Abstract: Poster Presentations |

Efficacy of Fondaparinux for Thromboprophylaxis in High-risk Patients Undergoing Hip Fracture Surgery FREE TO VIEW

Alexander G. Turpie, PharmD; Clifford W. Colwell, MD; Kenneth Bauer, MD; Bengt I. Eriksson, MD; Michael R. Lassen, MD
Author and Funding Information

Hamilton General Hospital, Hamilton, ON, Canada


Chest. 2003;124(4_MeetingAbstracts):240S. doi:10.1378/chest.124.4_MeetingAbstracts.240S
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PURPOSE:  Extended prophylaxis with fondaparinux may be even more beneficial for high-risk patients undergoing hip fracture surgery. We evaluated the efficacy of fondaparinux for thromboprophylaxis in predefined high-risk patients (female gender, age over 75 years, and impaired renal function) in the PENTHIFRA-PLUS trial.

METHODS:  All patients received fondaparinux 2.5 mg once daily for 7 days after surgery, and 656 patients were randomized double-blind to receive placebo or to continue to receive fondaparinux for 19 to 22 additional days. The primary efficacy outcome was venous thromboembolism (VTE) occurring during the double-blind period, defined as deep-vein thrombosis detected by mandatory bilateral venography, or documented symptomatic deep-vein thrombosis or pulmonary embolism.

RESULTS:  VTE Rate n/N (Percent)PlaceboFondaparinux77/220 (35.0)3/208 (1.4)*Risk Group:GenderMale11/69 (15.9)0/62 (0.0)Female66/151 (43.7)3/146 (2.1)Age (years)<658/41 (19.5)1/37 (2.7)[65–75[10/36 (27.8)1/48 (2.1)≥ 7559/143 (41.3)1/123 (0.8)Creatinine Clearance (mL/min)<308/15 (53.3)1/14 (7.1)[30–50[23/54 (42.6)0/65 (0.0)[50–80[32/97 (33.0)0/77 (0.0)≥8014/54 (25.9)2/50 (4.0)*

P < 0.001 v Placebo, relative risk reduction 96%

The rate of clinically relevant bleeding (fatal bleeding, bleeding in a critical organ, or bleeding leading to reoperation) was similar in both groups.CONCLUSIONS: Female gender, age, and impaired renal function were associated with an increased VTE risk without extended prophylaxis, and extended duration fondaparinux reduced the overall risk of developing VTE by 96%.

CLINICAL IMPLICATIONS:  VTE prophylaxis with fondaparinux up to 4 weeks after surgery for hip fracture is highly effective in all patients, including patients at high risk of developing VTE, without an increase in clinically relevant bleeding.

DISCLOSURE:  A.G. Turpie, Organon Sanofi-Synthelabo, LLC, grant monies.

Wednesday, October 29, 2003

12:30 PM - 2:00 PM




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