Abstract 3056: Paclitaxel-eluting Stents For In-stent Restenosis of Sirolimus-eluting Stents: 12 Month Outcomes
Objective: The purpose of this study was to evaluate the safety and clinical outcome of paclitaxel-eluting stent (PES) implantation for sirolimus-eluting stent (SES) restenosis.
Background: The optimal treatment for sirolimus-eluting stent (SES) restenosis is not known.
Methods: From March 2004 to May 2005, PES were implanted in 114 patients with 128 lesions with SES restenosis. Acute and 12 month clinical outcomes were determined through review of the medical record and/or telephone interview.
Results: Mean pt age was 66±12 years, including 37 pts (32%) with diabetes. Forty one percent of the lesions had undergone previous bare metal stenting, and 21% had received previous brachytherapy (all prior to SES implantation). Prior balloon angioplasty of SES restenosis had been performed in 21% of the lesions (during a prior hospitalization). In-hospital major adverse cardiac events (cardiac death, non-fatal MI, or repeat revascularization) occurred in 13 pts (11.4%), driven entirely by post-procedure non-Q wave MI. At a mean clinical follow-up of 16 ± 4.1 months, the rate of major adverse cardiac events was 27.7%, including one non-Q wave MI attributed angio-graphically to a non-target vessel. There were no deaths from cardiac causes, and subacute thrombosis occurred in 2 pts (1.8%). The overall incidence of target lesion revascularization (TLR) was 26%. TLR was significantly higher in lesions previously treated with brachytherapy (48% vs. 20%, p=0.01), previous balloon angioplasty for SES restenosis (42% vs. 21%, p=0.048), and any previous intervention other than the index SES placement (37% vs. 14%, p=0.009). In pts with de novo SES restenosis, TLR was 14%. TLR was lowest for focal SES patterns of restenosis (21%), compared to 47% for total occlusive SES restenosis (p=NS). Quantitative coronary angiography and multivariate analysis revealed that post-procedure diameter stenosis and length of PES implanted were independent predictors of TLR.
Conclusions: At 12 month follow-up, PES implantation for SES failure appears to be safe. In pts with de novo SES restenosis, TLR was 14%. Efficacy is reduced in the setting of prior target lesion interventions, total occlusions, greater residual diameter stenosis, and longer PES length.