Background: Up to 90% of patients referred for ultrasonography with suspected deep venous thrombosis (DVT) of the leg do not have the disease.
Objective: To evaluate the safety and efficiency of using a clinical decision rule that includes a point-of-care d-dimer assay at initial presentation in primary care to exclude DVT.
Design: A prospective management study.
Setting: Approximately 300 primary care practices in 3 regions of the Netherlands (Amsterdam, Maastricht, and Utrecht).
Patients: 1028 consecutive patients with clinically suspected DVT.
Intervention: Patients were managed on the basis of the result of the clinical decision rule, which included a d-dimer result. Patients with a score of 3 or less were not referred for ultrasonography and received no anticoagulant treatment; patients with a score of 4 or more were referred for ultrasonography.
Measurements: The primary outcome was symptomatic, objectively confirmed, venous thromboembolism during 3-month follow-up.
Results: The mean age of the 1028 study patients was 58 years, and 37% of patients were men. A valid score was obtained in 1002 patients (98%). In 500 patients (49%), with a score of 3 or less, 7 developed venous thromboembolism within 3 months (incidence, 1.4% [95% CI, 0.6% to 2.9%]). A total of 502 patients (49%) had a score of 4 or more; 3 did not have ultrasonography. Ultrasonography showed DVT in 125 patients (25%), for an overall prevalence in evaluable patients of 13% (125 of 1002). Of the 374 patients who had normal ultrasonography results, 4 developed venous thromboembolism within 3 months (1.1% [CI, 0.3% to 2.7%]).
Limitation: The study lacked a randomized design and relied on clinical follow-up to detect missed thrombotic disease.
Conclusion: A diagnostic management strategy in primary care by using a simple clinical decision rule and a point-of-care d-dimer assay reduces the need for referral to secondary care of patients with clinically suspected DVT by almost 50% and is associated with a low risk for subsequent venous thromboembolic events.
Funding: The Netherlands Organization for Scientific Research.