Evidence map›Paper›PMID 32719097›Full record

Trial reportHeart (British Cardiac Society)2021

A novel method to interpret early phase trials shows how the narrowing of the coronary sinus concordantly improves symptoms, functional status and quality of life in refractory angina.

E Marc Jolicoeur, Stefan Verheye, Timothy D Henry, Lawrence Joseph, Serge Doucet, Christopher J White, Elazer Edelman, Shmuel Banai

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Heart (British Cardiac Society), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01205893 (Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 28% 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.

NCT01205893 phase2completednot on this map

Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina

TypeinterventionalSponsorShockwave Medical, Inc.Ran2010 to 2013Enrolled104ConditionsRefractory AnginaArmsNeovasc Reducer, Control
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 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

8 authors at 7 institutions in 4 countries.

E Marc JolicoeurDepartment of Medicine, Interventional Cardiology, Montreal Heart Institute, Montreal, Quebec, Canada marc.jolicoeur@icm-mhi.org.ORCID 0000-0002-6384-2702
Stefan VerheyeAntwerp Cardiovascular Institute, ZNA Middelheim Hospital, Antwerpen, Belgium.
Timothy D HenryThe Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, Ohio, USA.
Lawrence JosephDepartment of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, Canada.
Serge DoucetDepartment of Medicine, Interventional Cardiology, Montreal Heart Institute, Montreal, Quebec, Canada.
Christopher J WhiteThe John Ochsner Heart & Vascular Institute, Ochsner Clinical School, University of Queensland, New Orleans, Louisiana, USA.
Elazer EdelmanInstitute for Medical Engineering and Science, Cambridge, Massachusetts, USA.
Shmuel BanaiThe Tel Aviv Medical Center, The Tel Aviv University Medical School, Tel Aviv, Israel.
Montreal Heart Institute · CABrigham and Women's Hospital · USChrist Hospital · USMcGill University · CAOchsner Medical Center · USTel Aviv University · ILZNA Middelheim Hospital · BE

Funding

Vascular Drug Delivery - Supplement for EquipmentR01GM049039 · NIGMS · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI EDELMAN, ELAZER R · 1994 to 2019
$8.9M
CIHRNIGMS NIH HHS R01 GM049039
6 · The paper itself

Abstract

backgroundReduction of the coronary sinus was shown to improve angina in patients unsuitable for revascularisation. We assessed whether a percutaneous device that reduces the diameter of the coronary sinus improved outcomes across multiple endpoints in a phase II trial.

methodsWe conducted a novel analysis performed as a post hoc efficacy analysis of the COSIRA (

resultsWe randomised 104 participants to either a device that narrows to coronary sinus (n=52) or a sham implantation (n=52). The reducer group met the prespecified criteria for concordance at the group level and demonstrated improvement in symptoms (0.59 CCS grade, 95% credible interval (CrI)=0.22 to 0.95), total exercise duration (+27.9%, 95% CrI=2.8% to 59.8%) and quality of life (stability +11.2 points, 95% CrI=3.3 to 19.1; perception +11.0, 95% CrI=3.3 to 18.7).

conclusionsThe reducer concordantly improved symptoms, functionality and quality of life compared with a sham intervention in patients with angina unsuitable for coronary revascularisation. Concordant analysis such as this one can help interpret early phase trials and guide the decision to pursue a clinical programme into a larger confirmatory trial. TRAIL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT01205893.

Indexed as

Coronary SinusFunctional StatusProstheses and ImplantsQuality of LifeAngina PectorisData Interpretation, StatisticalDouble-Blind MethodHumansTreatment Outcomecardiac catheterisation and angiographycoronary artery diseaseinterventional cardiology and endovascular procedurespercutaneous coronary intervention

Identifiers

PMID32719097
PMCPMC8641517
OpenAlexW3044949161

What OpenQuestion holds

Textmetadata
LicenceTDM
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 OpenQuestion graph.