Evidence map›Paper›PMID 37989381›Full record

ArticleBMJ open2023

Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial.

Xiangming Hu, Haiyan Xu, Can Wang, Yang Wang, Yan Wang, Daxin Zhou, Qifeng Zhu, Kai Xu, Jian Yang, Haibo Zhang and 13 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05375474 (Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 39% 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.

NCT05375474 phase4unknown statusnot on this map

Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR

TypeinterventionalSponsorChina National Center for Cardiovascular DiseasesRan2023 to 2025Enrolled650ConditionsTranscatheter Aortic Valve Replacement, Antithrombotic Therapy, Bioprosthetic Valve ThrombosisArmsOral anticoagulation therapy, Single antiplatelet therapy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
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

23 authors at 12 institutions in 1 country.

Xiangming HuDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Haiyan XuDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Can WangDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Yang WangMedical Research & Biometrics Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.ORCID 0000-0002-5040-2492
Yan WangDepartment of Cardiology, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen, Fujian, China.
Daxin ZhouDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.
Qifeng ZhuDepartment of Cardiology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Kai XuDepartment of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China.
Jian YangDepartment of Cardiovascular Surgery, Xijing Hospital, Air Force Medical University, Xi'an, Shaanxi, China.
Haibo ZhangDepartment of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Nan JiangDepartment of Cardiovascular Surgery, Tianjin Chest Hospital, Tianjin Medical University, Tianjin, China.
Junjie ZhangDepartment of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.
Zhenfei FangDepartment of Cardiovascular Medicine, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China.
Guosheng FuDepartment of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.ORCID 0000-0001-7027-0717
Yingqiang GuoDepartment of Cardiovascular Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
Yi LiDepartment of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
Moyang WangDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Dejing FengDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Guannan NiuDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Erli ZhangDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Yang ChenDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.ORCID 0000-0001-5911-8300
Yunqing YeDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China fuwaiwyj@163.com judia8510@163.com.
Yongjian WuDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China fuwaiwyj@163.com judia8510@163.com.ORCID 0009-0002-7803-0237
Chinese Academy of Medical Sciences & Peking Union Medical College · CNSun Yat-sen University · CNXiamen University · CNCapital Medical University · CNCentral South University · CNGeneral Hospital of Shenyang Military Region · CNNanjing Medical University · CNSecond Affiliated Hospital of Zhejiang University · CNSichuan University · CNSir Run Run Shaw Hospital · CNTianjin Chest Hospital · CNXijing Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe strategy for initiating antithrombotic therapy to prevent bioprosthetic valve thrombosis (BPVT) after transcatheter aortic valve replacement (TAVR) remains uncertain. There is still lacking evidence on the efficacy and safety of early 6 months usage of single-antiplatelet therapy (SAPT) or oral anticoagulant (OAC) after TAVR in patients without anticoagulant indications. METHODS AND ANALYSIS: This is a multicentre, randomised controlled, open-label trial, and 650 patients undergoing TAVR from 13 top TAVR centres in China will be recruited. Each eligible participant will be randomly assigned to two groups (1:1 ratio) as (1) SAPT (aspirin 75-100 mg for 6 months) group or (2) OAC group (warfarin, therapeutic international normalised ratio at 1.8-2.5 for 6 months), both followed by sequential aspirin 75-100 mg for 6 months. Participants in both groups will be invited for three follow-up visits of 1, 6 and 12 months after discharge. We will use both the net clinical benefit endpoint (composite of all-cause mortality, myocardial infarction, stroke/transient ischaemic attacks, peripheral artery thrombosis, intracardiac thrombosis and major bleeding and disabling or life-threatening bleeding) and the BPVT endpoint evaluated by four-dimensional CT as our primary endpoints. P value of <0.05 of two-sided test will be considered statistically significant. ETHICS AND DISSEMINATION: The present study was approved by the Institutional Review Boards at Fuwai Hospital, National Center for Cardiovascular Diseases of China (Approval No. 2023-1947). All patients will be informed of the details of the study and will sign an informed consent prior to inclusion in the study. Results of this study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05375474.

Indexed as

Myocardial InfarctionThrombosisTranscatheter Aortic Valve ReplacementAnticoagulantsAspirinHumansMulticenter Studies as TopicPlatelet Aggregation InhibitorsRandomized Controlled Trials as TopicTreatment OutcomeAnticoagulantsAspirinPlatelet Aggregation InhibitorsAnticoagulationRandomized Controlled TrialValvular heart disease

Identifiers

PMID37989381
PMCPMC10668142
OpenAlexW4388871211

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Registered trials

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.