Abstract | STUDY OBJECTIVE: DESIGN: Retrospective cohort study with a comparator group of patients from the RECORD 1-4 trials. SETTING: Two institutions within a regional health care system. PATIENTS: Four hundred forty adults who received at least one dose of rivaroxaban 10 mg daily after undergoing THA or TKA in the two institutions between August 2011 and October 2013 (cohort group), and 6183 patients who received rivaroxaban in the RECORD 1-4 trials (comparator group). MEASUREMENTS AND MAIN RESULTS: Postoperative bleeding was assessed in the cohort patients versus the patients in the RECORD trials. The primary outcome, occurrence of any postoperative bleeding, was a composite of major and clinically relevant nonmajor bleeding as defined in the RECORD trials. Any postoperative bleeding occurred in 6.8% of the cohort patients versus 3.2% of the RECORD trial patients (p<0.0001); 1.4% of the cohort patients versus 0.38% of the RECORD trial patients suffered a major bleed (p=0.013). Within defined major bleeding, bleeding leading to reoperation and clinically overt extrasurgical site bleeding resulting in either a hemoglobin level decrease of at least 2 g/dl or transfusion of 2 units or greater of packed red blood cells were reported in 0.68% versus 0.19% (p=0.073) and 0.68% versus 0.13% (p=0.032), respectively, of the cohort patients versus the RECORD trial patients. CONCLUSION: Overall, any postoperative bleeding in the cohort patients occurred significantly more frequently than that observed in the RECORD trial patients. The major bleeding rate was also significantly higher in the cohort patients, influenced by higher rates of bleeding leading to reoperation and clinically overt extrasurgical site bleeding resulting in either a hemoglobin decrease of at least 2 g/dl or transfusion of two units or greater of packed red blood cells. These findings from our pilot study are thought provoking and, thus, invite further investigation.
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Authors | Robert C Wood 3rd, David W Stewart, Lindsey Slusher, Hadi El-Bazouni, David Cluck, Jessica Freshour, Brian Odle |
Journal | Pharmacotherapy
(Pharmacotherapy)
Vol. 35
Issue 7
Pg. 663-9
(Jul 2015)
ISSN: 1875-9114 [Electronic] United States |
PMID | 26095331
(Publication Type: Comparative Study, Journal Article)
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Copyright | © 2015 Pharmacotherapy Publications, Inc. |
Chemical References |
- Factor Xa Inhibitors
- Rivaroxaban
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Arthroplasty, Replacement, Hip
- Arthroplasty, Replacement, Knee
- Clinical Trials as Topic
- Factor Xa Inhibitors
(adverse effects)
- Female
- Hemorrhage
(chemically induced, epidemiology)
- Humans
- Male
- Middle Aged
- Postoperative Complications
(chemically induced, epidemiology)
- Retrospective Studies
- Rivaroxaban
(adverse effects)
- Venous Thromboembolism
(prevention & control)
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