High versus low doses of unfractionated heparin for the treatment of superficial thrombophlebitis of the leg. A prospective, controlled, randomized study. [Effectiveness and tolerability of heparan sulfate in the treatment of superficial thrombophlebitis. Controlled clinical study vs sulodexide]. Low-molecular-weight heparin versus saphenofemoral disconnection for the treatment of above-knee greater saphenous thrombophlebitis: a prospective study. High vs. low doses of low-molecular-weight heparin for the treatment of superficial vein thrombosis of the legs: a double-blind, randomized trial. A pilot randomized double-blind comparison of a low-molecular-weight heparin, a nonsteroidal anti-inflammatory agent, and placebo in the treatment of superficial vein thrombosis. [Therapeutic management of superficial venous thrombosis with calcium nadroparin. Dosage testing and comparison with a non-steroidal anti-inflammatory agent]. Treatment of superficial vein thrombosis: clinical evaluation of Essaven gel--a placebo-controlled, 8-week, randomized study. Fondaparinux for the treatment of superficial-vein thrombosis in the legs. A randomized double-blind study of low-molecular-weight heparin (parnaparin) for superficial vein thrombosis: STEFLUX (Superficial ThromboEmbolism and Fluxum). Treatment of superficial vein thrombosis with standardized application of Essaven gel--a placebo-controlled, randomized study. [Clinical study of the therapeutic efficacy and tolerance of nimesulide in comparison with a sodium diclofenac in the treatment of acute superficial thrombophlebitis]. Treatment of acute superficial thrombosis and follow-up by computerized thermography. Tolerability and clinical efficacy of desmin in the treatment of superficial thrombovaricophlebitis. Comparison of oxyphenbutazone and placebo in the treatment of superficial thrombophelbitis: an object lesson in clinical trial design. Liposomal heparin spray: a new formula in adjunctive treatment of superficial venous thrombosis. Indomethacin in superficial thrombophlebitis. Topical formulation of heparin is effective in reducing the symptoms of superficial venous thrombosis: a monocenter, observer-blind, placebo-controlled randomized study. A randomized trial of dalteparin compared with ibuprofen for the treatment of superficial thrombophlebitis. A comparison of low-molecular-weight heparin and combined therapy of low-molecular-weight heparin with an anti-inflammatory agent in the treatment of superficial vein thrombosis. Evolution of superficial vein thrombosis treated with defibrotide: comparison with low dose subcutaneous heparin. Superficial thrombophlebitis of the legs: a randomized, controlled, follow-up study.
The optimal treatment of superficial thrombophlebitis of the leg is undefined. The main study objective was to assess the efficacy and safety of unmonitored high doses as compared to low doses of unfractionated heparin (UFH) for prevention of venous thromboembolic complications in patients with superficial thrombophlebitis of the thigh.
                Sixty consecutive patients with acute thrombophlebitis of the great saphenous vein, as assessed by ultrasonography, were randomized to subcutaneous injection twice daily of UFH in high unmonitored doses (12,500 IU for one week followed by 10,000 IU) or prophylactic doses (5,000 IU) for four weeks. The rate of asymptomatic involvement of the deep venous system and/or symptomatic thromboembolic events during a six-month follow-up period was assessed and compared between the two study groups.
                Six of the 30 patients (20.0 %; 95% CI, 7.7 to 38.6) randomized to low-dose UFH developed symptomatic or asymptomatic events as compared to 1 of the 30 patients (3.3%; 95% CI, 0.07 to 17.2) who received high-dose UFH (p=0.05 by one-sided Fisher's exact test). No patient experienced major bleeding complications in either group.
                The results of this study suggest that in patients with acute thrombophlebitis of the thigh unmonitored high doses of UFH are more effective than prophylactic doses of UFH for prevention of venous thromboembolic complications and do not enhance the risk of bleeding complications. One of the most interesting glycosaminoglycans (GAGs) is heparansulphate, known as the physiological activator of antithrombin III and involved in the maintenance of the antithrombotic potential of uninjured endothelium. The aim of our study was to evaluate the tolerability and effectiveness of heparansulphate with respect to sulodexide, another GAG suitable for the treatment of venous diseases. The study was performed in a open-label, controlled, with parallel and randomized groups, design. Thirty patients (aged 32-72 years) suffering from superficial thrombophlebitis were treated for two weeks with heparansulphate 100 mg t.i.d. or sulodexide 250 LSU b.i.d., both given orally. Some coagulative and fibrinolytic parameters (PT; aPTT; fibrinogen; euglobulin lysis time; t-PA; PAI-1; ATIII; alpha 2-antiplasmin; D-Dimer and platelets count) were assayed at the beginning and at the end of the study. Moreover signs and symptoms of disease (skin trophism; local pain; itch and oedema) were assessed. Heparansulphate and sulodexide were able to reduce signs and symptoms with similar degree and to significantly modify t-PA, alpha 2-antiplasmin and ATIII levels without any difference between treatments. Our issues show that heparansulphate can be useful in superficial thrombophlebitis management. The objective of this study was to assess the efficacy, safety, and cost of low-molecular-weight heparin compared to saphenofemoral disconnection for the treatment of internal saphenous proximal thrombophlebitis (SPT). Eighty-four consecutive patients diagnosed as presenting SPT alone (symptoms/echo-Doppler) were divided into 2 comparable groups treated with (1) saphenofemoral disconnection under local anesthesia with a short hospital stay (n = 45) or (2) prospective enoxaparin on an outpatient basis for 4 weeks (n = 39). Informed consent was obtained and inclusion, exclusion, and withdrawal criteria were established. Patients were followed up at 1, 3, and 6 months. Thirty patients per group completed the study requirements. In the disconnection group, 2 patients (6.7%) presented complications of the surgical wound, 1 (3.3%) had SPT recurrence (however, there was no deep venous thrombosis), and 2 (6.7%) had nonfatal pulmonary embolism confirmed by radionuclide scan. In the enoxaparin group, there were 2 cases (6.7%) of minor bleeding (epistaxis and rectal bleeding) and 3 (10%) recurrences of SPT. In the enoxaparin group there was no case of progression of the thrombosis to the deep venous system or pulmonary embolism. The study found no statistically significant differences between saphenofemoral disconnection and enoxaparin in the treatment of SPT, but the low-molecular-weight heparin group had socioeconomic advantages. In contrast with extensive information on the management of deep vein thrombosis of the lower extremities, little is known on the most appropriate treatment of the superficial vein thrombosis (SVT). In a multicenter, prospective, controlled, double-blind, double-dummy clinical trial, 164 consecutive patients with acute SVT of the great saphenous vein were randomized to receive the s.c. administration of either fixed prophylactic doses (2850 a-Xa IU) or body-weight adjusted therapeutic doses of nadroparin once daily for 1 month. The main study outcome was to compare the rate of asymptomatic and symptomatic extension of SVT and/or venous thromboembolic (VTE) complications during a 3-month follow-up period. Of the 81 patients randomized to the prophylactic doses, seven [8.6%; 95% confidence interval (CI), 3.5-17.0] developed SVT progression or VTE complications as compared with six of the 83 (7.2%; 95% CI, 2.8-15.1) allocated to the treatment group (absolute difference, 1.4; 96% CI, -6.9 to 9.7; P = 0.74). No patient in either group developed major bleeding. Our findings suggest that therapeutic doses of low-molecular-weight heparin, administered for 1 month in patients with SVT of the greater saphenous vein do not improve results obtained by prophylactic doses, administered for the same period, over a 3-month follow-up period. The efficacy and safety of antithrombotic treatment in patients with superficial vein thrombosis remain to be established in adequately designed trials.
                In a double-blind trial, 427 patients older than 18 years, with documented acute symptomatic superficial vein thrombosis of the legs, were randomly assigned to receive subcutaneous enoxaparin sodium, 40 mg; subcutaneous enoxaparin, 1.5 mg/kg; oral tenoxicam; or placebo, once daily for 8 to 12 days. The primary efficacy outcome was deep venous thromboembolism between days 1 and 12, defined as deep vein thrombosis detected by ultrasonography between days 8 and 12 or earlier if clinically indicated, or documented symptomatic pulmonary embolism. For the secondary efficacy outcomes, superficial vein thrombosis recurrence or extension was also considered.
                The incidence of deep venous thromboembolism by day 12 was 3.6% (4 of 111 patients) in the placebo group, 0.9% (1 of 109 patients) in the 40-mg enoxaparin group (P =.37 vs placebo), 1.0% (1 of 102 patients) in the 1.5-mg/kg enoxaparin group (P =.37 vs placebo), and 2.1% (2 of 94 patients) in the tenoxicam group (P =.69 vs placebo). The incidence of deep and superficial venous thromboembolism by day 12 was significantly reduced in all active treatment groups, from 30.6% (34 of 111 patients) in the placebo group to 8.3% (9 of 109 patients), 6.9% (7 of 102 patients), and 14.9% (14 of 94 patients) in the 40-mg enoxaparin (P<.001), 1.5-mg/kg enoxaparin (P<.001), and tenoxicam (P<.01) groups, respectively. No death or major hemorrhage occurred during the study.
                Treatment with a low-molecular-weight heparin or with an oral nonsteroidal anti-inflammatory agent should be evaluated further in the prevention of thromboembolic complications in patients with superficial vein thrombosis. This multicentre, randomised, open trial compared the efficacy and safety/acceptability of calcium nadroparin, a non-steroidal anti-inflammatory drug, naproxen, in the treatment of superficial venous thrombosis of the lower limbs, in 117 patients. Calcium nadroparin was given at two dosage regimens: a fixed dose (daily subcutaneous injection of 0.6 ml, i.e. 6150 anti-Xa IU, n = 38) or a dose adjusted for body weight (31.5 anti-Xa IU/kg, n = 40). The naproxen was given orally (500 mg as a single daily dose, n = 39). Treatment duration was 6 days in both groups. A very marked difference was found to the advantage of calcium nadroparin, although this difference did not reach the threshold of statistical significance with regard to repermeabilisation of the thrombosed superficial vein at the end of treatment. The most striking result concerned the regression of symptoms and signs. At the end of treatment (D7), there was a significant difference to the advantage of the calcium nadroparin groups, particularly regarding feelings of heat and redness (p < 0.001 in both cases). The persistence of symptoms and signs at 8 weeks was statistically less frequent (p = 0.007) in the calcium nadroparin groups than in the naproxen group. Efficacy did not differ between the calcium nadroparin fixed dose and calcium nadroparin weight-adjusted dose groups. No adverse events nor clinically significant laboratory abnormalities were encountered. Antithrombotic treatment of superficial venous thromboses with calcium nadroparin is well tolerated and appears to be associated with a greater improvement in symptoms and signs, in the short and mid-terms, than that obtained with an oral non-steroidal anti-inflammatory. The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG), in comparison with placebo in 30 patients with superficial vein thrombosis (SVT). The 8-week study evaluated SVT with an analogue clinical/symptomatic score. SVT was associated with varicose veins. In patients treated with active EG the decrease in score was significantly larger (p< 0.02) than in the placebo group. No intolerance was observed. The decrease in score in the placebo group was due to spontaneous resolution and to skin manipulation and massage. In conclusion local treatment with EG in SVT improves signs/symptoms much faster than placebo. This study confirms earlier observation on the effective, local use of EG in SVT. The efficacy and safety of anticoagulant treatment for patients with acute, symptomatic superficial-vein thrombosis in the legs, but without concomitant deep-vein thrombosis or symptomatic pulmonary embolism at presentation, have not been established.
                In a randomized, double-blind trial, we assigned 3002 patients to receive either fondaparinux, administered subcutaneously at a dose of 2.5 mg once daily, or placebo for 45 days. The primary efficacy outcome was a composite of death from any cause or symptomatic pulmonary embolism, symptomatic deep-vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial-vein thrombosis at day 47. The main safety outcome was major bleeding. The patients were followed until day 77.
                The primary efficacy outcome occurred in 13 of 1502 patients (0.9%) in the fondaparinux group and 88 of 1500 patients (5.9%) in the placebo group (relative risk reduction with fondaparinux, 85%; 95% confidence interval [CI], 74 to 92; P<0.001). The incidence of each component of the primary efficacy outcome was significantly reduced in the fondaparinux group as compared with the placebo group, except for the outcome of death (0.1% in both groups). The rate of pulmonary embolism or deep-vein thrombosis was 85% lower in the fondaparinux group than in the placebo group (0.2% vs. 1.3%; 95% CI, 50 to 95; P<0.001). Similar risk reductions were observed at day 77. A total of 88 patients would need to be treated to prevent one instance of pulmonary embolism or deep-vein thrombosis. Major bleeding occurred in one patient in each group. The incidence of serious adverse events was 0.7% with fondaparinux and 1.1% with placebo.
                Fondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatment of patients with acute, symptomatic superficial-vein thrombosis of the legs and did not have serious side effects. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT00443053.) Optimal doses and duration of low-molecular-weight heparin (LMWH) for the treatment of superficial vein thrombosis (SVT) are still uncertain.
                To compare the efficacy and safety of different doses and durations of LMWH parnaparin for symptomatic lower limb SVT.
                Outpatients with at least a 4-cm-long SVT of long or short saphenous veins or their collaterals were randomized to receive parnaparin either 8500 UI once daily ( o.d.) for 10 days followed by placebo for 20 days (group A) or 8500 UI o.d. for 10 days followed by 6400 UI once daily (o.d.) for 20 days (group B) or 4250 UI o.d. for 30 days (group C) in a double-blind fashion in 16 clinics. Primary outcome was the composite of symptomatic and asymptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and relapse and/or symptomatic or asymptomatic SVT recurrence in the first 33 days with 60 days follow-up.
                Among 664 patients, primary outcome occurred in 33/212 (15.6%), 4/219 (1.8%) and 16/217 (7.3%) subjects in groups A, B and C, respectively (B vs. A: absolute risk reduction [ARR]: 13.7%, 95% confidence intervals [CI]: 8-18.9 P<0.001; B vs. C: ARR: 5.5%; 95% CI: 1.6-9.4 P= 0.011; C vs. A: ARR: 8.2%, 95% CI: 2-14 P=0.012). During days 0-93, the event rate was higher in group A (22.6%) than either in group B (8.7%; P=0.001) or C (14.3%, P=0.034). No major hemorrhages occurred.
                An intermediate dose of parnaparin for 30 days is superior to either a 30-day prophylactic dose or a 10-day intermediate dose for lower limb SVT treatment.
                © 2012 International Society on Thrombosis and Haemostasis. The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) in comparison with placebo in 30 patients with superficial vein thrombosis (SVT). The 4-week study evaluated the average skin temperature and an analogue symptomatic score. Below-knee SVT was associated with large varicose veins. In patients treated with active EG the decrease in score and in the average, composite skin temperature was significantly larger than in the placebo and control groups. No intolerance was observed. The decrease in score and temperature in the placebo group was mainly due to skin manipulation and massage. In conclusion, treatment with EG in SVT improves symptoms and decreases skin temperature faster. This study confirms earlier observations on the effective use of EG in SVT. The efficacy and tolerability of nimesulide were assessed in a randomized study versus diclofenac sodium in the treatment of 50 patients affected with acute superficial thrombophlebitis. Both drugs, administered in a dose of 1 tablet b.i.d. for 10 days, evidenced a prompt and effective analgesic and anti-inflammatory activity. Particularly, the tolerability of nimesulide was excellent. Superficial vein thrombosis (SVT) is a common complication of varicose veins. Treatment may be surgical by removal of the superficial clots under local anesthetic or medical in association with elastic compression and mobilization. In this study 83 patients with SVT were randomised in treatments groups: A--superficial thrombectomy and elastic compression (EC); B--Ca Heparin (0.5 mgs b.i.b.) + EC; C--Venoruton (1 g, t.i.d.) + EC; D--Venoruton (1 g, t.i.d.) after superficial thrombectomy + EC; E--elastic compression. All treatments were applied for 8 weeks. The evolution of SVT was studied by a system, based on thermography, which analyse by a computerized system the variation of the hyperthermic areas (HA) on thermograms. This was associated with subjective and objective clinical evaluation. Results indicate a decrease of HA in all groups but patients treated with superficial thrombectomy show a significantly (p, 0.05) greater and faster reduction of HA. The reduction of HA produced by Venoruton was also significantly greater (p less than 0.05) than that observed in patients treated by Ca Heparin or elastic compression and it determined also a faster and greater (p less than 0.05) decrease of HA after thrombectomy. These results were confirmed by clinical observations. In conclusion results from this study indicate a positive effect of Venoruton in SVT in determining a faster decrease of hyperthermic areas probably by decreasing local inflammation. Fifty-six patients with superficial thrombovaricophlebitis of the lower limbs were enrolled in an open and multicenter (4 centers) trial for a period of thirty days. Patients were randomly allocated to three treatment groups to receive a new low-molecular-weight dermatan sulfate (Desmin) at the dose, respectively, of 100 mg once daily by subcutaneous (SC) route, 100 mg twice a day SC, and 200 mg once daily by intramuscular (IM) route. The general and local tolerability and the clinical efficacy of the drug were evaluated by means of clinical, instrumental, and laboratory parameters. Desmin proved capable of effectively improving the symptoms of patients affected by thrombovaricophlebitis, inducing rapid regression by the tenth day of treatment. The daily dose of 200 mg (either SC or IM) was more effective than the 100 mg dose. The systemic tolerability of the drug, administered for the first time for one month, was extremely good, without significant variations in the relevant laboratory tests. Local tolerance (at the site of injection) of the drug was also good. nan The objective of this study was to assess the efficacy and safety of liposomal heparin spray-a new formula of topical heparin delivery. This was a randomized, multicenter, controlled open clinical trial with 2 parallel groups. Forty-six outpatients with clinical signs of superficial venous thrombosis (SVT) were treated with either topical liposomal heparin spraygel (LHSG) (Lipohep Forte Spraygel, 4 puffs of 458 IU tid (n = 22) or with low-molecular-weight heparin (LMWH) (Clexane 40 mg once a day (n = 24), administered subcutaneously (sc). Main outcome measures were efficacy parameters (improvement of local symptoms-pain control and planimetric evaluation of erythema size, duplex Doppler assessment of thrombus regression) and safety parameters (documentation of adverse events, with particular reference to deep vein thrombosis [DVT] by duplex sonography, and patients' and investigators' assessment of drug tolerance). Patients' and investigators' subjective assessment of efficacy of treatment and change in basic biochemical parameters were defined as secondary outcome measures. Statistical analysis was performed with use of Wilcoxon test, Mann-Whitney U-test and Chi-square test. Regression of SVT-related symptoms, including pain, erythema, and thrombus presence, was shown as comparable in LHSG and LMWH groups. These results were corroborated by efficacy assessment by investigators and patients. Three cases of deep venous thrombosis in heparin spraygel and 1 in heparin sc group were reported. No significant adverse reactions were observed in the spraygel group, but 1 serious allergic reaction was observed in the LMWH group. Tolerance of new formula heparin was assessed as good. Heparin spraygel-a new topical mode of heparin application, seems a promising method of heparin delivery. This initial study has demonstrated comparable efficacy and safety of LHSG and LMWH in local treatment of SVT. These findings should be confirmed by further extensive study that will reach appropriate statistical power to support such conclusion, for despite heparin treatment, significant risk of DVT was demonstrated in both groups. nan The aim of the present, randomized, placebo controlled study was to assess the dose-dependent symptom reduction efficacy, safety and tolerability of heparin-spraygel (Viatromb 2.400 IU/g heparin spraygel) in patients with superficial vein thrombosis (SVT) of the lower limbs.
                A number of clinically relevant objectives; time to onset and intensity of symptoms' reduction reflected also by rescue medication consumption were considered and assessed.
                Pain reduction between the two time-points (days 0 and 7) was significant within both treatment groups (active drug and placebo). However, subjects treated with active drug reported a mean pain reduction (VAS) of 76.21 mm (93.13% decrease); in subjects treated with placebo it was 50.36 (61.35%) mm (P<0.0001). The difference in pain reduction between the active drug and placebo groups was significant (P<0.05). The proportion of responders (subjects with at least 50%reduction in pain (VAS) on day 7 and day 14) was higher within subjects treated with Viatromb (P<0.05). The extension of erythema, evaluated by planimetry indicated a significantly higher reduction (day 0 to 7 and 0 to 14) in Viatromb-treated subjects in comparison with placebo. In the Viatromb group, the reduction in thrombus size was remarkable towards placebo (P<0.05). Reduction of edema and pain (VRS) had comparable time courses. Both investigator's and subject's global assessment of efficacy were significantly better with Viatromb. No adverse events or reactions were reported during the study and the follow up period.
                Viatromb was significantly more effective than placebo in the symptomatic treatment of SVT. Superficial thrombophlebitis can produce pain and result in a deep vein thrombosis (DVT) if not treated. Conservative therapies including prescription of non-steroidal anti-inflammatory drugs (NSAID) and heat have been standard care. Recently, studies have been published reporting efficacy and safety of low-molecular-weight heparin for the treatment of superficial thrombophlebitis. However, there are few comparative trials to conservative therapy. We studied the effectiveness and safety of treatment with dalteparin compared with ibuprofen in patients with confirmed superficial thrombophlebitis.
                Consecutive patients were randomized to receive daily dalteparin vs. ibuprofen three times daily for up to 14 days. The primary outcome measure was the incidence of extension of thrombus or new symptomatic venous thromboembolism during the 14-day and 3-month follow-up period. The secondary outcome was a reduction in pain. The outcome measure of safety was the incidence of major and minor bleeding.
                Of 302 consecutive patients screened, 72 were enrolled. Four patients receiving ibuprofen compared with no patients receiving dalteparin had thrombus extension at 14 days (P = 0.05), however, there was no difference in thrombus extension at 3 months. Both treatments significantly reduced pain. There were no episodes of major or minor bleeding during the treatment period.
                Dalteparin is superior to the NSAID ibuprofen in preventing extension of superficial thrombophlebitis during the 14-day treatment period with similar relief of pain and no increase in bleeding. However, questions concerning the optimal treatment duration should be explored in future trials.
                © 2012 International Society on Thrombosis and Haemostasis. The optimal treatment of superficial vein thrombosis (SVT) of the leg has not been determined yet. The aim of this study is to evaluate the efficacy of low-molecular-weight heparin (LMWH) as compared with combined therapy of LMWH with an anti-inflammatory agent in treatment of SVT.
                Fifty patients with SVT of the greater saphenous vein were randomly assigned to be treated with Ca-nadroparin 190 IUAxa/kg in a single dose or with same dose of Ca-nadroparin and 60 mg oral acemetacine twice daily for 10 days. The efficacy of the two treatments to relieve symptoms and signs was evaluated by using visual analogue scale.
                Significant improvements were achieved for both groups after the treatment in terms of all four symptoms (P < 0.001). Treatment scores were in favour of LMWH with anti-inflammatory agent treatment group to relieve all four symptoms. The most significant and remarkable results obtained were for the reduction of pain and local tenderness (P < 0.05). No patient experienced major complications or mortality in either group.
                The results of this study suggest that the combined therapy of LMWH with an anti-inflammatory agent is more effective than LMWH. It may be an important option in the standard treatment of SVT. Forty patients with superficial vein thrombosis (SVT) or thrombophlebitis were randomly treated either with defibrotide (20) an antithrombotic/profibrinolytic drug or with low-dose subcutaneous heparin [LDSH] (20) for 3 weeks. The efficacy of the two treatments was evaluated by means of computerized thermography monitoring the decrease of the areas at maximum temperature (AMT) and using an analogue scale line to evaluate signs and symptoms. Defibrotide was found to be significantly more effective than LDSH in decreasing both AMT and analogue score after 2 and 3 weeks. By enhancing endogenous fibrinolysis, defibrotide reduced the deposition of fibrin, the ensuing inflammatory response and the production of new thrombi in the affected veins. This was shown by the progressive decrease in the hyperthermic areas. Thanks to its activity defibrotide may be able to promote a faster removal of thrombi and reduce the continuous formation of new thrombi in the inflamed veins. The aim of the present study was to evaluate the effects of different treatment plans (compression only, early surgery, low-dose subcutaneous heparin [LDSH], low-molecular-weight heparin [LMWH], and oral anticoagulant [OC] treatment) in the management of superficial thrombophlebitis (STP), by considering efficacy and costs in a 6-month, randomized, follow-up trial. Patients with STP, with large varicose veins without any suspected/documented systemic disorder, were included. Criteria for inclusion were as follows: presence of varicose veins; venous incompetence (by duplex); a tender, indurated cord along a superficial vein; and redness and heat in the affected area. All patients were ambulatory. Exclusion criteria were obesity, cardiovascular or neoplastic diseases, bone/joint disease, problems requiring immobilization, and age > 70 years. Patients with superficial thrombophlebitis without varicose veins and patients under treatment with drugs at referral were also excluded. Color duplex (CD) was used to detect concomitant deep vein thrombosis (DVT) and to evaluate the extension or reduction of STP at 3 and 6 months. Venography was not used. Of 562 patients included, 3.5% had had a recent DVT in the same limb affected by SVT and 2.1% in the contralateral limb. In six patients DVT was present in both limbs. These patients were treated with anticoagulants and excluded from the follow-up. After 3 and 6 months the incidence of STP extension was higher in the elastic compression and in the saphenous ligation groups (p < 0.05). There was no significant difference in DVT incidence at 3 months among the treatment groups. Stripping of the affected veins was associated with the lowest incidence of thrombus extension. The cost for compression alone was the lowest and the cost including LMWH was the highest. The average cost was 1,383 US$. However the highest social cost (lost working days, inactivity) was observed in subjects treated only with stockings.
Prophylactic dose fondaparinux given for six weeks appears to be a valid therapeutic option for ST of the legs. The evidence on oral treatments, topical treatment, or surgery is too limited and does not inform clinical practice about the effects of these treatments in terms of VTE and ST progression. Further research is needed to assess the role of the new oral direct thrombin and activated factor-X inhibitors, LMWH, and NSAIDs; the optimal doses and duration of treatment; and whether a combination therapy may be more effective than single treatment. Adequately designed and conducted studies are required to clarify the role of topical and surgical treatments.