title: Novel sirolimus-eluting stent Prolim® with a biodegradable polymer in the all-comers population: one year clinical results with quantitative coronary angiography and optical coherence tomography analysis.
abstract: BACKGROUND
  The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.
  
  
  METHODS
  We prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15 % of patients (randomly chosen) underwent optical coherence tomography imaging. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization at 12 months.
  
  
  RESULTS
  There were 204 patients enrolled, in whom 238 Prolim® stents were deployed (1.17 stent per patient). The mean age was 68 ± 10 years and 32.8 % were females. The examined stent was implanted in 5.9 % in STEMI patients, in 21.6 % - in NSTE-ACS and in 72.5 % - in patients with stable coronary artery disease. The Prolim® stent was most frequently implanted in right coronary artery (38.2 %) followed by left anterior descending artery (34.0 %). The cumulative major adverse cardiovascular events rate at 12 months was 6.9 %, and the clinically-driven target lesion revascularization rate - 5.4 %. At 12 months in quantitative coronary angiography the late lumen loss was 0.21 ± 0.18 mm, and in optical coherence tomography the mean neointima burden was 24.6 ± 8.6 %.
  
  
  CONCLUSIONS
  Sirolimus-eluting Prolim® stent with a biodegradable polymer is a feasible device with a very good safety profile and long-term clinical effectiveness.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02545985 .
authors.affiliation: Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, 137 Woloska Street, 02-507, Warsaw, Poland. biljacek@gmail.com.|Institute of Experimental and Clinical Medicine, Polish Academy of Science, Warsaw, Poland. biljacek@gmail.com.
authors.forename: Jacek
authors.initials: J
authors.lastname: Bil
authors.affiliation: Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, 137 Woloska Street, 02-507, Warsaw, Poland.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Gil
authors.affiliation: Faculty of Medical Sciences University of Varmia and Masuria, Olsztyn, Poland.
authors.forename: Adam
authors.initials: A
authors.lastname: Kern
authors.affiliation: Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, 137 Woloska Street, 02-507, Warsaw, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Pawłowski
authors.affiliation: Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, 137 Woloska Street, 02-507, Warsaw, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Seweryniak
authors.affiliation: Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, 137 Woloska Street, 02-507, Warsaw, Poland.
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Śliwiński
mesh_terms: D020341:Absorbable Implants; D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011044:Poland; D011108:Polymers; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; D020123:Sirolimus