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Reduction in Stent Thrombosis – better tablets or better stents?

Reduction in Stent Thrombosis – better tablets or better stents?. Dr James Cotton MD FRCP Heart and Lung Centre Wolverhampton. Speaker Fees/Honoraria/Travel Support Lilly/Daiichi Sankyo Schering-Plough The Medicines Company Medtronic Research Support J&J Cordis. MY CONFLICTS

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Reduction in Stent Thrombosis – better tablets or better stents?

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  1. Reduction in Stent Thrombosis – better tablets or better stents? Dr James Cotton MD FRCP Heart and Lung Centre Wolverhampton

  2. Speaker Fees/Honoraria/Travel Support Lilly/Daiichi Sankyo Schering-Plough The Medicines Company Medtronic Research Support J&J Cordis MY CONFLICTS OF INTEREST ARE

  3. New Generation DES ASA and Oral Anticoag ASA and Ticlopidine ASA and Clopidogrel Prasugrel Ticagrelor % Stent Thrombosis

  4. Risk of Definite Stent Thrombosis Cook, Windecker Circulation 2009

  5. 2.9 % Between 30 days to 3 years Slope = 0.6% / year Late 61 pts (40%) Early 91 pts (60%) N = 152 Patients 0 200 400 600 800 1000 1200 Angiographic DES Stent Thrombosis Bern - Rotterdam Cohort Study N = 8,146 Patients (SES=3875;PES=4271) 3 2 Cumulative probabiity of stent thrombosis (%) Incidence = 1.3/100 pts year 1 0 Days after stent implantation Cumulative Incidence 1.1% 1.2% 1.7% 2.3% 2.9% Wenaweser et al. ESC, Barcelona Sept 2006

  6. Better Drugs?

  7. Discontinuation of thienopyridine therapy:Milan-Siegburg Cohort Study Airoldi F et al Circulation 2007 116:745-54

  8. Stent Thrombosis and 2C19 polymorphisms Mega J et al JAMA 2010, 304(16) 1829-40

  9. Clopidogrel (300 mg) vs. prasugrel (60 mg)Phase I – healthy subjects 100.0 80.0 60.0 Inhibition of Platelet Aggregation (%) 40.0 20.0 0.0 clopidogrel responder clopidogrel non-responder -20.0 Response to clopidogrel Response to prasugrel *Responder =  25% IPA at 4 and 24 h Brandt JT et al. Am Heart J 2007;153:66.e9-e16

  10. 100.0 80.0 60.0 40.0 20.0 0.0 clopidogrel responder clopidogrel non-responder Clopidogrel (300 mg) vs. prasugrel (60 mg)Phase I – healthy subjects Inhibition of Platelet Aggregation (%) -20.0 Response to clopidogrel Response to prasugrel *Responder =  25% IPA at 4 and 24 h Brandt JT et al. Am Heart J 2007;153:66.e9-e16

  11. TRITON-TIMI 38: Stent thrombosis ratesat end of study prasugrel 4 clopidogrel 48% RRR (1.1% ARR) 52% RRR (1.2% ARR) 64% RRR (1.5% ARR) 3 P<0.0001 P<0.0001 P=0.0009 Stent Thrombosis* (%) 2.41 2.35 2 2.31 1 1.27 1.13 0.84 N=6,422 n=2,865 n=2,878 n=3,237 n=3,224 N=6,422 0 All Stents Drug-eluting Stents Bare-metal Stents *Stent thrombosis defined as Academic Research Consortium definite plus probable ARC = Academic Research Consortium ARR = Absolute Risk Reduction HR = Hazard Ratio NNT = Number Needed to Treat PCI = Percutaneous Coronary Intervention RRR = Relative Risk Reduction Wiviott SD et al. Lancet 2008;371:1353-1363

  12. TRITON-TIMI 38: Life Threatening Bleeds at 15 months (All ACS) both + aspirin (n=6,716) (n=6,741) P=0.01 P=NS 1.4% End Point (%) n=85 1.1% 0.9% 0.9% n=64 P=0.002 n=56 n=51 P=NS 0.4% 0.3% 0.3% n=21 0.1% n=19 n=17 n=5 Nonfatal Life Threatening Fatal Intracranial Subsets of Life Threatening Bleeds NS = Not Significant Wiviott SD et al. New Engl J Med 2007;357:2001-2015

  13. Will duration of DAPT be key? • DAPT - 2014 • REAL –LATE - 2011 • OPTIDUAL - 2013

  14. Better Stents?

  15. New stent technologies

  16. Comparative Endothelial Cell CoverageRabbit Denudation Model (14 Days) p=0.05 Express vs. Liberte p=0.001 Express vs. Element EC Strut Coverage (%) (14 Days) Stent Strut Thickness (µm) Express Liberté Element Soucy. EuroPCR 2010

  17. SPIRIT IV

  18. The Abluminal Biodegradable Polymer DES PLA biodegradation and BA9™ elution Abluminal biodegradable coating absorbed after 6-9 months* * In vivo testing in porcine model demonstrates abluminal coating is absorbed after 6 to 9 months - Data on file at Biosensors Intl 19

  19. Leaders Trial - Stent thrombosis

  20. Other Bioabsorbable polymer studies • COSTAR – II • ISAR-TEST 3 • ISAR TEST 4 • NOBORI CORE • NOBORI-I • RESELUTION No reduction ST for DES BP Vs DES PP Salinas P Abs AHA 2010 6032

  21. Genous- E-healing Registryn=4939 Silber S et al, Euro intervention In Press

  22. RES – 1 ( no coating) 200 patients NO ST ? Heparin coating may improve haemocompatability Evolutions of Nevo Stent

  23. Combo Bio-engineered Sirolimus Eluting Stent Granada, et al. CIRC Cardiovasc Interv, June 2010; 3

  24. The Lancet Vol 373 March 14 2009

  25. Absorb: histology and OCT

  26. Clinical trial aiming to demonstrate a reduction in ST from 0.4 to 0.2% 80% power 284,000 subjects! Further studies?

  27. ? Training

  28. THANKYOU

  29. ARC Definitions of ST • Definite Stent Thrombosis • Angiographic or pathological conformation of partial or total thrombotic occlusion within the peri-stent region AND at least one of: • Acute ischaemic symptoms • Ischaemic ECG changes • Elevated biomarkers • Probable Stent Thrombosis • Any unexplained death within 30 days of stent implantation • Any MI related to ischemia in the territory of the implanted stent without angiographic conformation of ST • Possible Stent Thrombosis • Any unexplained death beyond 30 days

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