Abstract
Objectives
The objective was to investigate the acute mechanical effects of post-dilatation on bioresorbable scaffolds (BRS) as determined by optical coherence tomography (OCT).
Background
Post-dilatation with high-pressure balloons is regarded as a key component of BRS implantation for treatment of coronary artery stenoses. However, the impact of post-dilatation on BRS in vivo has not been thoroughly investigated.
Methods
OCT was performed after the implantation procedure of 51 everolimus-eluting or novolimus-eluting polylactic acid-based BRS with (n = 27) or without non-compliant balloon post-dilatation (n = 24). The number of malapposed struts, strut fractures, edge dissections, residual in-scaffold area stenosis, and incomplete scaffold apposition area was analyzed over the complete length of each BRS with a spacing of 1 mm.
Results
OCT revealed a significantly lower incomplete scaffold apposition area if post-dilatation was performed (0.16 ± 0.49 mm2 with post-dilatation vs. 2.65 ± 2.78 mm2 without post-dilatation, p < 0.001), as well as a significantly lower absolute number of malapposed struts (1 ± 2 with post-dilatation vs. 13 ± 13 without post-dilatation, p < 0.001). No significant differences regarding residual in-scaffold area stenosis, strut fracture, edge dissection, symmetry index, or eccentricity index were observed in patients with vs. without post-dilatation.
Conclusion
Post-dilatation of BRS with non-compliant balloons significantly reduces the number of malapposed struts and incomplete scaffold apposition area without inducing higher rates of edge dissection or strut fracture.
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All patients gave written informed consent for the evaluation of clinical, angiographic, procedural, and OCT data. The study was performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. The Ethics Committee of the Justus Liebig University Hospital (Giessen, Germany) approved the study protocol (reference number 203/14).
Conflict of interest
Christian Hamm and Holger Nef received speaking honoraria from Abbott Vascular. Stephan Achenbach and Holger Nef have received research grants (to institution) from Abbott Vascular. Holger Nef also received a research grant (to institution) from Elixir Medical. All the other authors have no potential conflict of interest.
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F. Blachutzik and N. Boeder contributed equally.
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Blachutzik, F., Boeder, N., Wiebe, J. et al. Post-dilatation after implantation of bioresorbable everolimus- and novolimus-eluting scaffolds: an observational optical coherence tomography study of acute mechanical effects. Clin Res Cardiol 106, 271–279 (2017). https://doi.org/10.1007/s00392-016-1048-z
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DOI: https://doi.org/10.1007/s00392-016-1048-z