scholarly journals Randomized Comparison of Two Approaches to Initial Warfarin Dosing: Time in Therapeutic Range of International Normalized Ratio During Hospitalization

Kardiologiia ◽  
2017 ◽  
Vol 17 (9) ◽  
pp. 42-46
Author(s):  
L. N. Mishchenko ◽  
◽  
O. V. Averkov ◽  
I. G. Gordeev ◽  
N. N. Levchuk ◽  
...  
2020 ◽  
Vol 9 (6) ◽  
pp. 1698 ◽  
Author(s):  
Rungroj Krittayaphong ◽  
Thoranis Chantrarat ◽  
Roj Rojjarekampai ◽  
Pongpun Jittham ◽  
Poom Sairat ◽  
...  

Background: Warfarin remains the most commonly used oral anticoagulant (OAC) in Thailand for stroke prevention among patients with non-valvular atrial fibrillation (NVAF). The aim of this study was to investigate the relationship between time in therapeutic range (TTR) after warfarin initiation and clinical outcomes of NVAF. Methods: TTR was calculated by the Rosendaal method from international normalized ratio (INR) data acquired from a nationwide NVAF registry in Thailand. Patients were followed-up every six months. The association between TTR and clinical outcomes was analyzed. Results: There was a total of 2233 patients from 27 hospitals. The average age was 68.4 ± 10.6 years. The average TTR was 53.56 ± 26.37%. Rates of ischemic stroke/TIA, major bleeding, ICH, and death were 1.33, 2.48, 0.76, and 3.3 per 100 person-years, respectively. When patients with a TTR < 65% were compared with those with TTR ≥ 65%, the adjusted hazard ratios (aHR) for the increased risks of ischemic stroke/TIA, major bleeding, ICH, and death were 3.07, 1.90, 2.34, and 2.11, respectively. Conclusion: Poor TTR control is associated with adverse clinical outcomes in patients with NVAF who were on warfarin. Efforts to ensure good TTR (≥65%) after initiation of warfarin are mandatory to minimize the risk of adverse clinical outcomes.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3800-3800
Author(s):  
Robby Nieuwlaat ◽  
Ben Connolly ◽  
John Eikelboom ◽  
Stuart Connolly ◽  
Scott Kaatz

Abstract Abstract 3800 Rationale: Vitamin K antagonists, of which warfarin is the most widely used in North America, are some of the most difficult medications to control and require careful monitoring to keep the international normalized ratio (INR) in the therapeutic range. Anticoagulation clinics and computer-assisted decision support systems have been associated with an improved time patients spend in the therapeutic INR range, but these systems can be expensive. Also, patient self-management delivers the best INR control, but is only useful for patients who are capable to perform self testing and management. Simple, inexpensive and easy to use dosing algorithms have the potential to overcome some of these logistical barriers and offer a tool that could be used without the infrastructure of a formal anticoagulation clinic. We performed a systematic review to identify validated manual warfarin maintenance dosing algorithms that do not require computer support. Methods: MEDLINE was searched, without language restriction, by two independent reviewers for observational and experimental reports of warfarin dosing algorithms, nomograms or formulas. Studies that reported efficacy of anticoagulation clinics, patient self management and computer assisted warfarin dosing were reviewed for references for an underlying dosing process. Inclusion criteria for studies for this review were: 1) the tool needed to provide advice on maintenance dose adjustment and next INR testing, 2) the manual dosing tool needed to be compared to a control group, 3) time in therapeutic range or patient outcomes were reported, 4) the effect of the dosing method could be separated from other interventional aspects of warfarin management. Inter-rater agreement for inclusion of candidate studies was measured with the kappa statistic and disagreement was resolved by consensus. Results: Twenty-five studies were identified and 23 either did not report a manually useful tool (computer-based algorithm or complex formula), did not have a control comparator, did not report the time in therapeutic range or patient outcomes, or the effect of the tool could not be separated from other interventional aspects of anticoagulation clinics, computer systems or self-management. Only 2 studies fulfilled all of the inclusion criteria and there was 100% agreement between the two independent reviewers for their selection. Both studies were single center studies and used practice performance before implementation of the dosing tool as the comparator. One study (n=72) showed an improvement in the proportion of INRs in the therapeutic range from 32% to 46% (p < 0.05). The other study (n=1961) showed an improvement in the time in therapeutic range in patients with a target INR range of 2–3 from 67% to 73% (p < 0.001) and in patients with a range of 2.5–3.5, form 50% to 64% (p < 0.001). Data of the two studies were not pooled due to differences in the dosing tool, quality level of care and calculation of the primary outcome, and the negligible effect of the smaller study. Conclusion: We identified only 2 manually useful VKA maintenance dosing tools that have been compared with a control group. Both studies showed an improvement in the quality of INR control with a simple dosing algorithm, but the studies were limited by their pre/post interventional design. Our results stress the need for a randomized trial to validate the usefulness of a manual dosing algorithm which could yield a simple and inexpensive evidence-based method for many physicians managing patients taking a vitamin K antagonist. Disclosures: No relevant conflicts of interest to declare.


2021 ◽  
Vol 27 ◽  
pp. 107602962110214
Author(s):  
Zeynep Yapan Emren ◽  
Oktay Şenöz ◽  
Ahmet Erseçgin ◽  
Sadık Volkan Emren

The treatment process of patients using warfarin is expected to be hindered during the COVID-19 pandemic. Therefore we investigated whether the time in therapeutic range (TTR) and bleeding complications were affected during the COVID-19 pandemic. 355 patients using warfarin were included between March 2019 to March 2021. Demographic parameters, INR (international normalized ratio), and bleeding rates were recorded retrospectively. The TTR value was calculated using Rosendaal’s method. The mean age of the patients was 61 ± 12 years and 55% of them were female. The mean TTR value during the COVID-19 pandemic was lower than the pre-COVID-19 period (56 ± 21 vs 68 ± 21, P < 0.001). Among the patients, 41% had a lack of outpatient INR control. During the COVID-19 pandemic, 71 (20%) patients using VKA suffered bleeding. Among patients with bleeding, approximately 60% did not seek medical help and 6% of patients performed self-reduction of the VKA dose. During the COVID-19 pandemic, TTR values have decreased with the lack of monitoring. Furthermore, the majority of patients did not seek medical help even in case of bleeding.


2021 ◽  
Vol 10 (8) ◽  
pp. e59510816523
Author(s):  
Sérgio Henrique Simonetti ◽  
Gustavo Bernardes de Figueiredo Oliveira ◽  
Fabiana Cristina Lourenço ◽  
França João Ítalo Dias

To validate and analyze the accuracy of the Simonetti adherence score among patients on chronic use of vitamin K antagonists and their time in therapeutic range (TTR) of the international normalized ratio as a measure of quality of anticoagulation. A prospective cohort study with a nonrandomized intervention in patients from an anticoagulation center of a public hospital. Baseline data were collected from May to September 2017, and follow-up data were obtained eight months after a nurse-led  educational intervention, which was given to all patients after consent form and after applying the adherence score (N=205). The intervention was undertaken through 30-40 min conversation about relevant factors that had been previously identified in the score derivation study, which comprised drug-drug interactions, inadequate OAC use, comorbidities, effects of food on vitamin K absorption, and invasive procedures. A receiver operating characteristic (ROC) curve was applied to validate the adherence score in terms of prediction of INR out of recommended therapeutic range. At baseline, mean adherence score was 44.69 and standard deviation (SD) was 18.37, and   mean TTR was 41.07 (SD 15.40). Patients were reassessed after   8 months. At follow-up, there were significant improvements in mean adherence score 54.28 (SD 13.13), and in mean TTR 50.99 (SD 26.10). The Simonetti adherence score yielded high performance and accuracy in clinical practice among patients on chronic use of vitamin K antagonists. Our data indicate that nurse led educational intervention yielded favorable impact in terms of adherence score and TTR improvements.


Author(s):  
Chengxian Guo ◽  
Yun Kuang ◽  
Honghao Zhou ◽  
Hong Yuan ◽  
Qi Pei ◽  
...  

Background: Warfarin is an effective treatment for thromboembolic disease but has a narrow therapeutic index; optimal anticoagulation dosage can differ tremendously among individuals. We aimed to evaluate whether genotype-guided warfarin dosing is superior to routine clinical dosing for the outcomes of interest in Chinese patients. Methods: We conducted a multicenter, randomized, single-blind, parallel-controlled trial from September 2014 to April 2017 in 15 hospitals in China. Eligible patients were ≥18 years of age, with atrial fibrillation or deep vein thrombosis without previous treatment of warfarin or a bleeding disorder. Nine follow-up visits were performed during the 12-week study period. The primary outcome measure was the percentage of time in the therapeutic range of the international normalized ratio during the first 12 weeks after starting warfarin therapy. Results: A total of 660 participants were enrolled and randomly assigned to a genotype-guided dosing group or a control group under standard dosing. The genotype-guided dosing group had a significantly higher percentage of time in the therapeutic range than the control group (58.8% versus 53.2% [95% CI of group difference, 1.1–10.2]; P =0.01). The genotype-guided dosing group also achieved the target international normalized ratio sooner than the control group. In subgroup analyses, warfarin normal sensitivity group had an even higher percentage of time in the therapeutic range during the first 12 weeks compared with the control group (60.8% versus 48.9% [95% CI, 1.1–24.4]). The incidence of adverse events was low in both groups. Conclusions: The outcomes of genotype-guided warfarin dosing were superior to those of clinical standard dosing. These findings raise the prospect of precision warfarin treatment in China. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02211326.


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