Rationale and design of the RIBS IV randomised clinical trial (drug-eluting balloons versus everolimus-eluting stents for patients with drug-eluting stent restenosis)

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Publicated to:Eurointervention. 11 (3): 336-342 - 2015-01-01 11(3), DOI: 10.4244/EIJY14M09_07

Authors: Alfonso F; Pérez-Vizcayno M; Cárdenas A; Del Blanco B; García-Touchard A; López-Minguéz J; Rivero F; Masotti M; Zueco J; Cequier A; Morís C; Fernández-Ortíz A; Escaned J; Jiménez-Quevedo P; Gonzalo N; Fernández C; Macaya C; Rest Int-stent: D-eluting Balloon vs E-eluting Stent (RIBS IV) Study Invest; Working Group on Interventional Cardiology of the Spanish Society of Cardiology

Affiliations

Autonomous Univ Madrid, Hosp Univ La Princesa, Dept Cardiol, IIS IP, C Diego de Leon 62, Madrid 28006, Spain. Autonomous University of Madrid - Author

Hosp Univ Bellvitge, Barcelona, Spain Bellvitge University Hospital Catalan Health Institute University of Barcelona - Author

Hosp Univ Cent Asturias, Oviedo, Spain Central University Hospital Asturias - Author

Hosp Univ Clin Barcelona, Barcelona, Spain - Author

Hosp Univ Clin San Carlos, Madrid, Spain - Author

Hosp Univ Infanta Cristina, Badajoz, Spain - Author

Hosp Univ La Princesa, Madrid, Spain Hospital de La Princesa - Author

Hosp Univ Marques Valdecilla, Santander, Spain Hospital Universitario Marques de Valdecilla (HUMV) - Author

Hosp Univ Puerta Hierro Majadahonda, Madrid, Spain Hospital Puerta de Hierro-Majadahonda - Author

Hosp Univ Vail dHebron, Barcelona, Spain - Author

Abstract

This study will compare the efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with drug-eluting stent (DES) in-stent restenosis (ISR).This is a prospective, multicentre, randomised clinical trial comparing DEB and EES in patients with DES-ISR. The study is an investigator-driven initiative generated within the RIBS study programme. A total of 310 patients with DES-ISR will be included and randomised (1:1) to DEB or EES. Angiographic follow-up has been scheduled at six to nine months. Quantitative coronary analyses will be performed in a centralised core lab by blinded personnel. The primary endpoint of the study is minimal lumen diameter at angiographic follow-up. Other secondary angiographic endpoints include % diameter stenosis, late loss, net gain and binary restenosis rate. An independent clinical events committee will adjudicate clinical events after reviewing source documents. The main clinical outcome measure is a combined endpoint of cardiac death, myocardial infarction and target vessel revascularisation at one year. Individual components of the combined clinical endpoint and rates of target lesion revascularisation and stent thrombosis will also be compared.This randomised clinical trial will determine the relative efficacy of EES versus DEB in patients presenting with DES-ISR. (ClinicalTrials.gov Identifier: NCT01239940).

Keywords

Acetylsalicylic acidAdultAngiocardiographyArticleBlood vessel diameterClinical protocolClopidogrelComparative effectivenessControlled studyCreatine kinaseCreatine kinase blood levelDrug eluting stent restenosisDrug-eluting balloonsDrug-eluting stentsEverolimus eluting coronary stentEverolimus-eluting stentsFollow upHeart deathHeart infarctionHumanIn-stent restenosisLumen diameterMajor clinical studyMulticenter studyOutcome assessmentProspective studyPtca catheterRandomized controlled trialStent thrombosisStudy designTreatment durationTroponinVascular diseaseVessel revascularization

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Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Eurointervention due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2015, it was in position , thus managing to position itself as a Q1 (Primer Cuartil), in the category Medicine (Miscellaneous). Notably, the journal is positioned above the 90th percentile.

From a relative perspective, and based on the normalized impact indicator calculated from the Field Citation Ratio (FCR) of the Dimensions source, it yields a value of: 2.63, which indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: Dimensions May 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-05-02, the following number of citations:

WoS: 9
Scopus: 8
Europe PMC: 4
OpenCitations: 10

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