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.