A randomized double-blind study of low-molecular-weight heparin (parnaparin) for superficial vein thrombosis: STEFLUX (Superficial ThromboEmbolism and Fluxum)

Benilde Cosmi, Massimo Filippini, Daniele Tonti, Giampiero Avruscio, Angelo Ghirarduzzi, Eugenio Bucherini, Giuseppe Camporese, Davide Imberti, Gualtiero Palareti, Elisabetta Favaretto, Fausto Campana, Sonia Ragazzo, Fabio Ceccato, Stefania Rondinello, Maria Rosaria Veropalumbo, Matteo Iotti, Maria Andreozzi Giuseppe, Fabio Verlato, Davide Imberti, Vincenzo PriscoRosaria Greco, Leonardo Aluigi, Adriana Visoná, Beniamino Zalunardo, Zotta Laura, Tonello Diego, Carmelo Amico, Paolo Benin, Vincenzo Vella, Gianfranco Boccoli, Leonardo Chiodi, Daniele Aloisi, Lucia Angeloni, Demetrio Postacchini, Guido Cruciani, Ilenia Macchiati, Andrea Grossi, Saverino La Placa, Carlo Renzi, Dimitrios Kontothanassis

Research output: Contribution to journalArticle

37 Citations (Scopus)

Abstract

Background: Optimal doses and duration of low-molecular-weight heparin (LMWH) for the treatment of superficial vein thrombosis (SVT) are still uncertain. Objectives: To compare the efficacy and safety of different doses and durations of LMWH parnaparin for symptomatic lower limb SVT. Patients and 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 8500UIonce daily (o.d.) for 10days followed by placebo for 20days (group A) or 8500UIo.d. for 10days followed by 6400UIonce daily (o.d.) for 20days (group B) or 4250UIo.d. for 30days (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 33days with 60days 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

Original languageEnglish
Pages (from-to)1026-1035
Number of pages10
JournalJournal of Thrombosis and Haemostasis
Volume10
Issue number6
DOIs
Publication statusPublished - Jun 2012

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Low Molecular Weight Heparin
Thromboembolism
Double-Blind Method
Veins
Thrombosis
Recurrence
Numbers Needed To Treat
Saphenous Vein
Pulmonary Embolism
Venous Thrombosis
Lower Extremity
Outpatients
Placebos
Confidence Intervals
Safety
Fluxum
parnaparin
Therapeutics

Keywords

  • Deep vein thrombosis
  • Low molecular weight heparin
  • Pulmonary embolism
  • Randomized clinical trial
  • Superficial vein thrombosis
  • Venous thromboembolism

ASJC Scopus subject areas

  • Hematology

Cite this

A randomized double-blind study of low-molecular-weight heparin (parnaparin) for superficial vein thrombosis : STEFLUX (Superficial ThromboEmbolism and Fluxum). / Cosmi, Benilde; Filippini, Massimo; Tonti, Daniele; Avruscio, Giampiero; Ghirarduzzi, Angelo; Bucherini, Eugenio; Camporese, Giuseppe; Imberti, Davide; Palareti, Gualtiero; Favaretto, Elisabetta; Campana, Fausto; Ragazzo, Sonia; Ceccato, Fabio; Rondinello, Stefania; Veropalumbo, Maria Rosaria; Iotti, Matteo; Andreozzi Giuseppe, Maria; Verlato, Fabio; Imberti, Davide; Prisco, Vincenzo; Greco, Rosaria; Aluigi, Leonardo; Visoná, Adriana; Zalunardo, Beniamino; Laura, Zotta; Diego, Tonello; Amico, Carmelo; Benin, Paolo; Vella, Vincenzo; Boccoli, Gianfranco; Chiodi, Leonardo; Aloisi, Daniele; Angeloni, Lucia; Postacchini, Demetrio; Cruciani, Guido; Macchiati, Ilenia; Grossi, Andrea; La Placa, Saverino; Renzi, Carlo; Kontothanassis, Dimitrios.

In: Journal of Thrombosis and Haemostasis, Vol. 10, No. 6, 06.2012, p. 1026-1035.

Research output: Contribution to journalArticle

Cosmi, B, Filippini, M, Tonti, D, Avruscio, G, Ghirarduzzi, A, Bucherini, E, Camporese, G, Imberti, D, Palareti, G, Favaretto, E, Campana, F, Ragazzo, S, Ceccato, F, Rondinello, S, Veropalumbo, MR, Iotti, M, Andreozzi Giuseppe, M, Verlato, F, Imberti, D, Prisco, V, Greco, R, Aluigi, L, Visoná, A, Zalunardo, B, Laura, Z, Diego, T, Amico, C, Benin, P, Vella, V, Boccoli, G, Chiodi, L, Aloisi, D, Angeloni, L, Postacchini, D, Cruciani, G, Macchiati, I, Grossi, A, La Placa, S, Renzi, C & Kontothanassis, D 2012, 'A randomized double-blind study of low-molecular-weight heparin (parnaparin) for superficial vein thrombosis: STEFLUX (Superficial ThromboEmbolism and Fluxum)', Journal of Thrombosis and Haemostasis, vol. 10, no. 6, pp. 1026-1035. https://doi.org/10.1111/j.1538-7836.2012.04727.x
Cosmi, Benilde ; Filippini, Massimo ; Tonti, Daniele ; Avruscio, Giampiero ; Ghirarduzzi, Angelo ; Bucherini, Eugenio ; Camporese, Giuseppe ; Imberti, Davide ; Palareti, Gualtiero ; Favaretto, Elisabetta ; Campana, Fausto ; Ragazzo, Sonia ; Ceccato, Fabio ; Rondinello, Stefania ; Veropalumbo, Maria Rosaria ; Iotti, Matteo ; Andreozzi Giuseppe, Maria ; Verlato, Fabio ; Imberti, Davide ; Prisco, Vincenzo ; Greco, Rosaria ; Aluigi, Leonardo ; Visoná, Adriana ; Zalunardo, Beniamino ; Laura, Zotta ; Diego, Tonello ; Amico, Carmelo ; Benin, Paolo ; Vella, Vincenzo ; Boccoli, Gianfranco ; Chiodi, Leonardo ; Aloisi, Daniele ; Angeloni, Lucia ; Postacchini, Demetrio ; Cruciani, Guido ; Macchiati, Ilenia ; Grossi, Andrea ; La Placa, Saverino ; Renzi, Carlo ; Kontothanassis, Dimitrios. / A randomized double-blind study of low-molecular-weight heparin (parnaparin) for superficial vein thrombosis : STEFLUX (Superficial ThromboEmbolism and Fluxum). In: Journal of Thrombosis and Haemostasis. 2012 ; Vol. 10, No. 6. pp. 1026-1035.
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abstract = "Background: Optimal doses and duration of low-molecular-weight heparin (LMWH) for the treatment of superficial vein thrombosis (SVT) are still uncertain. Objectives: To compare the efficacy and safety of different doses and durations of LMWH parnaparin for symptomatic lower limb SVT. Patients and 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 8500UIonce daily (o.d.) for 10days followed by placebo for 20days (group A) or 8500UIo.d. for 10days followed by 6400UIonce daily (o.d.) for 20days (group B) or 4250UIo.d. for 30days (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 33days with 60days 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",
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T1 - A randomized double-blind study of low-molecular-weight heparin (parnaparin) for superficial vein thrombosis

T2 - STEFLUX (Superficial ThromboEmbolism and Fluxum)

AU - Cosmi, Benilde

AU - Filippini, Massimo

AU - Tonti, Daniele

AU - Avruscio, Giampiero

AU - Ghirarduzzi, Angelo

AU - Bucherini, Eugenio

AU - Camporese, Giuseppe

AU - Imberti, Davide

AU - Palareti, Gualtiero

AU - Favaretto, Elisabetta

AU - Campana, Fausto

AU - Ragazzo, Sonia

AU - Ceccato, Fabio

AU - Rondinello, Stefania

AU - Veropalumbo, Maria Rosaria

AU - Iotti, Matteo

AU - Andreozzi Giuseppe, Maria

AU - Verlato, Fabio

AU - Imberti, Davide

AU - Prisco, Vincenzo

AU - Greco, Rosaria

AU - Aluigi, Leonardo

AU - Visoná, Adriana

AU - Zalunardo, Beniamino

AU - Laura, Zotta

AU - Diego, Tonello

AU - Amico, Carmelo

AU - Benin, Paolo

AU - Vella, Vincenzo

AU - Boccoli, Gianfranco

AU - Chiodi, Leonardo

AU - Aloisi, Daniele

AU - Angeloni, Lucia

AU - Postacchini, Demetrio

AU - Cruciani, Guido

AU - Macchiati, Ilenia

AU - Grossi, Andrea

AU - La Placa, Saverino

AU - Renzi, Carlo

AU - Kontothanassis, Dimitrios

PY - 2012/6

Y1 - 2012/6

N2 - Background: Optimal doses and duration of low-molecular-weight heparin (LMWH) for the treatment of superficial vein thrombosis (SVT) are still uncertain. Objectives: To compare the efficacy and safety of different doses and durations of LMWH parnaparin for symptomatic lower limb SVT. Patients and 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 8500UIonce daily (o.d.) for 10days followed by placebo for 20days (group A) or 8500UIo.d. for 10days followed by 6400UIonce daily (o.d.) for 20days (group B) or 4250UIo.d. for 30days (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 33days with 60days 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

AB - Background: Optimal doses and duration of low-molecular-weight heparin (LMWH) for the treatment of superficial vein thrombosis (SVT) are still uncertain. Objectives: To compare the efficacy and safety of different doses and durations of LMWH parnaparin for symptomatic lower limb SVT. Patients and 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 8500UIonce daily (o.d.) for 10days followed by placebo for 20days (group A) or 8500UIo.d. for 10days followed by 6400UIonce daily (o.d.) for 20days (group B) or 4250UIo.d. for 30days (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 33days with 60days 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

KW - Deep vein thrombosis

KW - Low molecular weight heparin

KW - Pulmonary embolism

KW - Randomized clinical trial

KW - Superficial vein thrombosis

KW - Venous thromboembolism

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