“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 30 d 6 mo 9 mo 12 mo 2 -5 yrs Clinical Follow-Up 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 CYPHER SELECT™ n= ~850 Sites: Europe (10) Randomized (1:1), Single-Blind, Multi-Center Study BioMatrix Flex™ n= ~850 Angiographic Follow-Up at 9 months in 25% of patients LEADERS TRIAL DESIGN (PI: S. Windecker, Co-PI: P. Serruys) Limus Eluted from A Durable versus ERodable Stent Coating
BIOLIMUS ELUTING STENT − ABLUMINAL DES BIOLIMUS A9™ DRUG Biosensors’ proprietary rapamycin derivative Highest lypophilic profile of all common limus drugs BIODEGRADABLE PLA Co-released with BA9™ Fully biodegrades from the stent in 6 months ABLUMINAL COATING Improved healing More targeted tissue release Less systemic exposure
DESIGNED FOR IMPROVED HEALING AND LONG TERM SAFETY
STUDY SITES AND INVESTIGATORS is the fastest enrolling clinical PCI trial!
FLOW OF PATIENTS High clinical and angiographic FU achieved!
Sirolimus Stent 10.5% Biolimus Stent 9.2% P non-inferiority = 0.003 PRIMARY ENDPOINT CARDIAC DEATH, MI, OR TVR @ 9 MONTHS 12% Biolimus eluting stent reached its primary endpoint!
ANGIOGRAPHIC FOLLOW-UP RESULTS * P values for superiority Biolimus eluting stent has excellent outcomes in all angiographic variables and reached superiority in in-segment MLD
CARDIAC DEATH, MI, OR TVR @ 12 MONTHS 12.2% 10.7% Biolimus Stent Sirolimus Stent 12,3 % The LEADERS data demonstrate that the biolimus eluting stent is a safe and effective alternative!
EFFICACY ENDPOINTS @ 12 MONTHS The LEADERS 12 months data confirm the excellent results achieved at 9 months!
% 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! %
NEAR TO COMPLETE STRUT COVERAGE (>95%) p=0.005 The OCT subset demonstrates a significant 10 x better strut coverage for the DES with the abluminal biodegradable polymer! %
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-