The rig ight choice : : Endovascular Therapy vs vs Surgical Bypass for CLI Koen Deloose , MD Vascular Surgery, AZ Sint Blasius Dendermonde, Belgium
Disclosure Statement of Financial Interest I, Koen Deloose, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation
The right choice is…. • At least doing something …. 20 464 PAD pts who underwent major amputation (2003-2006) No Revasc/no Angio no Angio Angio only Goodney et al, Circ : Cardiovasc Qual Outcomes, 2012;5:94-102 iD3 Medical – 2016 | 3
THE LITERATURE • The only RCT directly comparing open bypass surgery with endovascular therapy in CLI patients : BASIL 429 pts, @ 27 UK hospitals, followed 5 years * primary endpoints : overall survival/amputation free survival * secondary endpoints : 30d mortality, MI, hematoma, woundinfection, reinterventions Bradbury et al, Lancet 2005;366:1925-34 iD3 Medical – 2016 | 4
BASIL primary endpoints @ 2 yr : NO DIFFERENCE BETWEEN BOTH GROUPS amputation free survival overall survival After 2 yrs, diverging curves in favor of surgery Bradbury et al, Lancet 2005;366:1925-34 iD3 Medical – 2016 | 5
BASIL secondary endpoints Bradbury et al, Lancet 2005;366:1925-34 iD3 Medical – 2016 | 6
BASIL authors ’ conclusions Bradbury et al, Lancet 2005;366:1925-34 iD3 Medical – 2016 | 7
BASIL criticism • SLI = CLI ??? : several subcohorts based on ankle/toe pressure measurements , Tcp02… • Best Medical Therapy ?? • Best Endovascular Therapy ?? Experience, materials, techniques (ex. 9 stents were placed …) • Endpoints? Not ideal for a direct comparison of revascularization strategies • Relatively late superiority of open surgery is quite irrelevant due to high overall mortality rates of CLI-patients … iD3 Medical – 2016 | 8
Indirect comparisons, meta- analysis…. • Söderstrom, Ann Surg 2010;252:765-773 • No statistical differences between Bypass/Endo iD3 Medical – 2016 | 9
Indirect comparisons, meta- analysis…. • Romiti et al. J Vasc Surg 2008:47(5):975-81 : >2500 pts • No statistical differences between Bypass/Endo in LSR iD3 Medical – 2016 | 10
Indirect comparisons, meta- analysis…. • Xiaoyang et al. Int J Clin Exp Med 2015:8(7):10595-602 -> amputation free survival @ 1, 3 & 5 yrs iD3 Medical – 2016 | 11
Indirect comparisons, meta- analysis…. • Xiaoyang et al. Int J Clin Exp Med 2015:8(7):10595-602 -> overall survival @ 30 days iD3 Medical – 2016 | 12
Indirect comparisons, meta- analysis…. • Xiaoyang et al. Int J Clin Exp Med 2015:8(7):10595-602 -> overall survival @ 1, 3 & 5 yrs iD3 Medical – 2016 | 13
Indirect comparisons, meta- analysis…. • Xiaoyang et al. Int J Clin Exp Med 2015:8(7):10595-602 -> Limb Salvage @ 1, 3 & 5 yrs iD3 Medical – 2016 | 14
Open Surgery = Invasive for our CLI-patients • 1 - 5% mortality rates • 10-20% of bypasses develop incisional wound complications • Large prospective NSQIP analysis of >2500 patients revealed bypass has ~20% peri-procedural complication rate, and 49% readmission rate at 6 months (65% are bypass related) • Meta-analysis showed 12% decline in ambulation and 15% loss of independent living post bypass surgery La Muragglia et al. Eur J Vasc Endovasc Surg 2012; 43(5):549-55 Conte et al. Seminars of Vascular Surgery 2012 25:108-114 Goodney et al. J Vasc Surg 2011 : 54(1) ; 100-108 iD3 Medical – 2016 | 15
Open Surgery = invasive for our CLI-patients • High risk category classification : ESRD with HD Extensive tissue loss >75yr Coronary disease Low Hct (<30%) • Available venous conduit : >3-4mm Conte et al. Results of the PREVENT III trial. J Vasc Surg 2006;43:742-751 iD3 Medical – 2016 | 16
Fast evolution endovascular world • Spectacular advancement in technics iD3 Medical – 2016 | 17
Fast evolution endovascular world • Spectacular advancement in devices 100 90 250 80 200 70 Primary Patency Rates at 1 Year ( % ) 60 150 Mean Lesion Length ( mm) 50 40 100 30 20 50 10 N= N= N= N= N= N= N= N= N= N= N= N= 71 135 45 703 119 72 260 228 147 50 159 0 0 Supera 500 Supera Tucson Mc Quade Viper Viabahn 25 Viastar Leipzig Zeller Zilver PTX Zilver PTX Zilver PMS LL CWZ Restore Registry Registry SAS PMS Japan iD3 Medical – 2016 | 18
Fast evolution endovascular world • Spectacular advancement in devices iD3 Medical – 2016 | 19
Our CLI treatment algorithm CLI patient • Heavily calcified TASC D+ (ATK+BTK) • “Frequent flyer” Surgical candidate failure ENDOVASCULAR • RISK score (PREVENT III criteria) • Vein availability Venous bypass Primary amputation/conservative R/ iD3 Medical – 2016 | 20
More clear view in the future … iD3 Medical – 2016 | 21
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