RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

Conditions

In-Stent Restenosis

Keywords

In-stent restenosis, Drug-eluting balloon, Drug-eluting stent, Angiography, Minimal lumen diameter

Brief summary

Treatment of patients with bare metal stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients suffering from bare metal stent restenosis.

Detailed description

Treatment of patients with bare metal stent restenosis remains a major clinical and technical challenge. Currently, drug-eluting stents are widely used in the management of these patients. Recently, the value of the paclitaxel-eluting balloon in this clinical setting has been suggested. However, there is only scarce observational data on the value of this new balloon in patients with bare metal stent restenosis. This prospective, multicenter, randomized clinical trial will compare two different interventional strategies (namely, paclitaxel-eluting balloon vs everolimus-eluting stent) in the treatment of patients with bare metal stent restenosis.

Cuesta J, Pérez-Vizcayno MJ, García Del Blanco B, Bosa F, Pérez de Prado A, Rumoroso JR, Romaguera R, Gutiérrez H, García Touchard A, López-Mínguez JR, Trillo R, de la Torre Hernández JM, Moreno R, Velázquez M, Moris C, Kockar MJ, Jiménez-Quevedo P, Bastante T, Del Val D, Rivero F, Alfonso F.

2024-08-016 citations

10.1016/j.jcin.2024.05.038

Usefulness of Drug-Eluting Balloons for Bare-Metal and Drug-Eluting In-Stent Restenosis (from the RIBS IV and V Randomized Trials).

Alfonso F, Pérez-Vizcayno MJ, García Del Blanco B, García-Touchard A, López-Mínguez JR, Sabaté M, Zueco J, Melgares R, Hernández R, Moreno R, Domínguez A, Sanchís J, Moris C, Moreu J, Cequier A, Romaguera R, Rivero F, Cuesta J, Gonzalo N, Jiménez-Quevedo P, Cárdenas A, Fernández C, Spanish Society of Cardiology.

2017-01-057 citations

10.1016/j.amjcard.2016.12.006

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis

Fernándo Alfonso, Marı́a José Pérez-Vizcayno, Bruno García del Blanco, Arturo García‐Touchard, José-Ramón López-Mínguez et al. (22 authors)

Circulation Cardiovascular Interventions2016-07-0126 citations

10.1161/circinterventions.115.003479

Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

Alfonso F, Pérez-Vizcayno MJ, García Del Blanco B, Otaegui I, Masotti M, Zueco J, Veláquez M, Sanchís J, García-Touchard A, Lázaro-García R, Moreu J, Bethencourt A, Cuesta J, Rivero F, Cárdenas A, Gonzalo N, Jiménez-Quevedo P, Fernández C, RIBS V Study Investigators.

2016-06-2051 citations

10.1016/j.jcin.2016.03.037

A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent).

Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García Del Blanco B, Seidelberger B, Iñiguez A, Gómez-Recio M, Masotti M, Velázquez MT, Sanchís J, García-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, López-Mínguez JR, Moreu J, Martí V, Moreno R, Jiménez-Quevedo P, Gonzalo N, Fernández C, Macaya C, RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology.

2014-01-08201 citations

10.1016/j.jacc.2013.12.006

Interventions

DEVICECoronary angioplasty using the paclitaxel-eluting balloon

Balloon angioplasty

DEVICECoronary angioplasty using the everolimus-eluting stent

Stent implantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

No

Inclusion criteria

PATIENT: * Age between 20 and 85 years * Signed informed consent * Acceptance of late angiographic control (6-9 months) * Angina and / or objective evidence of ischemia LESION: * In-Stent restenosis (\> 50% visual) any bare metal stent * Knowledge of prior stent location

Exclusion criteria

PATIENT: * Inclusion in another clinical research protocol * Women of childbearing age * Severe associated systemic disease (including renal or liver failure) * Severe depression of left ventricular ejection fraction (LVEF \<25%) * Disease that affects life expectancy * Recent myocardial infarction ( \<7 days) * Time of implantation of the previous BMS \<1 month * Severe difficulties expected for late angiographic study LESION: * Angiographic failure during implementation of initial stent(residual stenosis\> 50%) * Image of large thrombus in-stent (\> vessel diameter) * Tortuosity or Ca + + with very severe difficulties during prior stent deployment * Vessel diameter \<2 mm (visual estimate) * Restenosis only outside the stent (The edge of the stent is not affected) * Completely occlusive restenosis (100%, TIMI 0) * Very diffuse restenosis (\> 30 mm length)

Design outcomes

Primary

Measure	Time frame	Description
Minimal lumen diameter	Late angiographic follow-up (6-9 months)	Comparison of minimal lumen diameter at late angiographic follow-up (6-9 months) between the 2 treatment strategies (by quantitative coronary angiography)

Secondary

Measure	Time frame	Description
Combined clinical and angiographic end-points	6-9 months, 1 year and 3 years	A) Efficacy outcomes: A1) Angiographic: 1) Restenosis rate, 2) % diameter stenosis, 3) acute gain, 4) late loss, 5) net gain A2) Composite of death, myocardial infarction, target vessel revascularization and analysis of individual events B) Safety Outcomes: Stent thrombosis, Bleeding episodes. C) Pre-specified variables for subgroup analysis (RIBS I) D) Stratification (length and edge). Type of stent E) Influence of clinical variables and restenosis patterns on outcome

Countries

Spain

Outcome results

None listed