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Ann Intern Med. 2015 Jan 6;162(1):27-34. doi: 10.7326/M14-1275.

D-dimer testing to select patients with a first unprovoked venous thromboembolism who can stop anticoagulant therapy: a cohort study.

Abstract

BACKGROUND:

Normal D-dimer levels after withdrawal of anticoagulant therapy are associated with a reduced risk for recurrence in patients with unprovoked venous thromboembolism (VTE) and may justify stopping treatment.

OBJECTIVE:

To determine whether patients with a first unprovoked VTE and negative D-dimer test result who stop anticoagulant therapy have a low risk for recurrence.

DESIGN:

Prospective management study with blinded outcome assessment. (ClinicalTrials.gov: NCT00720915).

SETTING:

13 university-affiliated clinical centers.

PATIENTS:

410 adults aged 75 years or younger with a first unprovoked proximal deep venous thrombosis or pulmonary embolism who had completed 3 to 7 months of anticoagulant therapy.

INTERVENTION:

Anticoagulant therapy was stopped if D-dimer test results were negative and was not restarted if results were still negative after 1 month.

MEASUREMENTS:

Recurrent VTE during an average follow-up of 2.2 years.

RESULTS:

In 319 patients (78%) who had 2 negative D-dimer results and did not restart anticoagulant therapy, rates of recurrent VTE were 6.7% (95% CI, 4.8% to 9.0%) per patient-year overall (42 of 319), 9.7% (CI, 6.7% to 13.7%) per patient-year in men (33 of 180), 5.4% (CI, 2.5% to 10.2%) per patient-year in women with VTE not associated with estrogen therapy (9 of 81), and 0.0% (CI, 0.0% to 3.0%) per patient-year in women with VTE associated with estrogen therapy (0 of 58) (P = 0.001 for the 3-group comparison).

LIMITATIONS:

Imprecision in female subgroups. Results may not be generalizable to different D-dimer assays from the one used in the study.

CONCLUSION:

The risk for recurrence in patients with a first unprovoked VTE who have negative D-dimer results is not low enough to justify stopping anticoagulant therapy in men but may be low enough to justify stopping therapy in women.

PRIMARY FUNDING SOURCE:

Canadian Institutes of Health Research.

PMID:
25560712
DOI:
10.7326/M14-1275
[Indexed for MEDLINE]

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