[Ortho] Aspirin, Xarelto show no difference in preventing venous thromboembolism after TJA
Alexander Chelnokov
orthoforum на weborto.net
Ср Фев 28 01:55:41 YEKT 2018
Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty
David R. Anderson, M.D., Michael Dunbar, M.D., John Murnaghan, M.D.,
Susan R. Kahn, M.D., Peter Gross, M.D., Michael Forsythe, M.D., Stephane
Pelet, M.D., William Fisher, M.D., Etienne Belzile, M.D., Sean Dolan,
M.D., Mark Crowther, M.D., Eric Bohm, M.D., et al.
BACKGROUND
Clinical trials and meta-analyses have suggested that aspirin may be
effective for the prevention of venous thromboembolism (proximal
deep-vein thrombosis or pulmonary embolism) after total hip or total
knee arthroplasty, but comparisons with direct oral anticoagulants are
lacking for prophylaxis beyond hospital discharge.
METHODS
We performed a multicenter, double-blind, randomized, controlled trial
involving patients who were undergoing total hip or knee arthroplasty.
All the patients received once-daily oral rivaroxaban (10 mg) until
postoperative day 5 and then were randomly assigned to continue
rivaroxaban or switch to aspirin (81 mg daily) for an additional 9 days
after total knee arthroplasty or for 30 days after total hip
arthroplasty. Patients were followed for 90 days for symptomatic venous
thromboembolism (the primary effectiveness outcome) and bleeding
complications, including major or clinically relevant nonmajor bleeding
(the primary safety outcome).
RESULTS
A total of 3424 patients (1804 undergoing total hip arthroplasty and
1620 undergoing total knee arthroplasty) were enrolled in the trial.
Venous thromboembolism occurred in 11 of 1707 patients (0.64%) in the
aspirin group and in 12 of 1717 patients (0.70%) in the rivaroxaban
group (difference, 0.06 percentage points; 95% confidence interval
[CI],−0.55 to 0.66; P<0.001 for noninferiority and P=0.84 for
superiority). Major bleeding complications occurred in 8 patients
(0.47%) in the aspirin group and in 5 (0.29%) in the rivaroxaban group
(difference, 0.18 percentage points; 95% CI,−0.65 to 0.29; P=0.42).
Clinically important bleeding occurred in 22 patients (1.29%) in the
aspirin group and in 17 (0.99%) in the rivaroxaban group (difference,
0.30 percentage points; 95% CI,−1.07 to 0.47; P=0.43).
CONCLUSIONS
Among patients who received 5 days of rivaroxaban prophylaxis after
total hip or total knee arthroplasty, extended prophylaxis with aspirin
was not significantly different from rivaroxaban in the prevention of
symptomatic venous thromboembolism. (Funded by the Canadian Institutes
of Health Research; ClinicalTrials.gov number, NCT01720108.)
http://www.nejm.org/doi/full/10.1056/NEJMoa1712746
Alexander Chelnokov
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