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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

View larger version (28K): [in a new window]   Figure 1 Flow chart of patients included in the trial and patients with final angiographic follow-up. BA = balloon angioplasty; FU = follow-up; ISR = in-stent restenosis; Pts = patients; QCA = quantitative coronary angiography; Rx = randomization; SES = sirolimus-eluting stents.

View larger version (19K): [in a new window]   Figure 2 Cumulative frequency distribution curves of minimal lumen diameter (MLD) (in-segment analysis) before the procedure (PRE), after intervention (POST), and at follow-up (FU), in patients treated with balloon angioplasty (BA) and sirolimus-eluting stenting (SES).

View larger version (20K): [in a new window]   Figure 3 Restenosis risk according to treatment allocation and ten prespecified variables. The relative risk for short lesions was undefined, because 0% recurrence was found in the sirolimus-eluting stent (SES) group. No patient with in-stent restenosis of a coil stent (first ST Coil) was included. BA = balloon angioplasty; B/A = balloon/artery ratio; CI = confidence interval; LAD = left anterior descending coronary artery; RE = restenosis.

View larger version (17K): [in a new window]   Figure 4 Box whisker plot (median and interquartile range) of intravascular ultrasound findings at follow-up. (A) In-segment lumen volume. (B) In-stent lumen volume. (C) Neointimal proliferation volume. The median test was used to compare results between the two arms. The paired sample sign test was used to assess changes within each arm. +p < 0.05 (stent group, post-procedure vs. follow-up [FU]). BA = balloon angioplasty (blue); PRE = before the procedure; POST = after intervention; SES = sirolimus-eluting stents (red).