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JACC Cardiovasc Interv. 2018 May 28;11(10):981-991. doi: 10.1016/j.jcin.2018.02.037.

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

Author information

1
Hospital Universitario de La Princesa, Madrid, Spain. Electronic address: falf@hotmail.com.
2
Hospital Universitario Clínico San Carlos, Madrid, and Fundación Interhospitalaria Investigacion Cardiovascular, Madrid, Spain.
3
Hospital Universitario de La Princesa, Madrid, Spain.
4
Hospital Universitario Vall d'Hebron, Barcelona, Spain.
5
Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.
6
Hospital Universitario Infanta Cristina, Badajoz, Badajoz, Spain.
7
Hospital Universitario Clinic de Barcelona, Barcelona, Spain.
8
Hospital Universitario Marqués de Valdecilla, Santander, Spain.
9
Hospital Universitario de Belvitge, Barcelona, Spain.
10
Hospital Universitario 12 de Octubre, Madrid, Spain.
11
Hospital Universitario La Paz, Madrid, Spain.
12
Hospital Universitario de Alicante, Alicante, Spain.
13
Hospital Universitario Virgen de la Victoria, Málaga, Spain.
14
Hospital Universitario Central de Asturias, Oviedo, Spain.
15
Hospital Universitario Virgen de las Nieves, Granada, Spain.

Abstract

OBJECTIVES:

This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES).

BACKGROUND:

Treatment of patients with DES-ISR remains a challenge.

METHODS:

The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study.

RESULTS:

A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for "late" (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms.

CONCLUSIONS:

The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940).

KEYWORDS:

drug-eluting ballon(s); drug-eluting stent(s); everolimus-eluting stent(s); in-stent restenosis

PMID:
29798776
DOI:
10.1016/j.jcin.2018.02.037

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