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Low incidence of clinically important VTE observed after lower leg fractures
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Researchers found a low overall incidence of clinically important venous thromboembolism after the surgical repair of isolated tibia, fibula and ankle fractures, with no differences reported between patients who received dalteparin or placebo.
Two hundred sixty-five patients who required surgery for isolated lower-leg fractures were included in the multicenter, double-blind study and randomly assigned to either 5,000 units of subcutaneous dalteparin or matching placebo once daily for 2 weeks. Bilateral Doppler ultrasound (DUS) of patients’ proximal leg veins was performed at approximately 14 days postoperatively and at 3-month follow-up. The study’s primary effectiveness outcome was clinically important venous thromboembolism (CIVTE), or the composite of symptomatic venous thromboembolism (VTE) within 3 months postoperatively, as well as asymptomatic proximal deep vein thrombosis (DVT) on DUS. Major bleeding was considered the study’s primary safety outcome.
At 6-week and 3-month follow-up, the researchers assessed clinical status, unscheduled hospital visits or physician visits, symptoms for possible VTE, cointervention, bleeding and other adverse events through phone interviews. Objective diagnostic tests and prespecified diagnostic algorithms were used to investigate any clinical suspicion of DVT or pulmonary embolism during the 3-month study period, as well.
Of the 258 patients included as part of the analysis for primary outcome effectives, 130 patients had been assigned to dalteparin and 128 patients to placebo. There were two patients who received placebo who had talus and calcaneal fractures, and one patient who received dalteparin who had a patellar fracture.
CIVTE developed in only five patients total, two of whom received dalteparin and three of whom received placebo. Among the events, two were asymptomatic DVT detected on DUS at day 14 — one in each treatment group. Additionally, one case of symptomatic proximal DVT occurred in each treatment group, detected by DUS on day 11 in the placebo group and on day 17 in the dalteparin group. One asymptomatic, nonfatal pulmonary embolism occurred in the placebo group on day 11, and whole-leg DUS, which was performed as protocol violations, detected calf vein thrombi in three patients, according to the researchers. No fatal pulmonary emboli or cases of major bleeding were reported. – by Monica Jaramillo
Disclosures: Selby reports she is a consultant for Bayer, Boehringer Ingelheim, BMS/Pfizer, and Instrumentation Laboratory and has previously received grants from Boehringer Ingelheim and Bayer as well as payments for lectures from BMS/Pfizer. Please see the full study for a list of all other authors; financial disclosures.
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Selby R, et al. J Orthop Trauma. 2015;doi: 10.1097/BOT.0000000000000250.
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