Clinical outcomes following "off-label" versus "established" indications of bioresorbable scaffolds for the treatment of coronary artery disease in a real-world population.
OBJECTIVE
Our aim was to investigate one-year outcomes in patients treated with bioresorbable scaffolds (BRS) for "off-label" versus currently "established" indications.


RESULTS
Consecutive patients treated with BRS between May 2012 and September 2014 in two centres were retrospectively recruited. Patients who met inclusion criteria as defined by the ABSORB III study were allocated to the established indication group (ESTG; 21 patients with 35 lesions) and the remaining patients to the off-label group (OFLG; 168 patients with 225 lesions). Target vessel failure (TVF) and ischaemia-driven target lesion revascularisation (id-TLR) at one year were evaluated in both groups. Patients in the OFLG had a higher prevalence of diabetes mellitus and longer lesion length. Predilatation, post-dilatation and intracoronary imaging were conducted in the majority of patients. At one-year follow-up, TVF (0% vs. 7.8%, p=0.32) and id-TLR (0% vs. 4.5%, p=0.31) occurred only in the OFLG with no adverse events in the ESTG. Definite stent thrombosis occurred in two OFLG patients (1.3%).


CONCLUSIONS
In a real-world setting, the majority (88.9%) of patients were treated with BRS for off-label indications. Off-label use of BRS appears to be associated with an acceptable occurrence of outcomes considering the greater complexity of this patient group.
Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
Tadashi
T
Miyazaki
Neil
N
Ruparelia
Hiroyoshi
H
Kawamoto
Filippo
F
Figini
Azeem
A
Latib
Antonio
A
Colombo
D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003324:Coronary Artery Disease / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D056687:Off-Label Use; D062645:Percutaneous Coronary Intervention; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
D020123:Sirolimus