CERTIFY confirms non-inferiority of certoparin medical thromboprophylaxis
MedWire News: The low molecular weight heparin (LMWH) certoparin is non-inferior to unfractionated heparin (UFH) for prevention of venous thromboembolism (VTE) in elderly medical patients, German researchers say.
“The study showed that a prophylaxis with certoparin (3000 U anti Xa od) was at least as effective and safe as a prophylaxis with UFH (5000 IU tid),” report Hanno Reiss (Charité, Campus Virchow Klinikum, Berlin) and co-workers.
The CERTIFY study included 3239 acutely ill medical patients, aged 70 years or older (average, 78.8 years), expected to have significantly reduced mobility for at least 4 days.
The patients were treated with thromboprophylaxis for an average of 9.1 days and were followed-up for the composite endpoint of imaging-confirmed proximal deep vein thrombosis, symptomatic non-fatal pulmonary embolism, and VTE-related death.
The primary endpoint was reached by 3.94% of certoparin-treated patients compared with 4.52% of UFH-treated patients, giving an odds ratio (OR) of 0.97 and an absolute difference of –0.59%. Certoparin therefore met the study criteria for noninferiority to UFH set atan OR of 1.8 and 3.45% difference.
Major bleeding was comparable in the certoparin and UFH treatment groups (0.43% vs 0.62%), while the rate of any bleeding was significantly lower with certoparin (3.20% vs 4.58%, OR=0.69).
Certoparin- and UFH-treated patients also had comparable rates of overall serious adverse events (5.73% vs 6.63%) and all-cause mortality (1.27% vs 1.36%).
Reiss et al comment in the Journal of Thrombosis and Haemostasis that the CERTIFY study is “well representative for the variety of disease conditions leading to hospitalization on a general medical ward and was particularly enriched for elderly people with a mean age of 79 years.”
Noting that the findings are comparable to those of the PRINCE [The Thromboembolism-Prevention in Cardiac or Respiratory Disease With Enoxaparin] study of the LMWH enoxparin versus UFH, the team concludes: “Thus, the CERTIFY results add major information to the body of existing evidence for the role of heparins and definitively confirm the non-inferiority of certoparin versus UFH with respect to efficacy in medical patients.”
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By Lynda Williams