title: A randomized double-blind study of low-molecular-weight heparin (parnaparin) for superficial vein thrombosis: STEFLUX (Superficial ThromboEmbolism and Fluxum).
abstract: BACKGROUND
  Optimal doses and duration of low-molecular-weight heparin (LMWH) for the treatment of superficial vein thrombosis (SVT) are still uncertain.
  
  
  OBJECTIVE
  To compare the efficacy and safety of different doses and durations of LMWH parnaparin for symptomatic lower limb SVT.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Angiology & Blood Coagulation 'Marino Golinelli', S.Orsola-Malpighi University Hospital, Bologna, Italy. benilde.cosmi@unibo.it
authors.forename: B
authors.initials: B
authors.lastname: Cosmi
authors.forename: M
authors.initials: M
authors.lastname: Filippini
authors.forename: D
authors.initials: D
authors.lastname: Tonti
authors.forename: G
authors.initials: G
authors.lastname: Avruscio
authors.forename: A
authors.initials: A
authors.lastname: Ghirarduzzi
authors.forename: E
authors.initials: E
authors.lastname: Bucherini
authors.forename: G
authors.initials: G
authors.lastname: Camporese
authors.forename: D
authors.initials: D
authors.lastname: Imberti
authors.forename: G
authors.initials: G
authors.lastname: Palareti
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006470:Hemorrhage / Q000139:chemically induced; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000209:etiology; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000150:complications / Q000188:drug therapy* / Q000401:mortality
chemical_list: D000925:Anticoagulants; D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; C080945:parnaparin