Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1  Year in 1,232 XXXX From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II).

@entity1 @entity63 @entity75 @entity299 @entity583 @entity204
OBJECTIVES: 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 @entity1 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 @entity299 (MACE) (a composite of @entity204 , any @entity583 [ @entity583 ], and @entity63 -driven @entity75 revascularization) was analyzed according to the Dmax subclassification of scaffold oversize group versus scaffold nonoversize group. RESULTS: Of 1,248 @entity1 , pre-procedural Dmax was assessed in 1,232 @entity1 (98.7%). In 649 (52.7%) @entity1 , 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 @entity1 , the proximal and/or distal Dmax were larger than the implanted scaffold (scaffold nonoversize group). The rates of MACE and @entity583 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 @entity583 : 4.6% vs. 2.4%; log-rank p  = 0.04), mainly driven by a higher @entity583 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 @entity583 . (ABSORB Clinical Investigation, Cohort B [ABSORB Cohort B], NCT00856856; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND], NCT01023789; ABSORB II Randomized Controlled Trial [ABSORB II], NCT01425281).
