title: Proximal and distal maximal luminal diameters as a guide to appropriate deployment of the ABSORB everolimus-eluting bioresorbable vascular scaffold: a sub-study of the ABSORB Cohort B and the on-going ABSORB EXTEND Single Arm Study.
abstract: OBJECTIVE
  Due to the limited distensibility of the everolimus-eluting bioresorbable vascular scaffold (ABSORB) compared to metallic platform stents, quantitative coronary arteriography (QCA) is a mandatory requirement for ABSORB deployment in the on-going ABSORB EXTEND Single-Arm Study. Visual assessment of vessel size in the ABSORB Cohort B study often lead to under and over-sizing of the 3 mm ABSORB in coronary vessels (recommended range of the vessel diameter ≥ 2.5 mm and ≤ 3.3 mm), with an increased risk of spontaneous incomplete scaffold apposition post ABSORB deployment. We report whether mandatory QCA assessment of vessel size pre-implantation, utilizing the maximal luminal diameter (Dmax) and established interpolated reference vessel diameter (RVD) measurements, has improved device/vessel sizing.
  
  
  METHODS
  Pre-implantation post-hoc QCA analyses of all 101 patients from ABSORB Cohort B (102 lesions) and first consecutive 101 patients (108 lesions) from ABSORB EXTEND were undertaken by an independent core-laboratory; all patients had a 3 mm ABSORB implanted. Comparative analyses were performed.
  
  
  RESULTS
  Within ABSORB Cohort B, a greater number of over-sized vessels (> 3.3 mm) were identified utilizing the Dmax compared to the interpolated RVD (17 vessels, 16.7% vs. 3 vessels, 2.9%; P = 0.002). Comparative analyses demonstrated a greater number of appropriate vessel-size selection (75 vessels, 69.4% vs. 48 vessels, 47.1%; P = 0.001), a trend towards a reduction in implantation in small (< 2.5 mm) vessels (29 vessels, 26.9% vs. 40 vessels, 39.2%; P = 0.057) and a significant decrease in the implantation in large (> 3.3 mm) vessels (4 vessels, 3.7% vs. 17 vessels, 16.7%; P = 0.002) in ABSORB EXTEND. Bland-Altman plots suggested a good agreement between operator and core-laboratory calculated Dmax measurements.
  
  
  CONCLUSIONS
  The introduction of mandatory Dmax measurements of vessel size prior to ABSORB implantation significantly reduced the under-sizing of the 3.0 mm scaffold in large vessels validating the use of this technique in vessel sizing prior to ABSORB implantation.
authors.affiliation: Thoraxcenter, Erasmus University Medical Centre, Rotterdam, The Netherlands.
authors.forename: Vasim
authors.initials: V
authors.lastname: Farooq
authors.forename: Josep
authors.initials: J
authors.lastname: Gomez-Lara
authors.forename: Salvatore
authors.initials: S
authors.lastname: Brugaletta
authors.forename: Bill D
authors.initials: BD
authors.lastname: Gogas
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcìa-Garcìa
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Robert Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Antonio
authors.initials: A
authors.lastname: Bartorelli
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D004337:Drug Carriers; D000068338:Everolimus; D006801:Humans; D017202:Myocardial Ischemia / Q000000981:diagnostic imaging / Q000628:therapy*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D054457:Tissue Scaffolds; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D002317:Cardiovascular Agents; D004337:Drug Carriers; D000068338:Everolimus; D020123:Sirolimus