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“Real World”: SVG, De Novo or Restenotic Coronary Artery Lesions

LEADERS Trial Design (PI: S. Windecker, Co-PI: P. Serruys) L imus E luted from A D urable versus ER odable S tent Coating. Randomized (1:1), Single-Blind, Multi-Center Study. “Real World”: SVG, De Novo or Restenotic Coronary Artery Lesions

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“Real World”: SVG, De Novo or Restenotic Coronary Artery Lesions

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  1. LEADERS Trial Design(PI: S. Windecker, Co-PI: P. Serruys)LimusEluted from ADurable versus ERodableStent Coating Randomized (1:1), Single-Blind, Multi-Center Study “Real World”: SVG, De Novo or Restenotic Coronary Artery Lesions Chronic Stable Angina, Silent Ischemia, Acute Coronary Syndromes Vessel Diameters: ≥2.25 – ≤3.5 mm Stent Diameters: 2.25 – 3.5 mm Lesion Length: No limititation Stent Lengths: 8 - 28 mm Pre-Dilatation and Post-Dilatation @ Physicians Discretion CYPHER SELECT™ n= ~850 BioMatrix Flex™ n= ~850 Sites: Europe (10) ClinicalFollow-Up 30 d 6 mo 9 mo 12 mo 2 -5 yrs Angiographic Follow-Up at 9 months in 25% of patients Primary Endpoint: CV death, MI, clinically-indicated TVR at 9 months Key Secondary Endpoints: MACE at 30 days, 6 months, 12 months Clinically driven TLR, TVR, & TVF at 6 and 9 months MLD, Binary Restenosis and Late Loss at 9 months Angiographic study: In-stent % diameter stenosis Late loss, binary restenosis Anti-Platelet Therapy for a minimum of 12 months

  2. Designed for improved healing and long term safety

  3. FLOW OF PATIENTS High clinical and angiographic FU achieved!

  4. 15 10 Cumulative Incidence (%) 5 0 0 1 2 3 4 5 6 7 8 9 Months of Follow-up PrimaryEndpointCardiac Death, MI, or TVR @ 9 months Pnon-inferiority = 0.003 Sirolimus Stent 10.5% 12% Biolimus Stent 9.2% Biolimus eluting stent reached its primary endpoint!

  5. Angiographic Follow-up Results Biolimus eluting stent has excellent outcomes in all angiographic variables and reached superiority in in-segment MLD * P values for superiority

  6. Cardiac Death, MI, or TVR @ 12 months Biolimus Stent Sirolimus Stent 12.2% 12,3% 10.7% The LEADERS data demonstrate that the biolimus eluting stent is a safe and effective alternative!

  7. EfficacyEndpoints @ 12 Months The LEADERS 12 months data confirm the excellent results achieved at 9 months!

  8. % of lesions with > 5% uncovered struts p=0.005 % The OCT subset demonstrates a significant 10 x better strut coverage for the DES with the abluminal biodegradable polymer!

  9. Conclusions • The biolimus eluting stent with abluminal biodegradable polymer compared against the sirolimus eluting stent with durable polymer met its primary endpoint in the LEADERS trial and demonstrated to be safe and efficacious out to 12 months. • The biolimus eluting stent in LEADERS resulted in a 12% reduction compared to the sirolimus eluting stent in the primary clinical endpoint: Cardiac Death, MI & clinically indicated TVR at 9 months • All angiographic variables at 9 months the biolimus eluting stent has excellent outcomes compared to the sirolimus eluting stent with demonstrating superiority in in-segment MLD. • In the OCT subset the biolimus eluting stent struts are 10 times more frequently apposed and neointimal coverage of >95% of the stent struts is visualized with OCT 10 times more frequently compared with the sirolimus eluting stents-

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