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 the Orsiro sirolimus-eluting stent with a biodegradable polymer in combination with comprehensive optimal medical therapy following coronary interventions.

Methods:
This prospective, multicenter registry was conducted at six centers in Israel. Targeted LDL-C level was <70mg/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 endpoint was target vessel failure, a composite of cardiac death, target-vessel myocardial infarction and clinically driven target lesions revascularization. Secondary endpoints 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 an Orsiro stent. Mean age was 63.9±9.2 years, 27.5% were insulin dependent, 28.3% had a history of myocardial infarction, and 47.5% prior coronary interventions. Lesions were 3.0±0.5mm 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:
The Orsiro sirolimus-eluting stent with biodegradable polymer 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. (Trial #NCT01895712)