Comparing endoluminal bypass to open fem-pop bypasses; Final 1-year results of the SUPERB trial Michel Reijnen Rijnstate Hospital Arnhem, The Netherlands
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
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
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
Latest generation Viabahn Heparin-bonding technology Contoured proximal edge 25 cm long endografts
Heparin-bonded endograft Author Journal Year No. of Limbs Lesion Length (cm) Follow Up (yr) Primary Patency Secondary Patency LENSVELT Journal of Vascular Surgery, 2012 56 18,5 1 76% 89% VIPER Journal of Vascular and Interventional Radiology 2012 119 19 1 73% 92% VIASTAR Journal of the American College of Cardiology 2013 72 19,4 1 78% 90% TOTAL weighted results 247 19,0 75% 91%
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 2010 6 Dutch centers Clinicaltrials.gov: NCT01220245
SuperB trial Baseline characteristics Characteristic Surgical (n=63) Endoluminal (n=63) P value Age (years) 66.8 ± 7.9 68.5 ± 8.8 0.258 Gender (male; %) 80.6 72.6 0.289 Cardiovascular risk factors (%) Tobacco use 52.4 49.2 0.722 Hypertension 74.6 68.3 0.430 Diabetes mellitus 34.3 34.9 0.851 Dyslipidemia 69.8 7462 0.551 Cardiac disease 38.1 38.1 1.000 Renal insufficiency 15.9 9.5 0.285 Rutherford classification (%) 3 68.3 61.9 0.533 4 15.9 23.8 5 14.3 14.3 6 1.6 0 Preliminary analysis; Data may be subjected to changes
SuperB trial Baseline characteristics Characteristic Surgical (n=63) Endoluminal (n=63) P value ASA classification (%) I 1.6 0.0 0.441 II 65.6 55.6 III 31.1 42.9 IV 1.6 1.6 Pre-procedural ABI 0.56 ± 0.13 0.57 ± 0.12 0.968 PFWD (m) 100.0 ± 114.6 85.8 ± 64.4 0.401 Ulcus present (%) 15.9 17.5 0.811 Preoperative medication (%) Ascal 79.4 90.5 0.081 Acenacoumarol 14.3 4.8 0.069 Plavix 7.9 12.9 0.363 Statin 70.5 76.2 0.473 Preliminary analysis; Data may be subjected to changes
SuperB trial Anatomical characteristics Characteristic Surgical (n=63) Endoluminal (n=63) P value TASC-2 classification (%) B 4.9 3.3 0.580 C 14.8 21.7 D 80.3 75.0 Lesion length (cm) 23.4 ± 7.1 23.3 ± 8.3 0.934 Flush occlusion (%) 41.9 28.3 0.116 PA patent at P1 level (%) 91.9 91.7 0.573 Diameter PA (mm) 5.6 ± 0.8 5.2 ± 0.8 0.013 Number of unstenosed outflow vessels (%) 0 3.2 6.6 0.731 1 12.9 16.4 2 30.6 31.1 3 53.2 45.9 Preliminary analysis; Data may be subjected to changes
SuperB trial Anatomical characteristics Characteristic Surgical (n=63) Endoluminal (n=63) P value Technical success (%) 100 93.4 0.039 Conversion N (%) 4 (6.5) Post-procedural ABI 0.91 ± 0.18 0.92 ± 0.16 0.910 Surgical bypass (%) Venous 66.7 Prosthetic 31.7 Endoluminal bypass (mm) 5 14.0 6 70.2 7 12.3 8 3.5 Admission (days) 6.0 (4.4) 3.7 (3.4) 0.002 30-day morbidity (%) 55.6% 31.1% 0.006 30-day SAE 19.0% 24.6% 0.408 30-day mortality (%) 0 0 Preliminary analysis; Data may be subjected to changes
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% 0.909 Assisted primary patency 92.2% 87.1% 0.996 Secondary patency 96.1% 93.3% 0.761 12 MONTHS Primary patency 75.0% 67.3% 0.658 Assisted primary patency 84.6% 82.5% 0.978 Secondary patency 91.1% 90.2% 0.785 Difference Rutherford baseline vs. 12months Improved 51/98.1 47/97.9 Equal 1/1.9 1/2.1 Worsened 0 0 0.954 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
SuperB trial Clinical outcome Walking impairment questionnaire Characteristic Baseline 1month 12 months Distance baseline vs. 12 months Surgical 21.1 50.4 # 59.7 <0.001 Endoluminal 25.8 63.7 # 69.1 <0.001 Speed Surgical 29.2 37.2 53.6 <0.001 Endoluminal 34.0 56.6* # 61.0 <0.001 Stairs Surgical 44.2 55.2 61.3* 0.015 Endoluminal 53.3 70.4* # 76.7 <0.001 Total WIQ score Surgical 31.8 45.2 # 58.2 <0.001 Endoluminal 37.4 63.7* # 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
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
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
Comparing endoluminal bypass to open fem-pop bypasses; Final 1-year results of the SUPERB trial Michel Reijnen Rijnstate Hospital Arnhem, The Netherlands