1. for the PLATINUM SV Investigators
Two-Year Results of the PLATINUM SV Trial Evaluation of a 2.25mm Platinum Chromium Everolimus-Eluting Stent in De Novo Coronary Artery Lesions
Ian T. Meredith MBBS, PhD, Paul S. Teirstein MD, Gregg W. Stone MD, Robert L. Feldman, MD, Michael R. Mooney, MD, Christophe L. Dubois, MD, PhD, Dominic J. Allocco MD, Keith D. Dawkins MD
for the PLATINUM SV Investigators
Presentation Time: 10: :14
Session: Long-term outcomes after DES implantation
Session Date: Friday 18th May 2012
Session Time: 09: :20
Session Location: Room 342B

2. Disclosures IT Meredith:
Scientific advisory boards and honoraria from Boston Scientific, Medtronic and Abbott Vascular
PS Teirstein:
Research grants, honoraria, and consulting fees from Boston Scientific, Abbott Laboratories, Cordis, and Medtronic
GW Stone:
Consultant to Boston Scientific, Abbott Vascular and Medtronic
RL Feldman:
Scientific advisory board and honoraria from Boston Scientific
MR Mooney:
No conflict of interest
CL Dubois:
Scientific advisory board for Boston Scientific
DJ Allocco:
Full-time employee and stockholder of Boston Scientific
KD Dawkins:
The PLATINUM trial is funded by Boston Scientific Corporation, Natick, MA.

3. PROMUS Element Stent Overview
Novel platinum chromium PROMUS Element stent includes the same drug and polymer as XIENCE V
Designed to improve:
Deliverability
Vessel conformability
Side-branch access
Radiopacity
Radial strength
Fracture resistance
PROMUS Element
Drug: Everolimus
Polymer: PBMA & PVDF‑HFP
Polymer Thickness: 7 µm
Strut Thickness: 81 µm

4. PLATINUM Clinical Program
Patients
Primary Endpoint
100 (14 sites) Asia Pacific
Non-Inferior vs. TAXUS Express* (9-Month In-Stent Late Loss†) Meredith EuroInterv 2011;7:84
1530 (132 sites) US, EU, Japan, AP
Non-Inferior vs. XIENCE V (12-Month TLF) Stone J ACC 2011;57:1700
94 (23 sites) US, EU, Japan, AP
Non-Inferior vs. TAXUS Express* (12-Month TLF)
Meredith EuroInterv 2011;7(Suppl):M157 (PCR 2011)
102 (30 sites) US, EU, Japan, AP
Non-Inferior vs. TAXUS Express* (12-Month TLF) Teirstein JACC 2011;58(Suppl B):B65 (TCT 2011)
60 (14 sites) Japan
Non-Inferior vs. POBA* (9-Month MACE)
Saito CRT 2012
500 (15 sites) China
9-Month In-Stent Late Loss versus TAXUS Liberté
PLATINUM QCA
PLATINUM RCT
PLATINUM SV
PLATINUM LL
PLATINUM Japan SV
PLATINUM China RCT
* Performance Goal; †Efficacy Endpoint

5. PLATINUM WH RCT 2-Year TLF
CoCr-EES (N=749)
HR [95% CI] =
0.79 [0.50, 1.25]
P = 0.32
PtCr-EES (N=758)
Target Lesion Failure (%)
5.8%
4.4% 3 6 9 12 15 18 21 24
No. at risk
Months Since Index Procedure
CoCr-EES
749
738
737
729
717
703
685
758
747
742
739
727
718
700
PtCr-EES
TLF = cardiac death or MI related to the target vessel or ischemia-driven TLR
Gregg Stone, ACC 2012

6. PLATINUM WH RCT 2-Year TLF
Landmark Analysis
Target Lesion Failure (%)
Months Since Index Procedure
TLF = cardiac death or MI related to the target vessel or ischemia-driven TLR; Patients with Study Stents. 3 6 9 12 15 18 21 24
3.0%
1.2%
1-yr HR [95% CI] =
1.12 [0.63, 1.99]
P = 0.70
3.3%
1-yr to 2-yr HR [95% CI] =
0.44 [0.20, 0.97]
P = 0.04
CoCr-EES (N=749 at time 0, n=722 at 1 year)
PtCr-EES (N=758 at time 0, n=736 at 1 year)
Gregg Stone, ACC 2012

7. Study Design PLATINUM Small Vessel Study
OBJECTIVE: Evaluate safety & effectiveness of PROMUS Element EES for treatment of de novo lesions ≤28 mm long in a native coronary artery ≥2.25 mm to <2.50 mm in diameter (visual estimate)
DESIGN: Prospective, single-arm, multicenter
PRIMARY ENDPOINT: Target lesion failure at 12 months
COMPARATOR: Predefined performance goal based on historical TAXUS Express results
EES=everolimus-eluting stent 7

8. Major Endpoints PLATINUM Small Vessel Study Primary endpoint
Target lesion failure at 12 months (per protocol population*)
- Cardiac death related to the target vessel, or
- MI related to the target vessel, or
- Ischemia-driven target lesion revascularization
Additional endpoints
Components of target lesion failure
Stent thrombosis (ARC definite/probable)
Technical success†
Clinical procedural success‡
* Patients who received ≥1 assigned study stent
† Successful delivery & deployment of study stent to the target vessel, without balloon rupture or stent embolization
‡ Lesion DS<30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital cardiac death, MI, or TVR

9. Key Enrollment Criteria
PLATINUM Small Vessel Study
Inclusion
Exclusion
De novo lesion*
Excessive target lesion tortuosity
Lesion length ≤28 mm
Extreme target lesion angulation
Stenosis ≥50 to <100%; TIMI>1
Moderate/severe lesion calcification
RVD 2.25 to <2.50 mm
Side branch 2.0 mm diameter
Target lesion covered by 1 stent
MI ≤72 hrs prior/elevated enzymes
LVEF ≥30%
Stroke/TIA <6M before procedure
*One non-target lesion, located in a different vessel distribution from the target lesion, could be treated first with a commercially available treatment; must be a clinical angiographic success.
LVEF=left ventricular ejection fraction; MI=myocardial infarction; RVD=reference vessel diameter; TIA=transient ischemic attack; TIMI=Thrombolysis in Myocardial Infarction

10. PLATINUM SV Investigative Sites
94 pts. enrolled between Feb. & Dec at 23 centers
in Australia, Belgium, France, Japan, New Zealand & the United States
Top 9 Enrollers
Robert Feldman Mediquest Research Group, Munroe Regional Medical Center, Ocala, FL, USA 17
Tift Mann Wake Medical Center, Raleigh, NC, USA 13
Tommy Lee Bakersfield Memorial Hospital, Bakersfield, CA, USA 11
Abram Rabinowitz TexSan Heart Hospital, San Antonio, TX, USA
Dean Kereiakes Lindner Center for Research & Education, The Christ Hospital, Cincinnati, OH, USA 6
Didier Carrié Centre Hôpital Universitaire Rangueil, Toulouse, France 5
Louis Cannon Cardiac & Vascular Research Center of Northern Michigan, Petoskey, MI, USA 4
Christophe Dubois University Hospital Leuven, Leuven, Belgium 3
Michael Mooney Abbott Northwestern Hospital, Minneapolis, MN, USA
Patients

11. Baseline Characteristics
PLATINUM Small Vessel Study – Intent-To-Treat
Patients (N=94)
Male
72.3%
Stable angina
53.2%
Age (years)
64.3  11.0
Unstable angina
24.5%
Diabetes*
42.6%
Hyperlipidemia*
81.9%
Insulin
11.7%
Hypertension*
79.8%
Smoking (ever)
62.8%
Prior PCI
43.6%
Target Lesion (QCA, N=94)
RVD (mm)
2.08  0.29
MLD (mm)
0.51  0.21
Lesion length (mm)
14.15  7.03
DS (%)
75.1  9.5
* Medically treated
Numbers are % (n) or meanSD; DS=diameter stenosis; MLD=minimum lumen diameter; PCI=percutaneous coronary intervention; QCA=quantitative coronary angiography; RVD=reference vessel diameter

12. Procedural Characteristics
PLATINUM Small Vessel Study
Intent-To-Treat (N=94)
Technical success (per stent)*
96.8%
Clinical procedural success†
Max study stent deployment pressure (atm)
14.4  2.7
Pre-dilatation used
98.9%
Post-dilatation used
47.9%
Max post-dilatation pressure (atm)
16.8  4.0
Fluoroscopy time (min)
14.7  11.1
* Successful delivery & deployment of study stent to the target vessel, without balloon rupture or stent embolization (per stent)
† Lesion DS<30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital cardiac death, MI, or TVR
Numbers are % (n/N) or meanSD (n)

13. PLATINUM SV Primary Endpoint
Target Lesion Failure at 12 Months 24
Performance Goal = 21.1% 16
Per Protocol Population
89 patients received ≥1 PROMUS Element stent
Target Lesion Failure (%) 8
95% UCB
2.4% (2/84)*
Value of 2.4% with a 95% upper confidence bound of 7.3% is significantly less (P<0.001)
than the performance goal based on historical TAXUS Express results
Ian Meredith, PCR 2011

14. Study Flow at 2 Years PLATINUM Small Vessel Study
94 Patients Enrolled at 23 Clinical Sites
Not Treated with a Study Stent (N=5) (Per protocol, patients not treated with a study
stent were not followed beyond 1 year)
Study Stent Analysis Set (N=89)
No 2-Yr F/U (N=3) Withdrew Consent: 1
Missed 2-Yr Visit: 2
2-Year Clinical F/U or Death: 96.6% (86/89) 14

15. Study Stent Patients (N=89)
2-Year Antiplatelet Medication Usage
PLATINUM Small Vessel Study
Study Stent Patients (N=89)
Discharge
Aspirin
98.9% (88/89)
Thienopyridine
100.0% (89/89)
Aspirin + Thienopyridine
1 Year
97.6% (81/83)
84.3% (70/83)
83.1% (69/83)
2 Years
96.4% (80/83)
57.8% (48/83)
56.6% (47/83) 15 15

16. TLF and Revascularization
PLATINUM Small Vessel Study – 2 Years
Study Stent Population (N=89)
Patients (%)
N=4
N=8
N=2
N=7
TLF
TVR
TLR
Non-TLR
Study Stent Analysis Set, Time-to-Event Analysis
TLF=target lesion failure (cardiac death/MI related to the target vessel or ischemia driven TLR); TLR=target lesion revascularization; TVR=target vessel revascularization

17. Study Stent Population (N=89)
Safety Outcomes
PLATINUM Small Vessel Study – 2 Years
Study Stent Population (N=89)
Patients (%)
N=3
N=2
All Death
Cardiac Death MI
ARC ST
Study Stent Analysis Set, Time-to-Event Analysis
ARC = Academic Research Consortium (definite/probable/possible); MI = myocardial infarction; ST = stent thrombosis

18. Target Lesion Failure PLATINUM Small Vessel Study – 2 Years
4.7% 3 6 9 12 15 18 21 24
Months Since Index Procedure
# at Risk: 89 88 85 83
TLF = cardiac death or MI related to the target vessel or ischemia-driven TLR

19. Limitations
Single-arm study compared to a performance goal based on historical results with 1st generation TAXUS Express stent (chosen because there were no commercially available small vessel EES in the US at the time the study was designed)
Study not powered to assess rates of death, MI, ST, or TLR
Study not designed to distinguish impact of stent properties on deliverability, acute performance, or ease of use
EES=everolimus-eluting stent; MI=myocardial infarction; ST=stent thrombosis; TLR=target lesion revascularization

20. Summary & Conclusions PLATINUM Small Vessel Study
One-year primary endpoint was met with a 12-month TLF rate of 2.4% (2/84; per protocol group), significantly below the performance goal (P<0.001)
No deaths, MI, or ST events between 1 and 2 years
Low TLR rate at 2 years (2.5%)
Results of PLATINUM SV support both safety & efficacy of the PROMUS Element 2.25-mm stent

21. Thank You!

22. PLATINUM SV Study Organization
Principal Investigator
Gregg W. Stone, MD
Co-Principal Investigators
Ian T. Meredith, MBBS, PhD; Paul S. Teirstein, MD
Core Angiographic Laboratory
Jeffrey J. Popma, MD (Director) Angiographic Core Laboratory Beth Israel Deaconess Medical Center, Boston, MA, USA
Clinical Events Committee
David G. Hurrell, MD (Chair) Jeffrey Chambers, MD David D. Laxon, MD
Yale Wang, MD
Robert F. Wilson, MD
Data Monitoring Committee
W. Douglas Weaver, MD (Chair)
David P. Faxon, MD
Steven R. Bailey, MD
David J. Moliterno, MD
Jan G. P. Tijssen, PhD
Adam Greenbaum, MD
Data Management, Biostats Analysis, Safety Monitoring
Boston Scientific Corporation, Natick, MA, USA 22

23. Post Procedure Angiographic Outcomes
PLATINUM Small Vessel Study
Intent-To-Treat (N=94)
RVD, mm
2.08 ± 0.29
MLD, in-stent, mm
1.98 ± 0.19
MLD, in-segment, mm
1.64 ± 0.32
DS, in-stent, %
4.0 ± 11.0
DS, in-segment, %
21.3 ± 10.2
Acute gain, in-stent, mm
1.47 ± 0.27
Acute gain, in-segment, mm
1.13 ± 0.35
Numbers are meanSD (n)
DS=diameter stenosis; MLD=minimum lumen diameter; RVD=reference vessel diameter

24. Cardiac Deaths PLATINUM Small Vessel Study Patient A:
Unknown cause of death & thus adjudicated as a cardiac death (181 days post index procedure)
Patient B:
Unknown cause of death & thus adjudicated as a cardiac death (259 days post index procedure)
Patient C (no stent placed, not in 2-year study stent analysis group):
Attempted treatment of highly calcified mid-LAD lesion with no stent placed; 48 days later patient presented with chest pain & elevated troponins; repeat attempted treatment of mid-LAD lesion with rotablator & 5 non-study stents; procedural cardiac arrest & death (50 days post index procedure)