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James D. Douketis, MD, FRCPC; Gary A. Foster, PhD; Mark A. Crowther, MD, MSc, FRCPC; Martin H. Prins, MD, PhD; Jeffrey S. Ginsberg, MD, FRCPC

Arch Intern Med. 2000;160:3431-3436.

Background  In patients with venous thromboembolism (VTE), identifying clinical risk factors for recurrence during the initial 3 months of anticoagulant therapy and knowledge of the time course of recurrence may help clinicians decide about the frequency of clinical surveillance and the appropriateness of outpatient treatment.

Methods  Analysis of a randomized controlled trial database involving 1021 patients with VTE (750 with deep vein thrombosis [DVT] and 271 with pulmonary embolism [PE]) who were followed up for 3 months after the start of anticoagulant therapy. All patients received initial treatment with unfractionated heparin or a low-molecular-weight heparin (reviparin) and a coumarin derivative starting the first or second day of treatment, with a target international normalized ratio of 2.0 to 3.0.

Results  Four independent clinical risk factors for recurrent VTE were identified: (1) cancer (odds ratio [OR], 2.72; 95% confidence interval [CI], 1.39-5.32), (2) chronic cardiovascular disease (OR, 2.27; 95% CI, 1.08-4.97), (3) chronic respiratory disease (OR, 1.91; 95% CI, 0.85-4.26), and (4) other clinically significant medical disease (OR, 1.79; 95% CI, 1.00-3.21). Older age was associated with a decreased risk for recurrent VTE (OR, 0.76; 95% CI, 0.64-0.92). Previous VTE, sex, and idiopathic VTE were not risk factors for recurrence. In patients with DVT or PE, there was no significant difference in the rates of recurrent nonfatal VTE (4.8% vs 4.1%; P = .62), major bleeding (2.9% vs 2.2%; P = .53), and non-VTE death (6.4% vs 7.8%; P = .45), but recurrent fatal PE was more frequent in patients with PE than DVT (2.2% vs 0%; P<.01). There was a clustering of recurrent VTE episodes during the initial 2 to 3 weeks after the start of treatment.

Conclusions  During the initial 3 months of anticoagulant therapy, recurrent VTE is more likely to occur in patients with cancer, chronic cardiovascular disease, chronic respiratory disease, or other clinically significant medical disease. Patients with PE are as likely to develop recurrent VTE as those with DVT; however, recurrence is more likely to be fatal in patients who initially present with PE.

From the Departments of Medicine, McMaster University (Drs Douketis, Crowther, and Ginsberg) and St Joseph's Hospital (Drs Douketis, Foster, and Crowther), and the Father Sean O'Sullivan Research Centre (Dr Foster), Hamilton, Ontario; and the Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands (Dr Prins).

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