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for the PLATINUM SV Investigators

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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)


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