Table 3. Summary of annual outcomes through 5 years.
| Key outcomes | |||||
|---|---|---|---|---|---|
| Kaplan-Meier estimates | 1 year | 2 years | 3 years | 4 years | 5 years |
| Freedom from all-cause death with vital status*¶ | 96.1% | 92.2% | 87.8% | 83.5% | 78.9% |
| Freedom from CD-TLR*‡ | 92.8% | 83.5% | 77.1% | 73.0% | 69.4% |
| Proportion rates, % (n/N)§ | 1 year [14] | 2 years [12]‡ | 3 years [13] | 4 years | 5 years |
| CD-TLR | 7.5% (98/1,311) | 16.8% (214/1,276) | 22.9% (289/1,262) | 26.1% (330/1,266) | 30.1% (366/1,215) |
| Major adverse events | 12.0% (157/1,311) | 25.5% (325/1,276) | 34.8% (439/1,262) | 40.7% (515/1,266) | 48.5% (589/1,215) |
| All-cause death | 3.5% (46/1,311) | 7.9% (101/1,276) | 11.6% (147/1,262) | 15.5% (196/1,266) | 20.1% (244/1,215) |
| CD-TVR | 8.1% (106/1,311) | 17.6% (224/1,276) | 23.7% (299/1,262) | 26.9% (341/1,266) | 31.4% (381/1,215) |
| Major target limb amputation | 0.2% (3/1,311) | 0.7% (9/1,276) | 1.0% (12/1,262) | 1.1% (14/1,266) | 1.6% (19/1,215) |
| Thrombosis | 2.9% (38/1,311) | 4.5% (57/1,276) | 5.6% (71/1,262) | 5.6% (71/1,266) | 6.0% (73/1,215) |
| *Kaplan-Meier estimates based on final locked database. ¶Vital status not CEC adjudicated. ‡Results updated since the original publication. §Data derived from different snapshots from the database; site monitoring and collection of additional data between follow-up timepoints impacted the sample size at each time point. CD-TLR: clinically driven target lesion revascularisation; CD-TVR: clinically driven target vessel revascularisation | |||||