Clinical Outcomes of Drug-Coated Balloon Treatment After Successful Revascularization of de novo Chronic Total Occlusions

Eun Jung Jun; Eun-Seok Shin; Eu-Vin Teoh; Youngjune Bhak; Song Lin Yuan; Chong-Mow Chu; Scot Garg; Houng Bang Liew

doi:10.3389/fcvm.2022.821380

Clinical Outcomes of Drug-Coated Balloon Treatment After Successful Revascularization of de novo Chronic Total Occlusions

Front Cardiovasc Med. 2022 Apr 13:9:821380. doi: 10.3389/fcvm.2022.821380. eCollection 2022.

Authors

Eun Jung Jun^{1

2}, Eun-Seok Shin^{1

2}, Eu-Vin Teoh³, Youngjune Bhak⁴, Song Lin Yuan^{1

5}, Chong-Mow Chu³, Scot Garg⁶, Houng Bang Liew³

Affiliations

¹ Department of Cardiology, Ulsan Medical Center, Ulsan, South Korea.
² Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.
³ Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia.
⁴ Department of Biomedical Engineering, College of Information-Bio Convergence Engineering, Ulsan National Institute of Science and Technology (UNIST), Ulsan, South Korea.
⁵ Department of Cardiology, Dong-A University Hospital, Busan, South Korea.
⁶ Department of Cardiology, East Lancashire Hospitals NHS Trust, Lancashire, United Kingdom.

Abstract

Background: The safety and efficacy of drug-coated balloon (DCB) treatment for de novo coronary chronic total occlusion (CTO) remain uncertain. The aim of this study was to evaluate the outcomes of DCB only treatment for de novo CTO.

Methods: In this retrospective study, 101 vessels with de novo CTO lesions dilated by balloon angioplasty with thrombolysis in myocardial infarction flow grade 3 were included. Among them, 93 vessels successfully treated with DCB only treatment were analyzed. The study endpoint was major adverse cardiac events (MACE) at 2 years, a composite of cardiac death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR), and target vessel thrombosis. The secondary endpoint was late lumen loss (LLL) on follow-up coronary angiography.

Results: All 84 patients were followed up clinically, and 67 vessels underwent scheduled coronary angiography after 6 months. There were no procedural complications, and three vessels required bailout-stenting. The median follow-up was 720 days (interquartile range [IQR]; 406-1,268 days). MACE occurred in 8.3% of the patients after 1 year, including cardiac death (1.2%), TVR (7.1%), and no non-fatal MI and target vessel thrombosis. Two years after treatment, MACE occurred in 16.7% of the patients, including cardiac death (2.4%), non-fatal MI (3.6%), TVR (13.1%), and no target vessel thrombosis. The mean LLL was 0.03 ± 0.53 mm. Binary restenosis occurred in 14.9% of the treated vessels, and 3.0% of the vessels had late re-occlusion on follow-up coronary angiography.

Conclusions: If the result of revascularization using balloon angioplasty is good, the clinical outcomes of DCB only treatment of de novo CTOs at the 2-year follow-up are encouraging, with a low rate of hard endpoints and acceptable MACE rates (Clinical Trial Registration Information; Impact of Drug-coated Balloon Treatment in de novo Coronary Lesion; NCT04619277).

Keywords: chronic total occlusion (CTO); clinical outcome; coronary artery disease; de novo; drug-coated balloon (DCB).

Associated data

ClinicalTrials.gov/NCT04619277