Sirolimus-eluting stents for treatment of complex bypass graft disease: insights from the SECURE registry
Marco Costa1, Dominick J Angiolillo, Paul Teirstein
1Department of Cardiology, University of Florida, Shands, Jacksonville, FL 32209, USA.
Insights
Sirolimus-eluting stents (SES) show feasibility for treating high-risk bypass graft disease, offering a potential future therapy. Outcomes in graft disease patients were comparable to those with native vessel disease.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Bypass graft disease presents significant therapeutic challenges with limited treatment options.
- Percutaneous intervention and repeat coronary artery bypass graft (CABG) surgery have limitations in efficacy and patency.
- The effectiveness of sirolimus-eluting stents (SES) in de novo coronary artery disease is known, but their role in bypass graft disease is undefined.
Purpose of the Study:
- To evaluate the safety and feasibility of using SES for treating high-risk patients with bypass graft disease.
- To assess the clinical outcomes of SES implantation in patients with recurrent coronary disease and no alternative treatments.
Main Methods:
- The compassionate use of SES (SECURE) study enrolled patients with recurrent coronary disease ineligible for other treatments.
- Outcomes of 76 patients with graft lesions treated with SES were compared to 176 patients with native vessel lesions.
- Intravascular ultrasound (IVUS) was used for follow-up in 14 patients with graft SES treatment at 8 months.
Main Results:
- In-hospital outcomes were similar between groups, with 99% of patients discharged without adverse events.
- The 12-month incidence of target vessel failure (death, MI, TVR) was comparable between the bypass graft group (55.3%) and the native vessel group (45.5%).
- Intimal hyperplasia (IH) measured by IVUS was 11.8 +/- 16.5%, with 50% of graft SES patients showing <1% IH at 8 months.
Conclusions:
- Sirolimus-eluting stent implantation is feasible in high-risk patients with recurrent bypass graft disease.
- SES demonstrate potential as a future therapeutic option for managing complex bypass graft disease.
- The study supports the safety and efficacy of SES in a challenging patient population.
Unlabelled:
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.
