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

• Published in: The American heart journal 2018-03, Vol.197, p.35-42
• Main Authors: Wong, Yiu Tung Anthony, Kang, Do-Yoon, Lee, Jin Bae, Rha, Seung-Woon, Hong, Young Joon, Shin, Eun-Seok, Her, Sung-Ho, Nam, Chang Wook, Chung, Woo-Young, Kim, Moo Hyun, Lee, Cheol Hyun, Lee, Pil Hyung, Ahn, Jung-Min, Kang, Soo-Jin, Lee, Seung-Whan, Kim, Young-Hak, Lee, Cheol Whan, Park, Seong-Wook, Park, Duk-Woo, Park, Seung-Jung
• Format: Article
• Language: English
• Subjects: Aged; Angioplasty; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Angioplasty, Balloon, Coronary - methods; Catheters; Clinical trials; Coronary Angiography - methods; Coronary Angiography - statistics & numerical data; Coronary Restenosis - diagnosis; Coronary Restenosis - mortality; Coronary Restenosis - prevention & control; Coronary Vessels - diagnostic imaging; Coronary Vessels - pathology; Coronary Vessels - surgery; Drug delivery; Drug-Eluting Stents - adverse effects; Everolimus - therapeutic use; Female; Humans; Immunosuppressive Agents - therapeutic use; Implants; Male; Medical imaging; Middle Aged; Myocardial infarction; Outcome Assessment (Health Care); Paclitaxel - therapeutic use; Patients; Radiation therapy; Randomization; Republic of Korea; Restenosis; Secondary Prevention - methods; Secondary Prevention - statistics & numerical data; Stenosis; Stents; Studies; Surgical implants; Thrombosis
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2017.11.008

This study sought to evaluate the optimal treatment for in-stent restenosis (ISR) of drug-eluting stents (DESs). 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. 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). 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.