Enoxaparin versus Placebo to Prevent Symptomatic Venous Thromboembolism in Hospitalized Older Adult Medical Patients

• DOI: 10.1056/evidoa2200332
• Publication Date: 2023-06-27T15:08:28Z
• Authors: Dominique Mottier; Philippe Girard; Francis Couturaud; Karine Lacut; Emmanuelle Le Moigne; Nicolas Paleiron; Dewi Guellec; Olivier Sanchez; Virginie Cogulet; Silvy Laporte; Gisèle Marhic; Patrick Mismetti; Emilie Presles; Helia Robert-Ebadi; Isabelle Mahé; Ludovic Plaisance; Jean-Luc Reny; Pauline Darbellay...; Clémence Cuvelier; Catherine Le Henaff; Yannick Lambert; Marc Danguy des D...; Claire Rousseau L...; Sébastien Boutreux; Yves Bleher; Romain Decours; Albert Trinh-Duc; Guillaume Armengol; Ygal Benhamou; Aurélie Daumas; Sarah-Lou Guyot; Hugo De Carvalho; Bouchra Lamia; Marc Righini; Guy Meyer; Grégoire Le Gal
• Keywords: Cumulative incidence; Discontinuation; Clinical endpoint

BACKGROUND: Admission to the hospital is a major risk factor for development of venous thromboembolism (VTE). Whether thromboprophylaxis with low-molecular-weight heparin prevents symptomatic VTE in medically ill, hospitalized older adults remains debated. METHODS: In prospective, randomized, placebo-controlled, double-blind, multicenter trial, (>70 years age) acute medical conditions were randomly assigned receive 40 mg day (enoxaparin) or placebo 6 14 days. The primary efficacy outcome was cumulative incidence (distal proximal deep vein thrombosis, fatal nonfatal pulmonary embolism) at 30 safety bleeding. Secondary outcomes included and 90 RESULTS: trial prematurely discontinued September 2020, 5 after enrollment began, because drug supply issues. By time discontinuation, 2559 patients had been 47 centers. Median age 82 60% female. intention-to-treat population, occurred 22 out 1278 (cumulative incidence, 1.8%) enoxaparin group 27 1263 2.2%) difference, −0.4 percentage points; 95% confidence interval, −1.5 0.7), no significant difference (P=0.46). bleeding 0.9% 1.0% group. At days there emboli 25 group; all 39 embolism events resulted readmission and/or death, deaths from 11 CONCLUSIONS: This did not demonstrate that reduced 1 month. Because discontinued, larger trials are needed definitively address this question. (Funded by French Ministry Health Programme Hospitalier de Recherche Clinique, grant number PHRC-N-13-0283; ClinicalTrials.gov number, NCT02379806.)