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Abstract: Poster Presentations |

POOLED ANALYSIS OF FOUR STUDIES OF RIVAROXABAN: EFFECT ON SYMPTOMATIC EVENTS AND BLEEDING AND THE INFLUENCE OF CLINICALLY RELEVANT PATIENT SUBGROUPS FREE TO VIEW

Alexander G. Turpie, MD*; Michael R. Lassen, MD; Ajay Kakkar, MD; Bengt I. Eriksson, MD; Scott Berkowitz, MD; Frank Misselwitz, MD; Tiemo Bandel, MD; Martin Homering; Torsten Westermeier, PhD; Michael Gent, DSc
Author and Funding Information

McMaster University, Hamilton, ON, Canada


Chest


Chest. 2009;136(4_MeetingAbstracts):144S. doi:10.1378/chest.136.4_MeetingAbstracts.144S-a
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Abstract

PURPOSE:  Four phase III studies investigated the oral, direct Factor Xa inhibitor, rivaroxaban, for prevention of venous thromboembolism (VTE) after total hip or knee replacement (THR/TKR). Patients (N=12,729) received oral rivaroxaban 10 mg once daily (od) or subcutaneous enoxaparin 40 mg od (RECORD1–3) or 30 mg every 12 hours (RECORD4). In each study, rivaroxaban regimens showed superior efficacy to enoxaparin regimens.

METHODS:  Prespecified pooled analyses investigated outcomes in the total treatment duration pool (planned treatment period), total study duration pool (treatment and follow-up), and the day 12 ± 2 active treatment pool (enoxaparin-controlled period).

RESULTS:  Rivaroxaban significantly reduced the respective incidence of symptomatic VTE and death (composite endpoint) compared with enoxaparin regimens over the total treatment duration (0.57% vs 1.32%; p < 0.001), the total study duration (0.81% vs 1.63%; p < 0.001), and at day 12 ± 2 (0.47% vs 0.97%; p = 0.001). Rivaroxaban significantly reduced the composite of pulmonary embolism and death over the total study duration (0.47% vs 0.76%; p = 0.039). Respective rates of major bleeding with rivaroxaban and enoxaparin regimens were: total treatment duration, 0.39% vs 0.21% (p = 0.076); total study duration, 0.44% vs 0.27% (p = 0.135); day 12 ± 2, 0.34% vs 0.21% (p = 0.175). Respective rates for major plus clinically relevant non-major (CRNM) bleeding (composite endpoint) were: total treatment duration, 3.19% vs 2.55% (p = 0.039); total study duration, 3.35% vs 2.76% (p = 0.064); and at day 12 ± 2, 2.85% vs 2.45% (p = 0.186). Rivaroxaban reduced the composite of death, myocardial infarction, stroke, symptomatic VTE, and major bleeding over the total study duration versus enoxaparin regimens (post-hoc; p = 0.004). Rivaroxaban showed consistently superior efficacy to enoxaparin in the subgroups analysed (age, weight, gender, and renal function [creatinine clearance (CrCl) > 30 ml/min]). Small but significant differences in treatment-emergent major plus CRNM bleeding were seen in patients < 65 years, > 90 kg, or CrCl > 80 ml/min.

CONCLUSION:  Rivaroxaban significantly reduced the incidence of symptomatic VTE events compared with enoxaparin regimens, with increased but not significantly different major bleeding rates.

CLINICAL IMPLICATIONS:  Rivaroxaban reduces the incidence of symptomatic VTE events after THR and TKR, without requiring routine coagulation monitoring or dose-adjustment.

DISCLOSURE:  Alexander Turpie, Consultant fee, speaker bureau, advisory committee, etc. Sanofi-aventis, GSK, Astellas, Takeda, Portola, Bayer and Johnson & Johnson; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. This presentation will discuss a pooled analysis of four phase III trials that assessed the use of rivaroxaban for VTE prophylaxis following hip or knee arthroplasty. Rivaroxaban is approved for this indication in the EU and Canada but has not yet been approved for any indication in the US.

Wednesday, November 4, 2009

12:45 PM - 2:00 PM


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