Dataset Information

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

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).

SUBMITTER: Kun L

PROVIDER: S-EPMC8542469 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background and objectiveThe de novo coronary lesions are the most common form of coronary artery disease, and stent implantation still is the main therapeutic strategy. This network meta-analysis aims to evaluate the efficacy of drug-coated balloons only (DCB only) and DCB combined with bare-metal stents (DCB+BMS) strategies vs. drug-eluting stents (DES) and BMS approaches in coronary artery de novo lesion.MethodPubMed, EMBASE, and Cochrane Library databases were retrieved to include the relevant randomized controlled trials that compared DCB approaches and stents implantation in patients with de novo coronary artery diseases. The primary outcome was major adverse cardiac events (MACE). The clinical outcomes included target lesion revascularization (TLR), all-cause death, and myocardial infarction. The angiographic outcomes consisted of in-segment late lumen loss (LLL) and binary restenosis. The odds ratio (OR) and 95% confidence intervals (95% CIs) for dichotomous data, and weighted mean differences for continuous data were calculated in the Bayesian network frame.ResultA total of 26 randomized controlled trials and 4,664 patients were included in this study. The DCB-only strategy was comparable with the efficacy of MACE, clinical outcomes, and binary restenosis compared with DES. In addition, this strategy can significantly reduce the in-segment LLL compared with the first-generation (MD -0.29, -0.49 to -0.12) and the second-generation DES (MD -0.15, -0.27 to -0.026). However, subgroup analysis suggested that DCB only was associated with higher in-segment LLL than DES (MD 0.33, 0.14 to 0.51) in patients with acute coronary syndrome. Compared with DES, the DCB+BMS strategy had a similar incidence of myocardial infarction and all-cause death, but a higher incidence of MACE, TLR, and angiographic outcomes. In addition, DCB+BMS was associated with a similar incidence of myocardial infarction and all-cause death than BMS, with a lower incidence of MACE, TLR, and angiographic outcomes.ConclusionThe DCB only is associated with similar efficacy and lower risk of LLL compared with DES. In addition, the DCB+BMS strategy is superior to BMS alone but inferior to DES (PROSPERO, CRD 42021257567).Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/#recordDetails.