Evidence map›Paper›PMID 34397393›Full record

Trial reportJournal of medical Internet research2021

New Internet-Based Warfarin Anticoagulation Management Approach After Mechanical Heart Valve Replacement: Prospective, Multicenter, Randomized Controlled Trial.

Zhihui Zhu, Chenyu Li, Jinglun Shen, Kaisheng Wu, Yuehuan Li, Kun Liu, Fan Zhang, Zhenhua Zhang, Yan Li, Jie Han and 11 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical Internet research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  9. Tissue versus mechanical mitral valve replacement in patients aged 50-70: a propensity-matched analysis.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2024
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  13. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 5 institutions in 2 countries.

Zhihui ZhuDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-0037-194X
Chenyu LiRenal Division, Department of Medicine IV, Ludwig Maximilian University of Munich, Munich, Germany.ORCID 0000-0002-5402-584X
Jinglun ShenDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0001-7937-6171
Kaisheng WuDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0001-9741-7125
Yuehuan LiDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0001-8836-0198
Kun LiuDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-2220-2661
Fan ZhangDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-1154-8939
Zhenhua ZhangDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0001-7799-2560
Yan LiDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-3796-3727
Jie HanDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0001-6994-3371
Ying QinDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-2505-2857
Yu YangDepartment of Cardiovascular Surgery, Beijing Xuanwu Hospital, Beijing, China.ORCID 0000-0003-0354-0048
Guangpu FanDepartment of Cardiovascular Surgery, Peking University People's Hospital, Beijing, China.ORCID 0000-0002-1247-3871
Huajun ZhangDepartment of Cardiovascular Surgery, PLA General Hospital, Beijing, China.ORCID 0000-0003-2289-4538
Zheng DingDepartment of Pharmacy, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.ORCID 0000-0001-6689-4594
Dong XuDepartment of Cardiovascular Surgery, Beijing Xuanwu Hospital, Beijing, China.ORCID 0000-0002-5060-7279
Yu ChenDepartment of Cardiovascular Surgery, Peking University People's Hospital, Beijing, China.ORCID 0000-0001-7210-5942
Yingli ZhengDepartment of Pharmacy, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.ORCID 0000-0002-7482-9992
Zhe ZhengDepartment of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.ORCID 0000-0002-9162-6492
Xu MengDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-2218-6737
Haibo ZhangDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.ORCID 0000-0001-7249-3113
Capital Medical University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNPeking University · CNBeijing Xuanwu Traditional Chinese Medicine Hospital · CNLudwig-Maximilians-Universität München · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Quality of LifeWarfarinAnticoagulantsHeart ValvesHumansInternational Normalized RatioInternetProspective StudiesTreatment OutcomeAnticoagulantsWarfarincomplicationRCTtelemedicineTTRwarfarin

Identifiers

PMID34397393
PMCPMC8398748
OpenAlexW3180515950

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.