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A randomized comparison ofrepeat stenting with balloon angioplasty in patients with in-stent restenosis

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

^* University Hospital Clinico San Carlos, Madrid, Spain
University Hospital Marqués de Valdecilla, Santander, Spain
University Hospital of Bellvitge, Barcelona, Spain
Meixoeiro Hospital, Vigo, Spain
^|| University Hospital of Son Dureta, Palma de Mallorca, Spain
^¶ University Hospital Infanta Cristina, Badajoz, Spain
^# University Hospital Valle de Hebrón, Barcelona, Spain
^** University Hospital Santa Cruz y San Pablo, Barcelona, Spain
University Hospital La Princesa, Madrid, Spain
University Hospital Central Asturias, Oviedo, Spain
University Hospital of Santa Cruz, Lisbon, Portugal

View larger version (25K): [in a new window]   Figure 1 Trial profile. Of 891 consecutive patients undergoing repeat coronary interventions for in-stent restenosis during the study period, 450 (51%) were included in the trial. BA = balloon angioplasty arm; FU = follow-up; PCI = percutaneous coronary intervention; QCA = quantitative coronary angiography; ST = stent arm.

View larger version (23K): [in a new window]   Figure 2 Cumulative frequency distribution curves of the minimal lumen diameter before the procedure (PRE), immediately after intervention (POST), and at six months follow-up (FU), in patients treated with balloon angioplasty (BA) and repeat stenting (ST). (A) "Per-segment" analysis. (B) "In-lesion" analysis. After the procedure the distribution curve in the stent group is shifted to the right (with the two analyses) indicating a larger acute gain. At follow-up the results of the stent group are better than those in the balloon group in the "in-lesion" analysis (B), but not in the "per-segment" analysis (A).

View larger version (21K): [in a new window]   Figure 3 Rates, relative risks, and confidence intervals (CI) of restenosis according to the 10 prespecified variables. P values for the interaction (logistic regression analysis) were only significant for reference vessel size (p = 0.001). BA = balloon angioplasty; B/A = balloon to artery ratio; LAD = left anterior descending coronary artery; RE = restenosis; ST = stent.

View larger version (18K): [in a new window]   Figure 4 Kaplan-Meier estimates of the event-free survival at one year (death, myocardial infarction, or target vessel revascularization) according to treatment group. No differences were found between the two groups in the entire 450-patient population (Cox hazard ratio 0.81, 95% confidence interval [CI] 0.56 to 1.17) (A), but the event-free survival in patients with large vessels (3 mm) (B) was significantly greater in the stent group (Cox hazard ratio 0.31, 95% CI 0.2 to 0.73). This difference was due to the lower proportion of patients in the stent group that required target vessel revascularization. Note survival scales cut off at 60%. BA = balloon angioplasty; ST = stent.