Evidence map›Paper›PMID 35220449›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2022

Drug-coated balloons for small coronary artery disease in patients with chronic kidney disease: a pre-specified analysis of the BASKET-SMALL 2 trial.

Felix Mahfoud, Ahmed Farah, Marc-Alexander Ohlow, Norman Mangner, Jochen Wöhrle, Sven Möbius-Winkler, Daniel Weilenmann, Gregor Leibundgut, Florim Cuculi, Nicole Gilgen and 4 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01574534 (A Prospective, Randomized, Controlled, Open Label, Multicenter Trial to Test the Non-inferiority of Drug Eluting Balloon vs. Drug Eluting Stent Treatment in de Novo Stenoses of Small Native Vessels Regarding Efficacy and Safety), 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
3.3field-weighted citation impact, top 8% 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.

NCT01574534 nacompletednot on this map

A Prospective, Randomized, Controlled, Open Label, Multicenter Trial to Test the Non-inferiority of Drug Eluting Balloon vs. Drug Eluting Stent Treatment in de Novo Stenoses of Small Native Vessels Regarding Efficacy and Safety

TypeinterventionalSponsorUniversity Hospital, Basel, SwitzerlandRan2012 to 2020Enrolled758ConditionsCoronary Heart DiseaseArmsDrug eluting balloon, Drug eluting stent
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Coronary Drug-Coated Balloons for De Novo and In-Stent Restenosis Indications.Journal of the Society for Cardiovascular Angiography & Interventions
    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

14 authors at 7 institutions in 2 countries.

Felix MahfoudUniversitätsklinikum des Saarlandes, Saarland University, Kirrberger Str. 1, IMED, Geb. 41.1, 66421, Homburg, Saar, Germany. Felix.Mahfoud@uks.eu.ORCID http://orcid.org/0000-0002-4425-549X
Ahmed FarahKnappschaftskrankenhaus, Klinikum Westfalen, Dortmund, Germany.
Marc-Alexander OhlowSRH Wald-Klinikum, Gera, Germany.
Norman MangnerHerzzentrum Dresden, Technische Universität Dresden, Dresden, Germany.
Jochen WöhrleDepartment of Cardiology and Intensive Care, Medical Campus Lake Constance, Friedrichshafen, Germany.
Sven Möbius-WinklerUniversity Hospital Jena, Jena, Germany.
Daniel WeilenmannCantonal Hospital St Gallen, St Gallen, Switzerland.
Gregor LeibundgutCantonal Hospital Baselland, Liestal, Switzerland.
Florim CuculiCantonal Hospital Luzern, Luzern, Switzerland.
Nicole GilgenUniversity Hospital Basel, University of Basel, Basel, Switzerland.
Christoph KaiserUniversity Hospital Basel, University of Basel, Basel, Switzerland.
Marco CattaneoUniversity Hospital Basel, University of Basel, Basel, Switzerland.
Bruno SchellerUniversitätsklinikum des Saarlandes, Saarland University, Kirrberger Str. 1, IMED, Geb. 41.1, 66421, Homburg, Saar, Germany.
Raban V JegerUniversity Hospital Basel, University of Basel, Basel, Switzerland.
University of Basel · CHUniversitätsklinikum des Saarlandes · DEJena University Hospital · DEKantonsspital St. Gallen · CHKlinikum Westfalen (Germany) · DESRH Wald-Klinikum Gera · DETechnische Universität Dresden · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundData on the safety and efficacy of drug-coated balloon (DCB) compared to drug-eluting stent (DES) in patients with chronic kidney disease (CKD) are scarce, particularly at long term. This pre-specified analysis aimed to investigate the 3-year efficacy and safety of DCB versus DES for small coronary artery disease (< 3 mm) according to renal function at baseline.

methodsBASKET-SMALL-2 was a large multi-center, randomized, controlled trial that tested the efficacy and safety of DCBs (n = 382) against DESs (n = 376) in small vessel disease. CKD was defined as eGFR < 60 ml/min/1.73m

resultsA total of 174/758 (23%) patients had CKD, out of which 91 were randomized to DCB and 83 to DES implantation. The primary efficacy outcome during 3 years was similar in both, DCB and DES patients (HR 0.98; 95%-CI 0.67-1.44; p = 0.937) and patients with and without CKD (HR 1.18; 95%-CI 0.76-1.83; p = 0.462), respectively. Rates of cardiac death and all-cause death were significantly higher among patients with CKD but not affected by treatment with DCB or DES. Major bleeding events were lower in the DCB when compared to the DES group (12 vs. 3, HR 0.26; 95%-CI 0.07-0.92; p = 0.037) and not influenced by presence of CKD.

conclusionsThe long-term efficacy and safety of DCB was similar in patients with and without CKD. The use of DCB was associated with significantly fewer major bleeding events (NCT01574534). Central Illustration. Drug-coated balloon versus drug-eluting stents in small coronary artery disease with and without chronic kidney disease, a prespecified subgroup analysis of the BASKET-SMALL 2 trial.

Indexed as

Angioplasty, Balloon, CoronaryCoronary Artery DiseaseDrug-Eluting StentsPercutaneous Coronary InterventionRenal Insufficiency, ChronicCoated Materials, BiocompatibleDeathHumansTreatment OutcomeCoated Materials, BiocompatibleDrug-coated balloonRenal insufficiencyRevascularization strategies

Identifiers

PMID35220449
PMCPMC9242956
OpenAlexW4214616032

What OpenQuestion holds

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LicenceCC BY
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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.