Safety of fondaparinux to prevent venous thromboembolism in Japanese patients undergoing colorectal cancer surgery: a multicenter study

Purpose To investigate the safety and efficacy of fondaparinux (FPX) for venous thromboembolism (VTE) prophylaxis in Japanese patients undergoing colorectal cancer surgery. Methods The subjects of this multicenter, open-label, prospective observational study were patients undergoing resection of the colon/rectum for colorectal cancer. All patients were given FPX 2.5 or 1.5 mg by subcutaneous injection, once daily for 4-8 days, starting 24 h after surgery. The primary endpoint was any major bleeding event and the secondary endpoint was any symptomatic VTE event. Results Between February 2009 and December 2010, 619 patients from 23 institutions were enrolled in this study. The median duration of FPX prophylaxis was 4 days. The incidence of major bleeding was 0.81 % [5/619, 95 % confidence interval (CI) 0.3-1.9] and the incidence of minor bleeding was 9.5 % (59/619, 95 % CI 7.3-12.1). There was no fatal bleeding or symptomatic VTE. Multivariable analysis revealed the following to be risk factors for bleeding events: preoperative platelet count < 15 9 10(4)/mu l [odds ratio (OR) 4.521], male sex (OR 2.078), and blood loss during surgery < 50 ml (OR 2.019). Conclusion The administration of 2.5/1.5 mg FPX 24 h after colorectal cancer surgery is safe and effective.