How to perform a cost-effectiveness analysis with surrogate endpoint: renal denervation in patients with resistant hypertension (DENERHTN) trial as an example

Abstract

Whilst much uncertainty exists as to the efficacy of renal denervation (RDN), the positive results of the DENERHTN study in France confirmed the interest of an economic evaluation in order to assess efficiency of RDN and inform local decision makers about the costs and benefits of this intervention. The uncertainty surrounding both the outcomes and the costs can be described using health economic methods such as the non-parametric bootstrap. Internationally, numerous health economic studies using a cost-effectiveness model to assess the impact of RDN in terms of cost and effectiveness compared to antihypertensive medical treatment have been conducted. The DENERHTN cost-effectiveness study was the first health economic evaluation specifically designed to assess the cost-effectiveness of RDN using individual data. Using the DENERHTN results as an example, we provide here a summary of the principle methods used to perform a cost-effectiveness analysis.

Keywords:

• Renal denervation
• cost-effectiveness analysis
• economic evaluation
• resistant hypertension

Disclosure statement

J Bulsei, M Darlington and I Durand-Zaleski have no conflict of interest. M Azizi has received honoraria for advisory board meetings from Vessix, Boston Scientific Corporation, Cordis, Actelion, has received speakers’ honoraria from Cordis, CVRx, Servier; was involved as investigator in Symplicity HTN-2 (Ardian/Medtronic) and Reduce-HTN (Vessix/Boston Scientific Corporation) trials; has received a research grant from Servier.

Collaborators/investigators

Collaborators: H PEREIRA, I HAMDIDOUCHE

Investigators (with the number of patients enrolled and randomized at each center given in parentheses) and committees participated in the DENERHTN trial: Hôpital Européen Georges Pompidou, Paris (31/28) – L Amar, G Bobrie, A Lorthioir, M Monge, J-Y Pagny, PF Plouin, M Sapoval; Hôpital Cardiologique, Lille (20/15) – G Claisse, P Delsart, M Midulla, C Mounier-Vehier; Hôpital de la Croix Rousse and Hôpital Edouard Herriot, Lyon (14/13) – PY Courand, R Dauphin, JP Fauvel, P Lantelme, O Rouvière; Hôpital Saint André and Hôpital Pellegrin, Bordeaux (14/13) – A Cremer, P Gosse, N Grenier, Y Lebras, H Trillaud; Hôpital Arthur Gardiner, Dinard and CHU Rennes (12/12) – T Denolle, C Dourmap-Collas, JF Heautot, A Larralde, F Paillard; Hôpital de la Pitié Salpétrière, Paris (6/5) – P Cluzel, X Girerd, D Rosenbaum; Hôpital Bretonneau, Tours (5/4) – D Alison, JM Halimi; CHU Nancy-Brabois, Nancy (4/1) – M Claudon, B Popovic, P Rossignol, F Zannad; CHU de Grenoble, Grenoble (3/3) – JP Baguet, O Ormezzano, F Thony; CHU de la Timone, Marseille (3/3) – JM Bartoli, B Vaïsse; Hôpital la Milétrie, Poitiers (3/3) – J Drouineau, D Herpin, P Sosner, JP Tasu, S Velasco; Hôpital Lapeyronie and Hôpital Arnaud de Villeneuve, Montpellier (2/2) – J Ribstein, H Vernhet-Kovacsik; CHU Rangueil, Toulouse (2/2) – B Bouhanick, B Chamontin, H Rousseau; Hôpital Avicenne, Bobigny (1/1) – S Le Jeune, M Lopez-Sublet, JJ Mourad; Hôpital Pasteur, Nice (1/1) – L Bellmann, V Esnault, E Ferrari, Scientific Committee – M Azizi (chair), M Sapoval (cochair), G Bobrie, G Chatellier, PF Plouin, F Zannad, JM Halimi, JP Baguet, H Vernhet-Kovacsik, I Durand-Zaleski Data Safety Committee – JP Beregi (chair), M Lièvre, A Persu.

Additional information

Funding

The trial was sponsored by the Assistance Publique-Hôpitaux de Paris and funded by a grant from the French Ministry of Health (Soutien aux Technologies Innovantes et Coûteuses 2011, IC110175).