Table 2. CEC adjudicated outcomes through 5 years*¶.
Outcome | Rate |
---|---|
CD-TLR | 30.6% (366) |
Any TLR | 31.3% (374) |
Safety composite‡ | 67.4% (392) |
Major adverse event composite | 45.9% (589) |
Death (all-cause) | 19.5% (244) |
CD-TVR | 31.9% (381) |
Major target limb amputation | 1.7% (19) |
Thrombosis | 5.7% (73) |
*Up to 1,800 days post-procedure. ¶Per Kaplan-Meier estimate (number of patients with an event). ‡Defined as freedom from device- and procedure- related death through 30 days, major target limb amputation and CD-TVR within 5 years, per KM analysis. CD-TLR: clinically driven target lesion revascularisation; CD-TVR: clinically driven target vessel revascularisation; CEC: clinical events committee; TLR: target lesion revascularisation |