1. 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

2. 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

3. 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:

4. 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 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)

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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