Abstract
On the basis of observations made in recent years, it can be inferred that the incidence of venous thromboembolism (VTE) in Japan is as high as that in Western countries.
Since 2007, the use of fondaparinux for the prophylaxis of VTE following lower-limb orthopedic surgery has been approved for Japanese patients. This study was performed with an aim to investigate the safety and efficacy of fondaparinux for the prevention of VTE following hip surgery in Japanese patients.
From June 2007 to August 2008, we evaluated 141 consecutive patients (148 hips; average age, 65.6) undergoing total hip replacement (THR), consisted of cementless minimally invasive surgery, and hip fracture surgery (HFS), consisted of open reduction and internal fixation or bipolar hemiarthroplasty. We mainly used 2.5 mg of fondaparinux for a period extending up to 14 days. We estimated the symptomatic VTE and asymptomatic deep-vein thrombosis (DVT) rates in patients by ultrasonography performed on preoperative and postoperative day 3. In addition, we evaluated the pre-operative and postoperative plasma D-dimer levels on days 3, 7, and 14.
We determined that both the preoperative and postoperative incidence of symptomatic VTE was 0%. A D-dimer value of 20 ug/ml or higher was not observed on preoperative days 3 and 7; however, this value was observed in 2 hips on postoperative day 14. The incidence of asymptomatic DVT was observed to be 0.8% preoperatively and 4% postoperatively. In particular, the corresponding value following HFS was observed to be 7.7% preoperatively. The incidence of the hemorrhagic event was observed to be 14.9%. Bleeding was mostly observed in the surgical and drainage areas. An overall major bleeding incidence of 0.7% (1 patient) was observed. The corresponding value in patients in whom the administration of fondaparinux was discontinued by day 14 was 18.9%.
The study results indicate that fondaparinux is useful in Japanese patients for the prevention of VTE following hip surgery. However, the administration of this drug should be accompanied by additional measures to prevent the associated side effect of bleeding.
Correspondence should be addressed to Diane Przepiorski at ISTA, PO Box 6564, Auburn, CA 95604, USA. Phone: +1 916-454-9884; Fax: +1 916-454-9882; E-mail: ista@pacbell.net
