One-Year Outcomes of Peripheral Endovascular Device Intervention in Critical Limb Ischemia Patients: Sub-Analysis of the LIBERTY 360 Study

Figures & data

Table 1 Demographics and Baseline Characteristics

	Rutherford 5–6 (N=404)
Age (years)	69.2 ± 11.6 69.0 [62.0, 78.0] (N=403)
Male sex	272 (67.3)
Race
White	316 (78.2)
Black or African American	77 (19.1)
American Indian or Alaska Native	3 (0.7)
Asian	2 (0.5)
Other^a	6 (1.5)
Body mass index (kg/m^2)	29.4 ± 6.6 28.3 [24.7, 33.4]
Current or former smoker	245 (60.6)
History of:
Diabetes	315 (78.0)
Hyperlipidemia	326 (80.7)
Hypertension	372 (92.1)
Chronic renal disease	168 (41.6)
Coronary artery disease	229 (56.7)
Prior endovascular treatment of target limb	118/403 (29.3)
Previous amputation	N=404
Both limbs	23 (5.7)
Target limb	47 (11.6)
Non-target limb	57 (14.1)
None	277 (68.6)
Highest level of prior target limb amputation	N=70
Toe(s) only	66 (94.3)
Foot only	4 (5.7)
Highest level of prior contralateral limb amputation	N=80
Toe(s) only	39 (48.8)
Foot only	3 (3.8)
Below knee/above ankle	28 (35.0)
Above the knee	10 (12.5)

Notes: Data provided as mean ± standard deviation/median [IQR] or number (percentage) as appropriate. ^aOther race includes patients with more than one race category reported.

Figure 1 Device usage by lesion (N=558) assessed by angiographic core lab. *Hawk: Turbohawk, Silverhawk, Hawk One.

Abbreviations: BMS, bare-metal stent; DCB, drug-coated balloon; DES, drug-eluting stent; OAS, orbital atherectomy system; PTA, percutaneous transluminal angioplasty.

Figure 2 Changes in quality of life from baseline to 12 months (VascuQoL). Vascular Quality of Life Questionnaire: (A) Total score; (B) Physical activity subdomain score; (C) Symptom subdomain score; (D) Pain subdomain score; (E) Emotional subdomain score; and (F) Social subdomain score. Higher subdomain scores indicate better rating of health. Value presented as mean as recorded at each follow-up visit.

Abbreviations: BL, baseline; 30D, 30 days; 6M, 6 months; 12M, 12 months.

Table 2 Freedom from Major Adverse Events and Amputation Free Survival at 30 Days, 6 Months, and 12 Months

	30 Days	6 Months	12 Months
Freedom from MAE	93.5 (91.1, 95.9)	77.2 (72.9, 81.5)	65.5 (60.4, 70.6)
Freedom from death*	98.5 (97.3, 99.7)	91.2 (88.3, 94.1)	86.7 (83.2, 90.2)
Freedom from major amputation	97.2 (95.6, 98.8)	92.2 (89.5, 94.9)	89.6 (86.4, 92.8)
Freedom from TVR	97.0 (95.3, 98.7)	82.8 (78.8, 86.7)	72.1 (67.2, 77.0)
Amputation free survival	96.0 (94.1, 97.9)	84.7 (81.1, 88.4)	78.2 (73.9, 82.4)

Notes: *Death includes all-death, including those beyond 30 days. Values presented as estimated survival rate (lower, upper bound of 95% confidence interval).

Abbreviations: MAE, major adverse events; TVR, target vessel revascularization.

Figure 3 Kaplan–Meier curves for freedom from major adverse events (A) and amputation free survival (B) with number of subjects at risk.

Abbreviation: MAE, major adverse events.

Table 3 Target Limb Wound Healing

	Baseline (N=404)	30 Days		6 Months		12 Months
	Value	Value	Δ from Baseline	Value	Δ from Baseline	Value	Δ from Baseline
Number of wounds on target limb	1.5 ± 0.9 1.0 [1.0, 2.0] (N=404)	1.2 ± 1.0 1.0 [1.0, 2.0] (N=324)	−0.3 ± 0.8 0.0 [−1.0, 0.0]*	0.7 ± 0.8 0.0 [0.0, 1.0] (N=235)	−0.9 ± 1.1 –1.0 [−1.0, 0.0]*	0.4 ± 0.7 0.0 [0.0, 1.0] (N=207)	−1.2 ± 1.1 –1.0 [−2.0, −1.0]*

Notes: *Change in mean number of wounds from baseline significant via paired t-test (p <0.001). Values presented as mean ± standard deviation/median [IQR].

Figure 4 Critical limb ischemia (CLI) patients without revascularization (primary amputation treatment) vs LIBERTY 360 RC5-6 CLI patients (primary endovascular treatment). This summary graph shows the primary amputation rates presented in the literature and the major target limb amputation rates reported in LIBERTY, but it is not a head-to-head comparison since the analyses described vary in design.