1. The XIENCE V EXCEED Study
John A. McPherson, MD, FACC, FSCAI
Vanderbilt Heart and Vascular Institute

2. DISCLOSURES
John A. McPherson, MD
Consultant
Abbott Vascular

3. “1st-generation” DES Case
64 year-old male with unstable angina

4. “1st-generation” DES Case
JR4 guide
Choice Floppy Wire
Predil: 3.0 mm balloon
Unable to advance DES
Buddy wire not helpful
Three BMS deployed

5. “1st-generation” DES Case
“Excellent angiographic result”
Multiple BMS implanted
Procedure time: 74 minutes
Fluoro time: 16 minutes
Contrast use: 215 mL

6. XIENCE V: a “Next-Generation” DES
Based on the MULTI-LINK VISION Cobalt Chromium stent
MULTI-LINK
ML DUET
ML TRISTAR
ML TETRA
ML PENTA
ML ZETA
ML VISION
MULTI-LINK 8*
8th Generation ML Stent

7. “Next-Generation” DES Use: US Market Share

8. XIENCE US Post-Marketing Program
EXCEED
XIENCE V USA
Acute performance
Operator/Patient experience
N = 2500
Short, long-term outcomes
Clinical events
N = 8000
Spectrum of Post-Marketing Evaluation

9. XIENCE V EXCEED: Study Objective & Design
Objective: Assess XIENCE V acute performance, deliverability, and resource utilization during routine commercial use
Primary Endpoint: Overall physician-determined XIENCE performance and deliverability, assessed by a 13-item performance evaluation questionnaire
Coprimary Endpoint: Procedural success, defined as final in-stent %DS of < 50% for all stented lesions and without cardiac death, MI, or TLR at the end of the index procedure

10. XIENCE V EXCEED: Study Objective & Design
Prospective, open-label registry
2483 patients from 83 US centers
Eligibility:
All patients receiving XIENCE DES
No real exclusion criteria

11. Baseline Demographics
34% women
52% > 65 yrs

12. Clinical Presentation
ACS
Angina

13. Diseased Vessels and Lesion Location
Patients (%)
1 Vessel
1482 (59.6%)
2 Vessels
(24.1%)
3 Vessels
(16.3%)
Total Patients
2487
40.4% of patients had two or more diseased vessels

14. Treated Vessels and Lesion Location
Patients (%)
1 Vessel
2225 (89.4%)
2 Vessels
(10.2%)
3 Vessels
(0.4%)
Total Patients
2488
10.6% of patients had two or more treated vessels

15. Target Lesions and Lesion Location
Patients (%)
1 Lesion
1839 (73.9%)
2 Lesions
521 (20.9%)
3 Lesions
128 (5.1%)
Total Patients
2488
26.0% of patients had two or more target lesions

16. Complexity of Treated Lesions
AHA/ACC B2/C Lesions: 52.2%

17. Lesion Characteristics

18. Target Lesions (1.3 lesions/pt)
Total Lesion Length (mm)/Patient ± 15.5
< %
≥ %
≥ %
≥ %
Total Lesion Length (mm)/Lesion ± 9.4
< %
≥ %
≥ %
≥ %
31.2% of all lesions > 20 mm

19. Lesion Treatment and Stent Usage
No. of Target Lesions Treated 1.3 ± 0.6
No. of Implanted Stents/Lesion 1.1 ± 0.4
≥ 2 Stents %
Total Stent Length/Lesion ± 11.0
No. of Implanted Stents/Patient 1.5 ± 0.80
≥ 2 Stents %
Total Stent Length/Patient ± 17.9
Direct Stenting %
Post-Stent Dilatation %
IVUS Use %

20. Stent Implantion Details
(3725 Stents in 2488 Patients)

21. Pre-dilatation Stratified by Stent Diameters

22. Pre-dilatation Stratified by Stent Length

23. Stent Usage
Stent Diameter (mm)
Stent Length (mm)

24. Maximum Stent Balloon Pressure
Mean = 13.6 ± 3.23 (atm)
(Q1, Q3): (12.0, 16.0)

25. Low contrast use and fluoroscopy time
Resource Utilization
Procedure Time (min) ± 36.1
Amount of Contrast (ml) ± 94.5
Fluoroscopy Time (min) ± No. of Guide Wires ± 0.7
No. of Guiding Catheters ± 0.6
No. of Pre-Dilatation Balloons 1.3 ± 0.6
No. of Post-Dilatation Balloons ± 0.8
Low contrast use and fluoroscopy time

26. Contrast Use and Fluoro Time in EXCEED Compared to 1st-Gen DES
26.4%
Reduction
30.3%
Reduction
14.4
± 98.5
± 11.8
10.6
± 94.5
± 11.6
*P values were derived from post hoc analysis comparing two data sources, were not adjusted for multiple comparisons, and are being used for descriptive purposes only.

27. Acute Performance and Deliverability
Excellent Acute Performance and Deliverability
Agree %
Strongly Agree %
Moderately Agree %
Agree %
Disagree %
Moderately Disagree 0.7%
Strongly Disagree 0.1%

28. XIENCE V Performance Compared to 1st-Gen DES
Agree (%)
Disagree (%)
Excellent DELIVERABILITY of the Coronary Stent System (Track and Push)
97.7
2.3
Excellent FLEXIBILITY of Coronary Stent System
99.0
1.0
Excellent Ability to ACCESS and CROSS Lesion
97.5
2.5
Excellent Ability to PULL BACK the Undeployed System into Guide Catheter
98.7
1.3
Excellent Ability to RECROSS Lesion or Stent
98.3
1.7
Exceptional INFLATION/ DEFLATION Time
XIENCE V Performance
Agree (%)
Disagree (%)
Excellent BALLON WORKING LENGTH
99.0
1.0
Excellent System WITHDRAWAL from Stent Post-Deployment
97.8
2.2
Excellent System PULLBACK POST-DEPLOYMENT into Guide Catheter
97.9
2.1
Excellent GUIDE WIRE MOVEMENT
99.5
0.5
Excellent RADIOPACITY of the Deployed Stent
94.5
5.5
Excellent OVERALL PERFORMANCE and DELIVERABILITY
99.2
0.8

29. Procedural Success in Complex Cases
Procedure Success* %
[95% Confidence Interval] [98.9%, 99.6%]
Simpler Cases
More Complex Cases
Age ≤ 65
99.2%
Age > 65
99.3%
Lesions < 20 mm
Lesions ≥ 20 mm
99.4%
ACC A/B1
ACC B2/C Lesions
Stents ≥ 2.75 mm
Stents 2.5 mm
Single Lesion
Multiple Lesions
99.1%
Single Stent
Multiple Stents

30. Conclusions
In this large, multi-center, real-world registry, XIENCE V demonstrated:
Outstanding physician-determined acute performance and deliverability (99.2%)
A high procedure success rate (99.3%)
Despite the complexity of the EXCEED population, the “next-gen DES” elements (derived from a 13-item questionnaire) led to excellent overall MD satisfaction

31. Conclusions Despite the complexity of the EXCEED population,
Contrast volume was low
Fluoroscopy times were short
Patient safety and economic factors will place a greater emphasis on procedural resource utilization during DES implantation