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      Comparison of rivaroxaban and parnaparin for preventing venous thromboembolism after lumbar spine surgery

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          Abstract

          Background

          The aim of this study was to evaluate the effectiveness and safety of rivaroxaban for preventing venous thromboembolism (VTE) after lumbar spine surgery.

          Methods

          In this randomized, controlled study, 665 patients who underwent lumbar surgery were randomly assigned to receive either rivaroxaban or parnaparin. Rivaroxaban and parnaparin were used for preventing postoperative venous thrombosis. The occurrence of postoperative efficacy endpoint events (venous thrombosis) and safety endpoint events (hemorrhage) was compared for each group.

          Results

          Efficacy endpoint results: in the rivaroxaban group, there were 6 thrombotic events (1.7 %), 2 cases with severe VTE (0.6 %), and 3 cases with symptomatic VTE (0.9 %). In the parnaparin group, there were 10 thrombotic events (3.1 %), 4 cases with severe VTE (1.2 %), and 6 cases with symptomatic VTE (1.9 %). Safety endpoint results: in the rivaroxaban group, there were 21 cases with bleeding events (6.2 %), 2 cases with severe bleeding (0.6 %), and 19 cases with non-severe bleeding (5.6 %). In the parnaparin group, there were 21 bleeding events (6.2 %), 1 case with severe bleeding (0.3 %), and 16 cases with non-severe bleeding (4.9 %). The incidences of thromboembolic events, including severe and symptomatic VTE, were not significantly different between the two groups ( P > 0.05). Bleeding event rates, including severe and non-severe bleeding, were also not significantly different.

          Conclusions

          Rivaroxaban proved to be equally effective as parnaparin for anticoagulation therapy, with both drugs exhibiting a similar prevention effect against postoperative VTE after lumbar spine surgery, without increasing the risk of postoperative bleeding.

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          Most cited references18

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          Anticoagulants and spinal-epidural anesthesia.

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            Risk factors for spinal epidural hematoma after spinal surgery.

            A case-control retrospective analysis comparing patients who developed a postoperative spinal epidural hematoma with patients who did not develop this complication. To identify risk factors for the development of an epidural hematoma following spinal surgery. Neurologic deterioration following spinal surgery is a rare but devastating complication. Epidural hematomas should be suspected in the patient who demonstrates a new postoperative neurologic deficit. The risk factors that predispose a patient to a postoperative spinal epidural hematoma have not been identified. Patients who underwent spinal surgery at a single institution over a 10-year period were retrospectively reviewed. Twelve patients who demonstrated neurologic deterioration after surgery and required surgical decompression because of an epidural hematoma were identified. All cases involved lumber laminectomies. A total of 404 consecutive patients that underwent lumbar decompression and did not develop an epidural hematoma formed the control group. Factors postulated to increase the risk of postoperative spinal epidural hematoma were compared between the two groups using logistic regression. Multilevel procedures (P = 0.037) and the presence of a preoperative coagulopathy (P < 0.001) were significant risk factors. Age, body mass index, perioperative durotomies, and postoperative drains were not statistically significant risk factors. Patients who require multilevel lumbar procedures and/or have a preoperative coagulopathy are at a significantly higher risk for developing a postoperative epidural hematoma.
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              A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study.

              We performed a randomized dose-ranging study, double-blind for rivaroxaban doses and open-label for the comparator (low-molecular-weight heparin followed by vitamin K antagonists) to assess the optimal dose of rivaroxaban for the treatment of deep vein thrombosis. A total of 543 patients with acute deep-venous thrombosis received rivaroxaban 20, 30, or 40 mg once daily or comparator. Treatment lasted for 84 days. The primary efficacy outcome was the 3-month incidence of the composite of symptomatic venous thromboembolic complications and asymptomatic deterioration in thrombotic burden as assessed by comparison of ultrasound and perfusion lung scanning at day 84 with baseline. The main safety outcome was the composite of major bleeding and clinically relevant nonmajor bleeding. A total of 449 (83%) of the 543 patients could be included in the per-protocol population. The primary efficacy outcome occurred in 6.1%, 5.4%, and 6.6% of the rivaroxaban 20-, 30-, and 40-mg treatment groups, respectively, and in 9.9% of those receiving standard therapy. The main safety outcome occurred in 5.9%, 6.0%, and 2.2% of the rivaroxaban 20-, 30-, and 40-mg treatment groups, respectively, and in 8.8% of those receiving standard therapy. These results with simple fixed-dose oral regimens justify phase 3 evaluations (www.ClinicalTrials.gov no.NCT00395772).
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                Author and article information

                Contributors
                weiducn@163.com
                zhaohuiang@163.com
                Jingjiesci@163.com
                jianqing58@yeah.net
                BinghuaShen@yeah.net
                yanpingzhengcn@163.com
                Journal
                J Orthop Surg Res
                J Orthop Surg Res
                Journal of Orthopaedic Surgery and Research
                BioMed Central (London )
                1749-799X
                23 May 2015
                23 May 2015
                2015
                : 10
                : 78
                Affiliations
                [ ]Department of Spine Surgery, Yantaishan Hospital, Yantai, 264000 China
                [ ]Department of Orthopedic Surgery, Qilu Hospital of Shandong University, No. 107 Wenhuaxi Road, Jinan, 250012 China
                [ ]Department of Hematology, Yantaishan Hospital, Yantai, 264000 China
                Article
                223
                10.1186/s13018-015-0223-7
                4455337
                25998624
                20a566a2-cd15-4249-b7de-ddbd35197b62
                © Du et al. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 12 September 2014
                : 13 May 2015
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2015

                Surgery
                rivaroxaban,parnaparin,lumbar spine surgery,venous thromboembolism
                Surgery
                rivaroxaban, parnaparin, lumbar spine surgery, venous thromboembolism

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