Long-term clinical benefit of sirolimus-eluting stents in patients with in-stent restenosis results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study.
OBJECTIVE
We sought to assess the long-term effectiveness and safety of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR).


BACKGROUND
Treatment of patients with ISR remains a challenge. The long-term outcome of patients with ISR treated with SES remains unknown.


METHODS
The RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study was a randomized trial conducted in 150 patients with ISR (76 SES, 74 balloon angioplasty [BA]). The long-term (>1 year) clinical outcome and pre-specified subgroup analyses were pre-defined secondary study end points.


RESULTS
At 1 year, the event-free survival (death, myocardial infarction, target vessel revascularization [TVR]) was better in the SES group (88% vs. 69%, p < 0.005). Additional long-term (>3 years) clinical follow-up was obtained in 97% of patients (median 3.3 years). After the first year, 3 patients died (1 SES, 2 BA), 5 suffered myocardial infarction (4 SES, 1 BA), and 7 required TVR (4 SES, 3 BA). At last follow-up, definitive/probable/possible stent thrombosis was similar in both groups (2/2/1 SES vs. 1/0/3 BA, p = NS). At 4 years, the event-free survival was 76% in the SES arm and 65% in the BA arm (p = 0.019). On multivariate analysis, SES implantation was an independent predictor of event-free survival. Subgroup analyses were consistent with the main outcome measure.


CONCLUSIONS
In patients with ISR, SES implantation remains effective and safe at very long-term clinical follow-up.
Alfonso
Fernando
F
University Hospital, Clinico San Carlos, Madrid, Spain. falf@hotmail.com
Pérez-Vizcayno
María-José
MJ
Hernández
Rosana
R
Bethencourt
Armando
A
Martí
Vicens
V
López-Mínguez
José R
JR
Angel
Juan
J
Iñiguez
Andrés
A
Morís
César
C
Cequier
Angel
A
Sabaté
Manel
M
Escaned
Javier
J
Jiménez-Quevedo
Pilar
P
Bañuelos
Camino
C
Suárez
Alfonso
A
Macaya
Carlos
C
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D000077144:Clopidogrel; D023903:Coronary Restenosis / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005500:Follow-Up Studies; D006801:Humans; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use
D000903:Antibiotics, Antineoplastic; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D020123:Sirolimus