Economic evaluation of prolonged and enhanced ECG Holter monitoring in acute ischemic stroke patients

Abstract

Objective: Atrial fibrillation (AF) is a major cause for recurrent stroke, has severe impact on a patient’s health and imposes a high economic burden for society. Current guidelines recommend 24 h ECG monitoring (standard-of-care, SoC) to detect AF after stroke to reduce the risk of future events. However, paroxysmal AF (PAF) is difficult to detect within this period as it occurs infrequently and unpredictably. In a randomized controlled trial (Find-AF_RANDOMISED), prolonged and enhanced Holter ECG monitoring (EPM) revealed a significantly higher detection rate of AF compared to SoC, although its cost-effectiveness has not yet been investigated.

Methods: Based on the data of FIND-AF_RANDOMISED, an economic evaluation was conducted. One group received EPM for 10 days after the event, and at 3 and 6 months; the other group received SoC. Healthcare resource use and quality of life (QoL) data were measured at baseline, and after 6 and 12 months. Incremental costs and quality-adjusted life years (QALYs) between both groups were compared. Non-parametric bootstrapping and one-way-sensitivity analyses were performed.

Results: A total of 281 patients with healthcare resource use and QoL data for all measurement points were considered in the economic evaluation (complete case analysis, CCA). The CCA yielded nonsignificant 315€ lower mean costs and 0.0013 less QALYs for patients receiving EPM with no statistically significant differences in any cost categories. Sensitivity analyses revealed robust results. Bootstrapping the results indicated moderate probability of cost-effectiveness.

Conclusions: EPM yielded reduced not significantly different costs without affecting QoL and may be a useful strategy to detect PAF in acute ischemic stroke patients in time.

Keywords:

• Atrial fibrillation
• secondary prevention
• cost–benefit analysis
• quality-adjusted life years
• stroke

Transparency

Declaration of funding

The trial is sponsored by the IFS (Institut für anwendungsorientierte Forschung und klinische Studien) and supported by Boehringer Ingelheim with an unrestricted grant.

Declaration of financial/other relationships

K.G. has disclosed that he has received personal fees from Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo and Pfizer. G.F.H. has disclosed that he has participated as local PI in the clinical trials RESPECT-ESUS and MOnDafis. P.K. has disclosed that he has received honoraria for participation in clinical trials, contributions to advisory boards or oral presentations from: Abbvie, Bayer Vital, Biogen, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Genzyme, Novartis, Pfizer, TEVA and UCB. G.G. has disclosed that he has received remuneration from the University Medicine Göttingen for statistical analysis and work in the steering committee of the Find-AF_RANDOMISED trial. M.W.K. has disclosed that he obtained a travel grant from Pfizer. R.W. has disclosed that he has been an investigator or consultant for, or received fees from Bayer, Berlin Chemie, Bristol-Myers-Squibb, Boehringer Ingelheim, Boston Scientific, CVRx, Gilead, Johnson & Johnson, Medtronic, Novartis, Pfizer, Relypsa, Sanofi and Servier since 2003 outside the submitted work; he received research grants from Boehringer Ingelheim, European Union and Bundesministerium für Bildung und Forschung (BMBF). J.L. has disclosed that he has received honoraria for oral talks of Advisory Boarding from the following companies: Bayer Healthcare, Boehringer Ingelheim, Stryker, Pfizer, Daiichi Sankyo. No potential conflict of interest was reported by the other authors. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

None reported.