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Evolution of untreated calf deep-vein thrombosis in high risk symptomatic outpatients: the blind, prospective CALTHRO
Gualtiero Palareti1, Benilde Cosmi, Gianfranco Lessiani
1Department of Angiology and Blood Coagulation Marino Golinelli, University Hospital S Orsola-Malpighi, Bologna, Italy. gualtiero.palareti@unibo.it
Insights
The study found that untreated isolated calf deep-vein thrombosis (ICDVT) may lead to a higher rate of venous thromboembolism complications. Further research is needed to confirm the clinical significance of ICDVT in high-risk patients.
Area of Science:
- Vascular Medicine
- Diagnostic Imaging
- Clinical Outcomes Research
Background:
- The clinical significance and management of isolated calf deep-vein thrombosis (ICDVT) remain uncertain.
- Debate exists regarding the necessity of diagnosing and treating calf DVT due to its natural history.
Purpose of the Study:
- To investigate the complication rate of untreated isolated calf deep-vein thrombosis (ICDVT).
- To assess the risk of venous thromboembolism in patients with ICDVT.
Main Methods:
- Prospective study of symptomatic outpatients using serial compression ultrasonography (SCUS).
- Complete calf deep vein examination (CCUS) performed for patients with likely pre-test clinical probability or altered D-dimer, with results blinded.
- Primary outcome measured was the rate of venous thromboembolism at three months.
Main Results:
- Five outcomes (1.2%) were recorded in 431 subjects. ICDVT was diagnosed in 15.3% of patients.
- A significantly higher rate of outcomes was observed in subjects with ICDVT (7.8%) compared to those without (0.8%).
- After excluding early events, the difference in outcomes between groups became marginally significant (4.7% vs. 0.8%).
Conclusions:
- Untreated isolated calf deep-vein thrombosis may be associated with a relevant risk of thrombotic evolution, particularly in high-risk individuals.
- The findings suggest that ICDVT warrants further investigation to clarify its clinical impact and optimal management strategies.
- Larger studies are required to definitively address the natural history and management of ICDVT.
Abstract:
The natural history of calf deep-vein thrombosis (DVT) is still uncertain and it is debated whether it warrants to be diagnosed and treated. We aimed to investigate the complication rate of untreated isolated calf DVT (ICDVT). Symptomatic outpatients were prospectively managed with serial compression ultrasonography (SCUS). Those without proximal DVT and with likely pre-test clinical probability (PCP) or altered D-dimer received immediate subsequent complete examination of calf deep veins (CCUS) by a different operator. The result of CCUS was kept blind both to the managing doctor and the patient and disclosed after three months. Primary outcome was the rate of venous thromboembolism at three months. We examined 431 subjects (196 males; median age 68.0 years) in whom five outcomes were recorded (1.2%; 95% confidence intervals [CI]: 0.4-2.7). If CCUS results had been available, outcomes would have been recorded in 3/424 patients (0.7%; 95% CI: 0.2-2.1) with two events in subjects negative at both serial and complete CUS. ICDVT was diagnosed in 65 subjects (15.3%; 95% CI: 12-19); of whom 59 remained uneventful (one was lost to follow-up). A significant higher rate of outcomes was recorded in subjects with than without ICDVT (5/64; 7.8%; 95% CI: 3-17 vs. 3/351; 0.8%; 95% CI: 0-2; p=0.003). However, after excluding two events picked at serial CUS in subjects with ICDVT, the difference became barely significant (3/64; 4.7%; 95% CI: 1-13; p=0.049). Thrombotic evolution of untreated ICDVT in high-risk subjects may be relevant. Larger studies are needed to address this issue.
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