Premium
Three‐year clinical outcomes of patients treated with everolimus‐eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial
Author(s) -
Costa J. Ribamar,
Abizaid Alexandre,
Whitbourn Robert,
Serruys Patrick W.,
Jepson Nigel,
Steinwender Clemens,
Stuteville Marrianne,
Ediebah Divine,
Sudhir Krishnankutty,
Bartorelli Antonio L.
Publication year - 2019
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27715
Subject(s) - medicine , mace , target lesion , conventional pci , thrombosis , population , clinical trial , surgery , stent , logistic regression , bioresorbable scaffold , cardiology , myocardial infarction , percutaneous coronary intervention , environmental health
Background There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year‐performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial. Methods ABSORB EXTEND is a prospective, single‐arm, open‐label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0–3.8 mm (as assessed by on‐line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure. Results Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia‐driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for “bail out” stent. Conclusion At three‐year follow‐up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).