TABLE 4.
Risk of clinical outcomes at 30-day and long-term follow-up*.
| Endpoint | All patients | Propensity-matched sample | ||||||
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|
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| DCB group (n = 251) |
DES group (n = 792) |
Odds ratio (95% CI) | P-value | DCB group (n = 199) |
DES group (n = 398) |
Odds ratio (95% CI) | P-value | |
| 30-day follow up, n% | 251 (100.00%) | 792 (100.00%) | – | – | 199 (100.00%) | 398 (100.00%) | – | – |
| TLF† | 1 (0.40%) | 26 (3.28%) | 0.118 (0.016–0.873) | 0.012 | 1 (0.50%) | 14 (3.52%) | 0.139 (0.018–1.061) | 0.026 |
| Cardiac death | 0 (0.00%) | 9 (1.14%) | – | 0.124 | 0 (0.00%) | 6 (1.51%) | – | 0.186 |
| TVMI | 1 (0.40%) | 15 (1.89%) | 0.207 (0.057–1.576) | 0.138 | 1 (0.50%) | 6 (1.51%) | 0.330 (0.039–2.760) | 0.434 |
| Periprocedural | 0 (0.00%) | 10 (1.26%) | – | 0.130 | 0 (0.00%) | 4 (1.01%) | – | 0.307 |
| Non-periprocedural | 1 (0.40%) | 15 (0.63%) | 0.630 (0.073–5.414) | 1.000 | 1 (0.50%) | 2 (0.50%) | 1.000 (0.090–11.095) | 1.000 |
| Clinically driven TLR | 0 (0.00%) | 2 (0.25%) | – | 1.000 | 0 (0.00%) | 0 (0.00%) | – | – |
| Stent thrombosis | 0 (0.00%) | 10 (1.26%) | – | 0.130 | 0 (0.00%) | 4 (1.01%) | – | 0.307 |
| Definite | 0 (0.00%) | 2 (0.25%) | – | 1.000 | 0 (0.00%) | 0 (0.00%) | – | – |
| Probable | 0 (0.00%) | 8 (1.01%) | – | 0.210 | 0 (0.00%) | 4 (1.01%) | – | 0.307 |
| 1-year follow up, n% | 236 (94.02%) | 762 (96.21%) | – | 0.137 | 187 (93.97%) | 385 (96.73%) | – | 0.112 |
| TLF† | 10 (4.24%) | 75 (9.82%) | 0.406 (0.207–0.800) | 0.007 | 6 (3.21%) | 42 (10.91%) | 0.271 (0.113–0.649) | 0.002 |
| Cardiac death | 2 (0.85%) | 16 (2.10%) | 0.399 (0.091–1.746) | 0.271 | 2 (1.07%) | 9 (2.34%) | 0.452 (0.097–2.112) | 0.517 |
| TVMI | 3 (1.27%) | 19 (2.49%) | 0.504 (0.148–1.717) | 0.264 | 2 (1.07%) | 8 (2.08%) | 0.509 (0.107–2.423) | 0.511 |
| Clinically driven TLR | 7 (2.97%) | 49 (6.41%) | 0.446 (0.199–0.998) | 0.044 | 3 (1.60%) | 27 (7.01%) | 0.216 (0.065–0.722) | 0.006 |
| Stent thrombosis | 0 (0.00%) | 13 (1.71%) | – | 0.047 | 0 (0.00%) | 5 (1.30%) | – | 0.178 |
| Definite | 0 (0.00%) | 4 (0.52%) | – | 0.578 | 0 (0.00%) | 1 (0.26%) | – | 1.000 |
| Probable | 0 (0.00%) | 9 (1.18%) | – | 0.126 | 0 (0.00%) | 4 (1.04%) | – | 0.309 |
| All-cause death | 5 (2.12%) | 21 (2.76%) | 0.764 (0.285–2.048) | 0.591 | 5 (2.67%) | 10 (2.60%) | 1.030 (0.347–3.058) | 1.000 |
| 2-year follow up, n% | 218 (86.85%) | 714 (90.15%) | – | 0.140 | 170 (85.43%) | 358 (89.95%) | – | 0.103 |
| TLF† | 19 (8.64%) | 106 (14.64%) | 0.551 (0.330–0.921) | 0.021 | 13 (7.56%) | 52 (14.36%) | 0.487 (0.258–0.922) | 0.025 |
| Cardiac death | 7 (3.21%) | 30 (4.20%) | 0.756 (0.328-1.747) | 0.512 | 5 (2.94%) | 13 (3.63%) | 0.804 (0.282–2.293) | 0.683 |
| TVMI | 5 (2.29%) | 29 (4.05%) | 0.556 (0.213–1.454) | 0.225 | 4 (2.35%) | 14 (3.90%) | 0.594 (0.192–1.832) | 0.359 |
| Clinically driven TLR | 9 (4.09%) | 70 (9.68%) | 0.398 (0.195–0.810) | 0.009 | 5 (2.91%) | 34 (9.42%) | 0.288 (0.111–0.750) | 0.007 |
| Stent thrombosis | 0 (0.00%) | 17 (2.38%) | – | 0.018 | 0 (0.00%) | 6 (1.67%) | – | 0.184 |
| Definite | 0 (0.00%) | 6 (0.84%) | – | 0.345 | 0 (0.00%) | 1 (0.28%) | – | 1.000 |
| Probable | 0 (0.00%) | 11 (1.54%) | – | 0.077 | 0 (0.00%) | 5 (1.39%) | – | 0.182 |
| All-cause death | 12 (5.50%) | 41 (5.74%) | 0.956 (0.493–1.854) | 0.894 | 10 (5.88%) | 19 (5.31%) | 1.115 (0.507–2.453) | 0.786 |
*DCB, drug-coated balloon; DES, drug-coated balloon; CI, confidence interval; TLF, target lesion failure; TVMI, target vessel myocardial infarction; TLR, target lesion revascularization; MI, myocardial infraction.
†TLF defined as the composite outcome of cardiac death, target vessel myocardial infarction, and clinical driven target lesion revascularization.