Long-term results (three to five years) of the Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study.
OBJECTIVE
We sought to analyze the very late outcomes of patients treated for in-stent restenosis (ISR) according to treatment allocation and 10 prespecified variables.


BACKGROUND
Long-term results (>2 years) of patients with ISR undergoing repeat coronary interventions are not well established.


METHODS
The Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study compared these two strategies in 450 patients with ISR. A detailed systematic protocol was used for late clinical follow-up.


RESULTS
At one-year follow-up (100% of patients), the event-free survival was similar in the two groups (77% stent implantation [ST] arm, 71% balloon angioplasty [BA] arm, log-rank p = 0.19). Additional long-term clinical follow-up (median 4.3 years, range 3 to 5 years) was obtained in 98.6% of patients. During this time 22 additional patients died (9 ST arm, 13 BA arm), 7 suffered a myocardial infarction (3 ST arm, 4 BA arm), 23 required coronary surgery (11 ST arm, 12 BA arm), and 9 underwent repeat coronary interventions (4 ST arm, 5 BA arm) (nonexclusive events). At four years the event-free survival was 69% in the ST arm and 64% in the BA arm (log-rank p = 0.21). Among the 10 prespecified variables, vessel size > or = 3 mm had a major influence on the clinical outcome at four years, with better results in the ST group (hazard ratio 0.51, 95% confidence interval 0.3 to 0.89, p = 0.016).


CONCLUSIONS
Patients with ISR undergoing repeat interventions have a significant event rate at late follow-up. Continued medical surveillance should be continued after one year. Patients with large vessels have a better outcome after repeat stenting.
Alfonso
Fernando
F
University Hospital Clinico San Carlos, Madrid, Spain. falf@hotmail.com
Augé
José M
JM
Zueco
Javier
J
Bethencourt
Armando
A
López-Mínguez
José R
JR
Hernández
José M
JM
Bullones
Juan A
JA
Calvo
Isabel
I
Esplugas
Enrique
E
Pérez-Vizcayno
María J
MJ
Moreno
Raul
R
Fernández
Cristina
C
Hernández
Rosana
R
Gama-Ribeiro
Vasco
V
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D012086:Reoperation; D015607:Stents; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome