What does this research mean for the field?

Left atrial appendage closure with the Watchman device is cost-effective compared with aspirin and apixaban for stroke prevention in atrial fibrillation patients with contraindications to warfarin, becoming cost-saving by 8 years. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

February 2, 2016EP EuropaceOpen Access

Cost effectiveness of left atrial appendage closure with the Watchman device for atrial fibrillation patients with absolute contraindications to warfarin

Q: What is the clinical evidence from this study?

Population: Non-valvular atrial fibrillation with contraindications to warfarin. Intervention: Left atrial appendage closure (LAAC) with Watchman device vs. Aspirin and Apixaban. Primary outcome: Incremental cost-effectiveness ratio (ICER) compared with aspirin at 5 years (€16,971 per QALY).

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Key result

Watchman LAAC proves cost-effective vs. aspirin at 5 years and cost-saving vs. DOACs by 8 years.

€16,971 per QALY

Why the study?

Does left atrial appendage closure with the Watchman device improve cost-effectiveness and QALYs compared to aspirin or apixaban in patients with non-valvular AF and contraindications to warfarin?

Structured PICO

Does left atrial appendage closure with the Watchman device improve cost-effectiveness and QALYs compared to aspirin or apixaban in patients with non-valvular AF and contraindications to warfarin?

Population

A Markov cost-effectiveness model from a German healthcare perspective evaluating 70-year-old patients with non-valvular atrial fibrillation and contraindications to warfarin over a 20-year time horizon.

Intervention

Percutaneous left atrial appendage closure (LAAC) with the Watchman device.

Comparator

Aspirin therapy and apixaban therapy.

Outcome

Incremental cost-effectiveness ratio (ICER) and quality-adjusted life years (QALYs) over a 20-year time horizon.

Main Result

Effect estimate: €16,971 per QALY

Left atrial appendage closure with the Watchman device is a cost-effective and cost-saving strategy for stroke risk reduction in patients with non-valvular AF and contraindications to warfarin compared to aspirin and apixaban.

Limitations

Model allowed for only one clinical event per 3-month cycle and extrapolated data out to 20 years.
Based on data from randomized controlled studies which may not represent real-world clinical practice.
Reflects the German healthcare system and costs, which may not be generalizable to other healthcare systems.
Watchman ASAP data used covered only 14.4 months of follow-up and was not powered to assess long-term risk of hemorrhage or myocardial infarction.
Results are specific to the Watchman device and cannot be assumed to represent a class effect for LAAC.
Simplification of reality allowing only one clinical event per 3-month cycle
Extrapolates out to 20 years
Based on RCT data which may not represent real-world clinical practice
Reflects German healthcare system and costs, limiting generalizability
ASAP data only covered 14.4 months of follow-up
Results are specific to the Watchman device and cannot be assumed to represent a class effect

Implication

May support LAAC cost-effectiveness modeling in warfarin-contraindicated AF; leaves open prospective confirmation in real-world cohorts.

Abstract

AIMS: Atrial fibrillation (AF) patients with contraindications to oral anticoagulation have had few options for stroke prevention. Recently, a novel oral anticoagulant, apixaban, and percutaneous left atrial appendage closure (LAAC) have emerged as safe and effective therapies for stroke risk reduction in these patients. This analysis assessed the cost effectiveness of LAAC with the Watchman device relative to apixaban and aspirin therapy in patients with non-valvular AF and contraindications to warfarin therapy. METHODS AND RESULTS: A cost-effectiveness model was constructed using data from three studies on stroke prevention in patients with contraindications: the ASAP study evaluating the Watchman device, the ACTIVE A trial of aspirin and clopidogrel, and the AVERROES trial evaluating apixaban. The cost-effectiveness analysis was conducted from a German healthcare payer perspective over a 20-year time horizon. Left atrial appendage closure yielded more quality-adjusted life years (QALYs) than aspirin and apixaban by 2 and 4 years, respectively. At 5 years, LAAC was cost effective compared with aspirin with an incremental cost-effectiveness ratio (ICER) of €16 971. Left atrial appendage closure was cost effective compared with apixaban at 7 years with an ICER of €9040. Left atrial appendage closure was cost saving and more effective than aspirin and apixaban at 8 years and remained so throughout the 20-year time horizon. CONCLUSIONS: This analysis demonstrates that LAAC with the Watchman device is a cost-effective and cost-saving solution for stroke risk reduction in patients with non-valvular AF who are at risk for stroke but have contraindications to warfarin.

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Cite This Study

Reddy et al. (2016) studied Non-valvular atrial fibrillation with contraindications to warfarin. Left atrial appendage closure (LAAC) with Watchman device vs. Aspirin and Apixaban was evaluated on Incremental cost-effectiveness ratio (ICER) compared with aspirin at 5 years (€16,971 per QALY). Left atrial appendage closure with the Watchman device was cost-effective compared to aspirin at 5 years (ICER €16,971) and became cost-saving and more effective than both aspirin and apixaban at 8 years.

synapsesocial.com/papers/6a1a29ed0fc4dc4e42436b65 https://doi.org/10.1093/europace/euv412