1. On behalf of J. Belardi, M. Leon, L. Mauri,
Two-Year Outcomes of Patients Treated with the Resolute Zotarolimus-Eluting Stent in Different Indications: ST Elevation Myocardial Infarction versus Acute Coronary Syndrome Without ST Segment Elevation versus Stable Angina: A Pooled Analysis from the RESOLUTE Clinical Program
P. Widimský,
On behalf of J. Belardi, M. Leon, L. Mauri,
I. Meredith, F-J. Neumann, S. Saito, P. Serruys,
S. Silber, S. Windecker, A. Yeung and the RESOLUTE Clinical Program Investigators
ACC 2012

2. Background
Stent thrombosis (ST) with first generation DES has been a concern, in particular (very) late ST.
The risk of ST in patients with STEMI is known to be higher than in patients treated for other indications.
E.g., in the HORIZONS-AMI (STEMI <12h) the 2-yr ST rate was 4.1% with both BMS and PES.
There are limited data on patients treated with the Resolute ZES stratified by different clinical presentations: STEMI, non-ST elevated acute coronary syndrome (Non-STEACS) and stable angina (SA).

3. RESOLUTE Global Clinical Program
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)
2 yr
RESOLUTE Int4
Non-RCT Observational (R=2349)
2 yr
RESOLUTE US5
2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402)
2 yr
RESOLUTE Japan
2.5 – 3.5 mm Non-RCT (R=100) vs. Hx Control
2 yr
R Japan SVS
2.25 Non-RCT vs. PG (R=65)
< 1yr
RESOLUTE US
38 mm sub-study Non-RCT vs. PG (R=114)
< 1yr
R-China RCT
1:1 RCT vs. Taxus (R=200; T=200)
< 1yr
RESOLUTE Asia
Non-RCT Observational (R=312)
< 1yr
R-China Registry
Non-RCT Observational (R=1800)
< 1yr
Enrolling / Planning
RI-US Registry
Post-approval study (R=230)
plan
1 Meredith IT, et al. EuroIntervention. 2010;5: Serruys PW, et al. N Engl J Med. 2010;363: Silber S, et al. Lancet. 2011;377: Neumann FJ, et al. EuroIntervention. 2012;7(10): Yeung AC, et al. JACC. 2011;57: 3

4. RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina
Methods
RESOLUTE All Comers
N = 1140 (R-ZES arm)
RESOLUTE International
N = 2349
STEMI
N = 335
Non-STEACS
N = 1416
Stable Angina
N = 1260
Pooled patient level data from 2 all comer trials and stratified by clinical indication at time of procedure:
STEMI was defined as STEMI with onset of symptoms ≤ 24h
Non-STEACS included all patients with non-STEMI and unstable angina

5. RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina
Baseline Patient Characteristics %
STEMI
N=335
Non-STEACS
N=1416 SA
N=1260
Age (yr)
59.8 ± 11.3
63.8 ± 11.6
64.9 ± 10.1
Female
23.9
23.1
23.3
Diabetes mellitus
19.1
28.5
29.2
Hypertension
51.9
69.1
74.4
Hyperlipidemia
41.5
63.5
71.3
History of smoking
67.8
55.4
55.2
Current smoker
45.7
26.2
16.4
Family history of CAD
33.7
30.5
36.5
Prior MI
11.3
27.2
29.4
Prior PCI
27.9
37.6
Prior CABG
0.9
8.0
12.3

6. RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina
Lesion and Procedure Characteristics
STEMI
N=335 pts,
477 lesions
Non-STEACS
N=1416 pts,
2089 lesions SA
N=1260 pts,
1782 lesions
Multivessel stenting (%)
12.2
20.4
16.5
B2/C lesion type (%)
73.7
62.6
61.9
RVD (mm)1
2.89 ± 0.51
2.85 ± 0.51
2.83 ± 0.52
MLD (mm)1
0.40 ± 0.51
0.63 ± 0.49
0.65 ± 0.48
Diameter Stenosis (%)1
85.5 ± 17.9
77.2 ± 17.0
76.5 ± 17.3
Lesion Length (mm)1
16.8 ± 9.0
16.5± 9.6
16.7± 11.4
Long lesions (>27 mm, %)1
15.7
15.4
15.0
Small vessel (≤ 2.75mm, %)1
48.0
51.2
53.4
Bifurcation (%)
20.3
20.1
20.8
Total occlusion (%)
49.9
11.1
8.8
Complex patients (%)2
100.0
69.8
56.0
1 In RESOLUTE International (R-INT) trial angiographic measurements are site reported.
2 Complex patient definition: bifurcation, bypass grafts, ISR, AMI <72 hr, LVEF <30%, unprotected LM, >2 vessels stented, renal insufficiency or failure (creatinine >140 µmol/L), lesion length >27 mm, >1 lesion per vessel, lesion with thrombus or TO (preprocedure TIMI = 0).

7. RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina
Clinical Outcomes at 30 Days %
STEMI
n = 332
Non-STEACS
n = 1412 SA
n = 1257
Death (all)
0.6
0.4
0.1
Cardiac
0.0
Target vessel MI (all)
1.2
2.8
3.3
Cardiac death + target vessel MI
1.8
3.1
ST def/prob
0.7
Early (0 – 30d)
LST (>30d – 1yr) --
VLST (>1 yr)
TLR (clinically driven)
2.1
1.1
TVR (clinically driven)
2.7
0.8
1.3
TLF (cardiac death, target vessel MI, TLR)
3.0
3.4
3.8

8. RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina
Clinical Outcomes at 2 Years %
STEMI
n = 329
Non-STEACS
n = 1387 SA
n = 1235
Death (all)
2.1
4.8
3.7
Cardiac
1.8
3.2
2.0
Target vessel MI (all)
4.5
4.0
Cardiac death + target vessel MI
3.6
7.3
5.7
ST def/prob
2.4
1.2
1.1
Early (0 – 30d)
0.6
0.7
LST (>30d – 1yr)
0.4
0.2
VLST (>1 yr)
0.0
TLR (clinically driven)
5.5
5.2
5.4
TVR (clinically driven)
7.0
6.8
TLF (cardiac death, target vessel MI, TLR)
7.9
11.0
10.1

9. RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina
Outcomes at 2 Years
Event Rates (%)
Cardiac Death
TV-MI
TLR ST
ARC Def/Prob
TLR is ischemia driven.

10. RESOLUTE Pooled – STEMI, Non-STEACS, Stable Angina
Conclusions
The implantation of Resolute ZES in the acute phase of STEMI as well as in other clinical presentations appears to be safe and effective and the long term outcomes are very favorable, especially considering previously published outcomes in STEMI patients.
Late and very late stent thrombosis is extremely rare with R-ZES implantation irrespective of the original clinical presentation.