Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 May 9;19(1):84.
doi: 10.1186/s12931-018-0796-x.

Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study)

Julie Bulsei  1 , Sylvie Leroy  2 , Jeanne-Marie Perotin  3 , Hervé Mal  4 , Charles-Hugo Marquette  2 , Hervé Dutau  5 , Arnaud Bourdin  6 , Jean-Michel Vergnon  7 , Christophe Pison  8 , Romain Kessler  9 , Vincent Jounieaux  10 , Mathieu Salaün  11 , Armelle Marceau  4 , Sylvain Dukic  12 , Coralie Barbe  13 , Margaux Bonnaire  14 , Gaëtan Deslee  3 , Isabelle Durand-Zaleski  15 ; REVOLENS study group
Collaborators, Affiliations
Randomized Controlled Trial

Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study)

Julie Bulsei et al. Respir Res. .

Abstract

Background: The REVOLENS study compared lung volume reduction coil treatment to usual care in patients with severe emphysema at 1 year, resulting in improved quality-adjusted life-year (QALY) and higher costs. Durability of the coil treatment benefit and its cost-effectiveness at 2 years are now assessed.

Methods: After one year, the REVOLENS trial's usual care group patients received coil treatment (second-line coil treatment group). Costs and QALYs were assessed in both arms at 2 years and an incremental cost-effectiveness ratio in cost per QALY gained was calculated. The uncertainty of the results was estimated by probabilistic bootstrapping.

Results: The average cost of coil treatment in both groups was estimated at €24,356. The average total cost at 2 years was €9655 higher in the first-line coil treatment group (p = 0.07) and the difference in QALY between the two groups was 0.127 (p = 0.12) in favor of first-line coil treatment group. The 2-year incremental cost-effectiveness ratio (ICER) was €75,978 / QALY. The scatter plot of the probabilistic bootstrapping had 92% of the replications in the top right-hand quadrant.

Conclusion: First-line coil treatment was more expensive but also more effective than second-line coil treatment at 2 years, with a 2-year ICER of €75,978 / QALY.

Trial registration: ClinicalTrials.gov Identifier NCT01822795 .

Keywords: Coil treatment; Cost-effectiveness; QALY; Severe emphysema.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

The Ethics Committee of Dijon Est I and the French Agency for Medicines and Health Products Health approved the study protocol.

Competing interests

Hervé Mal received honorarium from Boehringer, Bayer, Roche, Astellas, Chiesi, Actellion, Pfizer, Novartis, GSK outside the submitted work; Charles Hugo Marquette has been involved as investigators in previous studies sponsored by BTG/PneumRx, and received travel reimbursements and speaker fees for educational sessions and consulting from BTG/PneumRx; Hervé Dutau received travel reimbursements and speaker fees for educational sessions and consulting from BTG/PneumRx; Arnaud Bourdin received honorarium from Astra Zeneca, GSK, Boehringer, Novartis, Teva, Chiesi, Actellion, Gilead, Roche outside the submitted work; Jean Michel Vergnon received travel reimbursements and speaker fees for educational sessions from BTG/PneumRx; Christophe Pison received honorarium from BTG/PneumRx and his hospital funds to conduct trials from Nuvaira, PulmonX, BTG/PneumRx; Vincent Jounieaux received travel reimbursements and speaker fees for educational sessions and consulting from BTG/PneumRx; Armelle Marceau received honorarium from BTG/PneumRx; Gaëtan Deslée has been involved as investigator in previous studies sponsored by BTG/PneumRx, and received travel reimbursements and speaker fees for educational sessions and consulting from BTG/PneumRx; Sylvie Leroy, Jeanne Marie Perotin, Romain Kessler, Mathieu Salaün, Margaux Bonnaire, Sylvain Dukic, Coralie Barbe, Isabelle Durand-Zaleski indicated no conflicts of interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the study (CONSORT). a The reasons for not performing bilateral treatment were death before second treatment (n=1), anaphylactic shock at induction of anesthesia for the second coil treatment (n=1) (further analyses demonstrated allergy to penicillin), and pneumonia after the first coil treatment leading to unwillingness of the patient to undergo a second coil treatment (n=1). Two patients with unilateral coil treatment at 3-month follow-up were treated with a contralateral coil treatment at 12 and 18 months post-randomisation. b These two patients were alive at 12 months, but did not come for the planned visit at 12 months, and were considered for subsequent assessment at 24 months. c Bilateral treatment not performed because of pneumothorax (n=1), pneumonia (n=2) or death (n=1). One patient was treated with a contralateral coil treatment at 27 months post first treatment. d One systolic pulmonary artery pressure > 50 mmHg and one anticoagulant therapy which could not be stopped for coil treatment and also active smoking.e 1 patient moved abroad and two patients refused to come back for the follow-up
Fig. 2
Fig. 2
Utilities during the 2-years follow-up period for both groups. The total QALYs in each group are represented by the area under the curves and the QALY difference between the 2 groups by the area between the curves
Fig. 3
Fig. 3
Scatter plot of incremental cost and effectiveness of first-line coil treatment compared to second-line coil treatment The set of ICERs estimated by the non-parametric bootstrap are presented by the cloud of points on the cost-effectiveness plane.
Fig. 4
Fig. 4
Cost-effectiveness acceptability curve showing the probability that first-line coil treatment is cost-effective compared to second-line coil treatment
See this image and copyright information in PMC

References

    1. Shah PL, Herth FJ, van Geffen WH, Deslee G, Slebos D-J. Lung volume reduction for emphysema. Lancet Respir Med. 2017;5:147–156. doi: 10.1016/S2213-2600(16)30221-1. - DOI - PubMed
    1. Makris D, Leroy S, Pradelli J, Benzaquen J, Guenard H, Perotin J-M, Zakynthinos S, Zakynthinos E, Deslee G, Marquette CH. Changes in dynamic lung mechanics after lung volume reduction coil treatment of severe emphysema. Thorax 2017. 10.1136/thoraxjnl-2017-210118. - PubMed
    1. Shah PL, Zoumot Z, Singh S, Bicknell SR, Ross ET, Quiring J, Hopkinson NS, Kemp SV, RESET trial Study group. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respir Med. 2013; 1: 233–240. - PubMed
    1. Deslée G, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Thiberville L, Leroy S, Marceau A, Laroumagne S, Mallet JP, Dukic S, Barbe C, Bulsei J, Jolly D, Durand-Zaleski I, Marquette CH, REVOLENS Study Group Lung volume reduction coil treatment vs usual Care in Patients with Severe Emphysema: the REVOLENS randomized clinical trial. JAMA. 2016;315:175–184. doi: 10.1001/jama.2015.17821. - DOI - PubMed
    1. Sciurba FC, Criner GJ, Strange C, Shah PL, Michaud G, Connolly TA, Deslée G, Tillis WP, Delage A, Marquette C-H, Krishna G, Kalhan R, Ferguson JS, Jantz M, Maldonado F, McKenna R, Majid A, Rai N, Gay S, Dransfield MT, Angel L, Maxfield R, Herth FJF, Wahidi MM, Mehta A, Slebos D-J, RENEW Study Research Group Effect of endobronchial coils vs usual care on exercise tolerance in patients with severe emphysema: the RENEW randomized clinical trial. JAMA. 2016;315:2178–2189. doi: 10.1001/jama.2016.6261. - DOI - PubMed

Publication types

Associated data

LinkOut - more resources