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3 Year Clinical Outcomes in
Patients with Diabetes Mellitus
from the RESOLUTE US Trial
Kimberly A Skelding, MD
on behalf of the RESOLUTE US Investigators
Orlando, Florida
SCAI 2013

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Author Disclosure
• Nothing to disclose

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RESOLUTE US – Diabetics
• Patients with diabetes have significantly higher
event rates because of:
– Endothelial dysfunction
– Impaired platelet function
– Altered coagulation / fibrinolysis
– Increased smooth muscle cell proliferation
• The ResoluteTM ZES is the only DES with an FDA
approved indication for patients who have coronary
artery disease and diabetes
• This post-hoc analysis reports the performance of
the ResoluteTM stent in the RESOLUTE US trial in
patients with diabetes
• Furthermore, these data are placed in context to the
larger dataset from the RESOLUTE Pooled clinical
program
Background

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Enrollment Complete – In Follow-up
RESOLUTE1 Non-RCT First-in-Human (R = 139) 5 yr
RESOLUTE AC2,3 1:1 RCT vs Xience V (R = 1140; X = 1152) 3 yr
Non-RCT Observational (R = 2349) 3 yr
2.25–4.0 mm Non-RCT vs Hx Control (R = 1402) 3 yrRESOLUTE US5
2.5–3.5 mm Non-RCT (R = 100) vs Hx ControlRESOLUTE Japan 2 yr
R Japan SVS 2.25 Non-RCT vs PG (R = 65) 1 yr
38 mm Substudy Non-RCT vs PG (R = 114) 1 yr
RESOLUTE Asia Non-RCT Observational (R = 312) 1 yr
RI-US Registry Post-approval Study (R ≈ 230) Enrolling
RESOLUTE US
RESOLUTE Global Clinical Program
Enrolling / Planning
1:1 RCT vs Taxus (R = 200; T = 200)R-China RCT 1 yr
RESOLUTE Int4
R-China Registry Non-RCT Observational (R = 1800) 1 yr
1Meredith IT, et al. EuroIntervention. 2010;5:692-7. 2Serruys PW, et al. N Engl J Med. 2010;363:136-46. 3Silber S, et al. Lancet.
2011;377:1241-47. 4Neumann FJ, et al. EuroIntervention. 2012;7(10):1181-8. 5Yeung AC, et al. JACC. 2011;57:1778-83.

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Hx Controls
Performance Goals
ResoluteTM ZES
2.25–3.5 Clinical (n=1242)
2.25–3.5 Angio/IVUS (n=100)
4.0 Angio (n=60)
38mm Clinical (n=110–175)
RESOLUTE US
Primary Endpoints:
• 2.25–3.5 Clinical → Target Lesion Failure at 12mo
• 2.25–3.5 Angio/IVUS → In-Stent LLL at 8mo
• 4.0 Angio → In-Segment LLL at 8mo
• 38 mm Clinical → Target Lesion Failure at 12mo
Drug Therapy: ASA and clopidogrel/ticlopidine ≥ 6mo (per guidelines)
De Novo Native Coronary Lesion
Vessel Diameter: 2.25 – 4.2 mm
Lesion Length: ≤ 27 mm
(≤ 35 mm lesions tx w/ 38 mm stent)
Clinical endpoints
Angio/IVUS endpoints
6mo 4yr3yr2yr12mo 18mo8mo 5yr9mo30d
N = max 1577 patients
Up to 135 US sites
Clinical Study Design

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Key Inclusion Criteria
Clinical evidence of ischemic
coronary disease
Single or double de novo lesion in
native coronary artery
Target lesion ≤27mm in
length, diameter stenosis ≥50%
<100%, and target RVD ≥2.25mm
≤4.2mm
Target vessel TIMI flow ≥2
Patient is able to take DAPT for at
least 6 months
Treatment of up to two lesions, if the
lesions are located in separate
target vessels
Key Exclusion Criteria
Acute MI within 72 hours of
index procedure
Previous PCI of target vessel within
9 months pre-procedure
Planned PCI of any vessel within
30 days post-procedure
Hx stroke or TIA within 6 months
LVEF <30%
RESOLUTE US
Key Eligibility Criteria
Mauri L, et al. Am Heart J. 2011;161:807-14.

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RESOLUTE US – Diabetic Patients
Baseline Characteristics
%
Diabetic Patients
N = 482
All Patients
N = 1402
Age (yr) 64.5 ± 10.2 64.1 ± 10.7
Male 62.2 68.3
Diabetes mellitus 100.0 34.4
IDDM 28.0 9.6
Hypertension 92.9 84.2
Hyperlipidemia 95.0 87.7
Current smoker 18.0 20.9
Prior MI 21.5 21.6
Prior PCI 35.3 32.7
Prior CABG 10.8 8.8
Clinical status:
Stable angina 56.3 56.1
Unstable angina 41.5 41.9
Myocardial infarction 2.2 2.1

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%
Non-Diabetics
N = 920
Non-IDDM
N = 347
IDDM
N = 135
Age (yr) 63.9±10.9 64.9±10.3 63.5±10.1
Male 71.4 66.0 51.1
Diabetes mellitus 0.0 100.0 100.0
IDDM 0.0 0.0 100.0
Hypertension 79.6 92.2 94.8
Hyperlipidemia 83.9 95.7 93.3
Current smoker 22.4 18.4 17.0
Prior MI 21.7 20.4 24.4
Prior PCI 31.3 32.9 41.5
Prior CABG 7.8 11.0 10.4
Clinical status:
Stable angina 42.9 40.9 44.4
Unstable angina 32.3 30.5 31.9
Myocardial infarction 1.5 1.4 2.2
RESOLUTE US – Diabetic Patients
Baseline Characteristics

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%
Diabetic
Patients
n = 465
All Patients
n = 1402
Death (all) 5.4 4.7
Cardiac 3.0 2.1
MI (target vessel) 1.5 2.1
Q Wave 0.2 0.1
Non Q wave 1.3 1.9
Cardiac death or target vessel MI 4.3 3.9
ST Def/Prob (all) 0.0 0.3
Early (0-30 days) 0.0 0.1
Late (31-360 days) 0.0 0.1
Very late (>360 days) 0.0 0.1
TLR (clinically driven) 6.7 4.9
TVR (clinically driven) 12.5 9.7
TLF (cardiac death, TV-MI, TLR) 10.8 8.5
TVF (cardiac death, TV-MI, TVR) 15.5 12.7
RESOLUTE US – Diabetic Patients
Clinical Outcomes at 36 Months

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10.8
6.7
3.0
1.5
0.0
8.5
4.9
2.1 2.1
0.3
RESOLUTE US – Diabetic Patients
Safety and Efficacy Outcomes at 36 Months
Diabetic (n=465/482)
Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR.
TLR is ischemia driven. Data are not prespecified or powered for the analysis shown.
Events[%]
All Patients (n=1341/1402)
TV-MITLR Cardiac
Death
ST
(ARC Def/Prob)
TLF

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%
Non-Diabetics
N = 920
Non-IDDM
N = 347
IDDM
N = 135
Death (all) 4.3 3.9 9.2
Cardiac 1.6 2.7 3.8
MI (target vessel) 2.4 1.2 2.3
Q Wave 0.1 0.3 0.0
Non Q wave 2.3 0.9 2.3
Cardiac death or target vessel MI 3.7 3.6 6.1
ST Def/Prob (all) 0.5 0.0 0.0
Early (0-30 days) 0.1 0.0 0.0
Late (31-360 days) 0.1 0.0 0.0
Very late (>360 days) 0.2 0.0 0.0
TLR (clinically driven) 4.0 6.0 8.4
TVR (clinically driven) 8.2 11.4 15.3
TLF (cardiac death, TV-MI, TLR) 7.3 9.6 13.7
TVF (cardiac death, TV-MI, TVR) 11.2 13.8 19.8
RESOLUTE US – Diabetic Patients
Clinical Outcomes at 36 Months
Data are not prespecified or powered for the analysis shown.

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0 360 720
CumulativeIncidenceofTLR
IDDM
Non-IDDM
Time After Initial Procedure (days)
0%
10%
15%
20%
5%
IDDM
No. at risk 135 135 133 123 118 117 114 110 108 107
% CI 0.00 0.75 3.87 7.00 7.00 7.00 7.84 7.84 7.84 8.70
Non-IDDM
No. at risk 347 347 345 337 325 321 316 307 301 296
% CI 0.00 0.29 1.46 3.51 4.40 4.70 5.00 5.00 5.32 6.02
Non-Diabetics
No. at risk 920 918 906 894 874 861 841 820 803 798
% CI 0.22 0.66 1.21 2.09 2.54 3.00 3.58 3.82 3.94 3.94
Non-Diabetics
1080
RESOLUTE US – Diabetic Patients
Cumulative Incidence of TLR at 36 Months
8.70%
3.94%
6.02%
Data are not prespecified or powered for the analysis shown.

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0 360 720
CumulativeIncidence
ofCardiacDeathorTVMI
IDDM
Non-IDDM
Time After Initial Procedure (days)
0%
10%
15%
5%
IDDM
No. at risk 135 134 132 127 126 125 122 118 115 114
% CI 0.74 1.49 2.99 2.99 2.99 3.78 4.57 5.38 6.20 6.20
Non-IDDM
No. at risk 347 346 344 340 335 334 330 321 316 312
% CI 0.29 0.58 1.44 1.73 1.73 2.03 2.92 2.92 3.23 3.54
Non-Diabetics
No. at risk 920 906 897 889 876 867 848 832 819 813
% CI 1.52 1.63 1.85 1.96 2.30 2.86 3.10 3.10 3.45 3.57
Non-Diabetics
1080
RESOLUTE US – Diabetic Patients
Cumulative Incidence of Cardiac Death or TVMI at 36 Months
6.20%
3.54%
3.57%
Data are not prespecified or powered for the analysis shown.

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0 360 720 1080
CumulativeIncidenceof
ARCDef/ProbStentThrombosis
IDDM
Non-IDDM
Time After Initial Procedure (days)
0%
1.5%
2.0%
1.0%
IDDM
No. at risk 135 135 134 128 127 126 123 120 117 116
% CI 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Non-IDDM
No. at risk 347 347 346 342 337 336 332 324 318 314
% CI 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Non-Diabetics
No. at risk 920 920 911 903 890 881 865 848 833 828
% CI 0.00 0.22 0.22 0.22 0.33 0.33 0.33 0.33 0.45 0.45
Non-Diabetics
0.5% 0.45%
0.0%
0.0%
RESOLUTE US – Diabetic Patients
Cumulative Incidence of ARC Def/Prob ST at 36 Months
Data are not prespecified or powered for the analysis shown.

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RESOLUTE US & Pooled Diabetics
• In this post-hoc analysis, the RESOLUTE US trial
showed very good outcomes in the diabetic
subgroup, despite the higher risk nature of the
diabetic patient population
• There was a low rate of TLF (10.8%) and TLR
(6.7%)
• No stent thrombosis out to 3 years
Conclusions