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Article Dans Une Revue European Heart Journal: Acute Cardiovascular Care Année : 2022

Diuretic vs. placebo in intermediate-risk acute pulmonary embolism: a randomized clinical trial

1 IMRB - Institut Mondor de Recherche Biomédicale
2 I2MC - Institut des Maladies Métaboliques et Cardiovasculaires
3 INSERM - Institut National de la Santé et de la Recherche Médicale
4 AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
5 Innovte - F-Crin INvestigation Network On Venous Thrombo-Embolism [CHU Saint-Etienne]
6 Department of Cardiology, University Hospital Jean Minjoz
7 PCVP / CARDIO - Marqueurs pronostiques et facteurs de régulations des pathologies cardiaques et vasculaires - UFC ( UR 3920)
8 Departement de Cardiologie [Hôpital Saint-Joseph - Marseille]
9 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
10 INP - Institut de neurophysiopathologie
11 CHRU Brest - Centre Hospitalier Régional Universitaire de Brest
12 UBO - Université de Brest
13 DMIP - Brest - Département de Médecine Interne et Pneumologie [Brest]
14 CHU Montpellier
15 UM - Université de Montpellier
16 CHU Bordeaux
17 UB - Université de Bordeaux
18 SAINBIOSE - Santé Ingénierie Biologie Saint-Etienne
19 Service Cardiologie [CHU Toulouse]
20 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
21 T2i - Transplantation, Immunologie, Inflammation [Tours]
22 CHU Henri Mondor [Créteil]
23 Hôpital Henri Mondor
24 HEGP - Hôpital Européen Georges Pompidou [APHP]
25 CIC 1418 - CIC - HEGP
26 Clinical Research Unit (URC Mondor), Hôpitaux Universitaires Henri-Mondor AP-HP
27 U955 Inserm - UPEC - IMRB - CEPIA/"Clinical Epidemiology And Ageing : Geriatrics, Primary Care and Public Health" [Créteil]
Anne Bernard
Gwenole Rohel
  • Fonction : Auteur
Bernard Tardy
  • Fonction : Auteur
  • PersonId : 1346259
Tabassome Simon
  • Fonction : Auteur
Muriel Paul

Résumé

Abstract Aims The role of diuretics in patients with intermediate-risk pulmonary embolism (PE) is controversial. In this multicentre, double-blind trial, we randomly assigned normotensive patients with intermediate-risk PE to receive either a single 80 mg bolus of furosemide or a placebo. Methods and results Eligible patients had at least a simplified PE Severity Index (sPESI) ≥1 with right ventricular dysfunction. The primary efficacy endpoint assessed 24 h after randomization included (i) absence of oligo-anuria and (ii) normalization of all sPESI items. Safety outcomes were worsening renal function and major adverse outcomes at 48 hours defined by death, cardiac arrest, mechanical ventilation, or need of catecholamine. A total of 276 patients underwent randomization; 135 were assigned to receive the diuretic, and 141 to receive the placebo. The primary outcome occurred in 68/132 patients (51.5%) in the diuretic and in 49/132 (37.1%) in the placebo group (relative risk = 1.30, 95% confidence interval 1.04–1.61; P = 0.021). Major adverse outcome at 48 h occurred in 1 (0.8%) patients in the diuretic group and 4 patients (2.9%) in the placebo group (P = 0.19). Increase in serum creatinine level was greater in diuretic than placebo group [+4 µM/L (−2; 14) vs. −1 µM/L (−11; 6), P < 0.001]. Conclusion In normotensive patients with intermediate-risk PE, a single bolus of furosemide improved the primary efficacy outcome at 24 h and maintained stable renal function. In the furosemide group, urine output increased, without a demonstrable improvement in heart rate, systolic blood pressure, or arterial oxygenation. ClinicalTrials.gov identifier NCT02268903.

Dates et versions

hal-03882615 , version 1 (02-12-2022)

Identifiants

Citer

Pascal Lim, Clément Delmas, Olivier Sanchez, Nicolas Meneveau, Roger Rosario, et al.. Diuretic vs. placebo in intermediate-risk acute pulmonary embolism: a randomized clinical trial. European Heart Journal: Acute Cardiovascular Care, 2022, 11 (1), pp.2-9. ⟨10.1093/ehjacc/zuab082⟩. ⟨hal-03882615⟩
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