Author + information
- Received August 21, 2005
- Revision received October 14, 2005
- Accepted October 25, 2005
- Published online June 6, 2006.
- Fernando Alfonso, MD⁎,⁎ (, )
- Maria-José Pérez-Vizcayno, MD⁎,
- Rosana Hernandez, MD⁎,
- Armando Bethencourt, MD†,
- Vicens Martí, MD‡,
- Jose R. López-Mínguez, MD§,
- Juan Angel, MD∥,
- Ramón Mantilla, MD¶,
- Cesar Morís, MD#,
- Angel Cequier, MD⁎⁎,
- Manel Sabaté, MD⁎,
- Javier Escaned, MD⁎,
- Raúl Moreno, MD⁎,
- Camino Bañuelos, MD⁎,
- Alfonso Suárez, MD⁎,
- Carlos Macaya, MD⁎,
- RIBS-II Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Fernando Alfonso, Cardiología Intervencionista, Instituto Cardiovascular, Hospital Universitario “San Carlos,” Ciudad Universitaria, Plaza de Cristo Rey, Madrid 28040, Spain.
Objectives We sought to assess the effectiveness of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR).
Background Treatment of patients with ISR remains a challenge.
Methods 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.
Results 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).
Conclusions In patients with ISR, the use of SES provides superior long-term clinical, angiographic, and IVUS outcome than BA treatment.
An unrestricted grant was obtained from Cordis, Spain.
- Received August 21, 2005.
- Revision received October 14, 2005.
- Accepted October 25, 2005.
- American College of Cardiology Foundation