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Stent Implantation Not Recommended for Revascularisation in Diabetics With Retinopathy: Presented at STS

By Michael Casasnovas

FORT LAUDERDALE, FL -- January 31, 2008 -- Sirolimus-eluting stent implantation is not suitable for revascularisation in patients with diabetic retinopathy, especially in patients with nonproliferative retinopathy, said researchers here at the 44th Annual Meeting of the Society of Thoracic Surgeons (STS).

"Coronary artery bypass graft [CABG] would be the first choice of revascularisation among these patients," said Akihiro Masuzawa, MD, Fellow in Thoracic Surgery, University of Tokyo, Tokyo, Japan.

"Patients with diabetic retinopathy have an increased risk of death from coronary heart disease with myocardial infarction," said Dr. Masuzawa. "The purpose of this study was to compare the outcome of sirolimus-eluting stent and coronary artery bypass graft revascularisation strategies for patients with diabetic retinopathy according to the different stages of retinopathy -- nonproliferative retinopathy and proliferative retinopathy."

Six hundred twenty-seven patients, including 51 nonproliferative retinopathy and 62 proliferative retinopathy patients, underwent sirolimus-eluting stent implantation from April 2004 to February 2007. For each retinopathy group, historical comparison groups undergoing CABG with the same stages of retinopathy were selected as controls, said Dr. Masuzawa at his poster presentation on January 28.

Time from initial revascularisation to followup was about 24 months for patients in the nonproliferative retinopathy-sirolimus-eluting stent group, 61.3 months for the nonproliferative retinopathy-CABG group, 22.2 months for the proliferative retinopathy-sirolimus-eluting stent group, and 59.5 months for the proliferative retinopathy-CABG group.

Dr. Masuzawa said that the rate of events at 22 months was 48.3% for nonproliferative retinopathy-sirolimus-eluting stent; 22.8% for nonproliferative retinopathy-CABG; 30.8% for proliferative retinopathy-sirolimus-eluting stent, and 26.1% for proliferative retinopathy-CABG.

Using Kaplan-Meier analysis for cardiac events, Dr. Masuzawa observed significant differences between the sirolimus-eluting stent group and the CABG group in entire diabetic retinopathy patients (P =.04) and especially in nonproliferative retinopathy patients (P =.03). He did not observe differences between the two groups in proliferative retinopathy patients.

The adjusted hazard ratio of sirolimus-eluting stent implantation for cardiac events in diabetic retinopathy patients was 1.89 (95% CI 1.10 - 3.25, P =.02).

Cox univariate analysis comparing sirolimus-eluting stent implantation and CABG in all patients and in each subgroup showed that CABG was significantly preferable to sirolimus-eluting stent implantation in all patients with diabetic retinopathy, in male patients, patients younger than 70 years, current smokers, patients with 3-vessel disease, patients with nonproliferative retinopathy, patients depending on any diabetic medication, and patients with dyslipidemia.

"Male sex and smoking habits were confounding factors for each other. Elevated hazard ratio of an age less than 70 might have influenced unknown variables like cardiologist's negative attitude toward invasive revascularisation for older patients," said Dr. Masuzawa.


[Presentation title: Coronary-Artery-Bypass Surgery Versus Coronary Implantation of Sirolimus-Eluting Stents in Patients With Diabetic Retinopathy. Abstract P34]

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