Abstract
Background and aims: Anti-coagulation is an important component of post-operative Venous-Thombo-Embolic (VTE) prophylaxis but can be associated with significant complications including hemorrhage. Current guidelines favour anti-coagulation for ≥ 14 days with little evidence evaluating the efficacy of anticoagulation <14 days. Our study hypothesizes that short course Low-Molecular-Weight-Heparin (LMWH for 5-7 days) in combination with Calf Compression Device (CCD) is equally effective as standard therapy LMWH (14 days) in preventing VTE and related events amongst patients undergoing Total-Knee-Replacement (TKR). Methods: Eighty-three patients undergoing TKR were randomly allocated to either: Group 1 short course LMWH (5-7 days) with CCD or Group 2 standard course LMWH only (14 days). Patients were followed up daily for five days post-operative and then at regular intervals for twelve weeks assessing for: deep-vein-thrombosis and pulmonary embolus, bleeding, exaggerated pain, wound infection, leg swelling and need for extended hospitalization beyond 5 days. Incidence comparisons between groups were made using Pearson’s chi-square or Fischer’s Exact tests and an accepted group treatment difference of 15% was selected based on previous studies to calculate equivalence powers. Results: The incidence of DVT was equal between groups (n=3), 2% (95% CI -13.4, 14.1%). There was a single case of asymptomatic PE in the short course group though the group difference was not significant (p=0.486). Patients in the short course therapy group also demonstrated significantly lower rates of post operative leg swelling (p=0.004). Group comparisons for all other study endpoints did not reach significance. Conclusions: In this study combined short course therapy was equally effective as standard therapy in preventing DVT and non-fatal PE, and superior to standard therapy in limiting post-operative leg swelling amongst patients undergoing TKR. Trial registered at Australian New Zealand Trial Registry: ACTRN12613000240741.
Highlights
Venous thromboembolism (VTE) can be associated with significant morbidity and mortality including fatal Pulmonary Embolus (PE), symptomatic Deep Vein Thrombosis (DVT) and PE, increased risk of recurrent VTE and chronic post-thrombotic syndrome [1]
One DVT in Group 1 was symptomatic and was recorded at the 4 week follow up assessment; this DVT progressed to asymptomatic PE
No DVT in Group 2 progressed to PE
Summary
Venous thromboembolism (VTE) can be associated with significant morbidity and mortality including fatal Pulmonary Embolus (PE), symptomatic Deep Vein Thrombosis (DVT) and PE, increased risk of recurrent VTE and chronic post-thrombotic syndrome [1]. In 2010, around two thousand deaths were reported from VTE and related events in Australia alone, 40% of which occurred in postoperative patients [2] Preventative measures such as anti-coagulation, intermittent pneumatic compression, anti-embolic stockings and early mobilization have all been shown to significantly reduce the incidence of VTE [2]. Other complications associated with anti-coagulation use which have the potential to cause considerable morbidity and mortality include injection site erythema, hematoma, Heparin Induced Thrombocytopenia (HIT) and allergy. These effects are amplified when treatment extends beyond fourteen days [4,5], alternative approaches to anti-coagulation regimens in the peri-operative period are required. Our study hypothesizes that short course Low-Molecular-Weight-Heparin (LMWH for 5-7 days) in combination with Calf Compression Device (CCD) is effective as standard therapy LMWH (14 days) in preventing VTE and related events amongst patients undergoing Total-Knee-Replacement (TKR)
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