Evidence map›Paper›PMID 39402005›Full record

Trial reportEuropean heart journal. Quality of care & clinical outcomes2025

Quality of life effects of renal artery stenting versus medical therapy for atherosclerotic renal-artery stenosis: results from the randomized CORAL trial.

Suzanne V Arnold, Kaijun Wang, Ajay J Kirtane, Elizabeth A Magnuson, Khaja M Chinnakondepalli, Christopher J Cooper, Lance D Dworkin, David J Cohen

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyComparative Study
In one paragraph

Trial report in European heart journal. Quality of care & clinical outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00081731 (Cardiovascular Outcomes in Renal Atherosclerotic Lesions), 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
–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.

NCT00081731 phase3completednot on this map

Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)

TypeinterventionalSponsorBaim Institute for Clinical ResearchRan2004 to 2013Enrolled947ConditionsAtherosclerosis, Cardiovascular Diseases, Hypertension, Renovascular, Renal Artery ObstructionArmsAtacand/HCT, Caduet, GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  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

8 authors.

Suzanne V ArnoldSaint Luke's Mid America Heart Institute, Kansas City, MO, USA.ORCID 0000-0003-3367-0302
Kaijun WangSaint Luke's Mid America Heart Institute, Kansas City, MO, USA.
Ajay J KirtaneColumbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, NY, USA.
Elizabeth A MagnusonSaint Luke's Mid America Heart Institute, Kansas City, MO, USA.
Khaja M ChinnakondepalliSaint Luke's Mid America Heart Institute, Kansas City, MO, USA.
Christopher J CooperUniversity of Toledo Medical Center, Toledo, OH, USA.
Lance D DworkinUniversity of Toledo Medical Center, Toledo, OH, USA.
David J CohenCardiovascular Research Foundation, New York NY and St. Francis Hospital, Roslyn, NY, USA.

Funding

CORAL: Clinical Coordinating CenterU01HL071556 · NHLBI · UNIVERSITY OF TOLEDO HEALTH SCI CAMPUS · PI COOPER, CHRISTOPHER J · 2004 to 2013
$19.3M
CORAL: Data Coordinating CenterU01HL072737 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI CUTLIP, DONALD · 2004 to 2013
$9.4M
CORAL: Economics and QOL Core LaboratoryU01HL072736 · NHLBI · SAINT LUKE'S HOSPITAL · PI COHEN, DAVID J · 2004 to 2013
$2.6M
CORAL Angiographic Core LaboratoryU01HL072735 · NHLBI · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI MATSUMOTO, ALAN H. · 2004 to 2010
$1.4M
Coral: Central GFR and Biochemistry LaboratoryU01HL072734 · NHLBI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI STEFFES, MICHAEL W. · 2004 to 2012
$1.3M
NHLBI NIH HHS U01 HL071556NHLBI NIH HHS U01 HL072734NHLBI NIH HHS U01 HL072735NHLBI NIH HHS U01 HL072736NHLBI NIH HHS U01 HL072737NIH HHS U01HL071556NIH HHS U01HL072734NIH HHS U01HL072735NIH HHS U01HL072736NIH HHS U01HL072737
6 · The paper itself

Abstract

backgroundRenal-artery stenosis can be associated with difficult to control hypertension, although renal-artery stenting has not been shown to improve clinical outcomes. Alternative antihypertensive medications could potentially result in quality of life benefits with renal-artery stenting. METHODS AND

resultsWe performed a pre-specified quality of life sub-study of the CORAL trial-multicenter, randomized, open-label trial of renal-artery stenting vs. medical therapy in patients with atherosclerotic renal-artery stenosis. Longitudinal growth curve models were used to compare the Physical Symptoms Distress Index (PSDI), SF-36, and EQ-5D scores over time between treatment groups. We also sought to validate the approach of assessing quality of life in hypertension studies. Among 906 patients (mean age 69.2 ± 9.1 years, 49.7% men), symptom frequency and distress due to side effects from antihypertensive medications changed minimally over time, with no significant differences between treatment groups. There were also no clinically significant differences between treatment groups for the SF-36 and its subscales or the EQ-5D. In internal validation of the quality of life measures, the PSDI correlated well with number/type of antihypertensive medications, and generic health status measures correlated with late clinical events.

conclusionsIn a large, multicenter, randomized clinical trial, we found no significant benefit of routine renal-artery stenting over medical management for the treatment of atherosclerotic renal-artery stenosis in terms of disease-specific or generic quality of life measures. As these quality of life measures are important to patients and are associated with medication compliance, future studies of antihypertensive treatments should consider including these quality of life measures as secondary outcomes.

trial registrationClinicalTrials.gov: NCT00081731.

Indexed as

Antihypertensive AgentsAtherosclerosisQuality of LifeRenal Artery ObstructionStentsAgedFemaleHumansMaleMiddle AgedTreatment OutcomeAntihypertensive AgentsHypertensionQuality of lifeRandomized trialRenal-artery stenting

Identifiers

PMID39402005
PMCPMC12714393

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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.