1. Long Term Safety and Effectiveness of XIENCE V® Everolimus Eluting Coronary Stent System in a Real-World Population: Three-Year Clinical Outcomes from XIENCE V® USA James B. Hermiller, Jr,1 Weiying Zhao,2 Luis Gruberg,3 William Lombardi,4 David R. Rutledge,2 Jin Wang,2 and Vivian W. Mao,2 and Mitchell W. Krucoff5
The Heart Center of IN, Indianapolis, Indiana
Abbott Vascular, Santa Clara, CA
Stony Brook University, Stony Brook, NY
Peacehealth St. Joseph Medical Center, Bellingham, WA
Duke University Medical Center, Durham, NC 1

2. Disclosures
James B. Hermiller: Abbott Vascular, Boston Scientific, Medtronic, and St. Jude: Consultant Fee/Honoraria/Speaker’s Bureau
Mitchell W. Krucoff: Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Edwards Lifesciences, Cappella: Research Grant; Abbott Vascular, Biosensors International, Boston Scientific, Cordis, Medtronic, Terumo, St. Jude Medical, Angel Medical Systems, Guided Delivery Systems, Edwards Lifesciences, Cardiac Dimensions Inc., Cappella: Research Consultant/Advisory Board and Speaker’s Bureau
Luis Gruberg: Eli Lilly, Daiichi Sankyo, AstraZeneca, and The Medicines: Consultant Fee/Honoraria/Speaker’s Bureau
William Lombardi: Abbott Vascular and Medtronic: Consultant Fee/Honoraria/Speaker’s Bureau ; Bridgepoint Medical Systems: Equity
David R. Rutledge, Vivian W. Mao, Weiying Zhao, Jin Wang: Abbott Vascular employees.
This study was sponsored by Abbott Vascular (Santa Clara, CA, USA).
XIENCE V® USA

3. Introduction
A recent 1-year multivariable analysis of real-world XVUSA patients demonstrated several independent predictors of adverse events.
Early DAPT interruption (≤30 days) was the most potent predictor of ST, whereas delayed interruption (>30 days) was not predictive.
XIENCE V® USA

4. Introduction
The safety and effectiveness of XIENCE V in these real-world patients continue to demonstrate low stent thrombosis and cardiac death/MI rates at two years (J Interv Card 2012, in press).
The objective of this analysis is to present 3-year results and to model for the first time multivariate predictors after 1 year.
XIENCE V® USA

5. Methods
XIENCE V USA is a large, prospective, multicenter, post-approval study designed to examine the safety and effectiveness of XIENCE V in patients from real-world clinical settings.
Patients were consecutively enrolled with no inclusion/exclusion criteria beyond informed consent and the exclusive use of XIENCE V during the index procedure.
The primary and co-primary endpoints were Academic Research Consortium (ARC)-defined ST (definite/probable) and the composite rate of cardiac death and MI.
XIENCE V® USA 5

6. Multivariable Cox Regression - Methods
Model: includes clinical, angiographic and procedural variables.
In patients with more than one lesion, the most severe vessel/lesion was chosen.
The multivariable model was created using stepwise regression, where variables were entered into the model either through clinical judgement or at the 0.05 significance level and removed at the 0.05 level (from the Wald chi-square statistic). Variables were eligible for inclusion in the multivariable model-building process if the variable was present for 90% of the subjects in the analyses, had a univariate p-value <0.05, and, if highly correlated with another variable (r>0.5 and p<0.05), had the higher level of significance.

7. Clinical, Angiographic, and Procedural Variables of the Predictor Analysis
16 Demographic and Clinical:
Age
Gender
Current Tobacco Use
Diabetes Requiring Rx
Hypertension Requiring Rx
Hypercholesterolemia Requiring Rx
Prior CABG
Prior CABG or Multiple Diseased Vessels*
Prior PCI
CCS III or IV
Prior MI
Acute Myocardial Infarction
Renal Insufficiency
Stroke
Left Ventricular Ejection Fraction
Number of Diseased Vessels
12 Angiographic:
Pre-procedure %DS
Pre-procedure TIMI
Target Lesion Length
In Stent Restenosis
Bifurcation
Ostial
ACC/AHA Lesion Class
CTO*
Target Vessel: LAD
Target Vessel: LM
Target Vessel Graft
Heavy Calcification
12 Procedural:
Pre Dilatation
Post Dilatation
Maximum Balloon Pressure
2.5mm Stent(s) Implanted
Number of Treated Lesions
Number of Treated Vessels
Bailout Stent Usage
Number of Stent Implanted
Total Length of All Stents
DAPT Interruption within 30 Days Post Procedure
DAPT Interruption after 30 Days Post Procedure
Permanent DAPT Discontinuation between 1 to 3 Years*
Note: Prior bracytherapy was removed
as a demographic/clinical variable.
*Variables not present in the original
1-year Naidu et al. analysis
XIENCE V® USA

8. Study Populations Patient Populations Standard Risk Overall Population
A total of 5034 patients were consecutively enrolled from 162 U.S. sites.
In addition to an analysis of the overall (all-comer) population, outcomes are also reported for patients who are defined as standard risk.
Patient Populations
Overall Population
Includes all available long-term
follow-up patients
Standard Risk
lesion length ≤ 28 mm,
reference vessel diameter
between 2.5 mm and 4.25 mm, patients considered on-label and near on-label
XIENCE V® USA

9. Patient Flow Long-Term Follow-up Cohort N=5034
14 Patients
Transferred to HCRI DAPT Study
Long-Term Follow-up Standard Risk Cohort
N=1871
Long-Term Follow-up Overall Cohort
N=5020
282 Early Terminations
108 Deaths
119 Lost to follow-up
41 Withdrew Consent
9 Withdrawn by Physician
5 Other
Follow-up at 1 year
N=1782 (95.2%)
Follow-up at 1 year
N=4738 (94.4%)
236 Early Terminations
123 Deaths
84 Lost to follow-up
11 Withdrew Consent
14 Withdrawn by Physician
4 Other
Follow-up at 2 years
N=1726 (92.3%)
Follow-up at 2 years
N=4502 (89.7%)
154 Early Terminations
117 Deaths
2 Lost to follow-up
25 Withdrew Consent
9 Withdrawn by Physician
1 Other
Follow-up at 3 years
N=1678 (89.7%)
Follow-up at 3 years
N=4348 (86.6%)
XIENCE V® USA

10. Baseline Patient Characteristics
Overall
(N = 5020)
Standard Risk
(N = 1871)
Age (yrs)
64.8
64.3
Male (%)
68.8
66.3
Diabetes (%)
35.7
31.0
Prior MI (%)
30.8
24.8
2 or More Vessel Disease (%)
40.8
30.7
AMI (%)
16.0 NA
Unstable Angina (%)
22.4
24.7
LVEF < 30% (%)
3.3
Renal Insufficiency (%)
11.1
Prior Cardiac Intervention (%)
PCI (%)
CABG (%)
51.3
40.1
15.5
44.2
36.6
8.8
N: total number of patients; NA: not applicable since patients were
excluded from the Standard Risk cohort
XIENCE V® USA 10

11. Lesion and Procedure Characteristics
Overall
(L = 7024)
Standard Risk
(L = 2309)
Graft Lesion (%)
4.8 NA
Left Main Lesion (%)
1.6
B2/C Lesion (%)
49.3
35.6
Restenosis (%)
9.4
Chronic Total Occlusion (%)
2.5
Bifurcation Lesion (%)
9.2
1.8
Ostial Lesion (%)
11.8
Lesion Length (mm)
16.0
14.2
# of Lesions Treated
1.4
1.2
# of Stents per Lesion
1.1
Stent Length per Lesion (mm)
21.2
18.6
Direct Stenting (%)
38.8
44.6
L: total number of lesions; NA: not applicable since patients were
excluded from the Standard Risk cohort
XIENCE V® USA 11

12. DAPT Usage and Stent Thrombosis
Similar dual anti-platelet therapy (DAPT) usage at 3 years between the Overall population and Standard Risk groups
Low overall rate of very late (ARC definite/probable) ST between 1-3 years
Overall Population
53.1% (2666/5020)
patients on DAPT
at 3 yrs
Standard Risk
54.8% (1026/1871)
patients on DAPT
at 3 yrs
Very late definite/probable
ST Rate (1-3 yrs)
0.22%
Very late definite/probable
ST Rate (1-3 yrs)
0.06%
DAPT usage at 1 year: 81.5% (overall) and 82.8% (standard risk)
DAPT usage at 2 years: 61.9% (overall) and 63.2% (standard risk)
XIENCE V® USA

13. ARC Definite/Probable Stent Thrombosis through 3 years
Overall Real-World Population
Standard Risk
Stent Thrombosis (%)
1.08%
0.38%
Years
Overall
5020
4665
4451
4310
Standard Risk
1871
1765
1715
1670
XIENCE V® USA

14. Real-World Landmarked
ARC Definite/Probable Stent Thrombosis from 1 to 3 years
Overall Real-World Population
10 Stent Thrombosis Events from 1 to 3 years
With only 53.1% of the overall population on DAPT at 3 years, DAPT discontinuation was not a predictor of ST.
Stent Thrombosis (%)
0.22%
Years
Overall
4665
4470
4328
XIENCE V® USA

15. Multivariable Predictors of ARC ST
from 1 to 3 Years in the Overall Population
Variables P
Value
Hazard Ratio
[95% CI]
Target Vessel Graft (Yes vs No)
0.003
19.47 [2.73, 139.1]
0.001
0.1 10
1000
XIENCE V® USA

16. Landmarked Clinical Outcomes from 1 to 3 years*
Overall Real- World
(N = 5020)
Standard Risk
(N = 1871)
Target Lesion Failure (ARC)
8.6%
5.6%
Cardiac Death or MI (ARC)
4.5%
2.4%
Target Lesion Revascularization
4.1%
*Rates are from Kaplan-Meier estimates
XIENCE V® USA

17. Multivariable Predictors of Cardiac Death or MI (ARC) from 1 to 3 Years in the Overall Population
Variables P
Value
Hazard Ratio
[95% CI]
Prior CABG (Yes vs. No)
0.01
2.01 [1.16, 3.49]
Renal Insufficiency (Yes vs. No)
0.04
1.91 [1.02, 3.55]
Prior MI (Yes vs. No)
1.91 [1.15, 3.15]
Diabetes Requiring Rx (Yes vs. No)
1.74 [1.04, 2.92]
0.10 1 10
Note: All resulting variables were demographic/clinical

18. Conclusions
In this large, real-world population of complex patient and lesion cohorts, neither DAPT interruption before or after 30 days nor permanent DAPT discontinuation after 1 year were predictors of stent thrombosis between 1-3 years.
The only predictor of stent thrombosis was target vessel graft.
Predictors of cardiac death or MI were associated exclusively with the patient’s disease state (including prior CABG, renal insufficiency, prior MI, diabetes requiring Rx).
The overall results demonstrate continued safety and effectiveness of XIENCE V through 3 years in a real-world setting.