Lessons learned from acute and late scaffold failures in the ABSORB EXTEND trial.
OBJECTIVE
Bioresorbable scaffolds are increasingly used in patients with coronary artery disease undergoing percutaneous coronary interventions. ABSORB EXTEND is an ongoing study that will recruit 800 patients. This report evaluates acute and late scaffold failure in the first 450 patients enrolled in ABSORB EXTEND who have completed 12 months follow-up.


RESULTS
Clinical event data from the first 450 patients enrolled in ABSORB EXTEND have demonstrated 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%) and four cases of subacute or late scaffold thrombosis (0.89%). All scaffold dislodgements occurred in the left circumflex (LCX), and in two cases dislodgement was observed after reinsertion of the same device. Two cases of subacute scaffold thrombosis and two late scaffold thromboses were observed. Two out of four cases of 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 of scaffold dislodgement and scaffold thrombosis as seen in the ABSORB EXTEND trial.
Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands.
Yuki
Y
Ishibashi
Yoshinobu
Y
Onuma
Takashi
T
Muramatsu
Shimpei
S
Nakatani
Javaid
J
Iqbal
Hector M
HM
Garcia-Garcia
Antonio L
AL
Bartorelli
Robert
R
Whitbourn
Alexander
A
Abizaid
Patrick W
PW
Serruys
D000368:Aged; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design / Q000379:methods; D054457:Tissue Scaffolds / Q000009:adverse effects*; D016896:Treatment Outcome