Comparison of drug-eluting stents and drug-coated balloon for the treatment of drug-eluting coronary stent restenosis: A randomized RESTORE trial

Yiu Tung Anthony Wong, Do Yoon Kang, Jin Bae Lee, Seung-Woon Rha, Young Joon Hong, Eun Seok Shin, Sung Ho Her, Chang Wook Nam, Woo Young Chung, Moo Hyun Kim, Cheol Hyun Lee, Pil Hyung Lee, Jung Min Ahn, Soo Jin Kang, Seung Whan Lee, Young Hak Kim, Cheol Whan Lee, Seong Wook Park, Duk Woo Park, Seung Jung Park

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Abstract

Background This study sought to evaluate the optimal treatment for in-stent restenosis (ISR) of drug-eluting stents (DESs). Methods This is a prospective, multicenter, open-label, randomized study comparing the use of drug-eluting balloon (DEB) versus second-generation everolimus-eluting stent for the treatment of DES ISR. The primary end point was in-segment late loss at 9-month routine angiographic follow-up. Results A total of 172 patients were enrolled, and 74 (43.0%) patients underwent the angiographic follow-up. The primary end point was not different between the 2 treatment groups (DEB group 0.15 ± 0.49 mm vs DES group 0.19 ± 0.41 mm, P =.54). The secondary end points of in-segment minimal luminal diameter (MLD) (1.80 ± 0.69 mm vs 2.09 ± 0.46 mm, P =.03), in-stent MLD (1.90 ± 0.71 mm vs 2.29 ± 0.48 mm, P =.005), in-segment percent diameter stenosis (34% ± 21% vs 26% ± 15%, P =.05), and in-stent percent diameter stenosis (33% ± 21% vs 21% ± 15%, P =.002) were more favorable in the DES group. The composite of death, myocardial infarction, or target lesion revascularization at 1 year was comparable between the 2 groups (DEB group 7.0% vs DES group 4.7%, P =.51). Conclusions Treatment of DES ISR using DEB or second-generation DES did not differ in terms of late loss at 9-month angiographic follow-up, whereas DES showed better angiographic results regarding minimal MLD and percent diameter stenosis. Both treatment strategies were safe and effective up to 1 year after the procedure.

Original languageEnglish
Pages (from-to)35-42
Number of pages8
JournalAmerican Heart Journal
Volume197
DOIs
Publication statusPublished - 2018 Mar 1

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Wong, Y. T. A., Kang, D. Y., Lee, J. B., Rha, S-W., Hong, Y. J., Shin, E. S., Her, S. H., Nam, C. W., Chung, W. Y., Kim, M. H., Lee, C. H., Lee, P. H., Ahn, J. M., Kang, S. J., Lee, S. W., Kim, Y. H., Lee, C. W., Park, S. W., Park, D. W., & Park, S. J. (2018). Comparison of drug-eluting stents and drug-coated balloon for the treatment of drug-eluting coronary stent restenosis: A randomized RESTORE trial. American Heart Journal, 197, 35-42. https://doi.org/10.1016/j.ahj.2017.11.008