title: Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial.
abstract: OBJECTIVE
  This study sought to demonstrate the 5-year clinical and functional multislice computed tomography angiographic results after implantation of the fully resorbable everolimus-eluting scaffold (Absorb BVS, Abbott Vascular, Santa Clara, California).
  
  
  BACKGROUND
  Multimodality imaging of the first-in-humans trial using a ABSORB BVS scaffold demonstrated at 2 years the bioresorption of the device while preventing restenosis. However, the long-term safety and efficacy of this therapy remain to be documented.
  
  
  METHODS
  In the ABSORB cohort A trial (ABSORB Clinical Investigation, Cohort A [ABSORB A] Everolimus-Eluting Coronary Stent System Clinical Investigation), 30 patients with a single de novo coronary artery lesion were treated with the fully resorbable everolimus-eluting Absorb scaffold at 4 centers. As an optional investigation in 3 of the 4 centers, the patients underwent multislice computed tomography (MSCT) angiography at 18 months and 5 years. Acquired MSCT data were analyzed at an independent core laboratory (Cardialysis, Rotterdam, the Netherlands) for quantitative analysis of lumen dimensions and was further processed for calculation of fractional flow reserve (FFR) at another independent core laboratory (Heart Flow, Redwood City, California).
  
  
  RESULTS
  Five-year clinical follow-up is available for 29 patients. One patient withdrew consent after 6 months, but the vital status of this patient remains available. At 46 days, 1 patient experienced a single episode of chest pain and underwent a target lesion revascularization with a slight troponin increase after the procedure. At 5 years, the ischemia-driven major adverse cardiac event rate of 3.4% remained unchanged. Clopidogrel was discontinued in all but 1 patient. Scaffold thrombosis was not observed in any patient. Two noncardiac deaths were reported, 1 caused by duodenal perforation and the other from Hodgkin's disease. At 5 years, 18 patients underwent MSCT angiography. All scaffolds were patent, with a median minimal lumen area of 3.25 mm(2) (interquartile range: 2.20 to 4.30). Noninvasive FFR analysis was feasible in 13 of 18 scans, which yielded a median distal FFR of 0.86 (interquartile range: 0.82 to 0.94).
  
  
  CONCLUSIONS
  The low event rate at 5 years suggests sustained safety after the implantation of a fully bioresorbable Absorb everolimus-eluting scaffold. Noninvasive assessment of the coronary artery with an option of functional assessment could be an alternative to invasive imaging after treatment of coronary narrowing with such a polymeric bioresorbable scaffold. (ABSORB Clinical Investigation, Cohort A [ABSORB A] Everolimus-Eluting Coronary Stent System Clinical Investigation [ABSORB]; NCT00300131).
authors.affiliation: Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Mark
authors.initials: M
authors.lastname: Webster
authors.forename: Koen
authors.initials: K
authors.lastname: Nieman
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D001672:Biocompatible Materials; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000517:prevention & control; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus; D005260:Female; D053805:Fractional Flow Reserve, Myocardial; D006801:Humans; D008297:Male; D008875:Middle Aged; D061330:Multidetector Computed Tomography; D009520:New Zealand; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus
keywords: CT; FFR; FFR(CT); ID; IQR; IVUS; MACE; MI; MSCT; OCT; PDLLA; PLLA; QCA; TLR; TVR; bioresorbable scaffold; computed tomography; everolimus; fractional flow reserve; interquartile range; intravascular ultrasound; ischemia-driven; major adverse cardiac event(s); multislice computed tomography; myocardial infarction; noninvasive fractional flow reserve according to multislice computed tomography; noninvasive functional assessment; optical coherence tomography; poly-d,l-lactide; poly-l-lactide; quantitative coronary angiography; target lesion revascularization; target vessel revascularization