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Volker Klauss, MD Patrick W. Serruys, Simon Wandel, Pawel Buszman,

LEADERS A Prospective, Randomised, Non-Inferiority Trial Comparing Biolimus-Eluting Stent With Biodegradable Polymer Versus Sirolimus-Eluting Stent With Durable Polymer. Volker Klauss, MD Patrick W. Serruys, Simon Wandel, Pawel Buszman,

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Volker Klauss, MD Patrick W. Serruys, Simon Wandel, Pawel Buszman,

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  1. LEADERSA Prospective, Randomised, Non-Inferiority Trial Comparing Biolimus-Eluting Stent With Biodegradable Polymer Versus Sirolimus-Eluting Stent With Durable Polymer Volker Klauss, MDPatrick W. Serruys, Simon Wandel, Pawel Buszman, Axel Linke, Thomas Ischinger, Franz Eberli, Roberto Corti, William Wijns, Marie-Claude Morice, Carlo di Mario, Robert-Jan van Geuns, Pedro Eerdmans, Gerrit-Anne van Es, Peter Jüni, Stephan Windecker 2-Year Clinical Follow-Up

  2. Disclosures • Volker Klauss, MD • Nothing to disclose

  3. Background: LEADERS at 1-Year • Comparison of BES with biodegradable polymer to SES with durable polymer resulted in: • Non-inferior MACE rate at 9 months (primary endpoint met: 9.2% BES vs. 10.5% SES, Pnon-inf =0.003)* • Non-inferiority in MACE confirmed at 12 months (10.7% BES vs. 12.1% SES, Pnon-inf <0.001) • BES showed superior strut coverage and stent apposition at 9 months in OCT sub-analysis • Similar rates of stent thrombosis (ARC definition) at 12 months • Two year clinical outcomes have not yet been reported *Windecker S et al. THE LANCET 2008; 372 No 9644: 1163-1173

  4. Biolimus-A9™ Eluting Stent Biolimus is a semi-synthetic sirolimus analogue with 10x higher lipophilicity and similar potency as sirolimus. Biolimus is immersed at a concentration of 15.6 g/mm into a biodegradable polymer, polylactic acid, and applied solely to the abluminal stent surface by a fully automated process. Polylactic acid is co-released with biolimus and completely desolves into carbon dioxide and water after 6-9 months. The stainless steel stent platform has a strut thickness of 112 m with a quadrature link design.

  5. Trial Design Stable and ACS Patients Undergoing PCI Assessor-blind 1:1 Randomisation N=1700 Patients BES BioMatrix Flex N=850 SES Cypher Select N=850 1:3 Randomisation Clinical F/U N=640 Angio F/U N=210 Clinical F/U N=640 Angio F/U N=210 1o endpoint: CV death, MI, clinically-indicated TVR (9 month) 2o endpoints: Death, CV death, MI, TLR, TVR Stent thrombosis according to ARC Angiographic study: In-stent % diameter stenosis Late loss, binary restenosis DAPT recommended for 12 month

  6. Patient Eligibility • Inclusion Criteria • Coronary artery disease • - Stable angina • - Silent ischemia • Acute coronary syndrome • including UA, NSTEMI and STEMI • At least one lesion with • - Diameter stenosis> 50% • - RVD: 2.25-3.5 mm • - Number of lesions: no limitation • - Number of vessels: no limitation • Lesion length: no limitation • Written informed consent • Exclusion Criteria • Known allergy to • aspirin, clopidogrel, heparin, • stainless steel, sirolimus, biolimus, • contrast material • Planned, elective surgery within 6 months of PCI unless dual APT could be maintained • Pregnancy • Participation in another trial

  7. Patient Demographics BESSES857 Patients850 Patients Age in years 65  1165  11 Male gender 75%75% Arterial hypertension 74%73% Diabetes mellitus26%23% - insulin-dependent 10%9% Hypercholesterolemia 65%68% Family history 40%44% Smoking 24%25% Previous MI 32%33% Previous PCI36%37% - with drug-eluting stent 12%14% Previous CABG11%13% Chronic stable angina 45%44%

  8. Patient Characteristics BESSES 857 Patients850 Patients Acute coronary syndrome55%56% - Unstable angina 22%21% - Non-ST-elevation MI 17%18% - ST-elevation MI 16%17% Left ventricular ejection fraction56  11%55  12% Number of lesions per patient1.5  0.71.4  0.7 Lesions per patient - 1 lesion63% 69% - 2 lesions29% 22% - 3 lesions7% 8% - > 4 lesions1% 2% De novo lesions92% 91% Long lesions (>20 mm)31% 27% Small vessels (RVD <2.75 mm)68% 69% Off label use81% 78%

  9. Patient Flow - Clinical Randomized (N=1,707) BES (N=832) SES (N=823) SES (N=850) SES (N=829) BES (N=837) BES (N=857) 3 = Lost to F/U 6 = Patient withdrawal 12 = Other Lost to F/U = 2 Patient withdrawal = 9 Other = 9 1-year follow-up* (N=1,666; 97.6%) 2-year follow-up* (N=1,655; 97.0%) 0 = Lost to F/U 0 = Patient withdrawal 6 = Other Lost to F/U = 0 Patient withdrawal = 2 Other = 3 *F/U window ±28 days

  10. MACE 2-year HR 0.84 [0.65 to 1.08] P = 0.18* 15.4% Δ 2.4% 13.0% 1-year HR 0.88 [0.66 to 1.17] P = 0.37* 20 BES SES 15 12.1% Δ 1.4% % 10 10.7% 5 0 0 3 6 9 12 15 18 21 24 Months MACE = Cardiac Death, MI, or Clinically-Indicated TVR * P values for superiority

  11. Cardiac Death or MI 1-year HR 1.01 [0.70 to 1.45] P = 0.95* 2-year HR 0.92 [0.66 to 1.27] P = 0.59* 10 9.1% BES Δ0.8% SES 8 8.3% 6.9% Δ0% 6.9% 6 % 4 2 0 0 3 6 9 12 15 18 21 24 Months *P values for superiority

  12. Clinically-Indicated TVR 2-year HR 0.86 [0.62 to 1.20] P = 0.37* 1-year HR 0.82 [0.56 to 1.19] P = 0.29* 10 BES 8.8% SES Δ1.1% 8 7.2% 7.7% Δ1.2% 6 % 6.0% 4 2 0 0 3 6 9 12 15 18 21 24 Months *P values for superiority

  13. 2-Year Safety Endpoints P=0.71* P=0.42* P=0.57* P=0.35* P=0.24* P=0.59* % *P values for superiority

  14. 2-Year Efficacy Endpoints P=0.17* P=0.25* P=0.58* P=0.54* P=0.37* % 1 1 1Clinically Indicated *P values for superiority

  15. Stratified Analysis of MACE @ 2 Years .25 .5 1 2 4 P Value P Int Risk Ratio (95% CI) SES BES

  16. Definite ST through 2 years 3.0 2.5 2.0 1.5 1.0 0.5 0.0 0 3 6 9 12 15 18 21 24 Zoom at 1% scale 2.5% +0.5% BES SES 2.2% 2.0% +0.2% % 2.0%

  17. Primary and Secondary Definite ST BES N=857 SES* N=850 Definite Stent Thrombosis % According to ARC Definition *Includes one secondary, definite ST occurring at 60 days in a patient who had early ST at 3 days

  18. Antiplatelet Agent Utilization

  19. Effect of DAPT Discontinuation Overall Population Patient who d/c DAPT P = 0.73* % N=0/154 N=3/479 N=2/163 N=0/484 *P values for superiority

  20. Conclusions Overall population Non-inferiority of BES vs SES in an all-comers population was sustained up to 2 years In the overall LEADERS population there were similar outcomes for BES and SES with respect to: MACE - BES:13% vs SES: 15.4% (PSup= 0.18) Cardiac Death/MI - BES: 8.3% vs SES: 9.1% (PSup= 0.59) Clinically indicated TVR – BES:7.7% vs SES:8.8% (PSup=0.37)

  21. Conclusions Subgroup analysis STEMI patients improved rate of MACE with BES compared to SES (8.1% vs 19.3% Psup< 0.01) Very Late Stent Thrombosis Although this was an all-comers study, very late stent thrombosis events were rare (BES 0.2% vs SES 0.5% PSup= 0.73) There were no VLST events in BES patients following discontinuation of DAPT

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