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Background: Isolated distal deep vein thrombosis (IDDVT) is a common form of venous thromboembolism (VTE). Limited data exist about the clinical characteristics, initial treatment, and short-term outcomes of these patients. Methods: Using the data from the RIETE registry (05/2001-02/2019), we identified patients with IDDVT without pulmonary embolism (PE). We determined the clinical presentation, initial treatment, and 30-day and 90-day outcomes. We compared the findings with patients with proximal DVT without PE. Results: We identified 5,359 patients with IDDVT (mean age 61±17 years, 50% women). The most prevalent comorbidities were hypertension (39%), anemia (28%), prior VTE (14%), active cancer (12%), heart failure (6.7%), and diabetes (6.6%). Recent surgery was reported in 16%. Most participants received anticoagulation (99%), most commonly with low-molecular-weight heparin (88%). No patient received thrombolytics and use of vena cava filters was rare (0.4%). At 30 days, 59 patients (1.1% [99% CI, 0.8%-1.5%]) died, including only 3 from PE (0.1% [99% CI, 0.01%-0.2%]), 44 (0.8% [99% CI, 0.5%-1.2%]) had nonfatal VTE recurrence, and 31 (0.6% [99% CI, 0.4%-0.9%]) had major bleeding. At 90 days, 2.9% (99% CI, 2.4%-3.6%) died (no additional death from PE), 1.5% (99% CI, 1.1%-2.0%) had nonfatal VTE recurrence, and 0.9% (99% CI, 0.6%-1.3%) had major bleeding. When compared with 25,420 individuals with proximal DVT without PE, those with IDDVT had lower co-morbidity burden including diabetes, heart failure, and cancer, but were more likely to have had recent surgery (P Conclusions: In a large multinational study, IDDVT occurred in patients with low comorbidity burden. Most patients with IDDVT received anticoagulation. Fatal PE was rare, and patients had a more benign prognosis compared with those with proximal DVT.

Isolated distal deep-vein thrombosis (iDDVT) is a distal deep-vein thrombosis (DVT) without proximal DVT or pulmonary embolism. Although its clinical significance is uncertain, its prevalence is increasing with the use of whole leg compression ultrasonography. Epidemiological data giving reported rates of venous thromboembolism (VTE) are scarce, and there is potential conflict regarding the need to treat with anticoagulant drugs. Therefore, iDDVT management varies widely from one country/physician to another.Data are available from two large multicenter observational studies of iDDVT and proximal DVT without pulmonary embolism (iPDVT), comparing risk factor profiles and early prognosis, and also from clinical trials on iDDVT.iDDVT and iPDVT differ in terms of risk factor profile, iPDVT being more associated with chronic risk factors and iDDVT with transient ones. In the short term, case fatality rates associated with iDDVT suggest that it is a clinically relevant entity and should at least be diagnosed. From a therapeutic point of view, differences in population profile and outcomes between iPDVT and iDDVT, and results from recent clinical trials in favor of a modest VTE potential of iDDVT indicate that specific randomized double-blind trials are necessary to determine an appropriate and accepted mode of care for iDDVT.