According to researchers, without thromboprophylaxis, major orthopedic surgery carries a high risk of VTE events, which manifests as deep vein thrombosis in two-thirds and as pulmonary embolism in approximately one-third of patients.
Researchers evaluated 168 patients who underwent elective primary total hip replacement (81 patients) or total knee replacement (87 patients) at one of seven orthopedic centers in Austria. Patients were started on an initial low-molecular-weight heparin of 40 mg daily for the prevention of VTE events. Enoxaparin was started before or after total hip or knee replacement surgery based on the clinical judgment of the investigator, and this treatment was switched to dabigatran of 220 mg daily at a time point also determined by the investigator.
Here are six key facts:
1. Of the 168 patients studied, 161 received both enoxaprin and dabigatran, two were treated with dabigatran only and five received enoxaprin only.
2. The majority of treated patients (82.6 percent) initiated oral dabigatran 22 to 26 hours after the finale dose of enoxaparin, and most (88.7 percent) began oral dabigatran at least 24 hours postoperatively.
3. The median time from final enoxaparin dose to initial dabigatran dose was 24 hours (range, four to 48 hours). Patients remained on dabigatran for a median of 36 days, which was similar for patients who underwent total hip replacement (median 35.5 days) and total knee replacement (median 37 days).
4. No instances of symptomatic VTE or all-cause mortality were reported at any time during the study.
5. There was only one occurrence of the primary safety variable. This bleeding event was at the surgical site and required treatment discontinuation after total knee replacement, but did not result in a significant drop in hemoglobin or necessitate transfusion. The event led to an estimated major bleeding event incidence of 0.61 percent. Very few bleeding events were reported overall; from last treatment with enoxaparin until 24 hours after last dose of dabigatran, minor bleeding events occurred in three additional patients.
6. During dabigatran treatment, at least one adverse event occurred in 44 (27 percent) patients; of these, 13 (8 percent) led to cessation of dabigatran. Serious adverse events during dabigatran treatment occurred in four (2.5 percent) patients.
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