Background: Drug-coated balloons (DCB) have been evaluated to be safe
and practical in treating coronary small vessel disease (SVD). However, evidence
about the practicality and safety of DCB in treating coronary lesions with
diameters greater than 3.0 mm is limited. Methods: 1166 patients who
received DCB angioplasty were enrolled and divided into groups of SVD or large
vessel disease (LVD) according to the target vessel diameters (3.0 mm for SVD;
3.0 mm for LVD). All participants received a 2-year follow-up. The two
main outcomes were patient-oriented composite endpoint (patient-oriented
composite endpoint (POCE), all-cause mortality, all myocardial infarctions [MI],
or any revascularization), and target lesion failure (target lesion failure
(TLF), cardiac death, target vessel MI, or ischemia-driven target lesion
revascularization). Results: In these patients, a total of 30 (2.6%)
TLF and 82 (7.0%) POCE were recorded. Patients in the LVD group showed
statistically greater rates of lesion success compared to the SVD group (752
[96.0%] vs. 380 [99.2%], p = 0.004) and procedural success (751
[95.9%] vs. 380 [99.2%], p = 0.003). No significant difference was
found in the 2-year risk of TLF (hazard ratio (HR) 1.41, 95% CI 0.58–3.44;
p = 0.455), POCE (HR 1.29, 95% CI 0.76–2.20; p = 0.354), MI
(HR 0.88, 95% CI 0.24–3.13; p = 0.837), revascularization (HR 1.22,
95% CI 0.68–2.21; p = 0.506), and stroke (HR 0.78, 95% CI
0.03–15.26; p = 0.784) between the SVD and LVD groups.
Conclusions: There was no discernible inferiority of the DCB
intervention in the LVD group as compared to the SVD group. The DCB intervention
is practical for coronary lesions with diameters higher than 3.0 mm.
