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ASA and NSAIDs with Melagatran/Ximelagatran or Enoxaparin Do NOT Increase Bleeding in Patients Undergoing Joint Replacement Surgery. The METHRO III Study
Abstract number: P1627
Dahl1 O, Eriksson2 B, Agnelli3 G, Cohen4 A, Mouret5 P, Rosencher6 N, Bylock7 A, Panfilov7 S, Andersson7 M, Ögren7 M
11Thrombosis Research Institute, London, UK 22Sahlgrenska University Hospital/Östra, Göteborg, Sweden 33University of Perugia, Perugia, Italy 44Guy's, King's, and St Thomas' School of Medicine, London, UK 55Frankfurt-Höchst Clinic, Frankfurt, Germany 66Paris M5 University and Cochin Hospital, Paris, France 77AstraZeneca R&D Mölndal, Mölndal, Sweden
Concomitant use of anti-inflammatory drugs and anticoagulants may raise concerns about bleeding in relation to surgery. Melagatran/ximelagatran has been approved as thromboprophylaxis in orthopaedic surgery, to be initiated 4–8 h after surgery. ASA <0.5 g/d and NSAIDs with t1/2 <20 h were allowed in the trials. A post-hoc analysis of the METHRO III study was undertaken to find out if this combination increased bleeding. Patients were randomized to either sc melagatran 3 mg started 4–12 h after surgery followed by oral ximelagatran 24 mg bid, or sc enoxaparin 40 mg daily started the evening before surgery. Treatment duration was 8–11 days. Analyses were performed based on first dose of melagatran administered 4–8 h and 8–12 h post-surgery. Data for the 4–8 h post-surgery group are presented in the table. Similar results were seen in the 8–12 h post-surgery group and the overall 4–12 h post-surgery population. | | N | Adjudicated bleeding* | Intraoperative bleeding (mL)¶ | Postoperative bleeding (mL)¶ |
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| Melagatran/ ximelagatran | 224 | 9.7 (5.9–14.7) | 222 (172–287) | 400 (340–471) | | +ASA | 32 | 3.6 (0.1–18.3) | 203 (102–402) | 378 (238–601) | | +NSAID | 429 | 11.8 (9.0–15.1) | 201 (166–243) | 376 (312–453) | | +ASA+NSAID | 64 | 10.3 (4.2–20.1) | 159 (89–283) | 313 (182–539) | | Enoxaparin | 438 | 10.9 (8.0–14.4) | 251 (211–299) | 435 (397–477) | | +ASA | 57 | 9.8 (3.3–21.4) | 236 (144–389) | 316 (197–506) | | +NSAID | 786 | 10.4 (8.4–12.6) | 215 (187–247) | 388 (344–438) | | +ASA+NSAID | 108 | 13.2 (7.6–20.8) | 156 (104–235) | 296 (199–441) | | *rate (%), (95% CI); ¶mean (95% CI) |
Conclusion: ASA and NSAIDs in addition to melagatran or enoxaparin did not increase bleeding in patients undergoing joint replacement surgery.
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