Comparing endoluminal bypass to open fem-pop bypasses; Final 1-year results of the SUPERB trial

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1 Comparing endoluminal bypass to open fem-pop bypasses; Final 1-year results of the SUPERB trial Michel Reijnen Rijnstate Hospital Arnhem, The Netherlands

2 Disclosure Speaker name: Michel Reijnen I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

3 Infrainguinal arterial occlusive disease Venous femoro-popliteal bypass is the gold standard for extensive lesions in the superficial femoral artery Vulnerable patient category with multiple co-morbidities Bypass surgery related to complications, prolonged hospital stay and reinterventions Endovascular alternatives are have been successfully used

4 Why using SE covered stents? They may reduce the incidence of re-stenosis Reduce ISR to a focal edge stenosis: Easier to treat Incidence independent of lesion length

5 Latest generation Viabahn Heparin-bonding technology Contoured proximal edge 25 cm long endografts

6 Heparin-bonded endograft Author Journal Year No. of Limbs Lesion Length (cm) Follow Up (yr) Primary Patency Secondary Patency LENSVELT Journal of Vascular Surgery, ,5 1 76% 89% VIPER Journal of Vascular and Interventional Radiology % 92% VIASTAR Journal of the American College of Cardiology ,4 1 78% 90% TOTAL weighted results ,0 75% 91%

7 SuperB trial Design Multicenter randomized trial Designed to demonstrate an equality in patency and an improved QOL using heparin-bonded eptfe covered stent compared to venous femoropopliteal bypass Primary end-points QOL at 30 days Patency at 1-year Start inclusion November Dutch centers Clinicaltrials.gov: NCT

8 SuperB trial Baseline characteristics Characteristic Surgical (n=63) Endoluminal (n=63) P value Age (years) 66.8 ± ± Gender (male; %) Cardiovascular risk factors (%) Tobacco use Hypertension Diabetes mellitus Dyslipidemia Cardiac disease Renal insufficiency Rutherford classification (%) Preliminary analysis; Data may be subjected to changes

9 SuperB trial Baseline characteristics Characteristic Surgical (n=63) Endoluminal (n=63) P value ASA classification (%) I II III IV Pre-procedural ABI 0.56 ± ± PFWD (m) ± ± Ulcus present (%) Preoperative medication (%) Ascal Acenacoumarol Plavix Statin Preliminary analysis; Data may be subjected to changes

10 SuperB trial Anatomical characteristics Characteristic Surgical (n=63) Endoluminal (n=63) P value TASC-2 classification (%) B C D Lesion length (cm) 23.4 ± ± Flush occlusion (%) PA patent at P1 level (%) Diameter PA (mm) 5.6 ± ± Number of unstenosed outflow vessels (%) Preliminary analysis; Data may be subjected to changes

11 SuperB trial Anatomical characteristics Characteristic Surgical (n=63) Endoluminal (n=63) P value Technical success (%) Conversion N (%) 4 (6.5) Post-procedural ABI 0.91 ± ± Surgical bypass (%) Venous 66.7 Prosthetic 31.7 Endoluminal bypass (mm) Admission (days) 6.0 (4.4) 3.7 (3.4) day morbidity (%) 55.6% 31.1% day SAE 19.0% 24.6% day mortality (%) 0 0 Preliminary analysis; Data may be subjected to changes

12 SuperB trial Patency and clinical outcome ITT analyses Surgical (n=61) Endoluminal (n=62) P value ITT analyses Surgical (n=61) Endoluminal (n=62) P value 6 MONTHS Primary patency 86.9% 79.4% Assisted primary patency 92.2% 87.1% Secondary patency 96.1% 93.3% MONTHS Primary patency 75.0% 67.3% Assisted primary patency 84.6% 82.5% Secondary patency 91.1% 90.2% Difference Rutherford baseline vs. 12months Improved 51/ /97.9 Equal 1/1.9 1/2.1 Worsened Primary patency: Patent reconstruction without significant stenosis (>70%/PSV ratio >2.5) Assisted-primary patency: : Patent reconstruction with reintervention for significant stenosis (>70% %/PSV ratio >2.5) Secondary patency: : Patent reconstruction with reintervention for occlusion Preliminary analysis; Data may be subjected to changes

13 SuperB trial Clinical outcome Walking impairment questionnaire Characteristic Baseline 1month 12 months Distance baseline vs. 12 months Surgical # 59.7 <0.001 Endoluminal # 69.1 <0.001 Speed Surgical <0.001 Endoluminal * # 61.0 <0.001 Stairs Surgical * Endoluminal * # 76.7 <0.001 Total WIQ score Surgical # 58.2 <0.001 Endoluminal * # 67.4 <0.001 * Denotes P < 0.05 surgical vs. endoluminal bypass # Denotes P < 0.05 baseline vs. 1 month Preliminary analysis; Data may be subjected to changes

14 SuperB trial Quality of Life RAND SF36 * Denotes P < 0.05 surgical versus endoluminal bypass # Denotes P < 0.05 baseline vs. 1 month At 1 month significant improvement in most domains in the endoluminal group and NOT in the surgical group At one year significant improvement in physical and role functioning, pain and health change in both groups At one year significant improvement in energy/fatigue and general health perception in endoluminal group only Preliminary analysis; Data may be subjected to changes

15 Conclusions SuperB trial was designed to establish the role of SE covered stents for extensive SFA occlusive disease and groups within the trial are very similar Endoluminal bypass is related to: Less morbidity and shorter admission A faster clinical improvement A faster an sustained improvement in QOL Equal patency rates and clinical improvement at oneyear Endoluminal bypass is a valid alternative for bypass surgery

16 Comparing endoluminal bypass to open fem-pop bypasses; Final 1-year results of the SUPERB trial Michel Reijnen Rijnstate Hospital Arnhem, The Netherlands