Concomitant use of medication with antiplatelet effects in patients receiving either rivaroxaban or enoxaparin after total hip or knee arthroplasty.
BACKGROUND
The RECORD programme compared oral rivaroxaban with enoxaparin for prevention of venous thromboembolism after elective total hip or knee replacement. This analysis compared the safety of concomitant use of specified medications with rivaroxaban and enoxaparin by evaluating postoperative bleeding rates from the pooled RECORD1-4 data.


METHODS
The co-medications were non-steroidal anti-inflammatory drugs and platelet function inhibitors, including acetylsalicylic acid (no dose restriction). The endpoints evaluated were the composite of major and non-major clinically relevant bleeding and any bleeding occurring after first oral study drug intake. The time relative to surgery was stratified into three time periods: day 1-3, day 4-7 and after day 7. Relative bleeding rate ratios for co-medication use versus non-use were derived using stratified Mantel-Haenszel methods and compared between rivaroxaban and enoxaparin groups.


RESULTS
Co-medication use with rivaroxaban or enoxaparin resulted in non-significant increases in bleeding events. Respective rate ratios were not significantly different between rivaroxaban and enoxaparin for all bleeding endpoints with concomitant use of non-steroidal anti-inflammatory drugs (any bleeding, 1.22 vs 1.22; major and non-major clinically relevant bleeding, 1.28 vs 0.90) and with concomitant use of platelet function inhibitors/acetylsalicylic acid (any bleeding, 1.32 vs 1.40; major and non-major clinically relevant bleeding, 1.11 vs 1.13).


CONCLUSIONS
This explorative analysis indicates that there is no significant increase in bleeding risk for rivaroxaban compared with enoxaparin when co-administered with non-steroidal anti-inflammatory drugs or acetylsalicylic acid, although, because of low usage, the experience with platelet function inhibitors (except acetylsalicylic acid) was limited.
Department of Orthopaedics, Sahlgrenska University Hospital/Mölndal, Mölndal, Sweden. b.eriksson@orthop.gu.se
Bengt I
BI
Eriksson
Nadia
N
Rosencher
Richard J
RJ
Friedman
Martin
M
Homering
Ola E
OE
Dahl
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000494:pharmacology / Q000627:therapeutic use*; D000925:Anticoagulants / Q000494:pharmacology / Q000627:therapeutic use*; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects*; D001241:Aspirin / Q000494:pharmacology / Q000627:therapeutic use*; D004347:Drug Interactions; D017984:Enoxaparin / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000494:pharmacology / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D000069552:Rivaroxaban; D013876:Thiophenes / Q000494:pharmacology / Q000627:therapeutic use*; D054556:Venous Thromboembolism / Q000209:etiology / Q000517:prevention & control*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000925:Anticoagulants; D017984:Enoxaparin; D009025:Morpholines; D010975:Platelet Aggregation Inhibitors; D013876:Thiophenes; D000069552:Rivaroxaban; D001241:Aspirin