title: Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II).
abstract: OBJECTIVE
  This study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography-maximal lumen diameter (Dmax).
  
  
  BACKGROUND
  Assessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies.
  
  
  METHODS
  A total of 1,248 patients received Absorb scaffolds in the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study (N = 101), ABSORB EXTEND (ABSORB EXTEND Clinical Investigation) study (N = 812), and ABSORB II (ABSORB II Randomized Controlled Trial) trial (N = 335). The incidence of major adverse cardiac events (MACE) (a composite of cardiac death, any myocardial infarction [MI], and ischemia-driven target lesion revascularization) was analyzed according to the Dmax subclassification of scaffold oversize group versus scaffold nonoversize group.
  
  
  RESULTS
  Of 1,248 patients, pre-procedural Dmax was assessed in 1,232 patients (98.7%). In 649 (52.7%) patients, both proximal and distal Dmax values were smaller than the nominal size of the implanted scaffold (scaffold oversize group), whereas in 583 (47.3%) of patients, the proximal and/or distal Dmax were larger than the implanted scaffold (scaffold nonoversize group). The rates of MACE and MI at 1 year were significantly higher in the scaffold oversize group than in the scaffold nonoversize group (MACE 6.6% vs. 3.3%; log-rank p < 0.01, all MI: 4.6% vs. 2.4%; log-rank p = 0.04), mainly driven by a higher MI rate within 1 month post-procedure (3.5% vs. 1.9%; p = 0.08). The independent MACE determinants were both Dmax smaller than the scaffold nominal size (odds ratio [OR]: 2.13, 95% confidence interval [CI]: 1.22 to 3.70; p < 0.01) and the implantation of overlapping scaffolds (OR: 2.10, 95% CI: 1.17 to 3.80; p = 0.01).
  
  
  CONCLUSIONS
  Implantation of an oversized Absorb scaffold in a relatively small vessel appears to be associated with a higher 1-year MACE rate driven by more frequent early MI. (ABSORB Clinical Investigation, Cohort B [ABSORB Cohort B], NCT00856856; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND], NCT01023789; ABSORB II Randomized Controlled Trial [ABSORB II], NCT01425281).
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Ishibashi
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Shimpei
authors.initials: S
authors.lastname: Nakatani
authors.affiliation: Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Sotomi
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Northern Region Heart Center, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
authors.forename: Pannipa
authors.initials: P
authors.lastname: Suwannasom
authors.affiliation: Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Maik J
authors.initials: MJ
authors.lastname: Grundeken
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.affiliation: Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.
authors.forename: Antonio L
authors.initials: AL
authors.lastname: Bartorelli
authors.affiliation: St. Vincent's Hospital, Fitzroy, Victoria, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.affiliation: Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.affiliation: Instituto de Cardiologia Dante Pazzanese, São Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: Auckland City Hospital, Auckland, New Zealand.
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Rapoza
authors.affiliation: Abbott Vascular, Diegem, Belgium.
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: yoshinobuonuma@gmail.com.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: International Centre for Cardiovascular Health, Imperial College, London, United Kingdom.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: bioresorbable scaffold; major adverse cardiac event(s); maximal lumen diameter