The efficacy of sulodexide in the prevention of postthrombotic syndrome.
OBJECTIVE
The aim of this open, observational registry was to evaluate the effects of antithrombotic treatment on the development of postthrombotic syndrome (PTS): the effects of "standard management" (SM; according to International Union of Angiology guidelines) were compared to SM in association with sulodexide or aspirin.


METHODS
Postthrombotic syndrome occurrence was observed in 3 nonparallel groups after deep venous thrombosis (DVT); the registry started after the end of the anticoagulation period. The target was to observe the occurrence of PTS in 5 years. Three possible options were suggested to the patients, and the patients and their caregivers defined the type of management. A group of 167 patients was involved in the SM with reevaluation every 6 months; the sulodexide group included 124 patients and the aspirin group included 48 patients.


RESULTS
The 3 groups were clinically similar and comparable for age and sex distribution. Of the 167 patients in the SM group, 154 patients completed 60 months of follow-up. The percentage of patients with PTS in the SM group ranged from 14.9% (1 year after the end of anticoagulation) to 19.5% (60 months). In the nonparallel group using sulodexide (124 comparable patients at inclusion; 115 at 60 months), the percentage of PTS was variable from 8.8% (1 year after anticoagulants) to 12.17% at 60 months. These percentages are significantly lower than those observed with SM. In the nonparallel aspirin group (48 patients at inclusion and 34 at 54 months), there was a PTS incidence of 23.5% at 54 months (vs 12.17% in the sulodexide group and 18.23% in the SM group). The incidence of PTS was significantly higher in comparison with the other 2 groups. The incidence of PTS was lower in the sulodexide group in comparison with the 2 other groups.


CONCLUSIONS
Sulodexide administration after DVT appears to be effective in preventing PTS in association with recommended management and a number of recurrent DVTs. Modalities of treatment, dosages, and timing of administration should be explored in more comprehensive and complete studies.
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Roberta
R
Luzzi
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy cardres@abol.it.
Gianni
G
Belcaro
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Mark
M
Dugall
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Shu
S
Hu
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Guido
G
Arpaia
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Andrea
A
Ledda
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Edmondo
E
Ippolito
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Marcello
M
Corsi
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Andrea
A
Ricci
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Roberto
R
Cotellese
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Giovanni
G
Agus
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Bruno M
BM
Errichi
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Umberto
U
Cornelli
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
M Rosaria
MR
Cesarone
Department of Biomed Sciences, Irvine3 Labs, Circulation Sciences, Chieti-Pescara University, Chieti and Pescara, Italy.
Morio
M
Hosoi
D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects; D006025:Glycosaminoglycans / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D054070:Postthrombotic Syndrome / Q000453:epidemiology / Q000517:prevention & control*; D013997:Time Factors
D000925:Anticoagulants; D005343:Fibrinolytic Agents; D006025:Glycosaminoglycans; C007858:glucuronyl glucosamine glycan sulfate; D001241:Aspirin
DVT; postthrombotic syndrome; sulodexide; thrombosis; veins; venous ulcers