Clinical and angiographic outcome of a single center, real world population treated with a dedicated technique of implantation for bioresorbable vascular scaffolds. The FAtebenefratelli Bioresorbable Vascular Scaffold (FABS) registry.

Abstract

OBJECTIVES:

With this prospective study we aim at investigating the long-term outcome of a consecutive cohort of patients successfully treated with bioresorbable scaffold (BVS) implantation.

BACKGROUND:

It is not clearly understood if there is a relation between the technique of BVS implantation and the outcome.

METHODS:

Between December 2012 and December 2014, all consecutive patients treated with BVS were included in this registry and received an angiographic follow-up. After a run-in phase, all BVS were implanted using a specific technique consisting of aggressive predilation, correct scaffold sizing, visually determined, and high-pressure post-dilation with a noncompliance balloon. Primary endpoint was late lumen loss (LLL) at 1-year angiographic follow-up and ischemia-driven target-lesion revascularization (ID-TLR) at 2-year clinical follow-up. Secondary endpoints were the occurrence of binary restenosis, major adverse cardiac events (MACE), and every single component of MACE (cardiac death, myocardial infarction, TLR) at 2 years.

RESULTS:

A total of 144 lesions in 122 patients treated consecutively with BVS, were enrolled. Diabetics were 29.5% and acute coronary syndrome at presentation occurred in 29.5% of patients. At the angiographic follow-up LLL was 0.38 ± 0.9. At 2-year clinical follow-up, ID-TLR occurred in eight patients (5.6%). We observed two cases of scaffold thrombosis (1.38%, one early and one very late). At multivariate statistical analysis, STEMI presentation remained a significant predictor for TLR.

CONCLUSIONS:

In a complex, all-comers real world population, BVS implantation with a specific, and standardized technique showed to be feasible, with acceptable mid-term angiographic and long-term clinical outcome.

• Authors: Bernardo Cortese, Gaetano di Palma, Enrico Cerrato, Roberto A Latini, Mostafa Elwany, Pedro S Orrego, Romano G Seregni
• Journal: Journal of interventional cardiology (J Interv Cardiol) Vol. 30 Issue 5 Pg. 427-432 (Oct 2017) ISSN: 1540-8183 [Electronic] United States
• PMID: 28853189 (Publication Type: Journal Article)
• Copyright: © 2017, Wiley Periodicals, Inc.

Topics

• Absorbable Implants
• Aged
• Coronary Angiography
• Coronary Artery Disease (diagnostic imaging, etiology, surgery)
• Female
• Humans
• Male
• Middle Aged
• Percutaneous Coronary Intervention (instrumentation, methods)
• Prospective Studies
• Registries
• Tissue Scaffolds
• Treatment Outcome