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Specialist Advice Support for Management of Severe Hereditary Angioedema Attacks: A Multicenter Cluster-Randomized Controlled Trial

Bernard Floccard 1 Gisele Kanny 2 Elinor Baker Ludovic Martin 3 Eric Vicaut 4 Frederic Adnet 5 Nicolas Javaud 6 Olivier Fain 7, 8, 9, 10 Isabelle Durand-Zaleski 11 David Launay 12, 13, 14 Laurence Bouillet 15 Anne Gompel 16, 17 Alain Sobel Maguy Woimant 5 Hasina Rabetrano 11 Tomislav Petrovic Frédéric Lapostolle 5, 18 Isabelle Boccon-Gibod 19, 15 Paul-Georges Reuter 20 Philippe Bertrand 21 Malha Mezaour 22 Brigitte Coppere 1
1 Hôpital Edouard Herriot [CHU - HCL]
2 UL - Université de Lorraine
3 MITOVASC - Physiopathologie Cardiovasculaire et Mitochondriale
4 Hôpitaux Universitaire Saint-Louis, Lariboisière, Fernand-Widal
5 Hôpital avicenne
6 Hôpital Jean Verdier [AP-HP]
7 Service de Médecine Interne [CHU Saint-Antoine]
8 DHU i2B - Service de rhumatologie, inflammation-immunopathologie- biothérapie [CHU Saint-Antoine]
9 SU FM - Sorbonne Université - Faculté de Médecine
10 CR Saint-Antoine - Centre de Recherche Saint-Antoine
11 Hôpital Hôtel-Dieu [Paris]
12 LIRIC - Lille Inflammation Research International Center
13 Département de Médecine interne et d'Immunologie clinique [CHRU Lille]
14 Centre national de référence des maladies auto-immunes systémiques rares (sclérodermie systémique) [Lille]
15 Clinique de médecine interne
16 Unité de Gynécologie
17 CHU Cochin [AP-HP]
18 AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
19 Centre National de Reference des Angioedemes à Kinines
20 SAMU 93 - UF Recherche-Enseignement-Qualité [Bobigny]
21 Membre du Réseau Epigénétique du Cancéropôle Grand-Ouest
22 CIAMS - Complexité, Innovation, Activités Motrices et Sportives
Abstract :

STUDY OBJECTIVE: Hereditary angioedema is a rare disease associated with unpredictable, recurrent attacks of potentially life-threatening edema. Management of severe attacks is currently suboptimal because emergency medical teams are often unaware of new specific treatments. The objective of this trial is to test whether a dedicated national telephone care-management strategy would reduce resource use during severe hereditary angioedema attacks.

METHODS: We conducted a cluster-randomized multicenter prospective trial of patients with a documented diagnosis of hereditary angioedema (type I, II or FXII hereditary angioedema). Participants were enrolled between March 2013 and June 2014 at 8 participating reference centers. The randomized units were the reference centers (clusters). Patients in the intervention arm were given a national free telephone number to call in the event of a severe attack. Emergency physicians in the SOS-hereditary angiœdema (SOS-HAE) call center were trained to advise or prescribe specific treatments. The primary outcome was number of admissions for angioedema attacks. Economic evaluation was also performed.

RESULTS: We included 100 patients in the SOS-HAE group and 100 in the control group. During the 2 years, there were 2,368 hereditary angioedema attacks among 169 patients (85%). Mean number of hospital admissions per patient in the 2-year period was significantly greater in the usual-practice group (mean 0.16 [range 0 to 2] versus 0.03 [range 0 to 1]); patient risk difference was significant: -0.13 (95% confidence interval -0.22 to -0.04; P=.02). Probabilistic sensitivity graphic analysis indicated a trend toward increased quality-adjusted life-years in the SOS-HAE group.

CONCLUSION: A national dedicated call center for management of severe hereditary angioedema attacks is associated with a decrease in hospital admissions and may be cost-effective if facilities and staff are available to deliver the intervention alongside existing services.

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https://hal.univ-angers.fr/hal-02616882
Contributeur : Okina Université d'Angers <>
Soumis le : lundi 25 mai 2020 - 03:35:47
Dernière modification le : mercredi 14 octobre 2020 - 04:15:00

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UNIV-ANGERS | HCL | RIIP | HEH | U938 | UNIV-LORRAINE | UNIV-ORLEANS | UNIV-LILLE | SU-MEDECINE | CNRS | CARDIOVASCULAR-MARKERS-IN-STRESSED-CONDITIONS | UNIV-PARIS13 | UNIV-PARIS5 | UNIV-PARIS7 | UP-SANTE | MITOVASC | USPC | SORBONNE-UNIVERSITE | UGA | UNIV-PARIS-SACLAY | UNIV-PARIS

Citation

Bernard Floccard, Gisele Kanny, Elinor Baker, Ludovic Martin, Eric Vicaut, et al.. Specialist Advice Support for Management of Severe Hereditary Angioedema Attacks: A Multicenter Cluster-Randomized Controlled Trial. Annals of Emergency Medicine, Elsevier, 2018, 72 (2), pp.194-203.e1. ⟨10.1016/j.annemergmed.2018.01.053⟩. ⟨hal-02616882⟩

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