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New warfarin anticoagulation management model after heart valve surgery: rationale and design of a prospective, multicentre, randomised trial to compare an internet-based warfarin anticoagulation management model with the traditional warfarin management model.

ABSTRACT: INTRODUCTION:Warfarin is an effective anticoagulant and the only oral anticoagulant available for patients with mechanical heart valves. The prothrombin time and the associated international normalised ratio (INR) are routinely tested to monitor the response to anticoagulation therapy in patients. Patients who undergo mechanical heart valve replacement need lifelong anticoagulation therapy, and their INR is regularly measured to adjust the anticoagulation strength and the dose of anticoagulation drugs. Appropriate warfarin anticoagulation management can reduce patient complications, such as bleeding and thrombosis, and improve the long-term survival rate. We propose modern internet technology as a platform to build a warfarin anticoagulation follow-up system after valve replacement surgery. This system will provide doctors and patients with more standardised and safer follow-up methods as well as a method to further reduce the risk of warfarin anticoagulation-related complications and improve its therapeutic effects. METHODS AND ANALYSIS:A prospective, multicentre, randomised, controlled trial will be conducted. A total of 700 patients who require long-term warfarin anticoagulation monitoring after heart valve replacement will be enrolled and randomly divided at a 1:1 ratio into a traditional outpatient anticoagulation management group and a group undergoing a new method of management based on the internet technology with follow-up for 1?year. Differences in the percentage of time in the therapeutic range (TTR), drug dose adjustments, bleeding/thrombosis and other related complications will be observed. The primary endpoint is the difference in the TTR between the two groups. The purpose of this study is to explore a safer and more effective mode of doctor-patient interaction and communication in the internet era. As of 13 July 2019, 534 patients had been enrolled. ETHICS AND DISSEMINATION:This study protocol was approved by the Ethics Committee of Beijing Anzhen Hospital, Capital Medical University. The results will be published in a peer-reviewed medical journal. TRIAL REGISTRATION NUMBER:ChiCTR1800016204.

SUBMITTER: Zhu Z

PROVIDER: S-EPMC6924837 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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New warfarin anticoagulation management model after heart valve surgery: rationale and design of a prospective, multicentre, randomised trial to compare an internet-based warfarin anticoagulation management model with the traditional warfarin management model.

Zhu Zhihui Z Li Yuehuan Y Meng Xu X Han Jie J Li Yan Y Liu Kun K Shen Jinglun J Qin Ying Y Zhang Haibo H

BMJ open 20191205 12

<h4>Introduction</h4>Warfarin is an effective anticoagulant and the only oral anticoagulant available for patients with mechanical heart valves. The prothrombin time and the associated international normalised ratio (INR) are routinely tested to monitor the response to anticoagulation therapy in patients. Patients who undergo mechanical heart valve replacement need lifelong anticoagulation therapy, and their INR is regularly measured to adjust the anticoagulation strength and the dose of anticoa ...[more]

PMID: 31811010

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Project description:BackgroundMechanical heart valve replacement (MHVR) is an effective method for the treatment of severe heart valve disease; however, it subjects patient to lifelong warfarin therapy after MHVR with the attendant risk of bleeding and thrombosis. Whether internet-based warfarin management reduces complications and improves patient quality of life remains unknown.ObjectiveThis study aimed to compare the effects of internet-based warfarin management and the conventional approach in patients who received MHVR in order to provide evidence regarding alternative strategies for long-term anticoagulation.MethodsThis was a prospective, multicenter, randomized, open-label, controlled clinical trial with a 1-year follow-up. Patients who needed long-term warfarin anticoagulation after MHVR were enrolled and then randomly divided into conventional and internet-based management groups. The percentage of time in the therapeutic range (TTR) was used as the primary outcome, while bleeding, thrombosis, and other events were the secondary outcomes.ResultsA total of 721 patients were enrolled. The baseline characteristics did not reach statistical differences between the 2 groups, suggesting the random assignment was successful. As a result, the internet-based group showed a significantly higher TTR (mean 0.53, SD 0.24 vs mean 0.46, SD 0.21; P<.001) and fraction of time in the therapeutic range (mean 0.48, SD 0.22 vs mean 0.42, SD 0.19; P<.001) than did those in the conventional group. Furthermore, as expected, the anticoagulation complications, including the bleeding and embolic events had a lower frequency in the internet-based group than in the conventional group (6.94% vs 12.74%; P=.01). Logistic regression showed that internet-based management increased the TTR by 7% (odds ratio [OR] 1.07, 95% CI 1.05-1.09; P<.001) and reduced the bleeding and embolic risk by 6% (OR 0.94, 95% CI 0.92-0.96; P=.01). Moreover, low TTR was found to be a risk factor for bleeding and embolic events (OR 0.87, 95% CI 0.83-0.91; P=.005).ConclusionsThe internet-based warfarin management is superior to the conventional method, as it can reduce the anticoagulation complications in patients who receive long-term warfarin anticoagulation after MHVR.Trial registrationChinese Clinical Trial Registry ChiCTR1800016204; http://www.chictr.org.cn/showproj.aspx?proj=27518.International registered report identifier (irrid)RR2-10.1136/bmjopen-2019-032949.

Project description:BackgroundPoor anticoagulation management of warfarin may lead to patient admission, prolonged hospital stays, and even death due to anticoagulation-related adverse events. Traditional non-web-based outpatient clinics struggle to provide ideal anticoagulation management services for patients, and there is a need to explore a safer, more effective, and more convenient mode of warfarin management.ObjectiveThis study aimed to compare differences in the quality of anticoagulation management and clinical adverse events between a web-based management model (via a smartphone app) and the conventional non-web-based outpatient management model.MethodsThis study is a prospective cohort research that includes multiple national centers. Patients meeting the nadir criteria were split into a web-based management group using the Alfalfa app or a non-web-based management group with traditional outpatient management, and they were then monitored for a 6-month follow-up period to collect coagulation test results and clinical events. The effectiveness and safety of the 2 management models were assessed by the following indicators: time in therapeutic range (TTR), bleeding events, thromboembolic events, all-cause mortality events, cumulative event rates, and the distribution of the international normalized ratio (INR).ResultsThis national multicenter cohort study enrolled 522 patients between June 2019 and May 2021, with 519 (99%) patients reaching the follow-up end point, including 260 (50%) in the non-web-based management group and 259 (50%) in the web-based management group. There were no observable differences in baseline characteristics between the 2 patient groups. The web-based management group had a significantly higher TTR than the non-web-based management group (82.4% vs 71.6%, P<.001), and a higher proportion of patients received effective anticoagulation management (81.2% vs 63.5%, P<.001). The incidence of minor bleeding events in the non-web-based management group was significantly higher than that in the web-based management group (12.1% vs 6.6%, P=.048). Between the 2 groups, there was no statistically significant difference in the incidence of severe bleeding and thromboembolic and all-cause death events. In addition, compared with the non-web-based management group, the web-based management group had a lower proportion of INR in the extreme subtreatment range (17.6% vs 21.3%) and severe supertreatment range (0% vs 0.8%) and a higher proportion in the treatment range (50.4% vs 43.1%), with statistical significance.ConclusionsCompared with traditional non-web-based outpatient management, web-based management via the Alfalfa app may be more beneficial because it can enhance patient anticoagulation management quality, lower the frequency of small bleeding events, and improve INR distribution.

Project description:Background: The management of warfarin-treated patients has been recognized as a challenge due to narrow therapeutic range and food and drug interactions in warfarin therapy. We aim to evaluate the effect of a pharmacist-led remote warfarin management model using a smartphone application (app) on anticoagulation therapy. Methods: Eligible patients who had received warfarin therapy after mechanical heart valve replacement were enrolled. The intervention group was offered a pharmacist-led remote warfarin management model using the app named Yixing. Yixing incorporates functions including automatic daily reminder, personal health record, educational program, and online counseling. The control group received traditional pharmacy services without Yixing. Co-primary outcomes were patients' awareness score of warfarin therapy obtained from questionnaire, the medication adherence measured by the percentage of the correct-warfarin-taken days in the monitored period, the fraction of time in therapeutic range (FTTR), and the incidence of anticoagulation-related complications. The needed information of the patients was acquired via electronic medical records from the hospital, Yixing system and telephone follow-up when necessary. Results: 64 and 66 patients were initially in the intervention and control groups respectively. After propensity score matching, 50 patients were assigned in each group. The intervention group had a median age of 51.0 years, in which 27 (54%) were male. The control group had a median age of 50.5 years, in which 28 (56%) were male. Patient awareness score in the intervention group was 8.00 (2.00), which was higher than that in the control group, with score at 6.50 (2.50) (p = 0.001). No significant difference was found in the percentage of the correct-warfarin-taken days between the two groups (p = 0.520). The median (interquartile range) value of FTTR was 80.3% (21.9%) and 72.1% (17.7%) in the intervention and control groups respectively (p = 0.033), and no significant differences in the incidence of anticoagulation-related complications were observed (p = 0.514). Conclusion: The pharmacist-led remote warfarin management model using Yixing improves patients' awareness of warfarin therapy and increases FTTR, but may not have significant improvements on medication adherence and safety.

Project description:ObjectivesWe investigated incidence and risk factors for postextraction bleeding in patients receiving warfarin and those not receiving anticoagulation therapy.DesignCross-sectional, multicentre, observational study.Setting26 hospitals where an oral surgeon is available.ParticipantsData on 2817 teeth (from 496 patients receiving warfarin, 2321 patients not receiving warfarin; mean age (SD): 62.2 (17.6)) extracted between 1 November 2008 and 31 March 2010, were collected. Warfarin-receiving patients were eligible when prothrombin time-international normalised ratio (PT-INR) measured within 7?days prior to the extraction was less than 3.0.InterventionsSimple dental extraction was performed, and incidence of postextraction bleeding and comorbidities were recorded.Primary and secondary outcome measuresPostextraction bleeding not controlled by basic haemostasis procedure was clinically significant.ResultsBleeding events were reported for 35 (7.1%) and 49 (2.1%) teeth, of which 18 (3.6%) and 9 (0.4%) teeth were considered clinically significant, in warfarin and non-warfarin groups, respectively, the difference between which was 3.24% (CI 1.58% to 4.90%). The incidence rates by patients were 2.77% and 0.39%, in warfarin and non-warfarin groups, respectively (incidence difference 2.38%, CI 0.65% to 4/10%). Univariate analyses showed that age (OR 0.197, p=0.001), PT-INR (OR 3.635, p=0.003), mandibular foramen conduction anaesthesia (OR 4.854, p=0.050) and formation of abnormal granulation tissue in extraction socket (OR 2.900, p=0.031) significantly correlate with bleeding incidence. Multivariate analysis revealed that age (OR 0.126, p=0.001), antiplatelet drugs (OR 0.100, p=0.049), PT-INR (OR 7.797, p=0.001) and history of acute inflammation at extraction site (OR 3.722, p=0.037) were significant risk factors for postextraction bleeding.ConclusionsOur results suggest that there is slight but significant increase in the incidences of postextraction bleeding in patients receiving warfarin. Although absolute incidence was low in both groups, the bleeding risk is not negligible.

Project description:BACKGROUND:Warfarin and similar vitamin K antagonists have been the standard therapy for patients with mechanical or biological valve prosthesis and atrial fibrillation (AF). Even with the appropriate use of therapy, some studies have reported that there is a high incidence of thromboembolic events, 1%-4% per year. Furthermore, a bleeding risk is significant, ranging from 2% to 9% per year, according to some studies. OBJECTIVE:The objective of our study was to examine the effect of dabigatran etexilate versus dose-adjusted warfarin for the prevention of intracardiac thrombus in persistent or permanent AF at least 3 months after aortic and/or mitral bioprosthesis replacement. METHODS:Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively (DAWA) is a phase 2, prospective, open label, randomized exploratory pilot study. The main variable to be observed in this study is intracardiac thrombus. From August 2013 to April 2015, 100 patients, at least 3 months after aortic and/or mitral bioprosthesis replacement and permanent or persistent AF postoperatively, who match eligibility criteria will be selected from Ana Nery Hospital in Salvador-Bahia with a follow-up of three months. Patients were randomly assigned in a 1:1 ratio to receive either dabigatran etexilate or warfarin. RESULTS:Although the present study has no statistic power to proof non-inferiority, it is expected that the dabigatran etexilate group will be protected as well as the warfarin group from intracardiac thrombus, without increasing the bleeding rates, since we are using safer doses (110 mg bid). The lack of necessity of monitoring INR is also another factor that contributes to a better adherence to the new drug and it can make all the difference in the manner of doing anticoagulation for patients with similar clinical characteristics. CONCLUSIONS:The study is in the recruitment phase. It is possible that dabigatran etexilate is as effective as warfarin in preventing the emergence of intracardiac thrombus in patients with AF and mitral and/or aortic bioprosthesis. TRIAL REGISTRATION:Clinicaltrials.gov NCT01868243; http://clinicaltrials.gov/ct2/show/NCT01868243 (Archived by WebCite at http://www.webcitation/6OABiuasd).

Dataset Information

New warfarin anticoagulation management model after heart valve surgery: rationale and design of a prospective, multicentre, randomised trial to compare an internet-based warfarin anticoagulation management model with the traditional warfarin management model.

Publications

New warfarin anticoagulation management model after heart valve surgery: rationale and design of a prospective, multicentre, randomised trial to compare an internet-based warfarin anticoagulation management model with the traditional warfarin management model.

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