Evidence map›Paper›PMID 40659682›Full record

Trial reportNature communications2025

Colchicine in patients with aortic stenosis undergoing transcatheter aortic valve replacement: a double-blind randomized trial.

Christoph Ryffel, Jonas Lanz, Nicole Guntli, Daryoush Samim, Monika Fürholz, Stefan Stortecky, Daijiro Tomii, Dik Heg, Martina Boscolo Berto, Alan Arthur Peters and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04870424 (Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04870424 phase3completednot on this map

Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement (Co-STAR): a Randomized-controlled Trial

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2021 to 2025Enrolled120ConditionsTranscatheter Aortic Valve Replacement, Atrial Fibrillation New Onset, Pacemaker, ColchicineArmsColchicine, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Association Between TNF-Alpha Levels and Atrial Fibrillation Outcomes: A Systematic Review and Meta-Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
  2. Review
  3. Article
  4. Observational
  5. Article
  6. Review
  7. Colchicine therapy in transcatheter aortic valve replacement: Modulating inflammation and outcomes.International journal of cardiology. Cardiovascular risk and prevention · 2026
    Review
  8. Review
  9. Review
  10. Review
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

15 authors.

Christoph RyffelDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.ORCID http://orcid.org/0000-0002-5861-5599
Jonas LanzDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Nicole GuntliDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Daryoush SamimDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Monika FürholzDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Stefan StorteckyDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Daijiro TomiiDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Dik HegDepartment of Clinical Research, University of Bern, Bern, Switzerland.ORCID http://orcid.org/0000-0002-8766-7945
Martina Boscolo BertoDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Alan Arthur PetersDepartment of Diagnostic, Interventional and Pediatric Radiology, Inselspital, Bern University Hospital, Bern, Switzerland.
David ReinekeDepartment of Cardiac Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Tobias ReichlinDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Christoph GräniDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.ORCID http://orcid.org/0000-0001-6029-0597
Stephan WindeckerDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Thomas PilgrimDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Thomas.pilgrim@insel.ch.ORCID http://orcid.org/0000-0001-8721-4068

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An inflammatory process may increase the risk of arrhythmias after transcatheter aortic valve replacement (TAVR). In this single-centre, double-blind, placebo-controlled, randomized trial we investigated the efficacy of colchicine to reduce a composite of new-onset atrial fibrillation or atrioventricular conduction disturbances requiring the implantation of a permanent pacemaker at 30 days after TAVR. Between September 21, 2021 and April 25, 2024, 120 patients with aortic stenosis undergoing TAVR (mean age 80.6 ± 5 years, 64% male) were randomly allocated to treatment with colchicine (n = 60) or placebo (n = 60). The trial was prematurely stopped due to a higher rate of stroke in the experimental group in a pre-specified interim analysis (5 [8.3%] versus 0 at maximum available follow-up, p = 0.022). In the intention-to-treat population, the primary endpoint occurred in 6 patients (10%) in the colchicine group and in 15 patients (25%) in the placebo group (risk-difference -15.0%, 95% CI -28.3 to -1.7, p = 0.031). The prespecified imaging endpoint, subclinical leaflet thrombosis, was detected in 13 of 48 patients (27%) in the colchicine group versus 26 of 48 patients (54%) in the placebo group (risk difference -27.1%. 95% CI -46.0% to -8.2%, p = 0.007). Here, we show that periprocedural treatment with colchicine may reduce the incidence of new-onset arrhythmias and subclinical leaflet thrombosis after TAVR. However, given the premature termination of the trial due to an unexpected increase in the stroke rate among patients treated with colchicine, confirmatory trials are warranted to corroborate the effect of anti-inflammatory treatment on the incidence of arrhythmias and subclinical leaflet thrombosis after TAVR. The trial was an investigator-initiated study supported by dedicated grants from the Bangerter-Rhyner Foundation and the Swiss Life Foundation. ClinicalTrials.gov Identifier: NCT04870424.

Indexed as

Aortic Valve StenosisColchicineTranscatheter Aortic Valve ReplacementAgedAged, 80 and overAortic ValveAtrial FibrillationDouble-Blind MethodFemaleHumansMalePostoperative ComplicationsStrokeTreatment OutcomeColchicine

Identifiers

PMID40659682
PMCPMC12259991

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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.