Research Article
Drug-Coated Balloon-Only Angioplasty Outcomes in Diabetic and Nondiabetic Patients with De Novo Small Coronary Vessels Disease
| Study endpoints | Overall population (n = 1198) | Nondiabetic (n = 768) | Diabetic (n = 430) | value |
| TLF | 28 (2.3%) | 11 (1.4%) | 17 (3.9%) | 0.006 | TLR | 13 (1%) | 4 (0.5%) | 9 (2%) | 0.014 | TVMI | 4 (0.3%) | 1 (0.1%) | 3 (0.6%) | 0.110 | Cardiac death | 11 (0.9%) | 6 (0.7%) | 5 (1.1%) | 0.513 | MACE | 40 (3.3%) | 21 (2.7%) | 19 (4.4%) | 0.120 | Myocardial infarction | 4 (0.3%) | 1 (0.1%) | 3 (0.6%) | 0.110 | TVR | 18 (1.5%) | 8 (1%) | 10 (2.3%) | 0.080 | All-cause death | 18 (1.5%) | 12 (1.5%) | 6 (1.3%) | 0.820 | Others | | | | | CABG + PCI | 56 (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 ± 0.7 | 2.5 ± 0.8 | 2.5 ± 0.2 | 0.629 | Minimum lumen diameter before angioplasty (mm) | 0.35 ± 1.87 | 0.39 ± 2.34 | 0.28 ± 0.23 | 0.315 | Minimum lumen diameter after angioplasty (mm) | 2.06 ± 0.35 | 2.07 ± 2.35 | 2.04 ± 2.35 | 0.136 | Acute gain | 1.79 ± 0.41 | 1.8 ± 0.41 | 1.77 ± 0.42 | 0.154 | Minimum lumen diameter 12 months after angioplasty (mm) | 1.97 ± 0.44 | 2 ± 0.39 | 1.89 ± 0.53 | 0.007 | Late lumen loss (mm) | 0.12 ± 0.30 | 0.09 ± 0.25 | 0.17 ± 0.37 | 0.003 | Binary restenosis, n (%) | 13 (2.4%) | 4 (1.1%) | 9 (4.8%) | 0.008 |
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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. |