Yiu Tung Anthony Wong1, Do-Yoon Kang2, Jin Bae Lee3, Seung-Woon Rha4, Young Joon Hong5, Eun-Seok Shin6, Sung-Ho Her7, Chang Wook Nam8, Woo-Young Chung9, Moo Hyun Kim10, Cheol Hyun Lee2, Pil Hyung Lee2, Jung-Min Ahn2, Soo-Jin Kang2, Seung-Whan Lee2, Young-Hak Kim2, Cheol Whan Lee2, Seong-Wook Park2, Duk-Woo Park11, Seung-Jung Park2. 1. Division of Cardiology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong. 2. Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. 3. Daegu Catholic University Medical Center, Daegu, South Korea. 4. Cardiovascular Center, Korea University Guro Hospital, Seoul, South Korea. 5. Departments of Cardiology, Chonnam National University Medical School, Gwangju, South Korea. 6. Ulsan University Hospital, Ulsan, South Korea. 7. The Catholic University of Korea, Daejeon ST. Mary's Hospital, Daejeon, South Korea. 8. Keimyung University Dongsan Medical Center, Daegu, South Korea. 9. SMA-SNU Boramae Medical Center, Seoul, South Korea. 10. Donga University Hospital, Busan, South Korea. 11. Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. Electronic address: dwpark@amc.seoul.kr.
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 1year after the procedure.
RCT Entities:
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 1year after the procedure.
Authors: Daniele Giacoppo; Fernando Alfonso; Bo Xu; Bimmer E P M Claessen; Tom Adriaenssens; Christoph Jensen; María J Pérez-Vizcayno; Do-Yoon Kang; Ralf Degenhardt; Leos Pleva; Jan Baan; Javier Cuesta; Duk-Woo Park; Heribert Schunkert; Roisin Colleran; Pavel Kukla; Pilar Jiménez-Quevedo; Martin Unverdorben; Runlin Gao; Christoph K Naber; Seung-Jung Park; José P S Henriques; Adnan Kastrati; Robert A Byrne Journal: Eur Heart J Date: 2020-10-07 Impact factor: 29.983