Alexandre Mebazaa1, Theodore E Spiro2, Harry R Büller2, Lloyd Haskell2, Dayi Hu2, Russell Hull2, Geno Merli2, Sebastian W Schellong2, Alex C Spyropoulos2, Victor F Tapson2, Yoriko De Sanctis2, Alexander T Cohen2. 1. From Université Paris Diderot, PRES Sorbonne Paris Cité and Department of Anesthesiology and Critical Care Medicine, Saint Louis Lariboisière University Hospitals, U942 Inserm, Paris, France (A.M.); Bayer HealthCare Pharmaceuticals Inc, Montville, NJ (T.E.S., Y.D.S.); Academic Medical Center, Amsterdam, The Netherlands (H.R.B.); Janssen Research & Development LLC, Raritan, NJ (L.H.); People's Hospital of Peking University, Beijing, China (D.H.); Foothills Hospital, Calgary, Alberta, Canada (R.H.); Thomas Jefferson Medical Center, Philadelphia, PA (G.M.); Dresden-Friedrichstadt Hospital, Dresden, Germany (S.W.S.); Hofstra North Shore-LIJ School of Medicine, Manhasset, NY (A.C.S.); Duke University Medical Center, Durham, NC (V.F.T.); and King's College Hospital, London, UK (A.T.C.). alexandre.mebazaa@lrb.aphp.fr. 2. From Université Paris Diderot, PRES Sorbonne Paris Cité and Department of Anesthesiology and Critical Care Medicine, Saint Louis Lariboisière University Hospitals, U942 Inserm, Paris, France (A.M.); Bayer HealthCare Pharmaceuticals Inc, Montville, NJ (T.E.S., Y.D.S.); Academic Medical Center, Amsterdam, The Netherlands (H.R.B.); Janssen Research & Development LLC, Raritan, NJ (L.H.); People's Hospital of Peking University, Beijing, China (D.H.); Foothills Hospital, Calgary, Alberta, Canada (R.H.); Thomas Jefferson Medical Center, Philadelphia, PA (G.M.); Dresden-Friedrichstadt Hospital, Dresden, Germany (S.W.S.); Hofstra North Shore-LIJ School of Medicine, Manhasset, NY (A.C.S.); Duke University Medical Center, Durham, NC (V.F.T.); and King's College Hospital, London, UK (A.T.C.).
Abstract
BACKGROUND: Whether heart failure (HF) increases the risk of venous thromboembolism (VTE) is not well established. In the phase III MAGELLAN (Multicenter, rAndomized, parallel Group Efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically iLL patients comparingrivaroxabAN with enoxaparin) trial, extended-duration rivaroxaban was compared with standard-duration enoxaparin followed by placebo for VTE prevention in 8101 hospitalized acutely ill patients with or without HF. The aim of this analysis was to evaluate the relationship between HF severity and the risk of VTE in MAGELLAN patients. METHODS AND RESULTS:Hospitalized patients diagnosed with HF were included according to New York Heart Association class III or IV at admission (n=2593). HF severity was determined by N-terminal probrain natriuretic peptide (NT-proBNP) plasma concentrations (median 1904 pg/mL). Baseline plasma D-dimer concentrations ranged from 0.6 to 1.7 μg/L for the less and more severe HF subgroups. Patients with more severe HF had a greater incidence of VTE versus patients with less severe HF, with a significant trend up to Day 10 (4.3% versus 2.2%; P=0.0108) and Day 35 (7.2% versus 4.1%; P=0.0150). Multivariable analysis confirmed that NT-proBNP concentration was associated with VTE risk up to Day 10 (P=0.017) and D-dimer concentration with VTE risk up to Day 35 (P=0.005). The association between VTE risk and HF severity that was observed in the enoxaparin/placebo group was not seen in the extended-duration rivaroxaban group. CONCLUSIONS:Patients with more severe HF, as defined by high NT-proBNP plasma concentration, were at increased risk of VTE. NT-proBNP may be useful to identify high short-term risk, whereas elevated D-dimer may be suggestive of high midterm risk. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00571649.
RCT Entities:
BACKGROUND: Whether heart failure (HF) increases the risk of venous thromboembolism (VTE) is not well established. In the phase III MAGELLAN (Multicenter, rAndomized, parallel Group Efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically iLL patients comparing rivaroxabAN with enoxaparin) trial, extended-duration rivaroxaban was compared with standard-duration enoxaparin followed by placebo for VTE prevention in 8101 hospitalized acutely ill patients with or without HF. The aim of this analysis was to evaluate the relationship between HF severity and the risk of VTE in MAGELLAN patients. METHODS AND RESULTS: Hospitalized patients diagnosed with HF were included according to New York Heart Association class III or IV at admission (n=2593). HF severity was determined by N-terminal probrain natriuretic peptide (NT-proBNP) plasma concentrations (median 1904 pg/mL). Baseline plasma D-dimer concentrations ranged from 0.6 to 1.7 μg/L for the less and more severe HF subgroups. Patients with more severe HF had a greater incidence of VTE versus patients with less severe HF, with a significant trend up to Day 10 (4.3% versus 2.2%; P=0.0108) and Day 35 (7.2% versus 4.1%; P=0.0150). Multivariable analysis confirmed that NT-proBNP concentration was associated with VTE risk up to Day 10 (P=0.017) and D-dimer concentration with VTE risk up to Day 35 (P=0.005). The association between VTE risk and HF severity that was observed in the enoxaparin/placebo group was not seen in the extended-duration rivaroxaban group. CONCLUSIONS:Patients with more severe HF, as defined by high NT-proBNP plasma concentration, were at increased risk of VTE. NT-proBNP may be useful to identify high short-term risk, whereas elevated D-dimer may be suggestive of high midterm risk. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00571649.
Authors: A R Folsom; P L Lutsey; S R Heckbert; K Poudel; S Basu; R C Hoogeveen; M Cushman; C M Ballantyne Journal: J Thromb Haemost Date: 2018-08-11 Impact factor: 5.824
Authors: Salva R Yurista; Herman H W Silljé; Kirsten T Nijholt; Martin M Dokter; Dirk J van Veldhuisen; Rudolf A de Boer; B Daan Westenbrink Journal: Cardiovasc Drugs Ther Date: 2021-10 Impact factor: 3.727