Pharmacodynamics of low molecular weight heparin in patients undergoing bariatric surgery: A prospective, randomised study comparing two doses of parnaparin (BAFLUX STUDY)

Imberti, Davide; Legnani, Cristina; Baldini, E; Cini, Michela; Nicolini, Alberto; Guerra, Manuela; Paoli, Marco De; Zanardi, Alberto; Palareti, Gualtiero

doi:10.1016/j.thromres.2009.04.021

Cited by 26 publications

(14 citation statements)

References 30 publications

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“…Our results are also consistent with those reported in three recently published studies on the pharmacodynamic activity of LMWHs in bariatric patients [26–28]. In a study of 66 patients undergoing surgery for severe obesity, Imberti and colleagues showed that a fixed prophylactic dose of parnaparin (4,250 IU/day) was able to achieve prophylactic anti-Xa levels in 98.3 % of patients, while a higher dosage (6,400 IU/day) was associated with excessive anti-Xa levels in 62.3 % of patients [26].…”

Section: Discussionsupporting

confidence: 93%

Prophylaxis of Venous Thromboembolism with Low Molecular Weight Heparin in Bariatric Surgery: a Prospective, Randomised Pilot Study Evaluating Two Doses of Parnaparin (BAFLUX Study)

Imberti

Baldini

Giorgi‐Pierfranceschi

et al. 2013

OBES SURG

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BackgroundThe optimal dose of low molecular weight heparin (LMWH) to prevent venous thromboembolism (VTE) after bariatric surgery remains controversial. The aim of this multicentre, open-label, pilot study was to evaluate the efficacy and safety of two different doses of the LMWH parnaparin administered to patients undergoing bariatric surgery.MethodsPatients were randomised to receive 4,250 IU/day (group A) or 6,400 IU/day (group B) of parnaparin s.c. for 7–11 days. Bilateral colour Doppler ultrasound of the lower limb was performed before surgery and at the end of the treatment period. The primary efficacy outcome was a composite of asymptomatic and symptomatic deep vein thrombosis, symptomatic pulmonary embolism and death from any cause during treatment. The primary safety endpoint was major and clinically relevant non-major bleeding.ResultsA total of 258 patients underwent randomization; 8 subjects were excluded following the safety analysis. One hundred thirty-one patients [106 females; mean age, 40.3 years (standard deviation (SD) ±9.6); mean body mass index (BMI), 44.6 kg/m2 (SD ±5.4)] were assigned to group A and 119 patients [93 females; mean age, 41.5 years (SD ±9.9); mean BMI, 44.2 kg/m2 (SD ±5.4)] were assigned to group B. The rate of the primary efficacy outcome was 1.5 % (two cases; 95 % confidence interval (CI), 0.2–6.0 %) in group A as compared with 0.8 % (one case; 95 % CI, 0.4–5.3 %) in group B (p = ns). The composite incidence of major bleeding and clinically relevant non-major bleeding was 6.1 % (eight cases; 95 % CI, 2.9–12.1 %) in group A and 5.0 % (six cases; 95 % CI, 2.1–11.1 %) in group B (p = ns).ConclusionsA parnaparin dose of 4,250 IU/day seems suitable for VTE prevention in patients undergoing bariatric surgery.

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Section: Discussionsupporting

confidence: 93%

Prophylaxis of Venous Thromboembolism with Low Molecular Weight Heparin in Bariatric Surgery: a Prospective, Randomised Pilot Study Evaluating Two Doses of Parnaparin (BAFLUX Study)

Imberti

Baldini

Giorgi‐Pierfranceschi

et al. 2013

OBES SURG

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“…This level of anti-Xa activity is sufficient to prevent venous thrombosis in humans. 24 However, the optimum dose of each drug needed to provide beneficial effects and minimize the risk of bleeding remains unknown. The results showed suppression of coagulation measured by TAT in both fondaparinux and enoxaparin groups.…”

Section: Figurementioning

confidence: 99%

Enoxaparin and fondaparinux attenuates endothelial damage in endotoxemic rats

Iba

Okamoto²,

Ohike³

et al. 2012

The Journal of Trauma and Acute Care Surgery

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“…Obese patients have an increased percent of fat per kilogram of total body weight (TBW), resulting in an increased volume of distribution of lipophilic drugs. However, the relative reduced vascularity of adipose tissue may result in overdosing of medications with large vascular distribution when dosing by TBW [28,29]. …”

Section: Vte Prevention With Pharmacologic Agentsmentioning

confidence: 99%

“…Additionally, Imberti et al demonstrated that increasing the prophylactic dosing of the LMWH parnaparin from a fixed dose of 4250 IU/day to a fixed dose of 6400 IU/day in bariatric surgery patients (BMI range: 36.1–64.1 kg/m 2 ) resulted in supraprophylactic anti-FXa levels (defined as >0.4 U/ml) in 62.3% of patients. By contrast, only approximately 2% of patients who received the lower dose developed a supratherapeutic (>0.4 U/ml) anti-FXa level [29]. …”

Section: Vte Prevention With Pharmacologic Agentsmentioning

confidence: 99%

Prevention of venous thromboembolism in obesity

Freeman

Pendleton

Rondina

2010

Expert Review of Cardiovascular Therapy

105

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Venous thromboembolism (VTE) is a significant cause of morbidity and mortality in hospitalized patients. Where appropriate, evidence-based methods of prophylaxis are implemented and the burden of VTE can be reduced substantially. Obesity, including morbid obesity, is associated with a high risk of VTE and, unfortunately, fixed doses of US FDA-approved anticoagulant regimens, including unfractionated heparins, low-molecular-weight heparins and factor Xa inhibitors, may not provide optimal VTE prophylaxis in these patients. Although the data are still limited, a rapidly growing body of literature and cumulative evidence suggests that anticoagulant dose adjustments in morbidly obese patients may optimize pharmacodynamic activity and reduce VTE risk. With the prevalence of morbid obesity continuing to rise, more high-quality clinical data are needed to better understand the pathobiology of VTE in obesity and provide effective, yet safe, prevention strategies.

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Pharmacodynamics of low molecular weight heparin in patients undergoing bariatric surgery: A prospective, randomised study comparing two doses of parnaparin (BAFLUX STUDY)

Cited by 26 publications

References 30 publications

Prophylaxis of Venous Thromboembolism with Low Molecular Weight Heparin in Bariatric Surgery: a Prospective, Randomised Pilot Study Evaluating Two Doses of Parnaparin (BAFLUX Study)

Prophylaxis of Venous Thromboembolism with Low Molecular Weight Heparin in Bariatric Surgery: a Prospective, Randomised Pilot Study Evaluating Two Doses of Parnaparin (BAFLUX Study)

Enoxaparin and fondaparinux attenuates endothelial damage in endotoxemic rats

Prevention of venous thromboembolism in obesity

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