Research Article

Drug-Coated Balloon-Only Angioplasty Outcomes in Diabetic and Nondiabetic Patients with De Novo Small Coronary Vessels Disease

Table 4

One-year outcomes.

Study endpointsOverall population (n = 1198)Nondiabetic (n = 768)Diabetic (n = 430) value

TLF28 (2.3%)11 (1.4%)17 (3.9%)0.006
 TLR13 (1%)4 (0.5%)9 (2%)0.014
 TVMI4 (0.3%)1 (0.1%)3 (0.6%)0.110
 Cardiac death11 (0.9%)6 (0.7%)5 (1.1%)0.513
MACE40 (3.3%)21 (2.7%)19 (4.4%)0.120
 Myocardial infarction4 (0.3%)1 (0.1%)3 (0.6%)0.110
 TVR18 (1.5%)8 (1%)10 (2.3%)0.080
 All-cause death18 (1.5%)12 (1.5%)6 (1.3%)0.820
Others
 CABG + PCI56 (4.6%)33 (4.2%)23 (5.3%)0.408

Angiographic follow-up at 12 months
Overall population (n = 535)Nondiabetic (n = 349)Diabetic (n = 186) value

Reference vessel diameter (mm)2.5 ± 0.72.5 ± 0.82.5 ± 0.20.629
Minimum lumen diameter before angioplasty (mm)0.35 ± 1.870.39 ± 2.340.28 ± 0.230.315
Minimum lumen diameter after angioplasty (mm)2.06 ± 0.352.07 ± 2.352.04 ± 2.350.136
Acute gain1.79 ± 0.411.8 ± 0.411.77 ± 0.420.154
Minimum lumen diameter 12 months after angioplasty (mm)1.97 ± 0.442 ± 0.391.89 ± 0.530.007
Late lumen loss (mm)0.12 ± 0.300.09 ± 0.250.17 ± 0.370.003
Binary restenosis, n (%)13 (2.4%)4 (1.1%)9 (4.8%)0.008

Statistically significant. CABG: coronary artery bypass graft; MACE: major adverse cardiac events; PCI: percutaneous coronary intervention; TLF: target lesion failure; TLR: target lesion revascularization; TVMI: target vessel myocardial infarction; TVR: target vessel revascularization.