Benchmark for Time in Therapeutic Range in Venous Thromboembolism: A Systematic Review and Meta-Analysis

Erkens, Petra M. G.; Cate, Hugo Ten; Büller, Harry R.; Prins, Martin H.

doi:10.1371/journal.pone.0042269

Cited by 76 publications

(70 citation statements)

References 66 publications

(133 reference statements)

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“…However, INR monitoring was intensive and required assessment at least once a month. The time patients spent in the target therapeutic range (INR, 2.0–3.0) was in line with that achieved in contemporary studies [18]. Therefore, we believe the results obtained in this large, global study, with limited exclusion criteria, are valid and can be generalized to typical patients with DVT and/or PE.…”

Section: Discussionsupporting

confidence: 86%

Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies

et al. 2013

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BackgroundStandard treatment for venous thromboembolism (VTE) consists of a heparin combined with vitamin K antagonists. Direct oral anticoagulants have been investigated for acute and extended treatment of symptomatic VTE; their use could avoid parenteral treatment and/or laboratory monitoring of anticoagulant effects.MethodsA prespecified pooled analysis of the EINSTEIN-DVT and EINSTEIN-PE studies compared the efficacy and safety of rivaroxaban (15 mg twice-daily for 21 days, followed by 20 mg once-daily) with standard-therapy (enoxaparin 1.0 mg/kg twice-daily and warfarin or acenocoumarol). Patients were treated for 3, 6, or 12 months and followed for suspected recurrent VTE and bleeding. The prespecified noninferiority margin was 1.75.ResultsA total of 8282 patients were enrolled; 4151 received rivaroxaban and 4131 received standard-therapy. The primary efficacy outcome occurred in 86 (2.1%) rivaroxaban-treated patients compared with 95 (2.3%) standard-therapy-treated patients (hazard ratio, 0.89; 95% confidence interval [CI], 0.66–1.19; pnoninferiority < 0.001). Major bleeding was observed in 40 (1.0%) and 72 (1.7%) patients in the rivaroxaban and standard-therapy groups, respectively (hazard ratio, 0.54; 95% CI, 0.37–0.79; p = 0.002). In key subgroups, including fragile patients, cancer patients, patients presenting with large clots, and those with a history of recurrent VTE, the efficacy and safety of rivaroxaban were similar compared with standard-therapy.ConclusionThe single-drug approach with rivaroxaban resulted in similar efficacy to standard-therapy and was associated with a significantly lower rate of major bleeding. Efficacy and safety results were consistent among key patient subgroups.Trial registrationEINSTEIN-PE: ClinicalTrials.gov, NCT00439777; EINSTEIN-DVT: ClinicalTrials.gov, NCT00440193.

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Section: Discussionsupporting

confidence: 86%

Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies

et al. 2013

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“…Third, we did not calculate time in therapeutic international normalized ratio (INR) range for warfarin patients. While INR control is somewhat predictive of the effectiveness and safety of vitamin K antagonists, it is well known that VTE patients treated with warfarin in routine US clinical practice spend only~56% of their time during the first 3 months of treatment (when recurrent VTE is most likely) in the therapeutic INR range [19,20] and African American patients may have among the poorest INR control [21]. Given the Optum EHR data used for this study covers patients throughout the US regardless of insurer (or no insurance), it is likely patients included in this study experienced at least similar suboptimal INR control.…”

Section: Discussionmentioning

confidence: 99%

Rivaroxaban versus warfarin for treatment and prevention of recurrence of venous thromboembolism in African American patients: a retrospective cohort analysis

Costa

Thompson²,

Ashton

et al. 2020

Thrombosis J

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Background: African Americans are under-represented in trials evaluating oral anticoagulants for the treatment of acute venous thromboembolism (VTE). The aim of this study was to evaluate the effectiveness and safety of rivaroxaban versus warfarin for the treatment of VTE in African Americans. Methods: We utilized Optum® De-Identified Electronic Health Record data from 11/1/2012-9/30/2018. We included African Americans experiencing an acute VTE during a hospital or emergency department visit, who received rivaroxaban or warfarin as their first oral anticoagulant within 7-days of the acute VTE event and had ≥1 provider visit in the prior 12-months. Differences in baseline characteristics between cohorts were adjusted using inverse probability-of-treatment weighting based on propensity scores (standard differences < 0.10 were achieved for all covariates). Our primary endpoint was the composite of recurrent VTE or major bleeding at 6-months. Three-and 12-month timepoints were also assessed. Secondary endpoints included recurrent VTE and major bleeding as individual endpoints. Cohort risk was compared using Cox regression and reported as hazard ratios (HRs) with 95% confidence intervals (CIs). Results: We identified 2097 rivaroxaban and 2842 warfarin users with incident VTE. At 6-months, no significant differences in the composite endpoint (HR = 0.96, 95%CI = 0.75-1.24), recurrent VTE (HR = 1.02, 95%CI = 0.76-1.36) or major bleeding alone (HR = 0.93, 95%CI = 0.59-1.47) were observed between cohorts. Analysis at 3-and 12-months provided consistent findings for these endpoints. Conclusions: In African Americans experiencing an acute VTE, no significant difference in the incidence of recurrent VTE or major bleeding was observed between patients receiving rivaroxaban or warfarin.

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“…Caucasian studies identified a mean TTR of 75.2% in months 4 to 12 or longer of warfarin management. 29 The Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) identified a mean TTR of 50.4% in East Asia region. 30 A study focusing on warfarin use in Japanese population using Japanese guideline recommended therapeutic range showed an overall TTR of 69.7% in nonvalvular AF patients.…”

Section: Status Of Warfarin Control In Hong Kongmentioning

confidence: 99%

Warfarin control in Hong Kong clinical practice

Lam

Lee

Mak

et al. 2019

Preprint

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Objectives: Time-in-therapeutic range (TTR) assesses safety and effectiveness of warfarin therapy using international normalized ratio (INR). This study aimed to investigate the status of TTR in Hong Kong and patients’ economic and clinical outcomes. Predictors of poor warfarin control and patient’s knowledge in warfarin therapy were assessed. Methods: A five-month observational study was conducted in Prince of Wales Hospital in Hong Kong. The TTRs calculated using Caucasian and Japanese therapeutic range were examined among patients on warfarin for at least one year. Patients’ knowledge was assessed using the Oral Anticoagulation Knowledge (OAK) test. Results: A total of 259 patients were included in this study, with 174 of them completed the OAK test. Using Caucasian therapeutic range, calculated mean TTR was 40.2 ± 17.1%, compared that of 49.1 ± 16.1% with Japanese therapeutic range (P<0.001). Mean TTR in patients with atrial fibrillation was higher than those with prosthetic heart valve (p<0.001). Predictability of TTR on clinical outcomes and economic outcomes was comparable between Caucasian and Japanese therapeutic range. Patients with ideal TTR had fewer clinical complications and lower warfarin-related healthcare costs. Patients with younger age, concurrent use of aspirin, frusemide, famotidine, pantoprazole and simvastatin were associated with poorer TTR. Mean score of OAK test was 54.1%. Only 24 patients (13.8%) achieved the satisfactory overall score of ≥75% in the test. Conclusion: Warfarin use in Hong Kong patients was poorly controlled regardless of indication. Patients’ knowledge towards warfarin use was suboptimal. More education to patients on warfarin use is warranted.

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Benchmark for Time in Therapeutic Range in Venous Thromboembolism: A Systematic Review and Meta-Analysis

Cited by 76 publications

References 66 publications

Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies

Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies

Rivaroxaban versus warfarin for treatment and prevention of recurrence of venous thromboembolism in African American patients: a retrospective cohort analysis

Warfarin control in Hong Kong clinical practice

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