1. EVOLVE China:
A Randomized Comparison of Biodegradable Polymer- and Permanent Polymer-coated Platinum Chromium Everolimus-Eluting Coronary Stents in China
Yaling Han MD, PhD
Department of Cardiology
The General Hospital of Shenyang Military Region
Shenyang, China

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Grant/Research Support
Boston Scientific, US

3. Study Design
OBJECTIVE: To assess the safety and effectiveness of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY TM Stent) for the treatment of patients with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate)
DESIGN: Prospective, multicenter, 1:1 randomized (SYNERGY to PROMUS Element Plus), single-blind non-inferiority trial
CONTROL: PROMUS ElementTM Plus Everolimus-Eluting Coronary Stent System (PROMUS ElementTM Plus Stent)
PRIMARY ENDPOINT: In-stent late loss by QCA at 9 months

4. Additional Endpoints:
Clinical Outcomes:
Target lesion revascularization (TLR) rate & target lesion failure (TLF) rate
Target vessel revascularization (TVR) rate & target vessel failure (TVF) rate
Myocardial infarction (MI, Q-wave and non–Q-wave) rate
All-cause death rate, cardiac death rate & non-cardiac death rate
Cardiac death or MI rate
All death or MI rate
All death/MI/TVR rate
Stent thrombosis (ST) rate (definite or probable by ARC definitions)
Angiographic endpoints measured by QCA at 9 months post-index procedure:
In-stent and in-segment percent diameter stenosis (%DS)
In-segment late loss
In-stent and in-segment binary restenosis rate
In-stent and in-segment minimum lumen diameter (MLD)
Peri-procedural endpoints:
Technical success rate
Clinical procedural success rate
MLD measured by QCA
Acute gain measured by QCA

5. Study Diagram
Patients with 1~2 de novo native coronary artery target lesion(s)
RVD 2.25mm to ≤4.00mm; Lesion length ≤34 mm
Peri-procedure: ASA ≥300 mg, clopidogrel ≥300 mg load unless on chronic Rx
Randomized 1:1
PROMUS ElementTM Plus Stent
SYNERGY TM Stent
Clinical 1, 6, 9, 12, 24, 36, 48, 60 months;
baseline & 9 months

6. Sample Size & Power Calculation
Expected mean difference in 9-month in-stent late loss between SYNERGY and PROMUS Element Plus = 0 mm
Expected common standard deviation = 0.40 mm
Test significance level () = 2.5% (1-sided)
Non-inferiority margin (∆) = 0.15 mm
Power (1) > 90%
Evaluable sample size per group = 160
Expected attrition rate = 20%
Number of randomized subjects per group = 200
Total planned enrollment will be 400 subjects
If the one-sided upper 97.5% confidence bound is < , and the P value < from one-sided Student t-test comparing the difference in late loss between SYNERGY and PROMUS Element Plus to delta, SYNERGY will be considered non-inferior to the control.

7. Enrollment Sites Investigator Clinical Site City, Country SYNERGY
PE Plus
Yuejin Yang
Cardiovascular Institute and Fu Wai Hospital
Beijing, China 41 40
Yaling Han
General Hospital of SY Military Region
Shenyang, China
Jian Zhang
TEDA International Cardiovascular Hospital
Tianjin, China 38
Guosheng Fu
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, China 13 12
Xi Su
Wuhan Asia Heart Hospital
Wuhan, China
Tiemin Jiang
Tianjin Affiliated Hospital of Armed Police Medical College 11
Wenyue Pang
Shengjing Hospital of China Medical University 10
Jiyan Chen
Guangdong General Hospital
Guangzhou, China 9
Zuyi Yuan
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, China
Hui Li
Daqing Oilfield General Hospital
Daqing, China 8
Haichang Wang
the First Affiliated Hospital of the Forth Military Medical University, Chinese PLA 4 5
Tao Hong
Peking University 1st Hospital 3
Liu Huiliang
Beijing Affiliated Hospital of Armed Police Medical College
Sun Fucheng
Beijing Hospital of the Ministry of Health 2
Total
205
207

8. EVOLVE China 12-Month Analysis High rates of clinical and angiographic follow-up

9. Baseline Demographics
Variable
SYNERGY (N = 205)
PE Plus (N = 207)
P value
Men
69.8% (143/205)
71.5% (148/207)
0.70
Age (years)
58.41±8.76 (203)
57.89±9.19 (205)
0.56
Current Diabetes Mellitus
23.9% (49/205)
22.7% (47/207)
0.77
Oral agent
18.5% (38/205)
15.9% (33/207)
0.49
Insulin
9.3% (19/205)
6.3% (13/207)
0.26
Unknown
0.5% (1/205)
1.4% (3/207)
0.62*
Hyperlipidemia†
25.0% (51/204)
23.8% (49/206)
Hypertension†
59.0% (121/205)
53.6% (111/207)
0.27
Stable Angina
19.4% (37/191)
24.4% (49/201)
0.23
Unstable Angina
74.3% (142/191)
71.1% (143/201)
0.48
Silent Ischemia
10.0% (20/201)
6.3% (13/205)
0.18
Previous MI
18.6% (38/204)
20.9% (43/206)
0.57
History of PCI
18.7% (38/203)
18.4% (38/206)
0.94
History of CABG
0.0% (0/204)
0.0% (0/205)
Undef
History of Renal Disease
2.0% (4/199)
2.0% (4/201)
1.00
Numbers are % (n/N); Intent-to-treat analysis; P-values are from the Chi-square test unless otherwise indicated; *Fisher's exact test; †medically-treated

10. Lesion & Procedure Characteristics (QCA)
Variable
SYNERGY (N=217 lesions/N=205pts)
PE Plus
(N=226 Lesions/N=207pts)
P value*
Target Lesion Vessel Location
LAD
47.5% (103/217)
51.3% (116/226)
0.42
LCx
17.5% (38/217)
22.6% (51/226)
0.18
RCA
35.0% (76/217)
26.1% (59/226)
0.04
Lesion Length (mm)
0.40
Reference Vessel Diameter (mm)
0.28
Modified AHA/ACC B2/C
82.5% (179/217)
79.6% (180/226)
0.45
Procedure Time (min)
0.15
Pre-Dilatation
99.0% (203/205)
99.0% (205/207)
1.oo
Post-Dilatation
1.00
Stent Length Implanted (mm)
0.97
Multiple Stents Implanted
9.3% (19/205)
14.0% (29/207)
0.13
Numbers are % (n/N) or Mean Standard Deviation; P-values are from the Chi-square test unless otherwise indicated; *Fisher's exact test
Procedure time defined as time from sheath placement to last guide catheter removal

11. Procedural Outcomes
Event
SYNERGY (N=205)
PE Plus
(N=207)
Relative Risk
[95% CI]
Difference
p-Value
Clinical Procedural Success*
98.0% (199/203)***
98.0% (201/205)***
1.00 [0.97, 1.03]
0.0% [NA]
1.0000
Technical Success**
99.5% (221/222)
99.2% (234/236)
1.00 [0.99, 1.02]
0.4% [NA]
* Clinical procedural success is a mean lesion diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.
** Technical success is successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization.
*** Clinical procedural failure:
Each group had 3 pts with in-hospital death, MI, or TVR ; and 1 pt post-Procedure TIMI < 3.

12. Dual Antiplatelet Therapy at 12 Months

13. Primary Endpoint

14. Angiographic Endpoints Post-Procedue & 9 Months
Measurement*
SYNERGY
(N = 200 lesions†)
PE Plus
(N = 197 lesions†)
P value
Post-Procedure
MLD (mm)
2.67±0.43
2.67±0.47
0.90
% DS
Acute Gain
1.78±0.48
1.87±0.52
0.08
9-Months
2.46±0.50
2.50±0.55
0.50
12.12±13.47
8.72±15.26
0.02
Binary Restenosis
2.0% (4/200)
2.0% (4/197)
1.00
Late Loss
0.20±0.32
0.17±0.37
0.37
*Measurements taken in-stent
†Paired lesion analysis included lesions with evaluable baseline, post-procedure, and 9-month follow-up angiograms with the exception of late loss where SYNERGY n=195; PE Plus n=195 lesions were analyzed
Numbers are Mean Standard Deviation; P-values are from the Chi-square test unless otherwise indicated; ‡Fisher's exact test

15. Clinical Endpoints at 12 Months
Event
SYNERGY (N = 205)
PE Plus
(N = 207)
P-value
All Death, MI, TVR
5.5% (11/199)
6.3% (13/205)
0.73
All Death
1.0% (2/199)
0.5% (1/205)
0.62*
Cardiac Death
0.0% (0/199)
0.0% (0/205)
Undef
Non-Cardiac Death MI
2.5% (5/199)
1.5% (3/205)
0.50*
Q-wave MI
1.5% (3/199)
0.12*
Non-Q-wave MI
1.00
TVR
4.4% (9/205)
0.30
TLR
2.0% (4/199)
2.9% (6/205)
0.75*
Non-TLR TVR
0.5% (1/199)
TLF
4.0% (8/199)
0.85
TVF
4.5% (9/199)
5.9% (12/205)
0.55
ARC Definite or Probable Stent Thrombosis
Definite Stent Thrombosis
Probable Stent Thrombosis
Numbers are % (n/N); P-values are from the Chi-square test unless otherwise indicated; *Fisher's exact test

16. Summary & Conclusions
The SYNERGY biodegradable polymer-coated EES was non-inferior to the PE Plus permanent polymer-coated EES for the primary endpoint of late loss at 9 months (P<0.001)
No significant difference between 2 groups in peri-procedural outcomes (technical success 99.5% in SYNERGY vs 99.2% in PE Plus groups, P>0.99; procedural success 98.0% vs 98.0%, P>0.99)
Clinical events rates were very low in both groups at 9-months and 1-year follow-ups
There was no stent thrombosis in the SYNERGY arm (one ST in the PE Plus group)
High rates of angiographic and clinical follow-up, and high compliance to DAPT in both groups
Clinical follow-up will continue through 5 years
The results of EVOLVE China are consistent with those from EVOLVE II

17. Thank you !