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.
OBJECTIVE
We sought to assess the effectiveness of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR).


BACKGROUND
Treatment of patients with ISR remains a challenge.


METHODS
The Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) study is a multicenter randomized trial conducted in 150 patients with ISR (76 allocated to SES and 74 to balloon angioplasty [BA]). The primary end point was recurrent restenosis rate at nine months. Secondary end points included prespecified subgroup analysis, lumen volume on intravascular ultrasound (IVUS), and a composite of major clinical events at one year.


RESULTS
Angiographic success was obtained in all patients. At 9-month angiographic follow-up (96% of eligible patients) minimal lumen diameter was larger (2.52 mm [interquartile range (IQR) 2.09 to 2.81] vs. 1.54 mm [IQR 0.91 to 2.05]; p < 0.001) and recurrent restenosis rate was lower (11% vs. 39%; p < 0.001) in the SES group. Prespecified subgroup analyses were consistent with the main outcome measure. Lumen volume on IVUS at 9 months was also larger (279 mm3 [IQR 227 to 300] vs. 197 mm3 [IQR 177 to 230]; p < 0.001) in the SES group. At one-year clinical follow-up (100% of patients), the event-free survival (freedom from death, myocardial infarction, and target vessel revascularization) was significantly improved in the SES group (88% vs. 69%; p < 0.004) as the result of a lower requirement for target vessel revascularization (11% vs. 30%; p < 0.003).


CONCLUSIONS
In patients with ISR, the use of SES provides superior long-term clinical, angiographic, and IVUS outcome than BA treatment.
Alfonso
Fernando
F
Clinico San Carlos University Hospital, Madrid, Spain. falf@hotmail.com
Pérez-Vizcayno
Maria-José
MJ
Hernandez
Rosana
R
Bethencourt
Armando
A
Martí
Vicens
V
López-Mínguez
Jose R
JR
Angel
Juan
J
Mantilla
Ramón
R
Morís
Cesar
C
Cequier
Angel
A
Sabaté
Manel
M
Escaned
Javier
J
Moreno
Raúl
R
Bañuelos
Camino
C
Suárez
Alfonso
A
Macaya
Carlos
C
D000368:Aged; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage* / Q000627:therapeutic use; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D020123:Sirolimus