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This Article Figures Only Full Text Full Text (PDF) View Online Appendix All Versions of this Article: j.jacc.2005.05.050v1 46/5/756    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (4) Citing Articles via Google Scholar Google Scholar Articles by Alfonso, F. Search for Related Content PubMed PubMed Citation Articles by Alfonso, F.

CLINICAL RESEARCH: CLINICAL TRIALS

Long-Term Results (Three to Five Years) of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Stenting (RIBS) Randomized Study

Fernando Alfonso, MD^_*,_*, José M. Augé, MD^,, Javier Zueco, MD, Armando Bethencourt, MD, José R. López-Mínguez, MD^||, José M. Hernández, MD^¶, Juan A. Bullones, MD^#, Isabel Calvo, MD^_**, Enrique Esplugas, MD, María J. Pérez-Vizcayno, MD^_*, Raul Moreno, MD^_*, Cristina Fernández, MD^_*, Rosana Hernández, MD^_*, Vasco Gama-Ribeiro, MD for the RIBS Investigators

^_* University Hospital Clinico San Carlos, Madrid, Spain
University Hospital Santa Cruz y San Pablo, Barcelona, Spain
University Hospital Marqués de Valdecilla, Santander, Spain
University Hospital Son Dureta, Palma de Mallorca, Spain
^|| University Hospital Infanta-Cristina, Badajoz, Spain
^¶ University Hospital Virgen de la Victoria, Malaga, Spain
^# University Hospital Carlos Haya, Malaga, Spain
^_** University Hospital Miguel Servet, Zaragoza, Spain
University Hospital Bellvitge, Barcelona, Spain
University Hospital Vila Nova de Gaia, Porto, Portugal
University Hospital Deceased

Manuscript received January 7, 2005; revised manuscript received April 25, 2005, accepted May 9, 2005.

^_* Reprint requests and correspondence: Dr. Fernando Alfonso, Cardiología Intervencionista, Hospital Universitario "San Carlos," Plaza de Cristo Rey, Madrid 28040, Spain (Email: falf{at}hotmail.com).

OBJECTIVES: We sought to analyze the very late outcomes of patients treated for in-stent restenosis (ISR) according to treatment allocation and 10 prespecified variables.

BACKGROUND: Long-term results (>2 years) of patients with ISR undergoing repeat coronary interventions are not well established.

METHODS: The Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study compared these two strategies in 450 patients with ISR. A detailed systematic protocol was used for late clinical follow-up.

RESULTS: At one-year follow-up (100% of patients), the event-free survival was similar in the two groups (77% stent implantation [ST] arm, 71% balloon angioplasty [BA] arm, log-rank p = 0.19). Additional long-term clinical follow-up (median 4.3 years, range 3 to 5 years) was obtained in 98.6% of patients. During this time 22 additional patients died (9 ST arm, 13 BA arm), 7 suffered a myocardial infarction (3 ST arm, 4 BA arm), 23 required coronary surgery (11 ST arm, 12 BA arm), and 9 underwent repeat coronary interventions (4 ST arm, 5 BA arm) (nonexclusive events). At four years the event-free survival was 69% in the ST arm and 64% in the BA arm (log-rank p = 0.21). Among the 10 prespecified variables, vessel size 3 mm had a major influence on the clinical outcome at four years, with better results in the ST group (hazard ratio 0.51, 95% confidence interval 0.3 to 0.89, p = 0.016).

CONCLUSIONS: Patients with ISR undergoing repeat interventions have a significant event rate at late follow-up. Continued medical surveillance should be continued after one year. Patients with large vessels have a better outcome after repeat stenting.

Abbreviations and Acronyms   BA = balloon angioplasty   ISR = in-stent restenosis   MI = myocardial infarction   PCI = percutaneous coronary intervention   RIBS = Restenosis Intrastent: Balloon angioplasty versus elective Stenting randomized study   ST = stent implantation

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