title: A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results.
abstract: OBJECTIVE
  This study sought to perform clinical and imaging assessments of the DESolve Bioresorbable Coronary Scaffold (BCS).
  
  
  BACKGROUND
  BCS, which is drug eluting, may have potential advantages compared with conventional metallic drug-eluting stents. The DESolve system, designed to provide vessel support and neointimal suppression, combines a poly-l-lactic acid-based scaffold with the antiproliferative myolimus.
  
  
  METHODS
  The DESolve First-in-Man (a non-randomized, consecutive enrollment evaluation of the DESolve myolimus eluting bioresorbable coronary stent in the treatment of patients with de novo native coronary artery lesions) trial was a prospective multicenter study enrolling 16 patients eligible for treatment. The principal safety endpoint was a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization. The principal imaging endpoint was in-scaffold late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 6 months. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging was performed at baseline and 6 months; multislice computed tomography (MSCT) was performed at 12 months.
  
  
  RESULTS
  Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold. At 12 months, there was no scaffold thrombosis and no major adverse cardiac events directly attributable to the scaffold. At 6 months, in-scaffold LLL (by QCA) was 0.19 ± 0.19 mm; neointimal volume (by IVUS) was 7.19 ± 3.56%, with no evidence of scaffold recoil or late malapposition. Findings were confirmed with OCT and showed uniform, thin neointimal coverage (0.12 ± 0.04 mm). At 12 months, MSCT demonstrated excellent vessel patency.
  
  
  CONCLUSIONS
  This study demonstrated the feasibility and efficacy of the DESolve BCS. Results showing low in-scaffold LLL, low % neointimal volume at 6 months, no chronic recoil, and maintenance of lumen patency at 12 months prompt further study. (DESolve First-in-Man; EudraCT number 2011-000027-32).
authors.affiliation: Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium. Electronic address: stefan.verheye@gmail.com.
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.affiliation: Mercy Angiography Unit, Auckland, New Zealand; Auckland City Hospital, Auckland, New Zealand.
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
authors.affiliation: Mercy Angiography Unit, Auckland, New Zealand; Auckland City Hospital, Auckland, New Zealand.
authors.forename: James
authors.initials: J
authors.lastname: Stewart
authors.affiliation: Auckland City Hospital, Auckland, New Zealand.
authors.forename: Mark
authors.initials: M
authors.lastname: Webster
authors.affiliation: Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium.
authors.forename: Elias
authors.initials: E
authors.lastname: Sanidas
authors.affiliation: Cardiovascular Research Center, Sao Paulo, Brazil.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Costa
authors.affiliation: Cardiovascular Research Center, Sao Paulo, Brazil.
authors.forename: J Ribamar
authors.initials: JR
authors.lastname: Costa
authors.affiliation: Cardiovascular Research Center, Sao Paulo, Brazil.
authors.forename: Daniel
authors.initials: D
authors.lastname: Chamie
authors.affiliation: Cardiovascular Research Center, Sao Paulo, Brazil.
authors.forename: Andrea S
authors.initials: AS
authors.lastname: Abizaid
authors.affiliation: Cardiovascular Research Center, Sao Paulo, Brazil.
authors.forename: Ibraim
authors.initials: I
authors.lastname: Pinto
authors.affiliation: Elixir Medical Corporation, Sunnyvale, California.
authors.forename: Lynn
authors.initials: L
authors.lastname: Morrison
authors.affiliation: Elixir Medical Corporation, Sunnyvale, California.
authors.forename: Sara
authors.initials: S
authors.lastname: Toyloy
authors.affiliation: Elixir Medical Corporation, Sunnyvale, California.
authors.forename: Vinayak
authors.initials: V
authors.lastname: Bhat
authors.affiliation: Elixir Medical Corporation, Sunnyvale, California.
authors.forename: John
authors.initials: J
authors.lastname: Yan
authors.affiliation: Cardiovascular Research Center, Sao Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000369:Aged, 80 and over; D001530:Belgium; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D019344:Lactic Acid / Q000737:chemistry; D008297:Male; D008422:Materials Testing; D008955:Models, Cardiovascular; D061330:Multidetector Computed Tomography; D064847:Multimodal Imaging / Q000379:methods; D009203:Myocardial Infarction / Q000175:diagnosis / Q000209:etiology; D058426:Neointima; D009520:New Zealand; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011091:Polyesters; D011108:Polymers / Q000737:chemistry; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D013997:Time Factors; D054457:Tissue Scaffolds; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide)
keywords: %DS; BCS; CK; DES; IVUS; LLL; MACE; MI; MSCT; OCT; PLLA; QCA; TLR; bioresorbable coronary scaffold; coronary disease; creatine kinase; drug-eluting; drug-eluting stent(s); imaging; intravascular ultrasound; late lumen loss; major adverse cardiac event(s); multislice computed tomography; myocardial infarction; optical coherence tomography; percent diameter stenosis; poly-l-lactic acid; quantitative coronary angiography; scaffold; stent(s); target lesion revascularization