Table III.
Long-term outcomes of study population
| Factor | BVS (n = 123) | EES (n = 141) | HR/OR (95% CI) | P-value |
|---|---|---|---|---|
| Primary endpoints: | ||||
| TLF: | ||||
| 12-month, % | 9.7 | 8.5 | 2.61 (0.90–7.56) | 0.076 |
| 24-month, % | 15.2 | 14.9 | 2.46 (0.85–7.07) | 0.095 |
| Secondary endpoints: | ||||
| PoCE: | ||||
| 12-month, % | 13.6 | 12.8 | 1.77 (0.79–3.95) | 0.16 |
| 24-month, % | 21.2 | 21.8 | 1.60 (0.72–3.56) | 0.25 |
| Device success (lesion basis)* | 95.4 | 96.6 | 1.15 (0.34–3.86) | 0.82 |
| Procedural success (patient basis)* | 95.1 | 94.3 | 1.40 (0.36–3.55) | 0.62 |
| Clinical outcomes, %: | ||||
| All-cause death: | ||||
| 12-month | 4.9 | 5.7 | 3.17 (0.72–13.86) | 0.13 |
| 24-month | 7.6 | 10.3 | 2.47 (0.64–9.51) | 0.19 |
| Cardiac death: | ||||
| 12-month | 3.9 | 5.7 | 2.44 (0.52–11.49) | 0.26 |
| 24-month | 6.1 | 10.3 | 1.83 (0.44–7.65) | 0.41 |
| All-MI: | ||||
| 12-month | 7.8 | 5.0 | 1.59 (0.52–4.87) | 0.41 |
| 24-month | 9.1 | 8.0 | 0.90 (0.28–2.88) | 0.85 |
| TV-MI: | ||||
| 12-month | 6.8 | 2.8 | 2.66 (0.69–10.32) | 0.16 |
| 24-month | 9.1 | 4.6 | 1.72 (0.44–6.76) | 0.44 |
| ID-TVR: | ||||
| 12-month | 7.8 | 2.8 | 3.96 (0.99–15.70) | 0.052 |
| 24-month | 12.1 | 4.6 | 3.31 (0.81–13.54) | 0.096 |
| ID-TLR: | ||||
| 12-month | 6.8 | 2.1 | 3.85 (0.83–17.72) | 0.084 |
| 24-month | 10.6 | 4.6 | 2.20 (0.58–8.41) | 0.25 |
| Scaffold/stent thrombosis: | ||||
| Definite* | 4.0 | 1.4 | 5.20 (0.73–36.78) | 0.10 |
| Acute* | 0.8 | 0.0 | –** | 0.94 |
| Subacute* | 2.4 | 0.0 | –** | 0.20 |
| Late* | 0.8 | 0.7 | –** | 0.54 |
| Very late* | 0.0 | 1.1 | –** | 0.95 |
*
Logistic regression with odds ratio and 95% confidence interval was performed.
**
Due to distribution of variables in both groups, logistic regression analysis was not possible.
χ2 test with the Yates correction was performed. BVS – bioresorbable vascular scaffold, CI – confidence interval, EES – everolimus-eluting cobalt chromium stent, ID-TLR – ischemia-driven target lesion revascularization, ID-TVR – ischemia-driven target vessel revascularization, HR – hazard ratio, MI – myocardial infarction, OR – odds ratio, PoCE – patient-oriented composite endpoint, TLF – target lesion failure, TV-MI – target vessel myocardial infarction.