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Prospective randomized trial of paclitaxel-coated balloon versus bare-metal stent in high bleeding risk patients with de novo coronary artery lesions

Shin, Eun-Seoka,*; Lee, Joo Myungb,*; Her, Ae-Youngd; Chung, Ju-Hyuna; Lee, Kyung Eune; Garg, Scoth; Nam, Chang-Wookf; Doh, Joon-Hyungg; Koo, Bon-Kwonc

doi: 10.1097/MCA.0000000000000755
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Background In patients with high bleeding risk, percutaneous coronary intervention is still debated. This study compared 9-month angiographic and physiologic results in patients with high bleeding risk and de novo coronary lesions treated with either paclitaxel-coated balloon (PCB) or bare-metal stent (BMS).

Patients and methods A total of 40 patients (40 lesions) with high bleeding risk who underwent successful balloon angioplasty with fractional flow reserve (FFR) after balloon angioplasty more than 0.80 were randomized 1 : 1 to treatment with PCB versus BMS. Dual antiplatelet therapy was limited to 1 month after the procedure.

Results Baseline clinical and lesional characteristics were well balanced between the two groups. There was no significant difference in the postprocedural FFR (0.87±0.06 in PCB vs. 0.89±0.06 in BMS, P=0.254). At 9 months, late luminal loss was significantly lower in the PCB group (0.2±0.3 vs. 1.2±0.8 mm, P<0.001). Restenosis only occurred in the BMS group (0 vs. 25.0%, P=0.049).

Conclusion In patients with high bleeding risk, FFR-guided PCB treatment showed superior efficacy in terms of angiographic and physiologic patency compared with BMS at mid-term follow-up with only 1 month of dual antiplatelet therapy (Clinicaltrials.gov identifier, NCT02456402).

aDepartment of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan

bDepartment of Internal Medicine, Samsung Medical Center, Division of Cardiology, Heart Vascular Stroke Institute, Sungkyunkwan University School of Medicine, Seoul

cDepartment of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea

dDepartment of Internal Medicine, Division of Cardiology

eDepartment of Mechanical and Biomedical Engineering, Kangwon National University, Chuncheon

fDepartment of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu

gDivision of Cardiology, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea

hDepartment of Cardiology, East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, UK

* Eun-Seok Shin and Joo Myung Lee contributed equally to the writing of this article

Correspondence to Eun-Seok Shin, MD, PhD, Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, 877 Bangeojinsunhwan-doro, Dong-gu, UlsanDong-gu, Ulsan 682-714, Republic of Korea Tel: +82 522 507 056; fax: +82 523 675 0805; e-mail: sesim1989@gmail.com

Received December 10, 2018

Received in revised form April 1, 2019

Accepted April 6, 2019

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