Abstract
Objective This network meta-analysis (NMA) assesses the clinical comparative efficacy and safety of sulodexide versus direct-acting oral anticoagulants (DOACs), vitamin K antagonist (VKA), and aspirin in patients with an unprovoked venous thromboembolism (VTE). Methods We conducted a literature search in MEDLINE, Embase, and Cochrane Library using both randomized controlled trials (RCTs) and observational studies. Reduction in recurrent deep venous thrombosis (r-DVT), pulmonary embolism (PE), major bleeding (MB), clinically relevant nonmajor bleeding (CRNMB) were the primary efficacy and safety outcomes. Other secondary end points were also included. We performed a fixed, random effects, and hierarchical models Bayesian NMA for each outcome. Results We identified 18 RCTs and seven observational studies. Random models showed sulodexide is the best treatment compared with DOACs, VKA, and aspirin at reducing the risk of CRNMB, for preventing death from any cause, and VTE/PE/myocardial infarction (MI)/stroke with 0.47, 0.81, and 0.65 probabilities, respectively. In the random model sulodexide was the best treatment for reducing the risk of MB with a 0.50 probability and hierarchical model that confirmed favorable results. Random and hierarchical models showed sulodexide and DOACs to be the best treatments for reducing PE risk. Sulodexide was more effective than aspirin for reducing r-DVT with 0.12 and less of 0.0001 probabilities, respectively. Conclusion Sulodexide is more effective for reducing MB and CRNMB, for preventing deaths from any cause, and from VTE/PE/MI/stroke, than other treatments, for both random and hierarchical models. Sulodexide showed to be more effective than aspirin in reducing the risk of r-DVT and PE. Sulodexide's reduction in bleeding while protecting from recurrent DVT risk makes this therapeutic option an important alternative for extended anticoagulation treatment.
Highlights
Venous thromboembolism (VTE) is a condition encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE), which occurs when a thrombus forms in a patient’s vein, often in the deep veins of the lower limbs or pelvis
Sulodexide is more effective for reducing major bleeding (MB) and clinically relevant nonmajor bleeding (CRNMB), for preventing deaths from any cause, and from VTE/PE/myocardial infarction (MI)/stroke, than other treatments, for both random and hierarchical models
Considering both random and hierarchical model, the results of network meta-analysis (NMA) showed that sulodexide as a therapeutic approach had a higher probability to be better than those of directacting oral anticoagulant (DOAC), vitamin K antagonist (VKA), and aspirin in some of the key outcomes (MB, clinically relevant non-MB, death from VTE/PE/MI/stroke, and death from any cause)
Summary
Venous thromboembolism (VTE) is a condition encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE), which occurs when a thrombus forms in a patient’s vein, often in the deep veins of the lower limbs or pelvis. There is a need for an increased understanding and knowledge of the advantages and disadvantages of each of these treatment options. This study, utilizing network meta-analysis (NMA) builds on a systematic review of RCTs and observational studies, to explore the benefits and risks incurred while using anticoagulant or antithrombotic-extended treatments to prevent recurrent VTE
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