Yonsei Med J.  2021 Nov;62(11):981-989. 10.3349/ymj.2021.62.11.981.

Sex-Related Outcomes of Successful Drug-Coated Balloon Treatment in De Novo Coronary Artery Disease

• Kun L
• Shin ES
• Jun EJ
• Bhak Y
• Garg S
• Kim TH
• Sohn CB
• Choi BJ
• Hui L
• Yuan SL
• Zhi W
• Hao J
• Zhentao S
• Qiang T

• KMID: 2521448
• DOI: http://doi.org/10.3349/ymj.2021.62.11.981

Abstract

Purpose
Although drug-coated balloon (DCB) treatment is known to be effective for de novo lesions, the influence of sex on angiographic and clinical outcomes remains unknown. This study aimed to investigate the angiographic and clinical impact of DCB treatment in patients with de novo coronary lesions according to sex.
Materials and Methods
A total of 227 patients successfully treated with DCB were retrospectively enrolled and divided into two groups according to sex. The primary endpoint was late lumen loss (LLL) at 6-month angiography, and the secondary endpoint was target vessel failure (TVF), which included cardiac death, target vessel myocardial infarction, target lesion revascularization, and target vessel thrombosis.
Results
The study enrolled 60 women (26.4%) and 167 men (73.6%). Compared to men, women had a smaller vessel size, larger DCB to reference vessel ratio, and more dissections after DCB treatment (55.0% vs. 37.1%, p=0.016). Women also had a significantly higher LLL compared to men (0.12±0.26 mm vs. 0.02±0.22 mm, p=0.012) at the 6-month follow-up angiography. During a median follow-up of 3.4 years (range 12.7–28.9 months), TVF was similar (women 6.7% vs. men 7.8%, p=0.944). In multivariable analysis, women were independently associated with a higher LLL.
Conclusion
LLL was higher in women, but there was no difference in TVF between women and men. Based on multivariable analysis, the women sex was an independent predictor of higher LLL (Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion; NCT04619277).

Keyword

Drug-coated balloon; balloon angioplasty; coronary artery disease; sex difference; clinical outcome