Sirolimus-eluting stents for the treatment of bare-metal in-stent restenosis: long-term clinical follow up.
BACKGROUND
Studies focusing on short- and mid-term follow up support the beneficial role of sirolimus-eluting stents (SES) in the treatment of in-stent restenosis (ISR), yet no long-term safety and/or efficacy data are available.


METHODS
Patients with ISR following bare-metal stenting (BMS) and treated with SES were prospectively studied. Baseline, procedural, and in-hospital data were appraised. The primary endpoint was the rate of major cardiovascular events (MACE) at long-term follow up (>9 months). Secondary endpoints were the individual contributors to MACE.


RESULTS
A total of 180 SES were implanted to treat 138 consecutive patients. Procedural success was achieved in all patients without in-hospital death, acute stent thrombosis, stroke, or urgent coronary artery bypass. During follow up, MACE occurred in 5.8% of patients at 6 months, 14.3% at 12 months, and 25% at 24 months. Specifically, all-cause mortality was 1.7% at 6 months, 3.5% at 12 months, and 4.8% at 24 months, for a total of 5 deaths. Target vessel revascularization occurred at 6, 12, and 24 months in 4.2%, 11.2%, and 15.9% of patients, respectively, while target lesion revascularization (TLR) alone accounted for 3.4% at 6 months, 9.6% at 12 months, and 11% at 24 months. Three case of myocardial infarction occurred during follow up (2.2%), without any surgical revascularization or stent thrombosis.


CONCLUSIONS
Treatment of ISR with SES appears safe and effective, even if a 10% annual rate of MACE can be expected, with a sizable portion of these due to apparently nontarget lesion events.
Sheiban
Imad
I
Interventional Cardiology, Division of Cardiology, University of Turin, San Giovanni Battista-Molinette Hospital, Turin, Italy. isheiban@yahoo.com
Chiribiri
Amedeo
A
Beninati
Serena
S
Moretti
Claudio
C
Omede
Pierluigi
P
Sciuto
Filippo
F
Marra
Walter Grosso
WG
Biondi-Zoccai
Giuseppe
G
Bollati
Mario
M
Gambino
Alfonso
A
Trevi
Gian Paolo
GP
D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003327:Coronary Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000473:pathology / Q000628:therapy*; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage; D015607:Stents
D007166:Immunosuppressive Agents; D020123:Sirolimus