Last updated on April 2018

The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study


Brief description of study

Venous thromboembolism (VTE) is a frequent condition, affecting 1.8 per 1,000 people every year. Admission to hospital is one of the main risk factors for VTE, and could account for up to 20% of all VTE, making VTE prevention in admitted patients an appealing option to reduce VTE global burden.

The landmark MEDENOX trial and others demonstrated the efficacy of low molecular weight heparins (LMWH) in reducing a composite outcome of symptomatic and asymptomatic events, the latter accounting for the vast majority of events.

Publication of these trials led to the implementation of thromboprophylaxis policies in hospitals, which acceptance has been variable. More recently, the use of thromboprophylaxis has been challenged after the publication of 1) a negative trial that used 'death from any cause' as main outcome, 2) a systematic review showing the lack of a clear efficacy on the risk of pulmonary embolism or death, 3) negative trials using new oral anticoagulants, 4) the last version of the American College of Chest Physicians Guidelines, focusing on symptomatic events only, downgraded its recommendation for thromboprophylaxis in medical patients to a 1B recommendation, restricting its use to patients 'at increased risk of thrombosis' and recommending against the use of thromboprophylaxis in patients at low risk of thrombosis, patients bleeding or at high risk of bleeding.

However, a limitation of this interpretation of the data is that in most trials, patients with screened asymptomatic events were treated with anticoagulants, preventing the occurrence of symptomatic events during follow-up. Moreover, subgroup analyses showed that elderly patients were at high risk of thrombosis in these trials, and that LMWH could be particularly efficient in this subgroup of patients. Conversely, their risk of bleeding is also higher than in younger patients and the current trials were not powered to detect a difference in the bleeding risk between groups. Finally, the diagnostic and therapeutic management of VTE is more challenging in the elderly. Therefore, we planned a randomized controlled trial on the efficacy of LMWH for the prevention of symptomatic VTE in elderly patients.

Clinical Study Identifier: NCT02379806

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Albert TRINH-DUC, Dr

Centre Hospitalier d'Agen
Agen, France
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Pierre-Marie ROY, Pr

CHU Angers
Angers, France
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Cécile BAUDEMONT, Dr

CH Angoul me
Angouleme, France
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Sandro AQUILANTI, Dr

CH d'Arras
Arras, France
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Marilucy LOPEZ-SUBLET, Dr

CHU Avicenne (APHP)
Bobigny, France
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Anne BOURGARIT-DURAND, Pr

H pital Jean Verdier (APHP)
Bondy, France
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Fabrice BONNET, Pr

CHU Bordeaux
Bordeaux, France
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Florence VERGNE, Dr

HIA Clermont-Tonnerre
Brest, France
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Karine LACUT, Pr

CHRU Brest
Brest, France
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Dominique MOTTIER, PU-PH

CHU Clermont-Ferrand
Clermont-Ferrand, France
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Isabelle MAHE, Pr

CH Louis Mourier de Colombes
Colombes, France
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Nicolas FALVO, Dr

CHU de Dijon
Dijon, France
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Laurence BOUILLET, Pr

CHU Grenoble
Grenoble, France
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Geneviève MAGADUR-JOLY, Dr

CH Guingamp
Guingamp, France
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Yves BLEHER, Dr

CHD Vend e
La Roche Sur Yon, France
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Nicolas VELMANS, Dr

CH Lannion-Trestel
Lannion, France
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Jean DOUCET, Pr

CHU Rouen
Le Petit Quevilly, France
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Marc LAMBERT, Pr

CHRU de Lille
Lille, France
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Dominique MOTTIER, PU-PH

H pital Saint-Vincent de Paul
Lille, France
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Pascale VERGNE-SALLE, Pr

CHU Limoges
Limoges, France
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Dominique MOTTIER, PU-PH

CH Bretagne Sud
Lorient, France
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Hélène DESMUR, Dr

H pital Edouard Herriot - CHU Lyon
Lyon, France
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Claire GRANGE, Pr

CHU Lyon
Lyon, France
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Patrick VILLANI, Pr

H pital de la Timone - AP-HM
Marseille, France
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Dominique MOTTIER, PU-PH

HIA Laveran Marseille
Marseille, France
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Isabelle QUERE, Pr

CHU de Montpellier
Montpellier, France
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Thomas BEHAR, Dr

Clinique Mutualiste M dico-chirurgical "Beau Soleil"
Montpellier, France
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Yannick LAMBERT, Dr

CH des Pays de Morlaix
Morlaix, France
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Tahar CHOUIHED, Dr

CHU Nancy
Nancy, France
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Dominique EL KOURI, Pr

CHU de Nantes
Nantes, France
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Olivier GUERIN, Pr

H pital Cimiez - CHU Nice
Nice, France
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Dominique MOTTIER, PU-PH

H pital Pasteur -CHU Nice
Nice, France
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Guy MEYER, Pr

HEGP - Paris
Paris, France
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Jean-François BERGMANN, Pr

H pital Lariboisiere
Paris, France
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Arsène MEKINIAN, Dr

H pital Saint-Antoine (APHP)
Paris, France
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Olivier HANON, Pr

H pital Broca- APHP
Paris, France
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Claire LEJEUNNE, Pr

H pita Cochin - APHP
Paris, France
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Pierre CHARLES, Dr

Institut Mutualiste Montsouris
Paris, France
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Sébastien BOUTREUX, dr

CH P rigueux
Perigueux, France
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Marc PACCALIN, Pr

CHU Poitiers
Poitiers, France
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Nadine CASTELLA, Dr

CH de Cornouaille - Quimper
Quimper, France
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Guillaume ARMENGOL, Dr

H pital Bois Guillaume - CHU Rouen
Rouen, France
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Michel ANDRE, Dr

CHU La R union - Site F lix Guyon
Saint Denis, France
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Hervé DECOUSUS, Pr

CHU de Saint Etienne
Saint Etienne, France
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Eric HUCHOT, Dr

CHU La R union - site du GHSR
Saint Pierre, France
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Dominique STEPHAN, Pr

CHRU Strasbourg- Service HTA et Maladies Vasculaires
Strasbourg, France
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Dominique MOTTIER, PU-PH

CHU Strasbourg - Service de M decine Interne
Strasbourg, France
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Antoine ELIAS, Pr

CH Intercommunal Toulon La Seyne sur Mer
Toulon, France
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Henri BERARD, Dr

HIA Sainte-Anne Toulon
Toulon, France
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Dominique MOTTIER, PU-PH

CH de Vernon
Vernon, France
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Alain-Eric DUBART, Dr

CH B thune
Béthune, France
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Sébastien LAMACHE, Dr

CH Public du Cotentin
Cherbourg, France
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Bouchra LAMIA, Pr

Groupe Hospitalier Le Havre
Le Havre, France
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Marc RIGHINI, Pr

H pitaux Universitaires de Gen ve
Genève, Switzerland
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