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Early vessel healing after implantation of biodegradable-polymer and durable-polymer drug-eluting stent: 3-month angioscopic evaluation of the RESTORE registry

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Abstract

The purpose of this study was to evaluate the vessel healing status 3 months after stent implantation of bioresorbable-polymer drug-eluting stents (BP-DESs) in comparison with durable-polymer DESs (DP-DESs) by angioscopy. Study design was a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful angioscopic examination at planned 3-month follow-up after the DES implantation in the native coronary artery were enrolled. We evaluated main, maximum, minimum strut coverage grades and coverage heterogeneity score defined as a difference between maximum and minimum coverage grades. All lesions were divided into three segments: proximal, mid, and distal segments. A total of 108 patients (66.6 ± 10 years) with 124 lesions were analyzed (BP-DES 57 patients 61 lesions 226 segments vs. DP-DES 57 patients 63 lesions 203 segments; six patients had both BP-DES and DP-DES). Patient and lesion demographics, procedural characteristics were well balanced. Main coverage grade (mean ± standard error; 1.08 ± 0.02 vs. 1.05 ± 0.03, p = 0.354) and minimum coverage grade (1.00 ± 0.00 vs. 1.00 ± 0.00, p > 0.999) were not significantly different between BP-DES and DP-DES groups. Maximum coverage grade was significantly higher in the BP-DES than in the DP-DES (1.45 ± 0.04 vs. 1.35 ± 0.04, p = 0.049). Coverage heterogeneity score did not differ between BP-DES and DP-DES groups (1.05 ± 0.07 vs. 0.90 ± 0.07, p = 0.162). At 3-month follow-up, the current BP-DES had higher maximum stent coverage than the contemporary DP-DES, while main and minimum coverage grades and heterogeneity of the neointimal coverage were comparable. Further prospective randomized trials should be conducted to evaluate the clinical significance of the present imaging results.

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Abbreviations

BP-DES:

Bioresorbable-polymer DESs

DES:

Drug eluting stent

DP-DES:

Durable-polymer DESs

OCT:

Optical coherence tomography

PCI:

Percutaneous coronary intervention

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Authors and Affiliations

  1. Department of Cardiology, Osaka Police Hospital, 10-31, Kitayama, Tennoji, 543-0035, Osaka, Japan

    Satoshi Suzuki, Yohei Sotomi, Tomoaki Kobayashi, Yuma Hamanaka, Shimpei Nakatani, Atsushi Hirayama & Yoshiharu Higuchi

  2. Department of Medicine II, Kansai Medical University, Hirakata, Japan

    Ichiro Shiojima

  3. Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan

    Yasushi Sakata

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  1. Satoshi Suzuki
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  2. Yohei Sotomi
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  3. Tomoaki Kobayashi
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  4. Yuma Hamanaka
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Correspondence to Yohei Sotomi.

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Conflict of interest

Y. Sotomi, S. Nakatani, and Y. Higuchi received speaker honoraria from Abbott Vascular Japan, Boston Scientific Japan, TERUMO, Cardinal Health, and Medtronic. Y. Sakata reports grants and personal fees from Daiichi-Sankyo, Bayer, Boehringer Ingelheim, and Bristol-Myers Squibb. A. Hirayama reports grants and personal fees from Boston Scientific Japan, Abbott Vascular Japan, Japan Lifeline, and Medtronic. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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Suzuki, S., Sotomi, Y., Kobayashi, T. et al. Early vessel healing after implantation of biodegradable-polymer and durable-polymer drug-eluting stent: 3-month angioscopic evaluation of the RESTORE registry. Int J Cardiovasc Imaging 35, 973–980 (2019). https://doi.org/10.1007/s10554-019-01580-2

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