ESVB 2013 State of the art: DES, DCB and the role of debulking Gunnar Tepe, Rosenheim
DES I Sirocco Sirolimus coating, quick release Duda et al., J Vasc Surg 2002; 106: 1505-1509 20
DES II Strides Everolimus coating, slow release Lammer et al., J Vasc Surg 2011; 54: 394-401 100% Strides Everolimus coating, slow-eluting, 104 pat. Primary Patency 75% 50% 25% Vienna PTA Vienna Stent 0% 0 40 80 120 160 200 240 280 320 360 400 Days Post Index Procedure 22
DES III Zilver PTX PTX adsorbed, quick release Dake et al., J Endovasc Ther 2011; 18: 613-623 PTX coating, fast- eluting all commers : - incl: long lesions (up to 4 stents) - in-stent RS 900 lesions, 1722 Zilver PTX f/u: 1, 6, 12 months (clinic, DUS, stent fractures) 23
DES III Zilver PTX PTX adsorbed, quick release Dake et al., J Endovasc Ther 2011; 18: 613-623 23
DES III Zilver PTX PTX adsorbed, quick release 23
DES III Zilver PTX costs De Cock et al., Cardiovasc Interv Radiol 2012; Cost calculations based on the French Health System Basis 1: 2-Year TLR-rate ot the Zilver PTX register and other BMS studies* (*Resilient, FAST, Durability adjusted on equal lesion length) 5 years 24
DES III Zilver PTX costs De Cock et al., Cardiovasc Interv Radiol 2012; Basis 3 Basis 2 limitations only French system Several hypothesis Cost of stents variabel + not specified 24
DEB vs. POPA (Cotavance) Tepe et al., New Engl. J Med 2008:358; 689-699 principle result DEB-Status a) several other DEBs under eval. b) further studies c) new DEB-indikationen 25
DEB vs. POPA (In.Pact) Werk et al., Circ Cardiovas Interv 2012: 5; 831-840 Study design Intervention DEB Control Numbers 44 47 De-novo lesions n (%) 30 (68.2%) 39 (82.9%) Restenotic lesions post-pta n (%) in-stent n (%) 7 (15.9%) 7 (15.9%) 2 ( 4.3%) 6 (12.8%) Avg. lesion length cm ± SD 7.0 ± 5.3 6.6 ± 5.5 DEB Control p value Successful gw crossing (%) 100% 100% 1.0 Pre-dilatation n (%) 6 (13.6%) 3 (6.4%) 0.31 Provisional Stent Rate n (%) 9 (20.5%) 16 (34%) 0.17 29
DEB vs. POPA (In.Pact) Werk et al., Circ Cardiovas Interv 2012: 5; 831-840 result DEB Control p value % Diameter stenosis %* 29.7% 39.5% 0.05 Binary Restenosis n (%)* 3 (8.6%) 11 (32.4%) 0.01 Late Lumen Loss mm* -0.01 0.65 p=0.001 Subgroups conclusion: effective, positive remodelling espec. effective in risk groups limitationen: 6 Pat. randomized twice Lang vs. kurz De-novo vs. RS Okkl vs. Stenose 29
DEB vs. POPA (Lutonix) ISET 2013 Study design Result
DEB vs. POPA (Lutonix) ISET 2013 24 Monats-f/u conclusion: effective, safe limitations: first DEBs with technical problems study desgn small patient numbers
DEB vs. POPA (metaanalysis) Cassese et al., Circ Cardiovas Interv 2012: 5; 331-338 selection studies Cassese et al. Circulation CI 2012 27
DEB vs. POPA (metaanalysis) Cassese et al., Circ Cardiovas Interv 2012: 5; 331-338 conclusion: safe, effective 27
DEB in in-stent restenosis Stabile et al., J Am Coll Cardiol 2012: 60; 1739-1742 Design: 39 patients with in-stent RS Pre-dilatation with conv. PTA-balloon + followed by DEB f/u US in all patients 4/39 with RS secundary patentcy: 100% conclusion: could work limitations: no control group 31
DEB vs. POPA (Cotavance) long-term LINC 2012, ISET 2013 Thunder long-term result 5 years after DEB (Thunder) a) safe b) benefit sustains
Further DEBs ongoing studies/in publication Eurocor Tacke IROS 2013, Biotronic Schulte LINC 2013
Possible limitation of DEBs calcium DEBs for prevention of pavk: restenosis Interventionell
Possible limitation of DEBs calcium Result after DEB treatment New symptoms after 8 months
+ Atherectomy
DEFINITIVE Anti-Restenosis Program Status Collaboration between Covidien / ev3 and MEDRAD to study plaque excision + drug-coated balloon (Cotavance ) vs. drug-coated balloon alone Pre-clinical work complete Purpose Assess and estimate the effect of treating a vessel with plaque excision prior to local drug delivery Achieve a breakthrough in outcomes for patients with severe calcification 2
DEFINITIVE AR Study Prospective, multicenter, randomized pilot study 1-year follow up evaluating target lesion percent stenosis 100 randomized patients Additional 25 patient with severe calcification will be enrolled in a non-randomized arm (treatment = PE + DCB) Principal Investigators: Professors Gunnar Tepe and Thomas Zeller First enrollment August 2011 Last patient in May 3 rd (registry arm) 2
DEB + Atherectomy After intervention Before intervention After 6 months
Conclusions