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2. Primary Results Following Percutaneous Coronary Intervention with the 38mm Resolute Zotarolimus-eluting Stent
Shirish Hiremath, Robaayah Zambahari,
Martin Leon, Laura Mauri, Alan Yeung and Michael Lee
On behalf of the RESOLUTE US and
RESOLUTE Asia Investigators
TCT 2012

3. Background
Implantation of drug-eluting stents in long coronary artery lesions is associated with a higher risk for restenosis and stent thrombosis related to the need for multiple and overlapping stents.
Historical data indicate that the XIENCE PRIME LL stent is associated with a 1yr TLF rate of 7.7% in long lesions1. Furthermore a recent publication showed no statistical differences at 1 year between R-ZES and SES for the treatment of long coronary artery lesions2.
The Resolute zotarolimus-eluting stent (R-ZES) is manufactured in a 38mm length to accommodate longer lesions but clinical data from the RESOLUTE Global Clinical Program to demonstrate efficacy and safety of the longer stent have not yet been reported.
1 Costa, M. et al. presented at TCT2011
2 Ahn, J-M, et al. Circ Cardiovasc Interv Oct 9. [Epub ahead of print]

4. RESOLUTE Global Clinical Program
2 Trials with Data for 38mm Resolute Stents
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
RESOLUTE Int4
Non-RCT Observational (R=2349)
3 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)
enrolling
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: 4

5. RESOLUTE 38mm
Methods
A sub-study of 2 prospective, multicenter clinical trials, RESOLUTE US and RESOLUTE Asia, enrolled patients with de novo coronary artery lesions amenable to treatment with the 38mm length R-ZES in target lesions of at least 35 mm.
The primary endpoint was target lesion failure (TLF*) at 1 year.
The rate of TLF at 1 year was compared to a performance goal of 19.0% derived from a logistic regression model.
All patients were prescribed dual antiplatelet therapy for a minimum of 6 months.
TLF is defined as cardiac death, target vessel myocardial infarction (TVMI), or clinically driven target lesion revascularization (TLR).

6. RESOLUTE 38mm Patient Flowchart RESOLUTE US RESOLUTE Asia
38mm Substudy
N = 114
38mm Substudy
N = 109
38 mm Substudy
N = 223
1 Year Follow-up
n = 222 (99.6%)

7. RESOLUTE 38mm Baseline Characteristics % N = 223 pts Age (yr)
60.9 ± 10.6
Male
78.9
Diabetes mellitus
37.7
IDDM
10.3
Hypertension
74.9
Hyperlipidemia
58.7
Current smoker
18.8
Family history of CAD
37.2
Prior MI
32.4
Prior PCI
27.4
Prior CABG
7.2
Cardiac status:
Stable angina
39.2
Unstable angina
47.4
Myocardial infarction
13.4

8. RESOLUTE 38mm Lesion & Procedure Characteristics N = 223 pts,
269 lesions
Number of diseased vessels (>50%)
Single
46.2
Double
36.3
Triple
17.5
Lesion location
LAD
52.0
LCx
20.2
RCA
44.4
Lesion length
Discrete (<10mm)
4.6
Tubular ( mm)
24.5
Diffuse (> 20mm)
70.9
Branch vessel disease
47.9
B2/C lesion
91.2
Lesion length (mm)
25.22 ± 8.83
RVD (mm)
2.78 ± 0.42
MLD (mm)
0.80 ± 0.36
Pre-procedure % diameter stenosis
71.33 ± 11.61
QCA measurements may have been made by careful visual estimate, on-line QCA or IVUS.

9. RESOLUTE 38mm Acute Success Rates % N = 223 patients, 269 lesions
Lesion success
(the attainment of <50% residual stenosis of the target lesion using any percutaneous method)
100%
Device success
(the attainment of <50% residual stenosis of the target lesion using only the assigned device)
97.0%
Procedure success
(the attainment of <50% residual stenosis of the target lesion and no in-hospital MACE)
96.3%

10. Time After Initial Procedure (months)
RESOLUTE 38mm
Dual Antiplatelet Therapy (DAPT) Usage
92.3
91.4
90.0
89.5
Patients on DAPT (%)
Time After Initial Procedure (months)

11. RESOLUTE 38mm Clinical Outcomes at 1 Year Primary endpoint met
Resolute 38mm (n = 222)
Events [%]
TLF
Performance
goal
Target lesion failure (TLF) is defined as cardiac death, target vessel MI and clinically driven TLR. Primary endpoint of TLF at 12 months was 5.4% with a one-sided 95% upper confidence bound of 8.6%, which was significantly less (P < 0.01) than the performance goal of 19.0%.

12. RESOLUTE 38mm Clinical Outcomes at 1 Year 30 Days % n = 223 6 Months
Death (all)
0.4
0.9
Cardiac
MI (target vessel)
3.6
Q Wave
Non Q wave
2.7
Cardiac death + target vessel MI
4.0
4.5
ST Def/Prob (all)
Early (< 30 days)
Late ( days) --
TLR
1.4
TVR
1.3
TLF (cardiac death, TV-MI, TLR)
5.4
TVF (cardiac death, TV-MI, TVR)
4.9
6.8
ST occurred in one patient on day 1 (probable ST) and in a second patient on day 4 (definite ST).
TLR and TVR are clinically driven. 12

13. RESOLUTE 38mm – Diabetic Patients
Clinical Outcomes at 1 Year
Diabetic, 38mm patients (n = 84)
Non-Diabetic, 38mm patients (n = 138)
P = 0.79
P = 0.64
P = 0.52
P = 0.49
P = 0.20
Events [%]
Cardiac
Death ST
(ARC Def/Prob)
TLF
TV-MI
TLR
All P-values are adjusted by propensity score for differences in baseline characteristics.
TLF (Target Lesion Failure) is defined as cardiac death, TVMI, or clinically driven TLR.

14. RESOLUTE 38mm
Conclusions
At 12 months, the rate of TLF was 5.4%, thereby meeting the primary endpoint for the 38mm Resolute stent.
Other clinical events rates were low and notably there were no late stent thrombosis events.
Furthermore, there were no statistical significant differences observed between patients with and without diabetes mellitus.
The 38mm length R-ZES was safe and effective in this selected population of long lesion patients.