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.
Por:
Alfonso F, Pérez-Vizcayno MJ, Cuesta J, García Del Blanco B, García-Touchard A, López-Mínguez JR, Masotti M, Zueco J, Cequier A, Velázquez M, Moreno R, Mainar V, Domínguez A, Moris C, Molina E, Rivero F, Jiménez-Quevedo P, Gonzalo N, Fernández-Pérez C and RIBS IV Study Investigators (Under the Auspices of the Interventional Cardiology
Publicada:
28 may 2018
Resumen:
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).
Filiaciones:
Alfonso F:
Hospital Universitario de La Princesa, Madrid, Spain
Pérez-Vizcayno MJ:
Hospital Universitario Clínico San Carlos, Madrid, and Fundación Interhospitalaria Investigacion Cardiovascular, Madrid, Spain
Cuesta J:
Hospital Universitario de La Princesa, Madrid, Spain
García Del Blanco B:
Hospital Universitario Vall d'Hebron, Barcelona, Spain
García-Touchard A:
Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain
López-Mínguez JR:
Hospital Universitario Infanta Cristina, Badajoz, Badajoz, Spain
Masotti M:
Hospital Universitario Clinic de Barcelona, Barcelona, Spain
Zueco J:
Hospital Universitario Marqués de Valdecilla, Santander, Spain
Cequier A:
Hospital Universitario de Belvitge, Barcelona, Spain
Velázquez M:
Hospital Universitario 12 de Octubre, Madrid, Spain
Moreno R:
Hospital Universitario La Paz, Madrid, Spain
:
Hospital Universitario de Alicante, Alicante, Spain
Domínguez A:
Hospital Universitario Virgen de la Victoria, Málaga, Spain
Moris C:
Hospital Universitario Central de Asturias, Oviedo, Spain
Molina E:
Hospital Universitario Virgen de las Nieves, Granada, Spain
Rivero F:
Hospital Universitario de La Princesa, Madrid, Spain
Jiménez-Quevedo P:
Hospital Universitario Clínico San Carlos, Madrid, and Fundación Interhospitalaria Investigacion Cardiovascular, Madrid, Spain
Gonzalo N:
Hospital Universitario Clínico San Carlos, Madrid, and Fundación Interhospitalaria Investigacion Cardiovascular, Madrid, Spain
Fernández-Pérez C:
Hospital Universitario Clínico San Carlos, Madrid, and Fundación Interhospitalaria Investigacion Cardiovascular, Madrid, Spain
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