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Conflicting findings between the Mitra-Fr and the Coapt trials: Implications regarding the cost-effectiveness of percutaneous repair for heart failure patients with severe secondary mitral regurgitation

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  • Xavier Armoiry
  • Jean-François Obadia
  • Peter Auguste
  • Martin Connock

Abstract

Purpose: Two randomized controlled trials (RCTs), Mitra-Fr and Coapt, evaluating the benefit of percutaneous repair (PR) for heart failure (HF) patients with severe mitral regurgitation, have led to conflicting results. We aimed to evaluate the impact of these trial results on the cost-effectiveness of PR using effectiveness inputs from the two RCTs. Methods: We developed a time varying Markov type model with three mutually exclusive health states: alive without HF hospitalisation, alive with HF hospitalisation, and dead. Clinically plausible extrapolations beyond observed data were obtained by developing parametric modelling for overall survival and HF hospitalisations using published data from each trial. We adopted the perspective of the French Health System and used a 30-year time horizon. Results were expressed as € / quality-adjusted life year (QALY) gained using utility inputs from literature. Findings: Results are presented using treatment efficacy measures from Mitra-F and Coapt trials respectively. With the Mitra-Fr data, after annual discounting, the base case model generated an incremental 0.00387 QALY at a cost of €25,010, yielding an incremental cost effectiveness ratio (ICER) of €6,467,032 / QALY. The model was sensitive to changes made to model inputs. There was no potential of PR being cost-effective. Implications: Cost effectiveness results were conflicting; reconciling differences between trials is a priority and could promote optimal cost effectiveness analyses and resource allocation.

Suggested Citation

  • Xavier Armoiry & Jean-François Obadia & Peter Auguste & Martin Connock, 2020. "Conflicting findings between the Mitra-Fr and the Coapt trials: Implications regarding the cost-effectiveness of percutaneous repair for heart failure patients with severe secondary mitral regurgitati," PLOS ONE, Public Library of Science, vol. 15(11), pages 1-12, November.
    • Handle: RePEc:plo:pone00:0241361
    DOI: 10.1371/journal.pone.0241361
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    References listed on IDEAS

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    1. Gian Luca Di Tanna & Anna Bychenkova & Frank O’Neill & Heidi S. Wirtz & Paul Miller & Briain Ó Hartaigh & Gary Globe, 2019. "Evaluating Cost-Effectiveness Models for Pharmacologic Interventions in Adults with Heart Failure: A Systematic Literature Review," PharmacoEconomics, Springer, vol. 37(3), pages 359-389, March.
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    4. Anders Alexandersson, 2004. "Graphing confidence ellipses: An update of ellip for Stata 8," Stata Journal, StataCorp LP, vol. 4(3), pages 242-256, September.
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