Evidence map›Paper›PMID 37164465›Full record

ArticleBMJ open2023

Atorvastatin and the influence on postoperative atrial fibrillation after surgical aortic valve replacement (STARC) in adults at Odense University Hospital, Denmark: study protocol for a randomised controlled trial.

Lytfi Krasniqi, Axel Brandes, Poul Erik Mortensen, Jordi Sanchez Dahl, Oke Gerke, Mulham Ali, Lars Peter Schødt Riber

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
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 NCT05076019 (Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement - a Randomized Controlled Trial), 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
0.4field-weighted citation impact, top 35% 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.

NCT05076019 narecruitingnot on this map

Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement - a Randomized Controlled Trial

TypeinterventionalSponsorOdense University HospitalRan2022 to 2027Enrolled266ConditionsPostoperative Atrial FibrillationArmsAtorvastatin 80mg, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Trial
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 2 institutions in 1 country.

Lytfi KrasniqiDepartment of Cardiac, Thoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark Lytfi.Krasniqi@rsyd.dk.ORCID 0000-0002-8048-9779
Axel BrandesDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark.
Poul Erik MortensenDepartment of Cardiac, Thoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark.
Jordi Sanchez DahlDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark.
Oke GerkeDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark.ORCID 0000-0001-6335-3303
Mulham AliDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark.
Lars Peter Schødt RiberDepartment of Cardiac, Thoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark.
University of Southern Denmark · DKOdense University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAtrial fibrillation (AF) is the most common postoperative complication after surgical aortic valve replacement (SAVR) and occurs in up to 50% of the patients. Development of postoperative AF (POAF) is associated with a 2-3 fold increased risk of adverse events, including stroke, myocardial infarction and death.Several studies have implied that prophylactic Atorvastatin therapy could prevent POAF in patients undergoing coronary artery bypass graft. These studies suggest that Atorvastatin has rapid and significant pleiotropic actions that reduce the risk of POAF. However, prophylactic treatment with statins has yet to be understood in SAVR. The aim of this study is to investigate whether prophylactic administration of torvastatin reduces POAF in patients undergoing SAVR. METHODS AND ANALYSIS: In this investigator-initiated, prospective, parallel-group, randomised, double-blind, placebo-controlled single-centre trial, 266 patients undergoing elective solitary SAVR with bioprosthetic valve, with no prior history of AF, and statin-naïve will be randomised (1:1) to treatment with Atorvastatin (80 mg once daily) or matching placebo for 1-2 weeks prior to and 30 days after surgery. The primary endpoint is POAF defined as an episode of irregular RR-intervals without a traceable p-wave of at least 30 s duration. After discharge and until day 30 after surgery, POAF will be documented by either rhythm strip or 12-lead ECG. ETHICS AND DISSEMINATION: Protocol approval has been obtained from the Regional Scientific Ethical Committee for Southern Denmark (S-20210159), The Danish Medicines Agency (2021103821) and the Data Protection Agency (21/65621).The trial is conducted in accordance with the Declaration of Helsinki, the ICH-GCP (International Conference on Harmonisation Good Clinical Practice) guidelines and the legal regulations of Denmark. Study findings will be shared via peer-reviewed journal publication and conference presentations. TRIAL REGISTRATION NUMBER: NCT05076019.

Indexed as

Atrial FibrillationHydroxymethylglutaryl-CoA Reductase InhibitorsAdultAortic ValveAtorvastatinDenmarkHospitalsHumansPostoperative ComplicationsProspective StudiesRandomized Controlled Trials as TopicAtorvastatinHydroxymethylglutaryl-CoA Reductase InhibitorsCardiac surgeryCARDIOLOGYEchocardiographyPacing & electrophysiologyValvular heart disease

Identifiers

PMID37164465
PMCPMC10174010
OpenAlexW4376132238

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.