| الوصف: |
Sylvia Haas,1 Gerlind Holberg,2 Reinhold Kreutz,3 Michael Rud Lassen,4 Lorenzo Mantovani,5 Verena Haupt,6 Kai Vogtländer,7 Alexander GG Turpie8 1Formerly Technical University of Munich, 2Bayer HealthCare AG, 3Institut für Klinische Pharmakologie und Toxikologie, Charité-Universitätsmedizin, Berlin, Germany; 4Glostrup Hospital, University of Copenhagen, Glostrup, Denmark; 5CESP-Center for Public Health Research, University of Milan-Bicocca, Monza, Italy; 6Bayer Vital GmbH, Leverkusen, 7Bayer Pharma AG, Wuppertal, Germany; 8Department of Medicine, Hamilton Health Services, Hamilton, ON, Canada Purpose: Real-world data on the use of rivaroxaban in the perioperative period in patients undergoing major orthopedic surgery are limited. Subsets of data from the Phase IV, noninterventional XAMOS study were analyzed to explore the potential influence of timing of the first thromboprophylactic dose, type of anesthesia, and concomitant mechanical prophylaxis on clinical outcomes in patients undergoing major orthopedic surgery in routine clinical practice. Patients and methods: In XAMOS, 8,778 patients received rivaroxaban (10 mg once daily) and 8,635 received standard-of-care (SOC) pharmacological prophylaxis (safety population). Crude incidences of symptomatic thromboembolic and treatment-emergent bleeding events were analyzed according to timing of the first postoperative thromboprophylactic dose, use of general or neuraxial anesthesia, and use of mechanical prophylaxis with pharmacological thromboprophylaxis. Results: In the rivaroxaban group, the incidences of symptomatic thromboembolic events were 0.7%, 1.0%, and 0.7% in patients receiving the first thromboprophylactic dose at ≤6 hours, >6 hours to ≤10 hours, and >10 hours to ≤24 hours after surgery, respectively. In the SOC group, the incidence of symptomatic thromboembolic events was slightly higher when the postoperative dose was given at >10 hours to ≤24 hours (1.8% vs 1.1% at ≤6 hours and 1.3% at >6 hours to ≤10 hours). The antithrombotic effect of ... |