Table 3.
Clinical outcomes up to 5 years follow-up.
| Clinical outcomes | 6 months | 1 year | 2 years | 3 years | 4 years | 5 years |
|---|---|---|---|---|---|---|
| Patients at follow-up, n (%)† | 83 (99) | 80 (95) | 78 (94) | 75 (89) | 72 (86) | 72 (86) |
| Primary endpoint n (%): | ||||||
| DoCE* | 6 (7.2) | 8 (9.7) | 13 (16) | 13 (18) | 13 (16) | 14 (18) |
| Cardiac death | 1 (1.2) | 1 (1.2) | 2 (2.5) | 3 (3.6) | 3 (3.6) | 3 (3.6) |
| ScT | 3 (3.6) | 4 (4.9) | 4 (4.9) | 4 (4.9) | 4 (4.9) | 4 (4.9) |
| TV-MI | 3 (3.6) | 4 (4.9) | 4 (4.9) | 4 (4.9) | 4 (4.9) | 4 (4.9) |
| TLR | 5 (6.1) | 7 (8.5) | 11 (14) | 11 (14) | 11 (14) | 12 (16) |
| Secondary endpoints, n (%): | ||||||
| TVR | 2 (2.5) | 2 (2.5) | 3 (3.9) | 3 (3.9) | 3 (3.9) | 7 (11) |
| CABG | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (2.5) | 2 (2.5) | 5 (6.1) |
| Non-cardiac death, n (%) | 0 (0.0) | 3 (3.6) | 4 (4.9) | 4 (4.9) | 4 (4.9) | 4 (4.9) |
Data are presented as number (percentage) and represent Kaplan-Meier estimates.
CABG, Coronary artery bypass grafting; DOCE, device-oriented composite endpoint; ScT, scaffold thrombosis; TLR, target lesion revascularization; TV-MI, target vessel myocardial infarction; TVR, target vessel revascularization.
DoCE (device-oriented composite endpoint) represents a hierarchical composite of cardiac death, scaffold thrombosis (ScT), target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR). Technically, only one adverse outcome of this composite was counted.
A total of seven patients died, and five patients were lost to follow-up (two of them left Switzerland and three withdrew from the study during follow-up).