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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Long-Term Clinical Benefit of Sirolimus-Eluting Stents in Patients With In-Stent Restenosis

Results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) Study

Fernando Alfonso, MD^_*,_*, María-José Pérez-Vizcayno, MD^_*, Rosana Hernández, MD^_*, Armando Bethencourt, MD, Vicens Martí, MD, José R. López-Mínguez, MD, Juan Angel, MD^||, Andrés Iñiguez, MD^¶, César Morís, MD^#, Angel Cequier, MD^_**, Manel Sabaté, MD, Javier Escaned, MD^_*, Pilar Jiménez-Quevedo, MD^_*, Camino Bañuelos, MD^_*, Alfonso Suárez, MD^_*, Carlos Macaya, MD^_* for the RIBS-II Investigators

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

Manuscript received June 12, 2008; revised manuscript received August 11, 2008, accepted August 19, 2008.

^_* 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 long-term effectiveness and safety of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR).

Background: Treatment of patients with ISR remains a challenge. The long-term outcome of patients with ISR treated with SES remains unknown.

Methods: The RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study was a randomized trial conducted in 150 patients with ISR (76 SES, 74 balloon angioplasty [BA]). The long-term (>1 year) clinical outcome and pre-specified subgroup analyses were pre-defined secondary study end points.

Results: At 1 year, the event-free survival (death, myocardial infarction, target vessel revascularization [TVR]) was better in the SES group (88% vs. 69%, p < 0.005). Additional long-term (>3 years) clinical follow-up was obtained in 97% of patients (median 3.3 years). After the first year, 3 patients died (1 SES, 2 BA), 5 suffered myocardial infarction (4 SES, 1 BA), and 7 required TVR (4 SES, 3 BA). At last follow-up, definitive/probable/possible stent thrombosis was similar in both groups (2/2/1 SES vs. 1/0/3 BA, p = NS). At 4 years, the event-free survival was 76% in the SES arm and 65% in the BA arm (p = 0.019). On multivariate analysis, SES implantation was an independent predictor of event-free survival. Subgroup analyses were consistent with the main outcome measure.

Conclusions: In patients with ISR, SES implantation remains effective and safe at very long-term clinical follow-up.

Key Words: angiography • angioplasty • restenosis • sirolimus-eluting stents

Abbreviations and Acronyms   BA = balloon angioplasty   CI = confidence interval   DES = drug-eluting stent(s)   HR = hazard ratio   ISR = in-stent restenosis   MI = myocardial infarction   SES = sirolimus-eluting stent(s)   TVR = target vessel revascularization

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