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Neth Heart J. 2017 Nov;25(11):611-617. doi: 10.1007/s12471-017-1038-4.

Everolimus-eluting bioresorbable vascular scaffold in daily clinical practice: A single-centre experience.

Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation

W S Remkes, R S Hermanides, M W Kennedy, E Fabris, E Kaplan, J P Ottervanger, A W J van 't Hof, E Kedhi

Affiliations

  1. Isala Hartcentrum, Zwolle, The Netherlands.
  2. Isala Hartcentrum, Zwolle, The Netherlands. [email protected].

PMID: 28913627 PMCID: PMC5653537 DOI: 10.1007/s12471-017-1038-4

Abstract

BACKGROUND: Recent evidence has raised concerns regarding the safety of the everolimus-eluting bioresorbable vascular scaffold (E-BVS) (Absorb, Abbott Vascular, Santa Clara, CA, USA). Following these data, the use of this device has diminished in the Netherlands; however, daily practice data are limited. Therefore we studied the incidence of safety and efficacy outcomes with this device in daily clinical practice in a single large tertiary centre in the Netherlands.

METHODS: All E‑BVS treated patients were included in this analysis. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel non-fatal myocardial infarction (TV-MI) and clinically-driven target lesion revascularisation (TLR). The secondary endpoint was the incidence of definite scaffold thrombosis.

RESULTS: Between October 2013 and January 2017, 105 patients were treated with 147 E‑BVS. This population contained 42 (40%) patients with diabetes mellitus and 43 (40.9%) undergoing treatment for acute coronary syndrome, and thus represents a high-risk patient cohort. Mean follow-up was 19.8 months. Intravascular imaging guidance during scaffold implantation was used in 64/105 (43.5%) patients. The primary endpoint (TLF) occurred in 3 (2.9%) patients. All-cause mortality and cardiac mortality occurred in 2 (2%) and 0 (0%) patients respectively. TV-MI occurred in 2 patients (1.9%): both were periprocedural and not related to the BVS implantation. TLR occurred in 1 patient (1.0%) during follow-up. No definite scaffold thrombosis occurred during follow-up.

CONCLUSION: This single-centre study examining the real-world experience of E‑BVS implantation in a high-risk population shows excellent procedural safety and long-term clinical outcomes.

Keywords: Bioresorbable scaffold; Coronary artery disease; Percutaneous coronary intervention; Scaffold thrombosis

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