A post-marketing assessment of major bleeding in total hip and total knee replacement surgery patients receiving rivaroxaban

References

• Della Valle CJ, Steiger DJ, Di Cesare PE. Thromboembolism after hip and knee arthroplasty: diagnosis and treatment. J Am Acad Orthop Surg 1998;6:327-36
   PubMedGoogle Scholar
• Agnelli G. Prevention of venous thromboembolism in surgical patients. Circulation 2004;110:IV4-12
   PubMed Web of Science ®Google Scholar
• Stacy Z. Novel oral anticoagulants for venous thromboembolism prophylaxis after total hip or knee replacement: an update on rivaroxaban (xarelto). PT 2013;38:45-50
   PubMedGoogle Scholar
• Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008;358:2776-86
   PubMed Web of Science ®Google Scholar
• Turpie AG, Lassen MR, Eriksson BI, et al. Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty. Pooled analysis of four studies. Thromb Haemost 2011;105:444-53
   PubMed Web of Science ®Google Scholar
• 2011 AAOS Clinical Guidelines on Preventing Venous Thromboembolic Disease in Patients Undergoing Elective Hip and Knee Arthroplasty. American Academy of Orthopedic Surgeons. Available at: http://www.aaos.org/research/guidelines/VTE/VTE_full_guideline.pdf [Last accessed 13 February 2016]
   Google Scholar
• Francis CW. Prevention of VTE in patients having major orthopedic surgery. J Thromb Thrombolysis 2013;35:359-67
   PubMed Web of Science ®Google Scholar
• Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease: CHEST Guideline and Expert Panel Report. Chest 2016;149:315-52
   PubMed Web of Science ®Google Scholar
• Guyatt GH, Akl EA, Crowther M, et al. Executive summary: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012;141:7-47S
   PubMed Web of Science ®Google Scholar
• Falck-Ytter Y, Francis CW, Johanson NA, et al. Prevention of VTE in orthopedic surgery patients: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012;141:e278-325S
   PubMed Web of Science ®Google Scholar
• Dahl OE, Quinlan DJ, Bergqvist D, Eikelboom JW. A critical appraisal of bleeding events reported in venous thromboembolism prevention trials of patients undergoing hip and knee arthroplasty. J Thromb Haemost 2010;8:1966-75
   PubMed Web of Science ®Google Scholar
• Schulman S, Angeras U, Bergqvist D, et al. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost 2010;8:202-4
   PubMed Web of Science ®Google Scholar
• Pannucci CJ, Swistun L, MacDonald JK, et al. Individualized venous thromboembolism risk stratification using the 2005 Caprini score to identify the benefits and harms of chemoprophylaxis in surgical patients: a meta-analysis. Ann Surg 2017. 10.1097/sla.0000000000002126
   PubMed Web of Science ®Google Scholar
• Cushner F, Agnelli G, FitzGerald G, Warwick D. Complications and functional outcomes after total hip arthroplasty and total knee arthroplasty: results from the Global Orthopaedic Registry (GLORY). Am J Orthop (Belle Mead NJ) 2010;39:22-8
   PubMedGoogle Scholar
• Turpie AG, Haas S, Kreutz R, et al. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost 2014;111:94-102
   PubMed Web of Science ®Google Scholar
• 2012 MHS Stakeholders’ Report. Available at: http://www.health.mil/Reference-Center/Reports?query=MHS +2012 [Last accessed 10 January 2015]
   Google Scholar
• Cunningham A, Stein CM, Chung CP, et al. An automated database case definition for serious bleeding related to oral anticoagulant use. Pharmacoepidemiol Drug Saf 2011;20:560-6
   PubMed Web of Science ®Google Scholar
• Tamayo S, Peacock WF, Patel M, et al. Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27 467 patients taking rivaroxaban. Clin Cardiol 2015;38:63-8
   PubMed Web of Science ®Google Scholar
• Staerk L, Lip GY, Olesen JB, et al. Stroke and recurrent haemorrhage associated with antithrombotic treatment after gastrointestinal bleeding in patients with atrial fibrillation: nationwide cohort study. BMJ (Clinical Research Ed) 2015;351:h5876
   PubMed Web of Science ®Google Scholar
• Kawai VK, Cunningham A, Vear SI, et al. Genotype and risk of major bleeding during warfarin treatment. Pharmacogenomics 2014;15:1973-83
   PubMed Web of Science ®Google Scholar
• Alonso A, Bengtson LG, MacLehose RF, et al. Intracranial hemorrhage mortality in atrial fibrillation patients treated with dabigatran or warfarin. Stroke 2014;45:2286-91
   PubMed Web of Science ®Google Scholar
• Lauffenburger JC, Farley JF, Gehi AK, et al. Effectiveness and safety of dabigatran and warfarin in real-world US patients with non-valvular atrial fibrillation: a retrospective cohort study. J Am Heart Assoc 2015;35:560-8
   Google Scholar
• Graham DJ, Reichman ME, Wernecke M, et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation 2015;131:157-64
   PubMed Web of Science ®Google Scholar
• Yao X, Abraham NS, Sangaralingham LR, et al. Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation. J Am Heart Assoc 2016;5:e003725
   PubMed Web of Science ®Google Scholar
• Ray WA, Chung CP, Murray KT, et al. Association of proton pump inhibitors with reduced risk of warfarin-related serious upper gastrointestinal bleeding. Gastroenterology 2016;151:1105-12.e10
   PubMed Web of Science ®Google Scholar
• Kwong L, Turpie AG. Real-world data confirm clinical trial outcomes for rivaroxaban in orthopaedic patients. Curr Orthop Pract 2015;26:299-305
   PubMedGoogle Scholar
• Baczek VL, Chen WT, Kluger J, Coleman CI. Predictors of warfarin use in atrial fibrillation in the United States: a systematic review and meta-analysis. BMC Fam Pract 2012;13:5
   PubMed Web of Science ®Google Scholar