What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Venous Thromboembolism (n=1461). Intervention: Sulodexide vs. Placebo or Acenocoumarol. Primary outcome: Recurrent venous thromboembolism (DVT or PE) (RR 0.51, 95% CI 0.35-0.74, p=0.0004).

August 8, 2018Open Access

Sulodexide for Secondary Prevention of Recurrent Venous Thromboembolism: A Systematic Review and Meta-Analysis

QJQingjun JiangIHI Corporation (United States)JBJun BaiUniversity Health Network JJJie JinGriffith University

Key Result

Sulodexide significantly reduced the recurrence of venous thromboembolism (RR 0.51) compared to control in patients after discontinuation of conventional anticoagulation treatment.

Study Design

Type

Meta-Analysis (n=1,461)

Structured PICO

Does sulodexide reduce recurrent deep vein thrombosis or pulmonary embolism in patients with venous thromboembolism after discontinuation of anticoagulant treatment?

Population

1461 patients with venous thromboembolism after discontinuation of anticoagulant treatment (pooled from 4 prospective controlled studies)

Intervention

Sulodexide

Comparator

Control group (placebo)

Outcome

Recurrent deep vein thrombosis (DVT) or pulmonary embolismhard clinical

Sulodexide significantly reduces the recurrence of VTE and superficial vein thrombosis after discontinuation of anticoagulation treatment compared with placebo, with a low risk of bleeding.

Main Result

Effect estimate: RR 0.51 (95% CI 0.35-0.74)

Absolute Event Rate: 5.22% vs 10.11%

p-value: p=0.0004

Limitations

Small number of included trials reduced statistical power
One of the included studies was a non-randomized study
Some studies did not report important outcomes, such as adverse events
Potential for selection and publication bias as data were extracted from publications

Abstract

Background: Patients with venous thromboembolism have high risk of recurrence after discontinuation of anticoagulant treatment. Extended anticoagulation, such as traditional anticoagulants, can reduce the risk of recurrence but is associated with increased risk of hemorrhage. Sulodexide is a natural glycosaminoglycan mixture which can prevent recurrent venous thromboembolism. However, its clinical efficiency and safety still remain controversial. Methods: A systematic search in Medline, EMBASE, Cochrane Library, Web of Science and bibliographies of retrieved articles was performed. Prospective controlled studies reporting the efficacy and safety of sulodexide on the secondary prevention of recurrent venous thromboembolism were included. Two reviewers independently extracted the following data: first author, year of publication, study design, characteristics of patients, data of interventions, doses of sulodexide, overall duration of drug administration, time of follow-up, efficacy and safety outcomes, adverse effects, and the quality of the included studies. The primary efficacy outcomes were recurrent deep vein thrombosis (DVT) or pulmonary embolism. The secondary efficacy outcomes included distal or superficial vein thrombosis and nonfatal or fatal myocardial infarction, stroke, and acute ischemia of the lower limbs. Safety outcome was possible hemorrhagic episodes. Results: Four studies involving 1461 patients were enrolled in this study. Meta-analysis showed that sulodexide significantly reduced the recurrent venous thromboembolism (RR 0.51, 95 % CI 0.35, 0.74, P=0.0004) and superficial vein thrombosis in the sulodexide group (RR 0.41, 95 % CI 0.22, 0.76, P=0.005). The safety of sulodexide was also reliable. The rate of bleeding was 0.28% in the sulodexide group and 1.60% in the control group, and design of study did not influence these results. Conclusions: Sulodexide could significantly reduce the recurrence of VTE after discontinuation of anticoagulation treatment as compared with placebo.

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