A randomized, double-blind study of certoparin vs. unfractionated heparin to prevent venous thromboembolic events in acutely ill, non-surgical patients: CERTIFY Study

作者：Riess H^*; Haas S; Tebbe U; Gerlach H E; Abletshauser C; Sieder C; Rossol S; Pfeiffer B; Schellong S M

来源：Journal of Thrombosis and Haemostasis, 2010, 8(6): 1209-1215.

DOI：10.1111/j.1538-7836.2010.03848.x

• certoparin
• deep vein thrombosis
• pulmonary embolism

Background: In medically ill patients, no contemporary double-blind head-to-head evaluation of low molecular weight heparin vs. unfractionated heparin (UFH) for the prevention of venous thromboembolic events is available. Objectives: To compare the efficacy and safety of certoparin with those of UFH. Patients/Methods: In this double-blind, randomized, controlled trial, acutely ill, non-surgical patients aged >= 70 years were randomized to certoparin (3000 U of anti-factor Xa once daily) or to UFH (5000 IU t.i.d.). The primary endpoint was the composite of proximal deep vein thrombosis as assessed by bilateral compression ultrasonography, symptomatic non-fatal pulmonary embolism and venous thromboembolism-related death, and was assessed by a blinded central adjudication committee. Non-inferioritymargins were set at 1.8 for the odds ratio (OR) and 3.45% for the absolute difference. Results: Three thousand two hundred and thirty-nine patients aged 78.8 +/- 6.3 years were treated for 9.1 +/- 3.4 days. The incidence of the primary endpoint was 3.94% in the certoparin group and 4.52% in the UFH group, with a difference in proportions of -0.59% [95% confidence interval (CI)) -2.09 to 0.92; P < 0.0001 for non-inferiority], and an OR of 0.87 (95% CI 0.60-1.26; P = 0.0001 for non-inferiority). Major bleeding occurred in 0.43% of certoparin-treated patients and 0.62% of UFH-treated patients (OR 0.69; 95% CI 0.26-1.83). Any bleeding occurred at 3.20% in certoparin-treated patients vs. 4.58% in UFH-treated patients (OR 0.69; 95% CI 0.48-0.99; P < 0.05), and 5.73% of certoparin-treated patients and 6.63% of UFH-treated patients experienced serious adverse events. All-cause mortality was 1.27% in certoparin-treated patients and 1.36% in UFH-treated patients. Conclusions: In acutely ill, non-surgical elderly patients, thromboprophylaxis with certoparin (3000 U of anti-FXa once daily) was non-inferior to 5000 IU of UFH t.i.d., with a favorable safety pro. le.

• 出版日期2010-6