusted life-years (QALYs), costs, and the incremental cost-effectiveness ratio (ICER; cost difference per QALY gained) from a health system perspective, with 3% annual discounting of both costs and QALYs. Cost-effectiveness was assessed using a €50 000 per QALY willingness-to-pay threshold. Results: The mean age of the 20 000-person simulated cohort was 77 years. In the base case analysis, DOAC therapy was associated with an additional 0.016 QALYs and an incremental cost of €1676 per patient, resulting in an ICER of €105 293 per QALY. In probabilistic sensitivity analysis, DOAC therapy was cost-effective in 35% of simulations and dominated in 38%, with a mean QALY gain of 0.016 per patient, a mean incremental cost of €2883 per patient, and a mean ICER of €176 772. Probabilistic sensitivity analyses by CHA2DS2-VASc (congestive heart failure; hypertension; age ≥75 years; diabetes; prior stroke, transient ischemic attack, or thromboembolism; vascular disease; age 65-74 years; and sex category) score showed probabilities of cost-effectiveness of 31%, 41%, and 52% for patients with scores less than 4, of 4, and greater than 4, respectively. Conclusions and Relevance: This economic evaluation found that routinely initiating DOAC therapy in all patients with device-detected subclinical AF is unlikely to be cost-effective. Whether treatment is cost-effective in patients with very high CHA2DS2-VASc scores is uncertain.
Winstén et al. (Mon,) conducted a other in Device-detected subclinical atrial fibrillation (n=20,000). Direct oral anticoagulant (DOAC) therapy vs. No anticoagulation was evaluated on Incremental quality-adjusted life-years (QALYs), costs, and the incremental cost-effectiveness ratio (ICER) (ICER €105 293 per QALY). Routine initiation of DOAC therapy in patients with device-detected subclinical AF yielded an ICER of €105,293 per QALY and is unlikely to be cost-effective.