CACTUS
PubMed • Full text
Clinical Question
In patients with symptomatic calf deep vein thrombosis, does treatment with LMWH help decrease extension?
Bottom Line
There is no difference between nadroparin and placebo in reducing the risk of extension of calf vein clots into the deeper venous system. Treatment with LMWH did have an increase risk of bleeding. Calf DVTs should not be treated with systemic anticoagulation.
Major Points
There are limited trials studying the need to treat isolated calf DVTs. The CACTUS trial shows that LMWH anticoagulation does not prevent extension of clots compared to placebo. Furthermore, there are increased risks of bleeding with anticoagulation. The ACCP has made guidelines to avoid treating calf DVTs, and using follow-up ultrasound to monitor for extension is an appropriate alternative.
Guidelines
Design
- Randomized, controlled trial
- N=
- LMWH (n=)
- Placebo (n=)
- Setting: ## centers in ## countries
- Enrollment: ####-###
- Mean follow-up: ## years
- Analysis: Intention-to-treat
- Primary outcomes:
- Efficacy: Extension of DVT, contralateral proximal DVT, or symptomatic PE at 42 days
- Safety: Major or clinically-relevant non-major bleeding at 42 days
Population
Inclusion Criteria
Exclusion Criteria
Baseline Characteristics
- Demographics: Age ## years, ##% women
Interventions
- Randomized to a group:
- LMWH - received nadroparin 171 UI/kg daily
- Placebo
Outcomes
Comparisons are LMWH vs. placebo.
Primary Outcomes
- Efficacy - Extension of DVT, contralateral proximal DVT, or symptomatic PE at 42 days
- 3% vs. 5% (RD -2.1%; 95% CI -7.8 to 3.5; P=0.54)
- Safety - Major or clinically-relevant non-major bleeding at 42 days
- 4% vs. 0% (RD 4.1%; 95% CI 0.4 to 9.2; P=0.0255)