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- Title
Aspirin after dalteparin was noninferior to continued dalteparin for preventing VTE after total hip arthroplasty.
- Authors
Steinberg, Daniel I.
- Abstract
Question Is extended prophylaxis using aspirin noninferior to prophylaxis using dalteparin for preventing symptomatic venous thromboembolism (VTE) after total hip arthroplasty (THA)? Methods Design Randomized controlled noninferiority trial (Extended Prophylaxis Comparing Low Molecular Weight Heparin to Aspirin in Total Hip Arthroplasty [EPCAT] trial). Current Controlled Trials ISRCTN11902170. Allocation Concealed.* Blinding Blinded* (patients, clinicians, study coordinators, data analysts, and outcome adjudication committee). Follow-up period 90 days. Setting 12 university-affiliated orthopedic centers in Canada. Patients 786 patients (mean age 58 y, 57% men) who had elective, unilateral THA. Exclusion criteria included conditions needing long-term anticoagulation other than aspirin < 100 mg/d, bleeding precluding anticoagulant prophylaxis, active peptic ulcer disease or gastritis precluding use of aspirin, heparin-induced thrombocytopenia, heparin or aspirin allergy, creatinine clearance < 30 mL/min/1.73 m2, platelet count < 100 x 109 cells/L, hip fracture in the past 3 months, metastatic cancer, or life expectancy < 6 months. Intervention All patients had subcutaneous injections of dalteparin, 5000 U daily, for 10 days after surgery, and then either daily oral aspirin, 81 mg, plus placebo injection (n = 386), or daily dalteparin injection, 5000 U, plus placebo tablet (n = 400), for 28 days. Outcomes Objectively confirmed, symptomatic, proximal deep venous thrombosis (DVT) of the leg or pulmonary embolism (PE). Other outcomes included major bleeding, clinically important nonmajor bleeding, death, stroke, myocardial infarction (MI), and wound infection. 1100 patients/group were needed to determine noninferiority of aspirin compared with dalteparin for symptomatic VTE (baseline rate 1.5%, minimal clinically important difference between groups 2.0%, 95% power, α = 0.05). Patient follow-up 99% (intention-to-treat analysis). Main results The trial was stopped early because of slow recruitment. Extended prophylaxis with aspirin was noninferior to dalteparin for PE or proximal DVT (Table); groups did not differ for other outcomes, including clinically important nonmajor bleeding or wound infection (Table), major bleeding (0% vs 0.3%), death (0% vs 0.3%), MI (0% vs 0.3%), or stroke (0% in both groups). Conclusion After initial prophylaxis with dalteparin, extended prophylaxis using aspirin was noninferior to extended prophylaxis using dalteparin for preventing symptomatic venous thromboembolism after total hip arthroplasty.
- Subjects
CANADA; THROMBOEMBOLISM prevention; SUBCUTANEOUS injections; ASPIRIN; COMBINATION drug therapy; CONFIDENCE intervals; STATISTICAL correlation; HEMORRHAGE; LONGITUDINAL method; EVALUATION of medical care; MYOCARDIAL infarction; ORAL drug administration; PATIENTS; POSTOPERATIVE care; PULMONARY embolism; STROKE; SURGERY; SURGICAL site infections; VENOUS thrombosis; TOTAL hip replacement; VEINS; STATISTICAL power analysis; RANDOMIZED controlled trials; RELATIVE medical risk; TREATMENT duration; DALTEPARIN (Drug); DESCRIPTIVE statistics
- Publication
ACP Journal Club, 2013, Vol 159, Issue 6, p11
- ISSN
1056-8751
- Publication type
Article
- DOI
10.7326/0003-4819-159-6-201309170-02012