A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial

• Published in: Journal of the American College of Cardiology 2006-06, Vol.47 (11), p.2152-2160
• Main Authors: Alfonso, Fernando, Pérez-Vizcayno, Maria-José, Hernandez, Rosana, Bethencourt, Armando, Martí, Vicens, López-Mínguez, Jose R, Angel, Juan, Mantilla, Ramón, Morís, Cesar, Cequier, Angel, Sabaté, Manel, Escaned, Javier, Moreno, Raúl, Bañuelos, Camino, Suárez, Alfonso, Macaya, Carlos
• Format: Article
• Language: English
• Subjects: Aged; Angioplasty; Cardiology; Confidence intervals; Coronary Angiography; Coronary Restenosis - diagnosis; Coronary Restenosis - etiology; Coronary Restenosis - therapy; Female; Follow-Up Studies; Heart attacks; Humans; Ischemia; Male; Medical imaging; Middle Aged; Radiation therapy; Sirolimus - administration & dosage; Sirolimus - therapeutic use; Stents; Stents - adverse effects; Surgery; Treatment Outcome; Ultrasonography, Interventional; Veins & arteries
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2005.10.078

We sought to assess the effectiveness of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR). Treatment of patients with ISR remains a challenge. The Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) study is a multicenter randomized trial conducted in 150 patients with ISR (76 allocated to SES and 74 to balloon angioplasty [BA]). The primary end point was recurrent restenosis rate at nine months. Secondary end points included prespecified subgroup analysis, lumen volume on intravascular ultrasound (IVUS), and a composite of major clinical events at one year. Angiographic success was obtained in all patients. At 9-month angiographic follow-up (96% of eligible patients) minimal lumen diameter was larger (2.52 mm [interquartile range (IQR) 2.09 to 2.81] vs. 1.54 mm [IQR 0.91 to 2.05]; p < 0.001) and recurrent restenosis rate was lower (11% vs. 39%; p < 0.001) in the SES group. Prespecified subgroup analyses were consistent with the main outcome measure. Lumen volume on IVUS at 9 months was also larger (279 mm3 [IQR 227 to 300] vs. 197 mm3 [IQR 177 to 230]; p < 0.001) in the SES group. At one-year clinical follow-up (100% of patients), the event-free survival (freedom from death, myocardial infarction, and target vessel revascularization) was significantly improved in the SES group (88% vs. 69%; p < 0.004) as the result of a lower requirement for target vessel revascularization (11% vs. 30%; p < 0.003). In patients with ISR, the use of SES provides superior long-term clinical, angiographic, and IVUS outcome than BA treatment.