title: BIOFLOW-III satellite-One-year clinical outcomes of diabetic patients treated with a biodegradable polymer sirolimus-eluting stent and comprehensive medical surveillance.
abstract: 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<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 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±9.2years, 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±0.5mm in diameter and 15.2±7.4mm long; mean stent diameter and length were 3.0±0.5mm and 19.2±6.8mm. Target vessel failure and target lesion failure at 12months 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]).
  
  
  CONCLUSIONS
  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.
  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%.
authors.affiliation: Rabin Medical Center, Petach Tikva, Israel. Electronic address: ran.kornowski@gmail.com.
authors.forename: Ran
authors.initials: R
authors.lastname: Kornowski
authors.affiliation: Rambam Medical Center, Haifa, Israel.
authors.forename: Ariel
authors.initials: A
authors.lastname: Roguin
authors.affiliation: Hadassah Hebrew University Medical Center, Jerusalem, Israel.
authors.forename: Haim
authors.initials: H
authors.lastname: Danenberg
authors.affiliation: Rabin Medical Center, Petach Tikva, Israel.
authors.forename: Hana Vaknin
authors.initials: HV
authors.lastname: Assa
authors.affiliation: Rambam Medical Center, Haifa, Israel.
authors.forename: Eitan
authors.initials: E
authors.lastname: Abergel
authors.affiliation: Meir Medical Center, Kfar Sava, Israel.
authors.forename: Eliezer
authors.initials: E
authors.lastname: Rozenbaum
authors.affiliation: Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: Victor
authors.initials: V
authors.lastname: Guetta
authors.affiliation: Rabin Medical Center, Petach Tikva, Israel.
authors.forename: Uri
authors.initials: U
authors.lastname: Landes
authors.affiliation: Hadassah Hebrew University Medical Center, Jerusalem, Israel.
authors.forename: Refat
authors.initials: R
authors.lastname: Jabara
authors.affiliation: Carmel Medical Center, Haifa, Israel.
authors.forename: Amnon
authors.initials: A
authors.lastname: Merdler
authors.affiliation: Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: Amit
authors.initials: A
authors.lastname: Segev
authors.affiliation: Meir Medical Center, Kfar Sava, Israel.
authors.forename: Morris
authors.initials: M
authors.lastname: Mosseri
authors.affiliation: Rabin Medical Center, Petach Tikva, Israel.
authors.forename: Abid
authors.initials: A
authors.lastname: Assali
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000369:Aged, 80 and over; D003324:Coronary Artery Disease / Q000628:therapy; D048909:Diabetes Complications; D003920:Diabetes Mellitus; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011108:Polymers / Q000627:therapeutic use; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus
keywords: Biodegradable polymer; Drug-eluting stent; Orsiro; Sirolimus