Long-term follow-up of patients with sirolimus-eluting stents for treatment of bare-metal in-stent restenosis.
BACKGROUND
Limited data is available on the long-term outcome after sirolimus-eluting stent (SES) implantation for in-stent restenosis.


METHODS
In 3 centers, consecutive patients (n=100) with percutaneous coronary intervention (PCI) for in-stent restenosis (n=110) were treated with SES: 28 lesions were focal, 40 diffuse, 17 proliferative, and 15 totally occluded (reference vessel diameter: 3.0+/-0.2 mm, lesion length: 13.8+/-5.7 mm).


RESULTS
SES implantation was successful in all patients. The mean follow-up was 50+/-12 months. The main univariate predictive factor of definite (4%) or probable (4%) SES thrombosis was revascularization without SES in a non-target site during the initial procedure (p<0.01). Repeated target lesion revascularization (TLR) was performed in 8 patients (8%) at 1 year, in 10 patients (10%) at 4 years. A cardiac event related to the SES occurred in 14 patients (14%) at one year, 17 patients (17%) at 4 years, and were associated with unstable angina (p<0.05), multivessel disease (p<0.02) and revascularization without SES in another site of the target vessel during the initial procedure (p<0.01).


CONCLUSIONS
SESs are effective at 4 years in the treatment of high risk patients with complex in-stent restenosis, with a low risk of TLR but a high risk of stent thrombosis. Most of cardiac events related to the target vessel occur during the first year, and are associated to a revascularization without SES in another site during the first procedure.
Le Feuvre
Claude
C
Cardiology Department, Pitié-Salpêtrière Hospital, 47 et 83 Bd de l'Hôpital, 75651 Paris cedex 13, France. claude.lefeuvre@psl.ap-hop-paris.fr
Healy-Brucker
Aude
A
Helft
Gérard
G
Monségu
Jacques
J
Varenne
Olivier
O
Spaulding
Christian
C
Collet
Jean P
JP
Beygui
Farzin
F
Barthélémy
Olivier
O
Choussat
Rémi
R
Montalescot
Gilles
G
Metzger
Jean Philippe
JP
D000368:Aged; D000789:Angina, Unstable / Q000453:epidemiology / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000706:statistics & numerical data; D003324:Coronary Artery Disease / Q000453:epidemiology / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology*; D003328:Coronary Thrombosis / Q000453:epidemiology; D054855:Drug-Eluting Stents / Q000009:adverse effects* / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008670:Metals; D008875:Middle Aged; D011237:Predictive Value of Tests; D012042:Registries; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors
D007166:Immunosuppressive Agents; D008670:Metals; D020123:Sirolimus