Prevention of Recurrent Deep Venous Thrombosis with Sulodexide: The SanVal Registry

Abstract

The aim of this study was to evaluate the prevention of recurrent deep vein thrombosis (R-DVT) with an oral antithrombotic agent (sulodexide) in moderate to high-risk subjects. A group of 405 patients was included into the multicenter registry. Both compression and an exercise program were used as well as a risk-factors control plan. After diagnosis of DVT, patients were treated with oral anticoagulants for 6 months. At the end of this period a coagulation study was made and patients started treatment with oral sulodexide capsules for a period of 24 months. The femoral, popliteal, tibial, and superficial veins were scanned with high-resolution ultrasound at inclusion;scans were repeated at 6, 12, 18, and 24 months. Of the 405 subjects included into the registry 178 in the control group (mean age 52.2; SD 11; M:F=90:88) and 189 in the treatment group (mean age 53.2; SD 10.3; M:F=93:96) completed the analysis period of 24 months. At 6 and 12 months the incidence of R-DVT was lower (p<0.05) in the treatment group. At 24 months the global incidence of R-DVT was 17.9% in the control group and 7.4% in the sulodexide group (p<0.05), 2.42 times lower than in controls. The 2 groups were comparable for age and sex distribution and for the localization of the thrombi at inclusion. Also the 2 groups of dropouts were comparable. In the control group there were 32 recurrent DVTs and 24 subjects lost to follow-up (total of 56) of 202 included subjects (27.7%) in comparison with 28 failures (14 recurrent DVTs and 14 lost subjects) of 203 subjects (13.8%) in the treatment group. This difference was statistically significant. In this analysis the incidence of DVT in controls was 2.07 times higher than in the treatment group subjects. In conclusion sulodexide was effective in reducing recurrent thrombotic events in high-risk subjects.

The optimal duration of anticoagulant therapy after unprovoked venous thromboembolism – still a challenging issue

“…Sulodexide is generally well tolerated and safe. The eff ectiveness of sulodexide in reducing recurrent VTE is known since about twelve years [67,68] and has been renewed after the recent publication of a double-blind, randomised SURVET trial, in which an extended treatment with sulodexide was compared to placebo in 616 patients who had completed the fi rst 3-12 months of VKA for a fi rst unprovoked VTE. Sulodexide 500 lipasemic units twice a day, administered for two years in addition to compression therapy, decreased the risk of recurrent VTE to about 50 %, without major bleeding or substantial side eff ects [69].…”

The role of sulodexide in chronic venous insufficiency

“…An open-controlled, prospective study conducted in Spain on the safety of sulodexide as a treatment for DVT compared to adjusted dose acenocoumarol concluded that there were no differences in DVT recurrence rates between the two agents, and that sulodexide patients were less prone to haemorrhages [25]. In Italy, a similar study was conducted on 405 patients with documented DVT [26]. These patients, after completing their predefined course of oral anticoagulants, were randomised to receive or not receive oral sulodexide.…”

Sulodexide: implicazioni cliniche ed economiche

“…Gli effetti del farmaco sono stati indagati anche per ciò che riguarda il trattamento della Sindrome Post-Trombotica (SPT) e la prevenzione della trombosi venosa profonda [10][11][12][13].…”

“…Lo scopo di un trial indipendente condotto nell'ambito del progetto "San Valentino" (progetto di studio della prevalenza e dell'evoluzione dell'arteriosclerosi subclinica e delle malattie vascolari in Italia centrale) è stato quello di valutare gli effetti preventivi del trattamento con sulodexide in pazienti a medio o alto rischio trombotico [13].…”

“…Come già approfondito (vedi paragrafo "Efficacia terapeutica e tollerabilità") sulodexide è stato studiato da Errichi et al in relazione alla sua efficacia nel prevenire la comparsa di retrombosi in pazienti con trombosi venosa profonda ad alto e medio rischio [13]. In base ai dati risultanti da questo studio gli autori hanno svolto un'analisi economica al fine di valutare l'impatto che un evento trombotico può avere sulla collettività e, soprattutto, se la prevenzione di tali eventi con sulodexide rappresenti una strategia costo/efficace.…”