“Real World”: SVG, De Novo or Restenotic Coronary Artery LesionsChronic 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 mmPre-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= ~850Sites: 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

DESIGNED FOR IMPROVED HEALING AND LONG TERM SAFETY

FLOW OF PATIENTS

High clinical and angiographic FU achieved!

0

5

10

15

0 1 2 3 4 5 6 7 8 9Months of Follow-up

Cum

ulat

ive

Inci

denc

e (%

)

Sirolimus Stent 10.5%

Biolimus Stent 9.2%

Pnon-inferiority = 0.003

PRIMARY ENDPOINTCARDIAC DEATH, MI, OR TVR @ 9 MONTHS

12%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 StentSirolimus Stent

12,3%

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

39.4

3.6

0

10

20

30

40

Uncovered Struts

Sirolimus Stent - Durable PolymerBiolimus Stent - Biodegradable Polymer

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-