Evidence map›Paper›PMID 33226545›Full record

ArticleCardiovascular drugs and therapy2022

Hemorrhage Risk Profiles among Different Antithrombotic Regimens: Evidence from a Real-World Analysis of Postmarketing Surveillance Data.

Xue Sun, Bi Ze, Ling-Jun Zhang, Yang-Zhong BaiMa, Wei Zuo, Bin Zhao, Luo-Bo GeSang

Abstract read
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In one paragraph

Article in Cardiovascular drugs and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 25% 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

6 citing papers in PubMed, 7 citations in OpenAlex.

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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

7 authors at 3 institutions in 1 country.

Xue SunPeople's Hospital of the Tibet Autonomous Region, Lhasa, 850000, China.
Bi ZePeople's Hospital of the Tibet Autonomous Region, Lhasa, 850000, China.
Ling-Jun ZhangInternal Medicine Branch of Cadiovascular Diseases/Plateau Medicine, People's Hospital of Tibet Autonomous Region, Lhasa, 850000, China.
Yang-Zhong BaiMaPeople's Hospital of the Tibet Autonomous Region, Lhasa, 850000, China.
Wei ZuoDepartment of Pharmacy, Peking Union Medical College Hospital, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China.
Bin ZhaoPeople's Hospital of the Tibet Autonomous Region, Lhasa, 850000, China. sunxue_2004@163.com.
Luo-Bo GeSangInternal Medicine Branch of Cadiovascular Diseases/Plateau Medicine, People's Hospital of Tibet Autonomous Region, Lhasa, 850000, China.
Tibet Autonomous Region People's Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNPeking Union Medical College Hospital · CN

Funding

Natural Science Foundation of Tibet XZ2017ZR-ZYZ26
6 · The paper itself

Abstract

backgroundAlthough the use of direct oral anticoagulants (DOACs) has been reported in patients with atrial fibrillation (AF), there is currently no consensus on the occurrence or characteristics of the hemorrhage risk in different antithrombotic regimens.

methodsDisproportionality and Bayesian analyses were performed in mining data of suspected hemorrhagic events after antithrombotic drug use from the FDA Adverse Event Reporting System (FAERS) from January 2004 to September 2019. The time to onset and fatality rate of hemorrhage following different antithrombotic regimens were also compared.

resultsA total of 84,998 reports of hemorrhage-related adverse events with the use of antithrombotic drugs were identified. The patients included were mostly from the Americas (80.87%) and Europe (13.22%), with most data submitted by nonhealthcare professionals. Among the seven antithrombotic drug monotherapies, betrixaban had the highest association with hemorrhage based on the highest reporting odds ratio (ROR, 829.95; 95% CI = 113.61-6063.15), proportional reporting ratio (PRR, 24.68, χ2 = 804.24), and multi-item gamma Poisson shrinker (MGPS, 24.68, 95% one-sided CI = 4.67). The combination therapies of clopidogrel plus new oral anticoagulants had higher RORs, PRRs, and empirical Bayesian geometric means (EBGMs) than the antithrombotic drug monotherapies. Hemorrhage associated with rivaroxaban plus clopidogrel appeared to have an earlier onset (171 days vs 219 days, 95% two-sided CI =68.68-27.34, p < 0.0001) and a lower fatality rate (15.30% vs 17.74%, p<0.05) than that associated with rivaroxaban monotherapy.

conclusionThis study provides a relevant overview of the hemorrhagic complications/fatalities associated with different antithrombotic regimens in their real-world use. Among the combination therapies, clopidogrel plus DOACs were found to have stronger associations with hemorrhage than traditional dual antithrombotic therapies. Rivaroxaban showed a stronger association with hemorrhage than other antithrombotic drug monotherapies, and apixaban monotherapy appeared to have weaker associations with hemorrhage than others.

Indexed as

AdolescentAdultAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overBayes TheoremDrug Therapy, CombinationFactor Xa InhibitorsFemaleFibrinolytic AgentsHemorrhageHumansMaleMiddle AgedPlatelet Aggregation InhibitorsProduct Surveillance, PostmarketingFactor Xa InhibitorsFibrinolytic AgentsPlatelet Aggregation InhibitorsAdverse drug eventsAntithromboticData miningHemorrhageSpontaneous reporting system

Identifiers

PMID33226545
OpenAlexW3109271917

What OpenQuestion holds

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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.