Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients
Background Asymptomatic proximal deep vein thrombosis (DVT) is an end point frequently used to evaluate the efficacy of anticoagulant thromboprophylaxis in medical patients. Recently, the clinical relevance of asymptomatic DVT has been challenged. Methods and Results The objective of this study was...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2021-03-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.120.019459 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Gary E. Raskob |
| collection | DOAJ |
| description | Background Asymptomatic proximal deep vein thrombosis (DVT) is an end point frequently used to evaluate the efficacy of anticoagulant thromboprophylaxis in medical patients. Recently, the clinical relevance of asymptomatic DVT has been challenged. Methods and Results The objective of this study was to evaluate the relationship between asymptomatic proximal DVT and all‐cause mortality (ACM) using a cohort analysis of a randomized trial for the prevention of venous thromboembolism (VTE) in acutely ill medical patients. Patients who received at least 1 dose of study drug and had an adequate compression ultrasound examination of the legs on either day 10 or day 35 were categorized into 1 of 3 cohorts: no VTE, asymptomatic proximal DVT, or symptomatic DVT. Cox proportional hazards model, with adjustment for significant independent predictors of mortality, were used to compare the incidences of ACM. Of the 7036 patients, 6776 had no VTE, 236 had asymptomatic DVT, and 24 had symptomatic VTE. The incidence of ACM was 4.8% in patients without VTE. Both asymptomatic proximal DVT (mortality, 11.4%; hazard ratio [HR], 2.31; 95% CI, 1.52–3.51; P<0.0001) and symptomatic VTE (mortality, 29.2%; HR, 9.42; 95% CI, 4.18–21.20; P<0.0001) were independently associated with significant increases in ACM. The analysis was post hoc, and ultrasound results were not available for all patients. Adjustment for baseline variables significantly associated with ACM may not fully compensate for differences. Conclusions Asymptomatic proximal DVT is associated with higher ACM than no VTE and remains a relevant end point to evaluate the efficacy of anticoagulant thromboprophylaxis in medical patients. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00571649. |
| first_indexed | 2024-12-13T09:03:18Z |
| format | Article |
| id | doaj.art-76037fab5c754e27b468a9743e724d78 |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-12-13T09:03:18Z |
| publishDate | 2021-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-76037fab5c754e27b468a9743e724d782022-12-21T23:53:07ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802021-03-0110510.1161/JAHA.120.019459Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical PatientsGary E. Raskob0Alex C. Spyropoulos1Alexander T. Cohen2Jeffrey I. Weitz3Walter Ageno4Yoriko De Sanctis5Wentao Lu6Jianfeng Xu7John Albanese8Chiara Sugarmann9Traci Weber10Concetta Lipardi11Theodore E. Spiro12Elliot S. Barnathan13Hudson College of Public HealthUniversity of Oklahoma Health Sciences Center Oklahoma City OKThe Feinstein Institutes for Medical Research and Zucker School of Medicine at Hofstra/Northwell Anticoagulation and Clinical Thrombosis Services Department of Medicine Northwell Health at Lenox Hill Hospital New York NYDepartment of Hematological Medicine Guys and St Thomas/NHS Foundation Trust, King's College London London United KingdomMcMaster University, and the Thrombosis and Atherosclerosis Research Institute Hamilton Ontario CanadaDepartment of Medicine and Surgery University of Insubria Varese ItalyStatistics and Data Insights Bayer US LLC Whippany NJBiostatistics Department Janssen Research and Development LLC Raritan NJBiostatistics Department Janssen Research and Development LLC Raritan NJCardiovascular Clinical Development Janssen Research and Development, LLC Raritan NJCardiovascular Clinical Development Janssen Research and Development, LLC Raritan NJCardiovascular Clinical Development Janssen Research and Development, LLC Raritan NJCardiovascular Clinical Development Janssen Research and Development, LLC Raritan NJBayer US, LLC Whippany NJCardiovascular Clinical Development Janssen Research and Development, LLC Raritan NJBackground Asymptomatic proximal deep vein thrombosis (DVT) is an end point frequently used to evaluate the efficacy of anticoagulant thromboprophylaxis in medical patients. Recently, the clinical relevance of asymptomatic DVT has been challenged. Methods and Results The objective of this study was to evaluate the relationship between asymptomatic proximal DVT and all‐cause mortality (ACM) using a cohort analysis of a randomized trial for the prevention of venous thromboembolism (VTE) in acutely ill medical patients. Patients who received at least 1 dose of study drug and had an adequate compression ultrasound examination of the legs on either day 10 or day 35 were categorized into 1 of 3 cohorts: no VTE, asymptomatic proximal DVT, or symptomatic DVT. Cox proportional hazards model, with adjustment for significant independent predictors of mortality, were used to compare the incidences of ACM. Of the 7036 patients, 6776 had no VTE, 236 had asymptomatic DVT, and 24 had symptomatic VTE. The incidence of ACM was 4.8% in patients without VTE. Both asymptomatic proximal DVT (mortality, 11.4%; hazard ratio [HR], 2.31; 95% CI, 1.52–3.51; P<0.0001) and symptomatic VTE (mortality, 29.2%; HR, 9.42; 95% CI, 4.18–21.20; P<0.0001) were independently associated with significant increases in ACM. The analysis was post hoc, and ultrasound results were not available for all patients. Adjustment for baseline variables significantly associated with ACM may not fully compensate for differences. Conclusions Asymptomatic proximal DVT is associated with higher ACM than no VTE and remains a relevant end point to evaluate the efficacy of anticoagulant thromboprophylaxis in medical patients. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00571649.https://www.ahajournals.org/doi/10.1161/JAHA.120.019459medically illmortalityproximal DVT |
| spellingShingle | 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 Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease medically ill mortality proximal DVT |
| title | Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients |
| title_full | Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients |
| title_fullStr | Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients |
| title_full_unstemmed | Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients |
| title_short | Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients |
| title_sort | association between asymptomatic proximal deep vein thrombosis and mortality in acutely ill medical patients |
| topic | medically ill mortality proximal DVT |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.120.019459 |
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