According to the current clinical guidelines, there is a recommendation for the administration of low molecular weight heparin as a treatment to prevent thrombosis in patients with fractures, but there are no studies comparing the effectiveness of the treatment compared to aspirin.
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In a study whose findings were published in The New England Journal of Medicine, the researchers conducted a non-inferiority, pragmatic, multicenter and randomized trial, in which patients aged 18 and over with a limb fracture (anywhere from the hip to the middle of the foot, or from the shoulder to to the wrist) who were treated surgically, or had a pelvic or acetabulum fracture. The patients were randomly assigned to receive treatment with low molecular weight heparin (enoxaparin) at a dose of 30 milligrams twice a day, or to treatment with aspirin at a dose of 81 milligrams twice a day while they were in the hospital. After discharge from the hospital, the patients continued to receive thromboprophylaxis according to the clinical protocols of each hospital. The primary outcome of the study was all-cause mortality after 90 days. Secondary outcomes included nonfatal pulmonary embolism, deep vein thrombosis, and bleeding complications.
As part of the study, a total of 12,211 patients were randomized to receive aspirin (6,101 patients) or low molecular weight heparin (6,110 patients). The mean age of the patients (±SD) was 44.6±17.8 years, 0.7% had a history of venous thrombosis, and 2.5% had a history of cancer. The patients received an average of 8.8±10.6 doses of prophylaxis in the hospital, and were prescribed thromboprophylaxis for a median period of 21 days upon discharge. Mortality occurred in 47 patients (0.78%) in the aspirin group and in 45 patients (0.73%) in the low-molecular-weight heparin group (difference, 0.05 percentage points; 96.2% confidence interval, -0.27 to 0.38; P<0.001 for non-interval -deficiencies of 0.75 percentage points). Deep vein thrombosis occurred in 2.51% of patients in the aspirin group and in 1.71% of the low-molecular-weight heparin group (difference, 0.80 percentage points; 95% confidence interval 0.28 to 1.31). The incidence of pulmonary embolism (1.49% in each group), bleeding complications and other serious adverse events were similar between the two groups.
In conclusion, in patients with surgically treated limb fractures or pelvic or acetabulum fractures, thromboprophylaxis with aspirin was not inferior to treatment with low molecular weight heparin in terms of mortality prevention. The treatment was associated with a low incidence rate of deep vein thrombosis and pulmonary embolism, and with a low 90-day mortality rate.
source:
N Engl J Med 2023; 388:203-213 DOI: 10.1056/NEJMoa2205973