Mid-term outcomes of using drug-coated balloon angioplasty for the treatment of large vessel de novo coronary lesions: comparison of large and small vessels.

Background: Although a number of studies involving small-vessel de novo coronary disease have indicated that drug-coated balloons (DCBs) angioplasty, provides clinical benefits, the clinical value of DCB in large-vessel lesions remains unclear. We therefore conducted a real-world study to evaluate the midterm clinical outcomes of DCB treatment in patients with de novo coronary lesions >3.0 mm.

Methods: We performed a retrospective study of 1,514 consecutive patients who received paclitaxel DCB angioplasty to treat de novo coronary lesions at Beijing Anzhen Hospital between June 2019 and November 2021. Lesions with a reference vessel diameter (RVD) ≥3.0 mm were defined as large-vessel disease (LVD), and lesions with an RVD ≤2.75 mm were defined as small-vessel disease (SVD). The LVD and SVD groups included 462 and 1,052 patients, respectively. The end points of the study were all-cause death, myocardial infarction (MI), stroke, and target vessel revascularization (TVR). Outcomes were compared between the LVD and SVD groups. The median follow-up was 34.2 months [interquartile range (IQR), 31.3 to 39.7 months] in the overall cohort.

Results: Of the 1,514 patients, 43 (2.8%) died, 21 (1.4%) experienced MI, and 21 (1.4%) experienced stroke; 167 (11.0%) underwent TVR. No significant differences were observed in mortality rate (LVD: 2.4%; SVD: 3.0%; P=0.32), MI (LVD: 1.1%; SVD: 1.5%; P=0.37), stroke (LVD: 0.9%; SVD: 1.6%, P=0.19) and TVR (LVD: 11.9%; SVD: 10.6%, P=0.92). After multivariate adjustment, the adjusted hazard ratios (HRs) [95% confidence interval (CI)] for LVD versus SVD were 1.092 (0.447-2.670; P=0.85) for death, 1.424 (0.464-4.369; P=0.54) for MI, 1.604 (0.529-4.864; P=0.40) for stroke, and 0.995 (0.719-1.378; P=0.98) for TVR, with no significant differences observed in any endpoints between the two groups.

Conclusions: The findings from this study indicate that the prognosis of DCB for patients with de novo lesions in vessels exceeding 3.0 mm are not significantly different compared to those of DCB for patients with SVD.