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. 2022 Dec 2;18(11):e940–e948. doi: 10.4244/EIJ-D-21-01098

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