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)

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...

Lessons learned from acute and late scaffold failures in the ABSORB EXTEND trial

Aims: Bioresorbable scaffolds are increasingly used in patients with coronary artery disease undergoing percutaneouscoronary interventions. ABSORB EXTEND is an ongoing study that will recruit 800 patients. Thisreport evaluates acute and late scaffold failure in the first 450 patients enrolled in ABSORB EXTEND whohave completed 12 months follow-up.Methods and results: Clinical event data from the first 450 patients enrolled in ABSORB EXTEND havedemonstrated low rates of ischaemia-driven MACE (4.2%) and target vessel failure (4.7%) at 12 months.There have been seven cases of device failure in this study: three cases of scaffold dislodgement (0.67%) andfour cases of subacute or late scaffold thrombosis (0.89%). All scaffold dislodgements occurred in the leftcircumflex (LCX), and in two cases dislodgement was observed after reinsertion of the same device. Twocases of subacute scaffold thrombosis and two late scaffold thromboses were observed. Two out of four casesof scaffold thrombosis seemed to be related to either premature discontinuation of dual antiplatelet therapy(DAPT) or resistance to clopidogrel.Conclusions: This is the first report specifically describing the incidence and the potential mechanisms ofscaffold dislodgement and scaffold thrombosis as seen in the ABSORB EXTEND trial.