BIOFLOW-III satellite—One-year clinical outcomes of diabetic patients treated with a biodegradable polymer sirolimus-eluting stent and comprehensive medical surveillance

Background Drug-eluting stents with biodegradable polymer might be particularly useful in diabetic patients who are at increased risk for target lesion/target vessel revascularization. We therefore aimed at assessing the safety and performance of a biodegradable polymer sirolimus-eluting stent (BP-SES) in combination with comprehensive optimal medical therapy following coronary interventions. Methods This prospective, multicenter registry was conducted at six centers in Israel. Aside of stent treatment, we aimed for an LDL-C level < 70 mg/dl; at one and six months post-intervention a diabetic consultancy was required, and follow-up data were collected at six and twelve months. The primary outcome measure was target vessel failure, a composite of cardiac death, target-vessel myocardial infarction and clinically driven target vessel revascularization. Secondary outcomes were target lesion failure, its individual components, and stent thrombosis. Results From August 2013 until May 2014, 120 diabetic patients with 158 lesions were treated with a BP-SES. Mean age was 63.9 ± 9.2 years, 27.5% were insulin dependent, 28.3% had a history of myocardial infarction, and 47.5% had prior coronary interventions. By visual estimation, lesions were 3.0 ± 0.5 mm in diameter and 15.2 ± 7.4 mm long; mean stent diameter and length were 3.0 ± 0.5 mm and 19.2 ± 6.8 mm. Target vessel failure and target lesion failure at 12 months occurred in seven (6.4% [95% CI: 3.1–13.0]) and four patients (3.5% [95% CI: 1.3–9.2]), respectively, and definite stent thrombosis in one patient (1.0% [95% CI: 0.1–7.0]). Conclusion Treatment with a BP-SES demonstrated excellent target-vessel and target-lesion revascularization rates in a high-risk diabetic patient population undergoing catheter-based revascularization followed by intensified medical care. Annotated table of contents In 120 high-risk diabetic patients with coronary artery stenosis, treatment with the Orsiro sirolimus-eluting stent with biodegradable polymer and comprehensive antidiabetic therapy resulted in excellent clinical outcomes. Target vessel revascularization occurred in 6.4% of patients and target lesion revascularization in 3.5%.