Alexander GG Turpie On behalf of Kenneth A Bauer, Scott D Berkowitz, Fred D Cushner, Bruce L Davidson, Michael Gent, Louis M Kwong, Michael R Lassen, Paul A Lotke, Frank Misselwitz, William D Fisher and the RECORD4 Study Investigators Comparison of rivaroxaban – an oral, direct Factor Xa inhibitor – and subcutaneous enoxaparin for thromboprophylaxis after total knee replacement
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Alexander GG Turpie On behalf of Kenneth A Bauer, Scott D Berkowitz, Fred D Cushner, Bruce L Davidson, Michael Gent, Louis M Kwong, Michael R Lassen, Paul.
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Alexander GG Turpie
On behalf of Kenneth A Bauer, Scott D Berkowitz, Fred D Cushner, Bruce L Davidson, Michael Gent, Louis M Kwong, Michael R Lassen, Paul A Lotke, Frank Misselwitz, William D Fisher and the RECORD4 Study Investigators
Comparison of rivaroxaban – an oral, direct Factor Xa inhibitor – and subcutaneous enoxaparin for thromboprophylaxis after total knee replacement
On-treatment bleeding; *1 patient had fatal post-operative upper GI bleed and a fall in hemogloblin leading to transfusion; † 1 intraspinal and 1 intracranial bleed with enoxaparin, 1 retroperitoneal bleed with rivaroxaban; ‡1 subject received only placebo and no active enoxaparin; §all 4 patients had a fall in hemogloblin leading to transfusion; safety population, n=3034
Adverse events
n %
Enoxaparin
30 mg q12h (n=1508)
Rivaroxaban 10 mg once daily
(n=1526)
Any adverse event 1312 87.0% 1319 86.4%
On treatment 1216 80.6% 1222 80.1%
During follow-up 239 15.8% 244 16.0%
Cardiovascular adverse events* 11 0.7% 7 0.5%
On treatment 8 0.5% 2 0.1%
During follow-up 3 0.2% 5 0.3%
Any post-operative wound-related infection
6 0.4% 6 0.4%
On treatment 3 0.2% 4 0.3%
Death 6 0.4% 6 0.4%
*Events occurring more than 1 day after the last intake of study drug during follow-up; safety population
Liver function tests: on-treatment abnormalities
n/N %
Enoxaparin 30 mg q12h
(n=1508)
Rivaroxaban 10 mg once daily
(n=1526)
ALT >3× ULN 38/1451 2.6% 19/1470 1.3%
ALT >5× ULN 15/1460 1.0% 5/1478 0.3%
ALT >10× ULN 2/1463 0.1% 1/1480 0.1%
ALT >3× ULN + TB >2× ULN 3/1464 0.2% 1/1481 0.1%
Safety population, n=3034; ALT, alanine transaminase; ULN, upper limit of normal; TB, total bilirubin;
RECORD4: summary
All p-values based on absolute weighted risk differences
0
2
4
6
8
10
12
Inci
den
ce (
%)
Enoxaparin 30 mg q12hRivaroxaban 10 mg once daily
6.9%10.1% 2.0% 1.2% 1.2% 0.7%0.3% 0.7%
RRR 31%
Total VTE
Major VTE
p=0.110
Major bleeding
p=0.012p=0.124 p=0.187
SymptomaticVTE
RECORD4: conclusions
Rivaroxaban demonstrated:
Superior efficacy for the primary endpoint (total VTE)
Low rate of major and symptomatic VTE events
Similar safety profile to enoxaparin
No statistically significant difference in major bleeding
Cardiovascular adverse events low and balanced between groups