Background
Bioresorbable scaffolds (BRS) are a novel technology in coronary intervention. However,
recent trials demonstrate higher rates of device failure compared to contemporary
drug-eluting stents. This study sought to utilise a clinical quality registry to assess
the medium-term safety of the Abbott Absorb BRS (Abbott Vascular, Santa Clara, CA,
USA), in an Australian context.
Methods
A prospective, observational study of 192 BRS percutaneous coronary interventions
(PCI) compared to 31,773 non-BRS PCIs entered in the Victorian Cardiac Outcomes Registry
from 2013 to 2017. The main outcome measure was patient-oriented composite endpoint
(POCE) events comprising all-cause mortality, any myocardial infarction (MI), and
any revascularisation.
Results
Bioresorbable scaffolds patients (mean age 61.6±10.5 years, 79% male) were younger,
had less comorbidity, less prior PCI, fewer ST elevation myocardial infarction (STEMI)
presentations, lower rates of multi-lesion disease and more adjuvant devices compared
to non-BRS PCI (all p<0.01). All-cause mortality was 2.1%, myocardial infarction (MI)
2.1%, scaffold thrombosis 3.1% and any revascularisation 14.1% (mean follow-up 27.4±8.9
months). POCE events occurred in 11.5% at 1 year and 16.9% at 2 years, comparable
to pooled-trial data. Multivariate predictors of POCE were >1 scaffold used (odds
ratio [OR] 4.6, 95% confidence interval [CI] 1.9-11.4, p<0.01) and scaffold diameter
≤2.5 mm (OR 3.3, 95% CI 1.4–7.6, p=0.02). Over 95% guideline adherence was achieved
in six of eight patient selection criteria and four of six device deployment criteria.
Conclusion
In an Australian setting, BRS were used in non-complex patients. Most guidelines for
use were adhered to and outcomes were comparable to pooled trial data. Clinical quality
registries are effective in assessing novel treatments and technologies when potential
safety concerns develop.
Keywords
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Article info
Publication history
Published online: December 03, 2019
Accepted:
November 21,
2019
Received in revised form:
September 4,
2019
Received:
June 7,
2019
Identification
Copyright
© 2019 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.
