PLATINUM Long Lesion 12-Month Outcomes Paul S. Teirstein, Gregg W. Stone, Ian T. Meredith, Tift Mann, Vincent J. Pompili, Louis A. Cannon, Michael R. Mooney, Shigeru Saito, Dominic J. Allocco, and Keith D. Dawkins for the PLATINUM LL Investigators

Disclosures PS Teirstein1: Grant Support/Research Contract (Abbott, Boston Scientific, Cordis, Medtronic: Modest); Consultant Fee/Honoraria/Speaker’s Bureau (Abbott, Boston Scientific, Cordis, Medtronic: Modest) GW Stone2: Consultant Fee/Honoraria/Speaker’s Bureau (Abbott, Boston Scientific, Medtronic: Modest) IT Meredith3: T Mann4: None VJ Pompili5: LA Cannon6: MR Mooney7: S Saito8: Consultant Fee/Honoraria/Speaker’s Bureau (Abbott, Boston Scientific Japan, Medtronic, TERUMO: Modest) DJ Allocco9: Salary/Salary Support/Employee (Boston Scientific: Significant) and Equity (Boston Scientific: Significant) KD Dawkins9: Affiliations: 1 Scripps Clinic, La Jolla, CA, USA; 2 Columbia University Medical Center, Cardiovascular Research Foundation, New York, NY, USA; 3 Monash Medical Centre, MonashHEART, Clayton, Victoria, Australia; 4 Wake Heart Associates, Raleigh, NC, USA; 5 The Ohio State University Medical Center, Columbus, OH, USA; 6 The Cardiac & Vascular Research Center of Northern Michigan, Northern Michigan Regional Hospital, Petoskey, MI, USA; 7 Minneapolis Heart Institute, Minneapolis, MN, USA; 8 Shonan Kamakura General Hospital, Kamakura City, Kanagawa, Japan; 9 Boston Scientific Corporation, Natick, MA, USA. The PLATINUM Long Lesion Study was supported by Boston Scientific Corporation

Introduction Long coronary lesions are associated with high restenosis rates and adverse clinical outcomes. The platinum chromium PROMUS Element everolimus-eluting stent (EES, Boston Scientific, Natick, MA) demonstrated noninferior clinical outcomes compared to the XIENCE V EES (Abbott, Santa Clara, CA) in lesions 24 mm.* The PLATINUM long lesion (LL) study assessed outcomes with PROMUS Element in de novo lesions >24 mm to 34 mm * Stone, et al. JACC 2011; 57: 1700-08

Methods DESIGN: Prospective, single-arm, multicenter PRIMARY ENDPOINT: Target lesion failure (TLF) at 12M Cardiac death related to the target vessel, or MI related to the target vessel, or Ischemia-driven target lesion revascularization (TLR) COMPARATOR: Predefined performance goal of 19.4% based on historical results with first generation TAXUS Express 32-mm paclitaxel-eluting stent (chosen because there were no commercially available long [≥32 mm] EES in the US at the time the study was designed)

Investigational Device Product Matrix PROMUS Element Everolimus-eluting Stent Length Diameter 32 mm, 38 mm 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm

Key Enrollment Criteria PLATINUM Long Lesion Study Inclusion Exclusion De novo lesion* Excessive target lesion tortuosity Lesion length >24 mm & ≤34 mm Extreme target lesion angulation Stenosis ≥50 to <100%; TIMI>1 Moderate/severe lesion calcification RVD ≥2.50 mm to ≤4.25 mm Side branch 2.0 mm diameter Target lesion coverable by 1 stent MI ≤30 days prior/elevated enzymes at index procedure with CK>2x ULN 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; ULN=upper limit of normal

Baseline Characteristics PLATINUM Long Lesion Study – Intent-To-Treat Patient (N=102) Male 62.7% Stable angina 56.4% Age (years) 65.9  9.8 Unstable angina 23.8% Diabetes* 30.0% Hyperlipidemia* 82.4% Insulin 9.0% Hypertension* Smoking (ever) 64.0% Prior PCI 38.2% Target Lesion (QCA, N=102) RVD (mm) 2.56  0.40 MLD (mm) 0.73  0.30 Lesion length (mm) 24.38  8.21 DS (%) 71.70  10.96 * Medically treated Numbers are % or meanSD; DS=diameter stenosis; MLD=minimum lumen diameter; PCI=percutaneous coronary intervention; QCA=quantitative coronary angiography; RVD=reference vessel diameter

Study Flow – Intent-to-Treat Population PLATINUM Long Lesion Study 102 Patients enrolled at 30 clinical sites No 12M f/u (N=6) Withdrew consent: 1 Missed 12M visit: 5 Death (N=1) 12-Month Clinical f/u or Death 94.1% (96/102) 8

Procedural Characteristics PLATINUM Long Lesion Study Intent-To-Treat (N=102) Technical success (per stent)* 98.2% Clinical procedural success† 100.0% Pre-dilatation used Post-dilatation used 54.9% Max post-dilatation pressure (atm) 18.6  3.5 Maximum pressure overall (atm) 17.5  3.0 Total amount of contrast used (cc) 197.0  93.5 Fluoroscopy time (min) 12.6  19.1 * 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 % or meanSD

Post Procedure Angiographic Outcomes PLATINUM Long Lesion Study Intent-To-Treat (N=102) MLD, in-stent, mm 2.39  0.32 MLD, in-segment, mm 2.08  0.37 DS, in-stent, % 6.82  9.46 DS, in-segment, % 19.50 7.66 Acute gain, in-stent, mm 1.66 0.36 Acute gain, in-segment, mm 1.35  0.40 Numbers are meanSD DS=diameter stenosis; MLD=minimum lumen diameter; RVD=reference vessel diameter

Stents Implanted in the Target Vessel PLATINUM Long Lesion Study 12 mm 20 mm 28 mm 32 mm 38 mm Total* 5 3 2 47 54 111 * Per protocol population (N=100); 90 patients received 1 study stent and 10 patients received >1 study stent

Antiplatelet Medication Usage PLATINUM Long Lesion Study Medication Pre-PCI* Discharge 12 Months Aspirin 100.0% 95.8% Thienopyridine 99.0% 93.7% Aspirin + Thienopyridine 89.5% *Per protocol, thienopyridine could be given up to 2 hours after the procedure PCI=percutaneous coronary intervention

PLATINUM LL Primary Endpoint Target Lesion Failure at 12 Months Performance Goal = 19.4% Per Protocol Population 100 patients received ≥1 PROMUS Element stent Target Lesion Failure (%) 95% UCB 3.2% (3/95)* * Value of 3.2% with a 95% upper confidence bound of 8.0% is significantly less (P<0.001) than the performance goal based on historical TAXUS Express results

Target Lesion Failure Components (12M) PLATINUM Long Lesion Study Per Protocol (N=100) ITT (N=102) 12-Month Time Point Target Lesion Failure 3.2% (3) 3.1% (3) Cardiac Death – Target Vessel 0.0% (0) MI – Target Vessel TLR – Ischemia Driven Numbers are % (n) ITT=intent-to-treat; MI=myocardial infarction; TLR=target lesion revascularization

Death, MI, ST & Revascularization PLATINUM Long Lesion Study – 12 Months Intent-To-Treat Population (N=102) 4.1% Event Rate (%) 3.1% 1.0% n=1 0% 0% 0% n=4 n=3 All Death Cardiac Death MI ARC ST (def/prob) TVR TLR ARC=Academic Research Consortium; MI=myocardial infarction; ST=stent thrombosis; TLR=target lesion revascularization; TVR=target vessel revascularization

Limitations Single arm study compared to a performance goal based on historical results with 1st generation TAXUS Express stent 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 MI=myocardial infarction; ST=stent thrombosis; TLR=target lesion revascularization

Summary & Conclusions PLATINUM Long Lesion Study Primary endpoint was met (P<0.001) with a low 12-month target lesion failure rate of 3.2% (3/95; per protocol group) There were 3 TLRs, 1 non-cardiac death, and no cardiac deaths, MIs or STs (ITT group) Results of PLATINUM LL support both safety & efficacy of the PROMUS Element 32-mm & 38-mm stents