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Slide 1 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am TAXUS PERSEUS A Novel Platinum Chromium, Thin-Strut.

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Presentation on theme: "Slide 1 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am TAXUS PERSEUS A Novel Platinum Chromium, Thin-Strut."— Presentation transcript:

1 Slide 1 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am TAXUS PERSEUS A Novel Platinum Chromium, Thin-Strut TAXUS Element Stent for the Treatment of de novo Coronary Stenoses Dean J. Kereiakes, MD; Louis A. Cannon, MD Robert L. Feldman, MD; Gregory J. Mishkel, MD; Abram C. Rabinowitz, MD; Robert Whitbourn, MBBS; Raymond Magorien, MD; Paul Underwood, MD; Keith D. Dawkins, MD

2 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 2 Conflict of Interest Disclosures Dr. Kereiakes received research grants from Boston Scientific, Cordis, Medtronic, and Abbott Vascular, and serves on the Advisory Boards for Boston Scientific and Abbott Vascular. The PERSEUS trials and this presentation were sponsored and funded by Boston Scientific Corporation, Natick, MA

3 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 3 MetalStainless Steel Pt Cr Radial Strength0.23N/mm0.24N/mm0.26N/mm Density8.0g/cc 9.9g/cc Strut Thickness132µm97µm81µm Nickel Content14% 9% Challenge Focal Bend Fatigue 1x12x Relative to Express 306x Relative to Express Stent Models234 Surface-to- Artery Ratio (across diameters) % % % Stent Technology Evolution: 3 Generations of TAXUS Stent Platinum Chromium (PtCr) Element Stent TAXUS Express TAXUS Liberté TAXUS Element Function Design & Delivery Impact of Change Strength Enhanced/ more uniform drug distribution Radiopacity Fracture resistance Flexibility Hypersensitivity Recoil Computer simulation

4 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 4 PERSEUS Workhorse (WH), 2.75mm - 4.0mm, 28mm PERSEUS Small Vessel (SV), 2.25mm - <2.75mm, 20mm TAXUS Element PES (N=942) TAXUS Element PES (N=224) TAXUS Express PES (N=320) Historic BMS Express (TAXUS V) (N=125) PERSEUS Clinical Trial Program 2 parallel Trials in single, de novo lesions NON-INFERIORITY Design, Randomized 3:1 Primary Endpoint : TLF* (12 mos) Secondary Endpoint : in-segment %DS (9 mos)** SUPERIORITY Design, Single Arm, Open Label Primary Endpoint : in-stent late loss (9 mos) Secondary Endpoint : TLF (12 mos) vs. Prespecified Performance Goal (PG) *TLF=ischemia-driven TLR or MI/cardiac death related to target vessel **QCA cohort randomly assigned

5 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 5 Bayesian analysis used to power the 1 o and 2 o endpoints Success criteria: 95% Bayesian probability that TAXUS Element is non-inferior to TAXUS Express Predefined delta: 4.1% (TLF); 0.20 ln(%DS)* Standard (frequentist) method used for all other endpoints Statistical Methods Allocco et al. Trials 2010;11:1. PERSEUS WH PERSEUS SV Frequentist approach used for all endpoints 1 o Endpoint: 2-sided t-test vs. historical BMS control (TAXUS V) 2 o Endpoint: 1-sided binomial test vs. a prespecified performance goal* *Based on TAXUS IV/V results

6 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 6 Principal Investigators Dean J. Kereiakes, MD Louis A. Cannon, MD Core Angiographic Laboratory Jeffrey J. Popma (Director), CardioVascular Institute at Beth Israel Deaconess Medical Center, Boston, MA, USA Clinical Events Committee Don Cutlip, MD (Chair) Julian Aroesty, MD Manish Chauhan, MD Germano DiSciascio, MD Kalon K. L. Ho, MD, MSc Joseph P. Kannam, MD Michel Vandormael, MD Data Monitoring Committee W. Douglas Weaver, MD (Chair) David P. Faxon, MD Kirk N. Garrett, MD, until August 2008 Steven R. Bailey, MD, December 2008 – present David J. Moliterno, MD Jan G. P. Tijssen, PhD Adam Greenbaum, MD PERSEUS Study Organization

7 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 7 Site NamePrincipal Investigator# Munroe Medical Center, Ocala, FLFeldman, Robert L.91 St. Johns Hospital, Springfield, ILMishkel, Greg56 Wake Medical Center, Raleigh, NCMann, Tift55 TexSan Heart Hospital, San Antonio, TXRabinowitz, Abram C.54 The Christ Hospital, Cincinnati, OHKereiakes, Dean J.52 St. Vincents Hospital, Melbourne, AustraliaWhitbourn, Robert50 Ohio State University Medical Ctr., Columbus, OHMagorien, Raymond50 Abbott Northwestern Hospital, Minneapolis, MSMooney, Michael44 South Denver Cardiology Assoc., Littleton, CODauber, Ira M.42 St. Vincents Hospital, Indianapolis, INBall, Michael39 North Mississippi Medical Center, Tupelo, MSBertolet, Barry37 Northern Michigan Hospital, Petoskey, MICannon, Louis A.36 PERSEUS Top 12 Combined WH & SV

8 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 8 Clinical & Angiographic Characteristics PERSEUS WH RCT Values are % (n/N) or mean±SD (N) TAXUS Express (N=320) TAXUS Element (N=942) P Value Age, years63.5±9.5 (320) 62.2±9.6 (942) 0.03 Male68.8 (220/320) 70.8 (667/942) 0.49 Diabetes25.0 (80/320) 24.6 (232/942) 0.89 Insulin7.5 (24/320) 7.3 (69/942) 0.92 Current Smoker23.5 (73/311) 24.3 (223/916) 0.76 Unstable Angina21.3 (68/320) 20.7 (195/942) 0.84 Prior CHF7.5 (24/318) 6.0 (56/937) 0.32 Ejection Fraction57.8±9.8 (317) 58.0±9.3 (939) 0.73 RVD, mm2.8±0.5 (320) 2.8±0.5 (942) 0.37 Lesion Length, mm14.1±5.8 (320) 14.2±6.1 (942) 0.68 Diameter Stenosis71.7±10.9 (320) 72.1±10.9 (942) 0.58 B2/C Lesions64.7 (207/320) 66.9 (630/942) 0.47

9 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 9 Procedural Outcomes PERSEUS WH Values are % (n/N) or mean±SD (N) TAXUS Express (N=320) TAXUS Element (N=942) P Value Technical Success*98.8 (338/342 stents) 99.2 (1005/1013 stents) 0.51 Stent Length:Lesion Length1.60±0.73 (319) 1.55±0.64 (940) 0.25 Multiple Stents 8.4 (27/320) 7.6 (72/942) 0.65 Max Stent Deploy Pressure14.0±2.8 (316) 13.7±2.4 (932) 0.15 Post-Dilation Used53.8 (172/320) 53.6 (505/942) 0.97 Max Post-Dilation Pressure16.6±3.3 (172) 16.6±3.6 (506) 0.95 Use of multiple stents for bailout indication only *Successful stent delivery and deployment to target vessel, without balloon rupture or stent embolization; per stent.

10 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 10 Post-Procedure QCA PERSEUS WH MLD (mm)Acute Gain (mm) 2.54 ± ±0.39 P=0.01P= ± ± ± ± ± ±0.48 In-StentIn-SegmentIn-StentIn-Segment P=0.09P=0.41 TAXUS Express PESTAXUS Element PES (61)(228)(61)(228)(61)(228)(61)(228) QCA Subset, Paired Lesion Analysis

11 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 11 Primary/Secondary Endpoints PERSEUS WH (Bayesian Analysis) 1 o Clinical Endpoint: TLF (97.7% complete F/U 12 mos) Posterior Probability of Non-Inferiority = o QCA Endpoint: ln(%DS) (87.6% complete F/U 9 mos) 95% Credible Interval Posterior Probability of Non-Inferiority = P(θ1- θ2 < 4.1% | data) 0.95 (μ1 – μ2 < 0.20 | data) 0.95 Δ 4.1% 95% Credible Interval 1.85% Δ 0.20 Difference: -0.57% Difference: -0.03

12 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 12 9-Month Late Loss (mm) 9-Month QCA Outcomes PERSEUS WH Late Loss (mm) 9-Month % Diameter Stenosis Diameter Stenosis (%) 0.26 ± ±0.55 P=0.33P= ± ± ± ± ± ±17.71 P=0.91P=0.92 QCA Subset, Paired Lesion Analysis In-StentIn-SegmentIn-StentIn-Segment (61)(228)(61)(228)(61)(228)(61)(228) TAXUS Express PESTAXUS Element PES

13 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide Month Clinical Outcomes PERSEUS WH TLFMACECardiac Death All-Cause Death MIST* (ARC Def/Prob) P=0.78P=0.86P>0.99 P=0.48P>0.99 Event Rates (per Patient, %) *TLF: ischemia-driven TLR, or MI/cardiac death related to the target vessel. MACE: MI, TVR, cardiac death TAXUS Express PES (N=320)TAXUS Element PES (N=942) (1/313)(4/918)(19/313)(52/922)(24/313)(68/922)(1/313)(5/922)(2/314)(6/922)(9/313)(20/922) *12m DAPT compliance 89%, both groups

14 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 14 Cumulative Event Rate (%) Cumulative TLF * to 12 Months PERSEUS WH 0 Days Since Index Procedure TAXUS Element (N=942) TAXUS Express (N=320) 6.0% 5.6% P=0.78 *TLF: ischemia-driven TLR, or MI/cardiac death related to the target vessel. 23% Angiographic Follow-Up Event Rate±SE; Log-Rank P Value

15 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 15 Cumulative Event Rate (%) Comparison of Ischemia-Driven TLR Between Non-QCA Stent Cohorts 0 Days Since Index Procedure % 2.8% 4.5% 2.3% SPIRIT IV Presented by G. Stone, TCT 2009 PERSEUS, TAXUS Express, Non-QCA subset (N=246) PERSEUS, TAXUS Element, Non-QCA subset (N=686) SPIRIT IV, TAXUS Express (N=1229) Baseline RVD PERSEUS: 2.8mm SPIRIT IV: 2.75mm Baseline Lesion Length PERSEUS, Element: 14.2mm SPIRIT IV, Xience: 14.8mm SPIRIT IV, XIENCE V/PROMUS (N=2458)

16 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 16 Clinical & Angiographic Characteristics PERSEUS SV Values are % (n/N) or mean±SD (N) Historic BMS* (N=125) TAXUS Element (N=224) P Value Age, years64.2±10.9 (125) 64.7±10.3 (224) 0.64 Male60.8 (76/125) 63.8 (143/224) 0.57 Diabetes32.0 (40/125) 36.6 (82/224) 0.39 Current Smoker22.2 (26/117) 13.6 (30/220) 0.04 Unstable Angina29.6 (37/125) 20.1 (45/224) 0.04 RVD, mm2.2±0.4 (125) 2.1±0.3 (224) <0.001 Lesion Length, mm12.9±5.1 (125) 11.7±5.1 (224) 0.04 Diameter Stenosis71.5±10.4 (125) 73.5±10.2 (224) 0.08 B2/C Lesions77.6 (97/125) 58.0 (130/224) <0.001 *TAXUS V

17 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 17 Post-Procedure QCA PERSEUS SV MLD (mm)Acute Gain (mm) 2.09 ± ±0.21 P=0.50P= ± ± ± ± ± ±0.30 In-StentIn-SegmentIn-StentIn-Segment P=0.007P=0.55 (108)(197)(108)(197)(108)(197)(108)(197) Paired Lesion Analysis Historic BMS ExpressTAXUS Element PES

18 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 18 Primary & Secondary Endpoints PERSEUS SV 2 o Endpoint: TLF (97.4% complete F/U 12 mos) 7.3% (16/218) TAXUS Element Mean 12m TLF: Upper 1-Sided 95% CI P< % PG* 19.5% In-Stent Late Loss (mm) 0.80 ± ± o Endpoint: Late Loss (87.4% complete F/U 9 mos ) Difference [95% CI]: [-0.54,-0.30] Superiority Met: P<0.001 BMS Express TAXUS Element N=108N=197 *Prespecified Performance Goal (lesion-matched TAXUS IV/V PES cohort)

19 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 19 Propensity-Adjusted 9m In-Stent Late Loss (mm) Propensity Adjustment of Primary Endpoint, PERSEUS SV In-Stent Late Loss (9m) Difference [95% CI]: [-0.59,-0.31] Superiority Met: P<0.001 BMS Express TAXUS Element 28 Variables Included: ClinicalAngiographic Age, gender, race Prior PCI, CABG, MI, TIA/CVA PVD CHF LVEF Angina CCS class 3/4 Current smoker Arrhythmia Treated diabetes Hyperlipidemia Hypertension Procedural GP IIb/IIIa LAD lesion RVD Lesion length %DS MLD Calcification Bend Tortuosity B2/C lesion Thrombus Aneurysm

20 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 20 Clinical Outcomes (12 Month) PERSEUS SV, Propensity Score Adjusted TLF * MACE Cardiac Death All-Cause Death MIST (ARC Def/Prob) P=0.01P=0.002P=0.26P=0.56P=0.26P=0.65 Event Rates (per Patient, %) *TLF: ischemia-driven TLR, or MI/cardiac death related to the target vessel. MACE: MI, TVR, cardiac death Historic BMS Express (N=125)TAXUS Element PES (N=224)

21 PERSEUS Primary Endpoint Dean Kereiakes ACC/i2 Late Breaking Trial Monday, March 15, 2010, 11:06 am Slide 21 Conclusions PERSEUS WH & SV Studies The TAXUS Element stent, which incorporates a novel platinum chromium metal alloy and thin strut design is: –Comparable in efficacy to the TAXUS Express stent in workhorse lesions –Superior in efficacy to the bare metal Express stent in small caliber vessels No clinical safety concerns regarding the novel platinum chromium alloy or Element stent design are evident


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