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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

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

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^_* for the RIBS-II Investigators

^_* Clinico San Carlos University Hospital, Madrid, Spain
Son Dureta University Hospital, Palma de Mallorca, Spain
San Pablo University Hospital, Barcelona, Spain
Infanta Cristina University Hospital, Badajoz, Spain
^|| Valle de Hebrón University Hospital, Barcelona, Spain
^¶ Meixoeiro University Hospital, Vigo, Spain
^# Central Asturias University Hospital, Oviedo, Spain
^_** Bellvitge University Hospital, Barcelona, Spain

Manuscript received August 21, 2005; revised manuscript received October 14, 2005, accepted October 25, 2005.

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

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.

Abbreviations and Acronyms   BA = balloon angioplasty   IQR = interquartile range   ISR = in-stent restenosis   IVUS = intravascular ultrasound   PCI = percutaneous coronary interventions   RIBS-II = Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting study   SES = sirolimus-eluting stents

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