SUPERSUB Trial: 1-yr outcomes of SUPERa SUBintimal stenting in CLI Patients
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1 SUPERSUB Trial: 1-yr outcomes of SUPERa SUBintimal stenting in CLI Patients Dr. L.M. Palena, MD Interventional Radiology Unit Foot & Ankle Clinic Policlinico Abano Terme (PD), ITALY
2 Disclosure I have the following potential conflicts of interest to report: X Consulting: ABBOTT
3 Focus of SUPERSUB Trial Diabetic Patients with CLI Long Femoro-popliteal, calcified CTO s (TASC C D) Multilevel, multivessel arterial disease Poor surgical candidates or s/p failed surgery. Previous EVT
4 EVT OUTCOMES in CLI: Historical-matched cohort treated with PTA. 12 m
5 Can we do better? SUPERSUB Trial Objectives: To assess long-term outcomes of subintimal Supera Stenting for long FEM-POP CTO s in CLI patients.
6 Subintimal Approach: Rationale Long (>15 cm), calcified, fem-pop CTO s are difficult to cross intraluminally. Crossing through the subintimal space creates a NEOLUMEN, which lacks the luminal and intimal disease burden. HOWEVER, Calcified intimal and medial boundaries make the neolumen resistant to PTA and lead to frequent recoiling. Which is addressed by Proper, progressive and aggressive vessel Preparation, prior to SUPERA Stenting.
7 FEATURED SUPERSUB CASE 82 y-o male with CLI, RF 5, DM, s/p TMA. TcPO2=12mmHg. Nonhealing surgical incision.
8 SUPERSUB TECHNIQUE
9 SUPERSUB TECHNIQUE
10 Results
11 1-year DUS Follow up
12 1-year Follow up
13 SUPERSUB: 1-yr Endpoints Primary Efficacy: Stent patency (PSVR < 2.0). Freedom from TLR. Primary Safety: Composite rate of freedom from death from any cause, major amputations, and TLR. Secondary: Stent integrity. Rutherford class shift. AFS. QoL improvement. Cost-efficiency analysis. Follow up: Scheduled visit and DUS at 1, 3, 6, 9 & 12 months.
14 SUPERSUB: Demographics
15 SUPERSUB: Results 34 consecutive diabetic, CLI patients (mean age 76.4 ± 7.5 years; 32 men) TASC D: 24/34 (70.6%) TASC C: 10/34 (29.4%) RF 5: 24/34 (70.6%) RF 6: 8/34 (23.5%) Moderate to severe calcification: 85.3%.
16 SUPERSUB: Results 0 to 1 tibial Runoff: 76.5%. 85.3% of patients underwent concomitant treatment of BTK arteries. Lesion length: 27.9 ± 10.2 (range 15-53) cm. Implanted stent length: 30.6 ± 11 (range 17-58) cm. Number of implanted stents: 2.2 ± 0.9 (range 1-4). Retrograde access in 12/34 (35.3 %) to re-enter in the Ideal Landing Zone.
17 Primary Efficacy T C PO 2 increase: OUTCOMES AT 1 YEAR: 12.7 ± 6.2 mmhg to 54.8 ± 8.4 mmhg (p< ) 2 Supera Stent occlusions 1 1m: d/c DAPT 2 Colon CA Acute Technical success: 100% 21.4%: Nominal Stent Deployment 60.7%: % elongation 17.8%: % shortening)
18 Primary Safety Freedom from intraprocedural complication rate: 85.3%. 5 patients (14.7%): SFA pseudoaneurysm after vessel preparation. Treatment: Supera Stenting F/U: US surveillance (1 day, 1 Wk, 1, 3,6,9,12 months). Mortality: 1 7-months (Not procedurerelated). No Major amputations (Limb salvage rate:100%).
19 Secondary End-Points
20 Secondary End-Points No stent fractures were identified at any QoL of the follow up points. Amputation free survival rate: 82.4%. 6 Patients (17.6%) underwent P < PRE-PLANNED minor amputations.
21 Secondary End-Points (Cost Efficiency)
22 Freedom from TLR
23 Efficacy and Safety Objectives Primary Efficacy Objective: Primary Patency Rate: 94.1% was superior to the 66% VIVA performance goal (p < ) Modified Primary Safety Objective: Freedom from death from any cause, TLR and Major amputation: 91.2% was not different from the 88% VIVA performance goal (p=0.132).
24 Conclusions SUPERa Stenting after SUBintimal Crossing of long (TASC C-D) Fem-pop CTOs in CLI patients is superior to current efficacy and modified safety performance goals (set for patients with IC). SUPERSUB provides superior Patency rates, Freedom from TLR, improvement in Rutherford Class, QoL, and Limb Salvage. SUPERSUB is a cost-effective (cost saving = reduction of repeated procedures and hospitalization time) therapeutic strategy. Larger, multicenter studies of this strategy with longer follow-up are warranted to determine the generalizability of these results SUPERSUB 2: (Currently enrolling )
25 SUPERSUB 2: Multicenter, prospective study of Supera Stenting after Subintimal Crossing of TASC C-D SFA-Pop lesions in CLI patients. Will enroll and follow up 100 CLI pts. SUPERSUB 2 Investigators: Thank you for your attention
26 SUPERSUB Trial: 1-yr outcomes of SUPERa SUBintimal stenting in CLI Patients Dr. L.M. Palena, MD Interventional Radiology Unit Foot & Ankle Clinic Policlinico Abano Terme (PD), ITALY
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