A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis.
OBJECTIVE
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 (> or =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.
Alfonso
Fernando
F
Unidad de Hemodinámica, Servicio de Cardiología Intervencionista, Instituto Cardiovascular, University Hospital San Carlos, Ciudad Universitaria, Plaza de Cristo Rey, Madrid 28040, Spain. falf@hotmail.com
Zueco
Javier
J
Cequier
Angel
A
Mantilla
Ramón
R
Bethencourt
Armando
A
López-Minguez
José R
JR
Angel
Juan
J
Augé
José M
JM
Gómez-Recio
Manuel
M
Morís
César
C
Seabra-Gomes
Ricardo
R
Perez-Vizcayno
María J
MJ
Macaya
Carlos
C
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology* / Q000401:mortality / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D017052:Hospital Mortality; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011174:Portugal / Q000453:epidemiology; D016016:Proportional Hazards Models; D012008:Recurrence; D012086:Reoperation; D012307:Risk Factors; D016037:Single-Blind Method; D013030:Spain / Q000453:epidemiology; D015607:Stents / Q000009:adverse effects* / Q000592:standards; D016019:Survival Analysis; D016896:Treatment Outcome