Evidence map›Paper›PMID 29527709›Full record

ArticleClinical cardiology2018

Drug-coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET-SMALL 2.

Nicole Gilgen, Ahmed Farah, Bruno Scheller, Marc-Alexander Ohlow, Norman Mangner, Daniel Weilenmann, Jochen Wöhrle, Peiman Jamshidi, Gregor Leibundgut, Sven Möbius-Winkler and 12 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical cardiology, 2018. 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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Efficacy and safety of drug-coated balloons according to coronary vessel size. A report from the BASKET-SMALL 2 trial.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2022
    Article
  8. 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

22 authors at 14 institutions in 3 countries.

Nicole GilgenUniversity Hospital Basel, University of Basel, Switzerland.
Ahmed FarahKnappschaftskrankenhaus, Klinikum Westfalen, Dortmund, Germany.
Bruno SchellerUniversity Hospital Saarland, Homburg, Germany.
Marc-Alexander OhlowCentral Clinic, Bad Berka, Germany.
Norman MangnerUniversity Hospital for Cardiology, Heart Center Leipzig, Germany.
Daniel WeilenmannCantonal Hospital St, Gallen, Switzerland.
Jochen WöhrleUniversity Hospital Ulm, Germany.
Peiman JamshidiCantonal Hospital Luzern, Switzerland.
Gregor LeibundgutCantonal Hospital Baselland, Liestal, Switzerland.
Sven Möbius-WinklerUniversity Hospital Jena, Germany.
Robert ZweikerMedical University Graz, Austria.
Florian KrackhardtCharité University Hospital, Berlin, Germany.
Christian ButterHeart Center Brandenburg, Bernau, Germany.
Leonhard BruchUnfallkrankenhaus Berlin, Germany.
Christoph KaiserUniversity Hospital Basel, University of Basel, Switzerland.
Andreas HoffmannUniversity Hospital Basel, University of Basel, Switzerland.
Peter RickenbacherUniversity Hospital Basel, University of Basel, Switzerland.
Christian MuellerUniversity Hospital Basel, University of Basel, Switzerland.
Frank-Peter StephanUniversity Hospital Basel, University of Basel, Switzerland.
Michael CoslovskyUniversity Hospital Basel, University of Basel, Switzerland.
Raban JegerUniversity Hospital Basel, University of Basel, Switzerland.ORCID http://orcid.org/0000-0003-1290-5491
BASKET-SMALL 2 Investigators
University of Basel · CHCharité - Universitätsmedizin Berlin · DEImmanuel Klinikum Bernau · DEJena University Hospital · DEKantonsspital Baselland · CHKlinikum Westfalen (Germany) · DELeipzig Heart Institute · DELuzerner Kantonsspital · CHMedical University of Graz · ATSaarland University · DEUnfallkrankenhaus Berlin · DEUniversity Hospital Ulm · DEUniversity of St.Gallen · CHZentralklinik Bad Berka · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug-eluting stents (DES) have limited efficacy due to increased rates of instent-restenosis, mainly caused by late lumen loss. Drug-coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten-Effektivitäts Trial: Drug-Coated Balloons vs. Drug-Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty-eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target-vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long-term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long-term safety and efficacy for the treatment of SVD in a large all-comer population.

Indexed as

Angioplasty, Balloon, CoronaryCardiac CatheterizationCardiac CathetersCardiovascular AgentsCoated Materials, BiocompatibleCoronary StenosisAgedCoronary RestenosisDrug-Eluting StentsEquipment DesignEquivalence Trials as TopicEuropeFemaleHumansMaleMiddle AgedCardiovascular AgentsCoated Materials, BiocompatibleAngioplastyCoronary Artery DiseaseDrug-Coated BalloonRandomized Controlled TrialSmall Coronary VesselTrial Design

Identifiers

PMID29527709
PMCPMC6001703
OpenAlexW2793282565

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.