A Prognostic Score to Identify Low-risk Outpatients with Acute Deep Vein Thrombosis in the Lower Limbs

Published:September 18, 2014DOI:



      No prior studies have identified which patients with deep vein thrombosis in the lower limbs are at a low risk for adverse events within the first week of therapy.


      We used data from the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) to identify patients at low risk for the composite outcome of pulmonary embolism, major bleeding, or death within the first week. We built a prognostic score and compared it with the decision to treat patients at home.


      As of December 2013, 15,280 outpatients with deep vein thrombosis had been enrolled. Overall, 5164 patients (34%) were treated at home. Of these, 12 (0.23%) had pulmonary embolism, 8 (0.15%) bled, and 4 (0.08%) died. On multivariable analysis, chronic heart failure, recent immobility, recent bleeding, cancer, renal insufficiency, and abnormal platelet count independently predicted the risk for the composite outcome. Among 11,430 patients (75%) considered to be at low risk, 15 (0.13%) suffered pulmonary embolism, 22 (0.19%) bled, and 8 (0.07%) died. The C-statistic was 0.61 (95% confidence interval [CI], 0.57-0.65) for the decision to treat patients at home and 0.76 (95% CI, 0.72-0.79) for the score (P = .003). Net reclassification improvement was 41% (P < .001). Integrated discrimination improvement was 0.034 for the score and 0.015 for the clinical decision (P < .001).


      Using 6 easily available variables, we identified outpatients with deep vein thrombosis at low risk for adverse events within the first week. These data may help to safely treat more patients at home. This score, however, should be validated.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to The American Journal of Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Kearon C.
        • Akl E.A.
        • Comerota A.J.
        • et al.
        American College of Chest Physicians. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.
        Chest. 2012; 141: e419S-e494S
        • Lozano F.
        • Trujillo-Santos J.
        • Barrón M.
        • et al.
        Home versus in-hospital treatment of outpatients with acute deep venous thrombosis of the lower limbs.
        J Vasc Surg. 2014; 59: 1362-1367
        • The EINSTEIN Investigators
        Oral rivaroxaban for symptomatic venous thromboembolism.
        N Engl J Med. 2010; 363: 2499-2510
        • Trujillo-Santos J.
        • Herrera S.
        • Page M.A.
        • et al.
        Predicting adverse outcome in outpatients with acute deep vein thrombosis. Findings from the RIETE Registry.
        J Vasc Surg. 2006; 44: 789-793
        • Muñoz-Torrero J.F.
        • Bounameaux H.
        • Pedrajas J.M.
        • et al.
        Effects of age on the risk of dying from pulmonary embolism or bleeding during treatment of deep vein thrombosis.
        J Vasc Surg. 2011; 54: 26S-32S
        • Ruíz-Giménez N.
        • Suárez C.
        • González R.
        • et al.
        Predictive variables for major bleeding events in patients presenting with documented acute venous thromboembolism. Findings from the RIETE Registry.
        Thromb Haemost. 2008; 100: 26-31
        • Nieto J.A.
        • Solano R.
        • Ruiz-Ribó M.D.
        • et al.
        Fatal bleeding in patients receiving anticoagulant therapy for venous thromboembolism: Findings from the RIETE Registry.
        J Thromb Haemost. 2010; 8: 1216-1222
        • Cockcroft D.W.
        • Gault M.H.
        Prediction of creatinine clearance from serum creatinine.
        Nephron. 1976; 16: 31-41
        • Hosmer D.W.
        • Hosmer T.
        • Le Cessie S.
        • Lemeshow S.
        A comparison of goodness-of-fit tests for the logistic regression model.
        Stat Med. 1997; 16: 965-980
        • Steyerberg E.W.
        • Harrell Jr., F.E.
        • Borsboom G.J.
        • Eijkemans M.J.
        • Vergouwe Y.
        • Habbema J.D.
        Internal validation of predictive models: efficiency of some procedures for logistic regression analysis.
        J Clin Epidemiol. 2001; 54: 774-781
        • Pencina M.J.
        • D'Agostino Sr., R.B.
        • D'Agostino Jr., R.B.
        • Vasan R.S.
        Evaluating the added predictive ability of a new marker: from area under the ROC curve to reclassification and beyond.
        Stat Med. 2008; 27: 157-172
        • Steyerberg E.W.
        • Vickers A.J.
        • Cook N.R.
        • et al.
        Assessing the performance of prediction models. A framework for traditional and novel measures.
        Epidemiology. 2010; 21: 128-138
        • Monreal M.
        • Sánchez Muñoz J.F.
        • Naraine V.S.
        • et al.
        Pulmonary embolism in patients with chronic obstructive pulmonary disease or congestive heart failure.
        Am J Med. 2006; 119: 851-858
        • Monreal M.
        • Falgá C.
        • Valle R.
        • et al.
        Venous thromboembolism in patients with renal insufficiency: findings from the RIETE Registry.
        Am J Med. 2006; 119: 1073-1079
        • Monreal M.
        • Kakkar A.K.
        • Caprini J.A.
        • et al.
        The outcome after treatment of venous thromboembolism is different in surgical and acutely ill medical patients. Findings from the RIETE Registry.
        J Thromb Haemost. 2004; 2: 1892-1898
        • Nieto J.A.
        • Bruscas M.J.
        • Ruiz-Ribo D.
        • et al.
        Acute venous thromboembolism in patients with recent major bleeding. The influence of the site of bleeding and the time elapsed on outcome.
        J Thromb Haemost. 2006; 4: 2367-2372
        • Laporte S.
        • Mismetti P.
        • Décousus H.
        • et al.
        Clinical predictors for fatal pulmonary embolism in 15,520 patients with venous thromboembolism. Findings from the Registro Informatizado de la Enfermedad Tromboembólica venosa (RIETE) Registry.
        Circulation. 2008; 117: 1711-1716
        • Nauffal D.
        • Ballester M.
        • Reyes R.L.
        • et al.
        Influence of recent immobilization and recent surgery on mortality in patients with pulmonary embolism.
        J Thromb Haemost. 2012; 10: 1752-1760
        • Monreal M.
        • Falgá C.
        • Valdés M.
        • et al.
        Fatal pulmonary embolism and fatal bleeding in cancer patients with venous thromboembolism: findings from the RIETE Registry.
        J Thromb Haemost. 2006; 4: 1950-1956
        • Di Micco P.
        • Ruiz-Giménez N.
        • Nieto J.A.
        • et al.
        Platelet count and outcome in patients with acute venous thromboembolism.
        Thromb Haemost. 2013; 110: 1025-1034
        • Cook N.R.
        Use and misuse of the receiver operating characteristic curve in risk prediction.
        Circulation. 2007; 115: 928-935