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W.S. Remkes and R.S. Hermanides contributed equally to this article.
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.
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.
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.
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.
Serruys PW, Chevalier B, Sotomi Y, et al. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016;388:2479–91. CrossRefPubMed
Ellis SG, Kereiakes DJ, Stone GW, et al. Everolimus-eluting bioresorbable vascular scaffolds in patients with coronary artery disease: ABSORB III trial 2‑year results. Presented at: ACC 2017. March 18, 2017, Washington, DC. https://www.tctmd.com/news/absorb-iii-two-year-results-show-higher-mace-rate-compared-xience (2017, accessed 17 April 2017).
Wykrzykowska JJ, Kraak RP, Hofma SH, et al. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med. 2017;376(24):2319–2328. https://doi.org/10.1056/NEJMoa1614954
US Food and Drug Administration. Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: letter to healthcare providers – FDA investigating increased rate of major adverse cardiac events. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm547256.htm. Published on. March, Vol. 18. 2017.
Onuma Y, Sotomi Y, Shiomi H, et al. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial. EuroIntervention. 2016;12:1090–101. CrossRefPubMed
Serruys PW, Chevalier B, Dudek D, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1‑year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385:43–54. CrossRefPubMed
Tanaka A, Latib A, Kawamoto H, et al. Clinical outcomes of a real world cohort following bioresorbable vascular scaffold implantation utilizing an optimized implantation strategy. EuroIntervention. 2017;12(14):1730–1737. https://doi.org/10.4244/EIJ-D-16-00247
Brugaletta S, Gori T, Low AF, et al. Absorb Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Metallic Stent in ST-Segment Elevation Myocardial Infarction: 1‑Year Results of a Propensity Score Matching Comparison: The BVS-EXAMINATION Study (Bioresorbable Vascular Scaffold-A Clinical. JACC Cardiovasc Interv. 2015;8:189–97. CrossRefPubMed
Foin N, Gutierrez-Chico JL, Nakatani S, et al. Incomplete Stent Apposition Causes High Shear Flow Disturbances and Delay in Neointimal Coverage as a Function of Strut to Wall Detachment Distance: Implications for the Management of Incomplete Stent Apposition. Circ Cardiovasc Interv. 2014;7:180–9. CrossRefPubMed
- Everolimus-eluting bioresorbable vascular scaffold in daily clinical practice: A single-centre experience
W. S. Remkes
R. S. Hermanides
M. W. Kennedy
J. P. Ottervanger
A. W. J. van ’t Hof
- Bohn Stafleu van Loghum