title: Expanded clinical use of everolimus eluting bioresorbable vascular scaffolds for treatment of coronary artery disease.
abstract: BACKGROUND
  Limited data are currently available on the performance of everolimus eluting bioresorbable vascular scaffold (BVS) for treatment of complex coronary lesions representative of daily practice.
  
  
  METHODS
  This is a prospective, mono-center, single-arm study, reporting data after BVS implantation in patients presenting with stable, unstable angina, or non-ST segment elevation myocardial infarction caused by de novo stenotic lesions in native coronary arteries. No restrictions were applied to lesion complexity. Procedural results and 12-month clinical outcomes were reported.
  
  
  RESULTS
  A total of 180 patients have been evaluated in the present study, with 249 treated coronary lesions. Device Success per lesion was 99.2%. A total of 119 calcified lesions were treated. Comparable results were observed among severe, moderate and noncalcified lesions in term of %diameter stenosis (%DS) (20.3 ± 10.5%, 17.8 ± 7.7%, 16.8 ± 8.6%; P = 0.112) and acute gain (1.36 ± 0.41 mm, 1.48 ± 0.44 mm, 1.56 ± 0.54 mm; P = 0.109). In bifurcations (54 lesions), side-branch ballooning after main vessel treatment was often performed (33.3%) with low rate of side-branch impairment (9.3%). A total of 29 cases with coronary total occlusions were treated. After BVS implantation %DS was not different from other lesion types (17.2 ± 9.4%, vs. 17.7 ± 8.6%; P = 0.780). At one year, all-cause mortality was reported in three cases. The rate of target lesion revascularization and target vessel revascularization was 3.3%. The rate of definite scaffold thrombosis was 2.6%.
  
  
  CONCLUSIONS
  The implantation of the everolimus eluting bioresorbable vascular scaffold in an expanded range of coronary lesion types and clinical presentations was observed to be feasible with promising angiographic results and mid-term clinical outcomes. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Roberto
authors.initials: R
authors.lastname: Diletti
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Ishibashi
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Cordula
authors.initials: C
authors.lastname: Felix
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.|Cardialysis BV, Rotterdam, The Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Shimpei
authors.initials: S
authors.lastname: Nakatani
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Nicolas M
authors.initials: NM
authors.lastname: van Mieghem
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Eveliyn
authors.initials: E
authors.lastname: Regar
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Peter P
authors.initials: PP
authors.lastname: de Jaegere
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Nienke
authors.initials: N
authors.lastname: van Ditzhuijzen
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Jiang Ming
authors.initials: JM
authors.lastname: Fam
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Jurgen M R
authors.initials: JMR
authors.lastname: Ligthart
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Mattie J
authors.initials: MJ
authors.lastname: Lenzen
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Felix
authors.initials: F
authors.lastname: Zijlstra
authors.affiliation: Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Robert
authors.initials: R
authors.lastname: Jan van Geuns
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D060050:Angina, Stable / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D000789:Angina, Unstable / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000066491:Clinical Decision-Making; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D000072658:Non-ST Elevated Myocardial Infarction / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D018579:Patient Selection; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D061205:Vascular Calcification / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus
keywords: bioabsorbable devices/polymers; coronary artery disease; interventional devices/innovation