Graft disease remains a therapeutic challenge. Procedural complications and unsatisfactory patency rates are realized with both percutaneous intervention and repeat coronary artery bypass graft (CABG) surgery. The efficacy of sirolimus-eluting stents (SES) for the treatment of de novo coronary artery disease has been established, but the use of this technology to treat bypass graft disease remains undefined. The aim of this study was to evaluate the safety and feasibility of SES to treat patients with high-risk bypass graft disease.
Methods: The compassionate use of SES (SECURE) study included patients with recurrent coronary disease and no acceptable alternative available treatment, including brachytherapy or CABG. Outcomes from 76 patients (n = 94 lesions) with graft lesions treated with SES in the U.S. were compared with the outcomes of 176 patients (n = 311 lesions) with only native vessels. IVUS follow-up was performed at 8 months in 14 patients with graft SES treatment.
Results: In-hospital outcomes were similar between both groups, with 99% of patients discharged without adverse events. The incidence of target vessel failure including death, MI, and TVR at 12 months in the bypass graft group (55.3%) was similar to that observed in the native vessel group (45.5%, p = 0.17). Intimal hyperplasia (IH) measured by IVUS was 11.8 +/- 16.5%; 50% of patients with graft SES had < 1% IH at 8 months.
Conclusion: Implantation of SES in high-risk patients with recurrent bypass graft disease is feasible. SES represents a future.