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J Am Coll Cardiol, 2003; 42:796-805, doi:10.1016/S0735-1097(03)00852-0 © 2003 by the American College of Cardiology Foundation |
* 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
Manuscript received November 13, 2002; revised manuscript received April 21, 2003, accepted April 24, 2003.
* Reprint requests and correspondence: Dr. Fernando Alfonso, Unidad de Hemodinámica, Servicio de Cardiología Intervencionista, Instituto Cardiovascular, Hospital Universitario "San Carlos," Ciudad Universitaria, Plaza de Cristo Rey, Madrid 28040, Spain.
falf{at}hotmail.com
OBJECTIVES: This randomized trial compared repeat stenting with balloon angioplasty (BA) in patients with in-stent restenosis (ISR).
BACKGROUND: Stent restenosis constitutes a therapeutic challenge. Repeat coronary interventions are currently used in this setting, but the recurrence risk remains high.
METHODS: We randomly assigned 450 patients with ISR to elective stent implantation (224 patients) or conventional BA (226 patients). Primary end point was recurrent restenosis rate at six months. Secondary end points included minimal lumen diameter (MLD), prespecified subgroup analyses, and a composite of major adverse events.
RESULTS: Procedural success was similar in both groups, but in-hospital complications were more frequent in the balloon group. After the procedure MLD was larger in the stent group (2.77 ± 0.4 vs. 2.25 ± 0.5 mm, p < 0.001). At follow-up, MLD was larger after stenting when the in-lesion site was considered (1.69 ± 0.8 vs. 1.54 ± 0.7 mm, p = 0.046). However, the binary restenosis rate (38% stent group, 39% balloon group) was similar with the two strategies. One-year event-free survival (follow-up 100%) was also similar in both groups (77% stent vs. 71% balloon, p = 0.19). Nevertheless, in the prespecified subgroup of patients with large vessels (
3 mm) the restenosis rate (27% vs. 49%, p = 0.007) and the event-free survival (84% vs. 62%, p = 0.002) were better after repeat stenting.
CONCLUSIONS: In patients with ISR, repeat coronary stenting provided better initial angiographic results but failed to improve restenosis rate and clinical outcome when compared with BA. However, in patients with large vessels coronary stenting improved the long-term clinical and angiographic outcome.
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