Abstract
We report a case of a 65-year-old female patient treated with an everolimus-eluting bioresorbable scaffold (BRS) after rotational atherectomy of a severely calcified lesion of the left anterior descending coronary artery. The implanted BRS restenosed 10 months after implantation and was treated with a scoring balloon followed by drug-eluting balloons with good immediate and long-term results. To the best of our knowledge, this is the first report of a balloon-only treatment of a restenosis occurring more than 6 months after BRS implantation; angiographic and optical coherence tomography images after treatment and at two-year follow-up are presented.
Case report
A 65-year-old female patient presented in January 2013 with unstable angina. Coronary angiography showed a severely calcified long lesion of the proximal and mid segments of the left anterior descending coronary artery [Video S1 (please see enhanced content link on title page)]. In view of the angiographic findings, a decision was taken to do a planned rotational atherectomy (RA), which was performed with the Rotablator™ (Boston Scientific) using 1.5 then 1.75 mm burr sizes, followed by implantation of two overlapping 3.0 × 28 mm bioresorbable scaffolds (BRS) (Absorb™, Abbott). Post-dilatation was done using a 3.0 mm non-compliant balloon at 20 atm. Intravascular ultrasound (IVUS) showed a good result with a minimal overlapping zone (Fig. 1). A coronary angiography done 10 months later due to recurrent angina revealed a significant restenosis of the implanted BRS. Optical coherence tomography (OCT) showed a diffuse homogeneous intra-scaffold neointimal tissue with a minimum luminal area of 1.59 mm2 at the distal BRS and 1.98 mm2 at the proximal one (Fig. 2). A scoring balloon angioplasty using a 3.0 × 10 mm AngioSculpt™ scoring balloon (AngioScore) was performed followed by 3.5 × 20 and 3.0 × 20 mm Pantera Lux™ (Biotronik) paclitaxel eluting balloons (DEB) in the proximal and distal scaffolds, respectively. OCT clearly showed the neointimal cuts achieved by the scoring elements (white arrowheads, Fig. 3), neointimal disruption with some intraluminal material (yellow arrowheads, Fig. 3) and lumen expansion. At 2 years after balloon angioplasty (almost 3 years after BRS implantation), the patient remained asymptomatic and a scheduled angiographic control showed a patent vessel with no significant lesions. OCT showed favorable evolution of the neointimal damage caused by the scoring balloon and maintenance of the initial lumen expansion, with partial resorption of the scaffold struts for which footprints were still visible (Fig. 4).
Compliance with Ethics Guidelines
Informed consent was obtained from the patient for being included in the study.
Discussion
The most important proposed advantage of BRS over the current metallic stent technology is to restore the natural physiologic vasomotor function and to hinder late thrombotic events. In our case, the initial treatment strategy was using RA in disrupting the continuity of intravascular calcium rings facilitating BRS implantation and potentially achieving a stent-free vessel in the long-term.
RA is a safe and effective method for lesion preparation before stent implantation [1] and its use could be extrapolated before BRS implantation, where lesion preparation is of utmost importance. However, additional vessel injury with RA has been previously suggested to be associated with increased late lumen loss [2]. In our case, this mechanism appears very likely because the in-scaffold restenosis was diffuse and affected both implanted BRSs.
The rate of target-lesion revascularization ranges from 1 % to 3.3 % after BRS implantation [3, 4]. The most often used method for the treatment of in-scaffold restenosis is a drug-eluting stent (DES) [5], but there is no sufficient data supporting this approach, and the optimal treatment strategy is still uncertain. Drug-eluting balloons have demonstrated their efficacy in treatment of restenosis following metallic stent implantation [6]. Additionally, scoring balloon predilatation prevents balloon slippage and enhances local plaque disruption, and its use in combination with DEB angioplasty improved angiographic results in the ISAR-DESIRE 4 Study [7]. In this reported case, by adopting the scoring/paclitaxel-coated balloon strategy, we tried avoiding a metallic stent implantation targeting to maintain the long-term benefits of BRS. The entire resorption process of BRS takes approximately 3 years to complete. However, between 3 and 6 months and as a consequence of hydrolysis of ester bonds, the device loses its structural continuity, and the radial strength decreases considerably until it is lost [8]. This loss of radial force is suspected to be source of recoil when balloon dilatation is performed alone after 6 months. In this patient, the vessel wall 10 months after BRS implantation opposed minimal recoil to the scoring/DEB treatment, which achieved sufficient stable lumen size and remained effective until 2 years of follow-up.
In our case we tried to highlight the possibility of a balloon-only treatment of a restenosed bioresorbable scaffold. With an adequate initial lesion preparation, this strategy can be even applied in severely calcified coronary lesions. Finally, given the limited data, there is a need for further examination of the place of RA before BRS implantation and the optimal treatment strategy for in-scaffold restenosis from future RCTs.
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Acknowledgments
No funding or sponsorship was received for publication of this article. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published.
Disclosures
G. Richardt reports receiving an institutional research Grant from Biotronik and St. Jude Medical. G. Richardt is also an advisory board member for Abbott Vascular and Boston Scientific and reports receiving lecture fees from Abbott Vascular, Biotronik, Boston Scientific, and Edwards Lifesciences. M. Abdel-Wahab is a proctor for Boston Scientific and reports receiving an institutional research grant from Biotronik and St. Jude Medical. A. Allali has no conflicts of interest to declare.
Compliance with Ethics Guidelines
Informed consent was obtained from the patient for being included in the study.
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Allali, A., Abdel-Wahab, M. & Richardt, G. Two-year Optical Coherence Tomography Findings after Balloon-Only Treatment of Bioresorbable Scaffold Restenosis in a Calcified Coronary Lesion: A Case Report. Cardiol Ther 5, 223–228 (2016). https://doi.org/10.1007/s40119-016-0068-0
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DOI: https://doi.org/10.1007/s40119-016-0068-0