Arzu Kalayci1, C Michael Gibson1, Gerald Chi1, Megan K Yee1, Serge Korjian1, Sudarshana Datta1, Tarek Nafee1, Mike Gurin1, Noah Haroian1, Iqra Qamar1, Russell D Hull2, Adrian F Hernandez3, Alexander T Cohen4, Robert A Harrington5, Samuel Z Goldhaber6. 1. Division of Cardiovascular, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States. 2. Division of Cardiology, R.A.H Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada. 3. Duke Clinical Research Institute, Durham, North Carolina, United States. 4. Department of Haematological Medicine, Guy's and St Thomas' Hospitals, King's College, London, United Kingdom. 5. Division of Cardiovascular Medicine, Department of Medicine, Stanford University, Stanford, California, United States. 6. Division of Cardiovascular, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States.
Abstract
AIM: Asymptomatic deep vein thrombosis (DVT) diagnosed with compression ultrasound (CUS) is a common endpoint in trials assessing the efficacy of anticoagulants to prevent venous thromboembolism (VTE), but the relationship of asymptomatic thrombus to mortality remains uncertain. METHODS: In the APEX trial (ClinicalTrials.gov: NCT01583218), 7,513 acutely ill hospitalized medical patients were randomly assigned to extended-duration betrixaban (35-42 days) or enoxaparin (10 ± 4 days). Asymptomatic DVT was assessed once with CUS between day 32 and 47, and mortality was assessed through 77 days. RESULTS: A total of 309 asymptomatic DVTs were detected through CUS. Of these, 133 (4.27%) subjects were in the betrixaban group, and 176 (5.55%) subjects were in the enoxaparin group (relative risk = 0.77, 95% confidence interval [CI] = 0.62-0.97, p = 0.025, number needed to treat = 79). With respect to all-cause mortality due to cardiovascular diseases, non-cardiovascular diseases and unknown causes, the number of the deaths was 5 (1.67%), 4 (1.34%) and 1 (0.33%) in the asymptomatic DVT group and 25 (0.42%), 33 (0.56%) and 11 (0.19%) in the no DVT group, respectively. Subjects with an asymptomatic DVT had an almost threefold increase in the risk of all-cause mortality compared with subjects without DVT (hazard ratio = 2.87, 95% CI = 1.48-5.57, p = 0.001). A positive linear trend was observed between greater thrombus burden and mortality during the follow-up (p = 0.019). CONCLUSION:Asymptomatic DVT was associated with approximately threefold increased risk of short-term all-cause mortality in patients hospitalized with an acute medical illness within the prior 77 days. A positive linear trend was observed between greater thrombus burden and mortality during the follow-up. Georg Thieme Verlag KG Stuttgart · New York.
RCT Entities:
AIM: Asymptomatic deep vein thrombosis (DVT) diagnosed with compression ultrasound (CUS) is a common endpoint in trials assessing the efficacy of anticoagulants to prevent venous thromboembolism (VTE), but the relationship of asymptomatic thrombus to mortality remains uncertain. METHODS: In the APEX trial (ClinicalTrials.gov: NCT01583218), 7,513 acutely ill hospitalized medical patients were randomly assigned to extended-duration betrixaban (35-42 days) or enoxaparin (10 ± 4 days). Asymptomatic DVT was assessed once with CUS between day 32 and 47, and mortality was assessed through 77 days. RESULTS: A total of 309 asymptomatic DVTs were detected through CUS. Of these, 133 (4.27%) subjects were in the betrixaban group, and 176 (5.55%) subjects were in the enoxaparin group (relative risk = 0.77, 95% confidence interval [CI] = 0.62-0.97, p = 0.025, number needed to treat = 79). With respect to all-cause mortality due to cardiovascular diseases, non-cardiovascular diseases and unknown causes, the number of the deaths was 5 (1.67%), 4 (1.34%) and 1 (0.33%) in the asymptomatic DVT group and 25 (0.42%), 33 (0.56%) and 11 (0.19%) in the no DVT group, respectively. Subjects with an asymptomatic DVT had an almost threefold increase in the risk of all-cause mortality compared with subjects without DVT (hazard ratio = 2.87, 95% CI = 1.48-5.57, p = 0.001). A positive linear trend was observed between greater thrombus burden and mortality during the follow-up (p = 0.019). CONCLUSION: Asymptomatic DVT was associated with approximately threefold increased risk of short-term all-cause mortality in patients hospitalized with an acute medical illness within the prior 77 days. A positive linear trend was observed between greater thrombus burden and mortality during the follow-up. Georg Thieme Verlag KG Stuttgart · New York.
Authors: Jeffrey I Zwicker; Joanna Roopkumar; Maneka Puligandla; Benjamin L Schlechter; Anish V Sharda; David Peereboom; Robin Joyce; Bruno Bockorny; Donna Neuberg; Kenneth A Bauer; Alok A Khorana Journal: Blood Adv Date: 2020-05-26
Authors: Gary E Raskob; Alex C Spyropoulos; Alexander T Cohen; Jeffrey I Weitz; Walter Ageno; Yoriko De Sanctis; Wentao Lu; Jianfeng Xu; John Albanese; Chiara Sugarmann; Traci Weber; Concetta Lipardi; Theodore E Spiro; Elliot S Barnathan Journal: J Am Heart Assoc Date: 2021-02-15 Impact factor: 5.501
Authors: Alex C Spyropoulos; Concetta Lipardi; Jianfeng Xu; Colleen Peluso; Theodore E Spiro; Yoriko De Sanctis; Elliot S Barnathan; Gary E Raskob Journal: TH Open Date: 2020-03-13