Retrospective Evaluation of Postoperative Adverse Drug Events in Patients Receiving Rivaroxaban After Major Orthopedic Surgery Compared with Standard Therapy in a Community Hospital

Cieri, Nicole E.; Kusmierski, Kristen; Lackie, Cynthia L; Opdorp, August Van; Hassan, Amany K.

doi:10.1002/phar.1888

Cited by 4 publications

(4 citation statements)

References 13 publications

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“…The characteristics and target outcomes of the included studies are listed in Table 1. We included 11 RCTs, 22–32 5 prospective cohort studies, 33–37 43 retrospective cohort studies, 51–93 and 13 case–control studies 38–50 . The studies included in the final analysis had been conducted in the United States (37.5%, 27/72), Canada (16.7%, 12/72), multiple countries (international studies) (6.9%, 5/72), Japan (6.9%, 5/72), Finland (5.5%, 4/72) and Australia (5.5%, 4/72).…”

Section: Resultsmentioning

confidence: 99%

“…Of these, 588 articles were considered potentially eligible for full‐text review, and 72 ( n = 4 502 273) were included in the final analysis (see Figure 1). 22–93 …”

Section: Resultsmentioning

confidence: 99%

“…No significant difference was found for bleeding or thromboembolic events. Another study ( n = 2380) compared enoxaparin plus warfarin to warfarin alone 60 . No significant difference was found for both bleeding and thromboembolic events with a short‐term transition period of concomitant use of enoxaparin and warfarin compared to warfarin alone.…”

Section: Resultsmentioning

confidence: 99%

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Drug–drug interactions with warfarin: A systematic review and meta‐analysis

Wang

Zeraatkar

Obeda

et al. 2021

Brit J Clinical Pharma

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The objective of this paper is to systematically review the literature on drugdrug interactions with warfarin, with a focus on patient-important clinical outcomes.Methods: MEDLINE, EMBASE and the International Pharmaceutical Abstract (IPA) databases were searched from January 2004 to August 2019. We included studies describing drug-drug interactions between warfarin and other drugs. Screening and data extraction were conducted independently and in duplicate. We synthesized pooled odds ratios (OR) with 95% confidence intervals (CIs), comparing warfarin plus another medication to warfarin alone. We assessed the risk of bias at the study level and evaluated the overall certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.Results: Of 42 013 citations identified, a total of 72 studies reporting on 3 735 775 patients were considered eligible, including 11 randomized clinical trials and 61 observational studies. Increased risk of clinically relevant bleeding when added to warfarin therapy was observed for antiplatelet (AP) regimens (OR = 1.74; 95% CI 1.56-1.94),

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Section: Resultsmentioning

confidence: 99%

“…Of these, 588 articles were considered potentially eligible for full‐text review, and 72 ( n = 4 502 273) were included in the final analysis (see Figure 1). 22–93 …”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Drug–drug interactions with warfarin: A systematic review and meta‐analysis

Wang

Zeraatkar

Obeda

et al. 2021

Brit J Clinical Pharma

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“…1 However, direct oral anticoagulants, with their rapid onset of action, also cause hemorrhage requiring emergency care, 1 especially after orthopedic surgery. [2][3][4] Thus, warfarin continues to be prescribed after hip and knee arthroplasty, particularly among high-risk orthopedic patients. 5 The risk of hemorrhage rises exponentially with international normalized ratio (INR) values higher than 3 or 4.…”

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confidence: 99%

Effect of Low-Intensity vs Standard-Intensity Warfarin Prophylaxis on Venous Thromboembolism or Death Among Patients Undergoing Hip or Knee Arthroplasty

Gage

Bass

Lin

et al. 2019

JAMA

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IMPORTANCE The optimal international normalized ratio (INR) to prevent venous thromboembolism (VTE) in warfarin-treated patients with recent arthroplasty is unknown. OBJECTIVE To determine the safety and efficacy of a target INR of 1.8 vs 2.5 for VTE prophylaxis after orthopedic surgery. DESIGN, SETTING, AND PARTICIPANTS The randomized Genetic Informatics Trial (GIFT) of Warfarin to Prevent Deep Vein Thrombosis enrolled 1650 patients aged 65 years or older initiating warfarin for elective hip or knee arthroplasty at 6 US medical centers. Enrollment began in April 2011 and follow-up concluded in October 2016. INTERVENTIONS In a 2 × 2 factorial design, participants were randomized to a target INR of 1.8 (n = 823) or 2.5 (n = 827) and to either genotype-guided or clinically guided warfarin dosing. For the first 11 days of therapy, open-label warfarin dosing was guided by a web application. MAIN OUTCOMES AND MEASURES The primary outcome was the composite of VTE (within 60 days) or death (within 30 days). Participants underwent screening duplex ultrasound postoperatively. The hypothesis was that an INR target of 1.8 would be noninferior to an INR target of 2.5, using a noninferiority margin of 3% for the absolute risk of VTE. Secondary end points were bleeding and INR values of 4 or more. RESULTS Among 1650 patients who were randomized (mean age, 72.1 years; 1049 women [63.6%]; 1502 white [91.0%]), 1597 (96.8%) received at least 1 dose of warfarin and were included in the primary analysis. The rate of the primary composite outcome of VTE or death was 5.1% (41 of 804) in the low-intensity-warfarin group (INR target, 1.8) vs 3.8% (30 of 793) in the standard-treatment-warfarin group (INR target, 2.5), for a difference of 1.3% (1-sided 95% CI, −ϱ to 3.05%, P = .06 for noninferiority). Major bleeding occurred in 0.4% of patients in the low-intensity group and 0.9% of patients in the standard-intensity group, for a difference of −0.5% (95% CI, −1.6% to 0.4%). The INR values of 4 or more occurred in 4.5% of patients in the low-intensity group and 12.2% of the standard-intensity group, for a difference of −7.8% (95% CI, −10.5% to −5.1%). CONCLUSIONS AND RELEVANCE Among older patients undergoing hip or knee arthroplasty and receiving warfarin prophylaxis, an international normalized ratio goal of 1.8 compared with 2.5 did not meet the criterion for noninferiority for risk of the composite outcome of VTE or death. However, the trial may have been underpowered to meet this criterion and further research may be warranted.

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Enoxaparin-sodium/warfarin

2017

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Retrospective Evaluation of Postoperative Adverse Drug Events in Patients Receiving Rivaroxaban After Major Orthopedic Surgery Compared with Standard Therapy in a Community Hospital

Abstract: We observed a small, yet significant, increase in rivaroxaban-related bleeding in the immediate postoperative period relative to warfarin or warfarin with the addition of enoxaparin for the prevention of VTE after major orthopedic surgery.

Cited by 4 publications

References 13 publications

Drug–drug interactions with warfarin: A systematic review and meta‐analysis

Drug–drug interactions with warfarin: A systematic review and meta‐analysis

Effect of Low-Intensity vs Standard-Intensity Warfarin Prophylaxis on Venous Thromboembolism or Death Among Patients Undergoing Hip or Knee Arthroplasty

Enoxaparin-sodium/warfarin

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