Author + information
- Received November 13, 2002
- Revision received April 21, 2003
- Accepted April 24, 2003
- Published online September 3, 2003.
- Fernando Alfonso, MD*,* (, )
- Javier Zueco, MD†,
- Angel Cequier, MD‡,
- Ramón Mantilla, MD§,
- Armando Bethencourt, MD∥,
- José R López-Minguez, MD¶,
- Juan Angel, MD#,
- José M Augé, MD**,
- Manuel Gómez-Recio, MD††,
- César Morís, MD‡‡,
- Ricardo Seabra-Gomes, MD§§,
- María J Perez-Vizcayno, MD*,
- Carlos Macaya, MD*,
- Restenosis Intra-stent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators
- ↵*Reprint requests and correspondence:
Dr. Fernando Alfonso, Unidad de Hemodinámica, Servicio de Cardiología Intervencionista, Instituto Cardiovascular, Hospital Universitario “San Carlos,” Ciudad Universitaria, Plaza de Cristo Rey, Madrid 28040, Spain.
Objectives This randomized trial compared repeat stenting with balloon angioplasty (BA) in patients with in-stent restenosis (ISR).
Background Stent restenosis constitutes a therapeutic challenge. Repeat coronary interventions are currently used in this setting, but the recurrence risk remains high.
Methods We randomly assigned 450 patients with ISR to elective stent implantation (224 patients) or conventional BA (226 patients). Primary end point was recurrent restenosis rate at six months. Secondary end points included minimal lumen diameter (MLD), prespecified subgroup analyses, and a composite of major adverse events.
Results Procedural success was similar in both groups, but in-hospital complications were more frequent in the balloon group. After the procedure MLD was larger in the stent group (2.77 ± 0.4 vs. 2.25 ± 0.5 mm, p < 0.001). At follow-up, MLD was larger after stenting when the in-lesion site was considered (1.69 ± 0.8 vs. 1.54 ± 0.7 mm, p = 0.046). However, the binary restenosis rate (38% stent group, 39% balloon group) was similar with the two strategies. One-year event-free survival (follow-up 100%) was also similar in both groups (77% stent vs. 71% balloon, p = 0.19). Nevertheless, in the prespecified subgroup of patients with large vessels (≥3 mm) the restenosis rate (27% vs. 49%, p = 0.007) and the event-free survival (84% vs. 62%, p = 0.002) were better after repeat stenting.
Conclusions In patients with ISR, repeat coronary stenting provided better initial angiographic results but failed to improve restenosis rate and clinical outcome when compared with BA. However, in patients with large vessels coronary stenting improved the long-term clinical and angiographic outcome.
- Received November 13, 2002.
- Revision received April 21, 2003.
- Accepted April 24, 2003.
- American College of Cardiology Foundation