Bare Metal Stents
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Bare Metal Stents: Will Their Lower Thrombosis Advantage over DES Vanish Against the CoCr-Everolimus Eluting Stents? Armando Tellez, SOLACI Congress 2012, Mexico.

Bare Metal Stents: Will Their Lower Thrombosis Advantage over DES Vanish Against the CoCr-Everolimus Eluting Stents? Armando Tellez, SOLACI Congress 2012, Mexico.

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Bare Metal Stents Bare Metal Stents Presentation Transcript

  • Bare Metal Stents: Will Their LowerThrombosis Advantage over DES Vanish Against the CoCr-Everolimus Eluting Armando Tellez, MD Skirball Center for Cardiovascular Research Cardiovascular Research Foundation New York, NY
  • Disclosures• I, Armando Tellez, 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
  • 1st Gen Drug-Eluting Stents Late loss = 0 Great Success at follow up after 1st Generation DES implantation NO RESTNOSIS7 years
  • 1st Gen Drug-Eluting Stents Late loss = 0 Great Success at follow up after 1st Generation DES implantation NO RESTNOSIS = Delayed Vascular Healing7 years Giant cells BMS DES EosInflammation Fibrin Persistance Incomplete Endothelialization Toxi c positive remodeling/ Polymer Malapposition
  • 1st Gen Drug-Eluting Stents Late loss = 0 Great Success at follow up after 1st Generation DES implantation Late stent NO RESTNOSIS = Delayed Vascular Healing thrombosis 7 years Giant cells BMS DESEos Inflammation Fibrin Persistance Incomplete Endothelialization Toxi c positive remodeling/ Polymer Malapposition
  • 1st Gen Drug-Eluting Stents Late loss = 0 Great Success at follow up after 1st Generation DES implantation Late stent NO RESTNOSIS = Delayed Vascular Healing thrombosis 7 years Giant cells BMS DESEos Inflammation Fibrin Persistance Incomplete Endothelialization Toxi c positive remodeling/ Polymer Malapposition
  • 1st Gen Drug-Eluting Stents PES (N=93 BMS (N=32 Lesions, 34 142 Lesions, 9997 P Struts) Struts) Strut-level analysis Struts analyzed 384±297 322±213 0.51 Total Covered Struts 32 257 9878 % Covered Struts 94.3±7.0 98.9±2.5 <0.0001 Embedded 88.1±12.3 98.0±4.3 <0.0001 Protruding 6.3±8.0 1.0±2.1 <0.0001Total Uncovered Struts 1885 119 % Uncovered Struts 5.7±7.0 1.1±2.5 <0.0001 Apposed 4.8±5.3 1.0±2.3 <0.0001 Malapposed 0.9±2.1 0.1±0.2 0.0003 Neointimal thickness 0.17±0.12 0.34±0.17 <0.0001 Guagliumi G et al. Circulation 2011;123:274-281
  • ARC-ST (Definite/Probable) at 5 Years TAXUS I, II-SR, IV & V (n=2,797) 5% TAXUS (n=1400) BMS (n=1397) 5-Year HR [95% CI]:Stent thrombosis (%) 4% 1.37 [0.79, 2.38] 2.3% P=0.26 (n=30) 3% 2% 1% 1.7% (n=22) 0% 0 1 2 3 4 5 YearsEvent Rate ± 1.5 SE Stone GW et al. JACC CV Int 2011;4:530–42
  • Myocardial Infarction at 5 Years TAXUS I, II-SR, IV & V (n=2,797) 15% TAXUS (n=1400) Myocardial infarction (%) BMS (n=1397) 5-Year HR [95% CI]: 1.15 [0.87, 1.53] 7.7% 10% (n=102) P=0.33 5% 6.6% (n=89) 0% 0 1 2 3 4 5 YearsEvent Rate ± 1.5 SE Stone GW et al. JACC CV Int 2011;4:530–42
  • Myocardial Infarction: Landmark Analysis TAXUS I, II-SR, IV & V (n=2,797) 10% TAXUS (n=1400) Myocardial infarction (%) BMS (n=1397) 1-5 Year HR [95% CI]: 1.67 [1.06, 2.65] 4.5% P=0.03 5% 0-1 Year HR [95% CI]: 3.8% 0.89 [0.62, 1.27] P=0.52 4.0% 2.3% 0% 0 1 2 3 4 5 YearsEvent Rate ± 1.5 SE Stone GW et al. JACC CV Int 2011;4:530–42
  • SYNTAX: ARC Stent Thrombosis Definite ARC ST (Per Patient) Probable ARC ST (Per Patient) 8.8 ~4.5% ST ~1.3% ST/yr in year 1 in years 2-4 Patients, % 2.6 1.7 1.4 1.3 1.1 0.3 Acute Subacute Late Very Late Total ≤1d 2-30d 31-365d 366-730d 731-1095d 1096-1460d 4 year Days Postprocedure1 patient had an ST 1d and 6d post-procedure; therefore, counted in the ≤1d and 2-30d intervals but only once in the total. Serruys PW. TCT 2011SYNTAX 4-year Outcomes • EACTS 2011 • Serruys • October 2011 • Slide 11
  • HORIZONS-AMI: Stent Thrombosis (ARC Definite or Probable) 6 TAXUS DES (n=2238) Stent Thrombosis (%) EXPRESS BMS (n=744) 5 4.8% 4 4.3% 3.4% 3 3-yr HR [95%CI]= 3.1% 1.10 [0.74, 1.65] 2 P=0.63 1-yr HR [95%CI]= 1 0.92 [0.58, 1.45] P=0.72 0 0 3 6 9 12 15 18 21 24 27 30 33 36 MonthsNumber at riskTAXUS DES 2238 2108 2066 2013 1980 1932 1341EXPRESS BMS 744 695 683 664 654 637 425 Stone GW et al. Lancet 2011;377:2193-204
  • 100 100 Y=17.8x + 30.4 Y=16.5x + 31.3 r= 0.73 r= 0.66Neointima% Stenosis Neointima% Stenosis 80 P <0.01 80 P <0.01 n=21 n=21 60 60 40 40 20 20 0 0 0 1 2 3 0 1 2 3 Injury Score Inflammatory Score Score 0 Score 1 Score 2 Score 3 J Am Coll Cardiol. 1998 Jan;31(1):224-30
  • Impact of Strut Thickness on Vascular Healing and Neointimal Formation in BMS Rabbit Model: 7-Days Thin= 82 um Thick= 162 um Thick Thin 28-Days (%) Thick Thick 40 3 Strut Coverage Thin (%) Thin Score 60 30 2 P= 0.008 20 40 20 1 10 0 0 0 Thick Thin Fibrin Score Inflammation Score % StenosisPresented by Renu Virmani
  • Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO-2) Trial Deep Wall Trauma Reduction Thin-Strut Thick-Strut p Value (n = 309) (n = 302)B2/C Lesions 255 (82) 213 (70) < 0.001Chronic Occlusions, n (%) 15 (5) 26 (9) 0.06Restenotic Lesions, n (%) 10 (3) 13 (4) 0.49Lesion Length, mm 13.9 ± 7.8 14.1 ± 7.8 0.77Vessel Size, mm 2.93 ± 0.50 2.91 ± 0.51 0.68Diameter Stenosis, % 68.2 ± 18.9 70.8 ± 20.4 0.11 p <0.001 p <0.001 p Value Thin-Strut Thick-Strut (n = 229) (n = 236) MLD, mm 1.96 ± 0.76 1.70 ± 0.83 < 0.001 DS, % 33.4 ± 21.5 42.4 ± 24.1 < 0.001 LL, mm 0.93 ± 0.61 1.19 ± 0.69 < 0.001 LL index 0.51 ± 0.37 0.65 ± 0.44 < 0.001 Restenosis, n (%) 41 (17.9) 74 (31.4) < 0.001 Pache J. JACC. 2003 Apr 16;41(8):1283-8
  • Impact of Strut Thickness on Vascular Healing and Neointimal Formation in BMS Strut Coverage at 14 days in Rabbit P=0.05 % P=0.001 100 94.83 80 88 77 60 40 20 0 Express Liberté Element Express Liberté Element 132 μm 97 μm 81 μm Soucy N, Feygin J et al, EuroIntervention 2011
  • Progression in Stent Platform Design Strut Thickness and Biomaterials 1st 2nd 3rd 4th 1st Gen Generation Generation Generation Generation BVSStainless Steel Cobalt Alloys Platinum Chromium PLLA0.140 mm 0.132 mm 0.096 mm 0 .081 mm 0.091 mm 0.081 mm 0.081 mm 0.074 mm 0.150 mm(0.0055” ) (0.0052”) (0.0038”) (0.0032” ) (0.0036”) (0.0032”) (0.0032”) (0.0029”) (0.0059”) TAXUS® TAXUS® Xience V® Endeavor® Xience SYNERGY™ BVSCypher® Express® Liberté® Stent Stent Prime® Stent Stent Stent Stent Stent
  • SPIRIT II, III, IV and COMPARE trials Pooled database analysis (n=6,789)Stent thrombosis (ARC definite/probable) 3 EES (n=4,247) HR: 0.30 [0.19, 0.47] PES (n=2,542) p<0.001 ARC def or prob (%) Stent thrombosis 2.3% 2 1 0.7% 0 0 3 6 9 12 15 18 21 24 Time in Months Number at risk XIENCE 4247 4177 4082 3998 3479 TAXUS 2542 2463 2408 2350 2110 Kereiakes DJ et al. EuroIntervention 2011:7:74-83
  • SPIRIT II, III, IV and COMPARE trials Pooled database analysis (n=6,789)Stent thrombosis (ARC def/prob) at 2 years 0.25 (0.12–0.52) 0.34 (0.19–0.62) P=0.0002 P=0.0002 Planer D et al. JACC Cardiovasc Interv. 2011;4:1104-15
  • 14 Day Endothelialization: Rabbit Iliac Model XIENCE V CYPHER TAXUS ENDEAVOR Joner M et al. JACC 2008;52:333-42
  • Functional Endothelial Re-growth Rabbit Iliac, CD-31 Staining, 14-day CD-31 = PECAM (Platelet Endothelial Cell Adhesion Molecule), which mediates adhesion to endothelial cells and function in immunity,inflammation and wound healing. The presence of CD-31 is an indicator of endothelial healing and normal endothelial function. XIENCE™ V CYPHER® TAXUS® ENDEAVOR™ Over Struts Between Struts CD31: Green Channel Joner M et al. JACC 2008;52:333-42
  • The Concept of Fluoropassivation Fluoropolymer coated surfaces are thromboresistant in blood-contact application 20 3000Thrombus Formation (%) 18 30 min 60 min 16 120 min 2500 Platelets / mm2 14 2000 12 10 1500 8 6 1000 4 500 2 0 0 PAN PAN91 PAN82 PAN73 PVDF BASE PP0212L PTM0212F PTM0212I Comparison of thrombus formation ratio of Platelet adhesion onto different polymeric surfaces PAN/PVDF blend membranes after 30, 60 and after 15 min exposure to blood at 150 rpm (37° C). 120 min incubation (n=3). Platelet count measured using 51Cr method. Ting-Yu Liu et al. Polym. Adv. Technol. Massa TM et al. J Biomed Materials Research 2005;16:413–419 Part A DOI 10.1002/jbm.a
  • Biocompatibility XIENCE V – Thromboresistant Chandler Blood Loop Test (2 h Exposure) p = 0.0001Weight of Thrombus (µg) Adhered on Stent 4000 3138 3500 3000 p = 0.003 2500 2000 p = 0.02 1500 752 871 1000 211 500 0 XIENCE V (n = 10) Endeavor (n = 8) Cypher (n = 8) Taxus Liberte (n = 8) Data on file at Abbott Vascular
  • Hemocompatible Polymer Unheparinized Ex-Vivo Shunt Study 0.25 200Avg. Weight Increase (g) 0.20 Blood Flow (mL/min) 150 XIENCE V n=9 0.15 100 0.10 50 0.05 VISION n=8 0.00 0 XIENCE V VISION 5 minutes 30 minutes n=9 n=8 Low thrombus adherence presumably XIENCE V: No reduced flow between due to smooth coating integrity and 5 minutes and 30 minutes porcine in-vivo. hemocompatibility of the XIENCE V polymer. Data on file at Abbott Vascular
  • Stent Thrombosis is Affected by Stent Design, Deployment and PolymerImpact of strut thickness and Xience V polymer coating In vitro pulsatile Chandler loop model with porcine blood 2 Relative platelet cell adhesion 49%↑; P<0.001 LDH Adsorbance for ML VISION (81 µm) LDH Adsorbance for Stent formulation / 1.8 1.6 1.4 1.2 1.0 24%↓; P=0.002 0.8 0.6 0.4 0.2 0.0 ML VISION (81 µm) TS VISION (162 µm) XIENCE V (96.6 µm) TS = thick strut Kolandaivelu K et al. Circulation 2011;123:1400-1409
  • Stent Thrombosis is Affected by Stent Design, Deployment and Polymer Impact of stent malapposition In vitro pulsatile Chandler loop model with porcine blood P=0.037 P<0.001 LDH Adsorbance for Malapposed Condition LDH Adsorbance for Approved ML VISION 2 P<0.001 P=ns 64%↑; 1.8 58%↑; P<0.001 1.6 P<0.001 27%↓; 1.4 P=0.04 Similar to 1.2 (81 µm) apposed XV 1 DES 0.8 0.6 0.4Apposed Mal- 0.2 ML apposed 0 Vision ML ML VISION ML VISION TS VISION XIENCE V Vision (81 µm) (81 µm) (162 µm) (69.9 µm) APPOSED CONTROL MALAPPOSED Kolandaivelu K et al. Circulation 2011;123:1400-1409
  • EXAMINATION Trial1504 pts with STEMI undergoing PCI within 48° (85% primary PCI within 12°) were randomized to Xience V EES vs. Vision BMS Stent thrombosis (Def/prob) within 1 year Acute Subacute Late Vision 2.6% p = 0.01 Xience V 0.9% 0 1 2 3 Definite ST was reduced with Xience V from 1.9% to 0.5%, p=0.01 Sabate M. ESC 2011
  • Stent Thrombosis Network Meta-analysis Primary EP: ARC Definite ST (FU through 2 years) BMS 9 studies PES FDA approved stents (BMS, SES, PES, End-ZES, Res- ZES, CoCr-EES, PtCr-EES) 49 RCTsEnd-ZES 6 studies SES 50,844 pts CoCr-EES CoCr-EES has the lowest rate of stent thrombosis within 2 years of implantation. Res-ZES Pt-Cr-EES Palmerini T et al. Lancet 2012:On-line