XAMOS

XArelto in the prophylaxis of postsurgical VTE after elective Major Orthopaedic Surgery of hip or knee (2013)

Condition

Prophylaxis of VTE in patients undergoing major orthopaedic surgery of the hip or knee (predominantly elective arthroplasty)

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Objective

To compare the safety and effectiveness of rivaroxaban after elective major orthopaedic surgery with other pharmacological thromboprophylaxis in everyday clinical practice

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Trial design

Non-interventional, open-label, controlled cohort study
Active treatment: rivaroxaban 10 mg p.o. once-daily, starting 6–10 hours post surgery (n=8778)
Control treatment: standard-of-care thromboprophylaxis including lowmolecular-weight heparins (LMWH), unfractionated heparins (UFH), fondaparinux, dabigatran etexilate, acetylsalicylic acid and vitamin K antagonists (n=8635)
The type, duration and dose of pharmacological agents were determined by the attending physician before patients entered the study

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Endpoints

Primary outcome: bleeding events, symptomatic thromboembolic events (DVT, PE), uncommon adverse events (incidence rate between 0.1% and 1%), all-cause mortality
Secondary outcome: health care resource use, treatment convenience, patient compliance, use in special patient populations, such as renal impairment

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Trial participants

17413 patients, aged 18 years or older, who were to undergo hip or knee replacement surgery (or hip fracture surgery where rivaroxaban is indicated) and in whom a decision on pharmacological thromboprophylaxis had already been made

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Results

Efficacy outcome: In the safety population (17413 patients), symptomatic thromboembolic events (arterial and venous) occurred in 78 of 8778 patients (0.9%) in the rivaroxaban group compared with 117 of 8635 patients (1.4%) in the standard-of-care group (OR 0.65). Patients receiving rivaroxaban had a significantly lower incidence of symptomatic VTE (0.6% vs. 1.0%) and a numerically lower incidence of arterial thromboembolic events (0.2% vs. 0.3%)
Safety outcome: Major bleeding events occurred in 0.4% of the patients treated with rivaroxaban and in 0.3% of patients given the standard-of-care thromboprophylaxis (OR 1.19). The rates of non-major bleeding were 4.2% and 2.8%, respectively. In both treatment arms similar incidences of other serious adverse events were observed. All-cause mortality was ~0.1% in both groups
During the period from hospital discharge until treatment completion, more patients in the standard-of-care group required support from general practitioners (10.3% vs. 8.7%) and nurse home visits (6.9% vs. 2.6%). Patients receiving rivaroxaban reported a higher degree of satisfaction in terms of treatment tolerability and convenience, compared with those receiving standard-of-care therapy

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Summary

Efficacy: In unselected patients undergoing hip or knee surgery in routine practice, rivaroxaban was associated with a significantly lower incidence of symptomatic thromboembolic events than the current standard-of-care thromboprophylaxis
Safety: Rates of any bleeding events were increased with rivaroxaban, but major bleeding was similar between the treatment arms

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Reference

(1) Turpie AG, Schmidt AC, Kreutz R, Lassen MR, Jamal W, Mantovani L, Haas S. Rationale and design of XAMOS: non-interventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery. Vasc Health Risk Manag 2012;8:363-370
(2) Turpie AG, Haas S, Kreutz R, Mantovani LG, Pattanayak CW, Holberg G, Jamal W, Schmidt A, van Eickels M, Lassen MR. 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; doi: 10.1160/TH13-08-0666. Epub 2013 Oct 24

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Corresponding author

Alexander G.G. Turpie, MD, Department of Medicine, Hamilton Health Sciences, General Division, 237 Barton Street East, Hamilton, Ontario, Canada, e-mail: turpiea@mcmaster.ca

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