EPCAT I
Trial question
Is aspirin noninferior to dalteparin for extended VTE prophylaxis after total hip arthroplasty?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 778
778 patients (334 female, 444 male).
Inclusion criteria: patients undergoing elective unilateral total hip arthroplasty who had an initial dalteparin prophylaxis for 10 days.
Key exclusion criteria: hip fracture in the previous 3 months, metastatic cancer, life expectancy < 6 months, major bleeding, active peptic ulcer disease or gastritis that precluded aspirin use, aspirin allergy, heparin-induced thrombocytopenia or heparin allergy.
Interventions
N=380 aspirin (81 mg once daily for 28 days).
N=398 dalteparin (5,000 U once daily for 28 days).
Primary outcome
Symptomatic venous thromboembolism
0.3%
1.3%
1.3 %
1.0 %
0.7 %
0.3 %
0.0 %
Aspirin
Dalteparin
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in symptomatic VTE (0.3% vs. 1.3%; AD 1%, 95% CI -0.5 to 2.5).
Secondary outcomes
No significant difference in major bleeding (0% vs. 0.3%; AD 0.25%, 95% CI -4.9 to 1).
No significant difference in VTE or clinically relevant bleeding (0.8% vs. 2.5%; AD 1.7%, 95% CI -0.3 to 3.8).
No significant difference in clinically significant nonmajor bleeding (0.5% vs. 1%; AD 0.48%, 95% CI -1 to 2).
Safety outcomes
No significant differences in wound infections, arterial vascular events, deaths.
Conclusion
In patients undergoing elective unilateral total hip arthroplasty who had an initial dalteparin prophylaxis for 10 days, aspirin was noninferior to dalteparin with respect to symptomatic VTE.
Reference
Anderson DR, Dunbar MJ, Bohm ER et al. Aspirin versus low-molecular-weight heparin for extended venous thromboembolism prophylaxis after total hip arthroplasty: a randomized trial. Ann Intern Med. 2013 Jun 4;158(11):800-6.
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