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

DISCLOSURES John A. McPherson, MD Consultant Abbott Vascular

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

“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

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

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

“Next-Generation” DES Use: US Market Share

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

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

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

Baseline Demographics 34% women 52% > 65 yrs

Clinical Presentation ACS Angina

Diseased Vessels and Lesion Location Patients (%) 1 Vessel 1482 (59.6%) 2 Vessels 599 (24.1%) 3 Vessels 406 (16.3%) Total Patients 2487 40.4% of patients had two or more diseased vessels

Treated Vessels and Lesion Location Patients (%) 1 Vessel 2225 (89.4%) 2 Vessels 253 (10.2%) 3 Vessels 10 (0.4%) Total Patients 2488 10.6% of patients had two or more treated vessels

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

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

Lesion Characteristics

Target Lesions (1.3 lesions/pt) Total Lesion Length (mm)/Patient 21.4 ± 15.5 < 10 12.0% ≥ 10-20 43.4% ≥ 20-30 22.8% ≥ 30 21.7% Total Lesion Length (mm)/Lesion 16.3 ± 9.4 < 10 16.2% ≥ 10-20 52.6% ≥ 20-30 23.8% ≥ 30 7.4% 31.2% of all lesions > 20 mm

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 11.3% Total Stent Length/Lesion 20.8 ± 11.0 No. of Implanted Stents/Patient 1.5 ± 0.80 ≥ 2 Stents 35.3% Total Stent Length/Patient 27.5 ± 17.9 Direct Stenting 45.5% Post-Stent Dilatation 42.6% IVUS Use 13.6%

Stent Implantion Details (3725 Stents in 2488 Patients)

Pre-dilatation Stratified by Stent Diameters

Pre-dilatation Stratified by Stent Length

Stent Usage Stent Diameter (mm) Stent Length (mm)

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

Low contrast use and fluoroscopy time Resource Utilization Procedure Time (min) 28.2 ± 36.1 Amount of Contrast (ml) 145.6 ± 94.5 Fluoroscopy Time (min) 10.6 ± 11.6 No. of Guide Wires 1.3 ± 0.7 No. of Guiding Catheters 1.2 ± 0.6 No. of Pre-Dilatation Balloons 1.3 ± 0.6 No. of Post-Dilatation Balloons 1.3 ± 0.8 Low contrast use and fluoroscopy time

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.

Acute Performance and Deliverability Excellent Acute Performance and Deliverability Agree 99.2% Strongly Agree 74.5% Moderately Agree 18.2% Agree 6.5% Disagree 0.8% Moderately Disagree 0.7% Strongly Disagree 0.1%

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

Procedural Success in Complex Cases Procedure Success* 99.3% [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

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

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