1. Comparison of Everolimus- and Biolimus-Eluting Coronary Stents With Everolimus-Eluting Bioresorbable Vascular Scaffolds: 2-year Outcomes of the EVERBIO II Trial
Serban Puricel, MD

2. Disclosure Statement of Financial Interest
I, Serban Puricel DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3. Puricel et al. J Am Coll Cardiol. 2015 Mar 3;65(8):791-801.
Single-center, assessor-blinded, randomized controlled superiority trial with an allocation ratio of 1:1:1 enrolling a total of 240 patients
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Puricel et al. J Am Coll Cardiol Mar 3;65(8): 2

4. Patients with stable CAD or ACS undergoing PCI
End points
Patients with stable CAD or ACS undergoing PCI
Clinical 1, 6, 9, 12 months, 2 & 5 y; 9 months
Primary end point
In-stent late lumen loss (LLL) at 9 months
Secondary end points
In-segment LLL
Device-oriented MACE (cardiac death, tv myocardial infarction and target-lesion revascularization)
Patient-oriented MACE (death, myocardial infarction and any repeat revascularization)
Stent thrombosis according to ARC
The trial design was as follows:

6. Reminder I – Baseline characteristics characteristics5

7. Reminder II – Procedural characteristics
p-value
EES
BES
EES&BES
BVS
EES/BES
N=112
N=117
N=229
N=96
vs. BVS
Target coronary artery
0.31
0.05
0.19
LM, n(%)
1 (1)
2 (1)
0 (0)
LAD, n(%)
44 (39)
34 (29)
78 (34)
44 (46)
LCX, n(%)
21 (19)
27 (23)
48 (21)
24 (25)
RCA, n(%)
40 (36)
48 (41)
88 (38)
Arterial graft, n(%)
2 (2)
3 (1)
Vein graft, n(%)
4 (4)
6 (5)
10 (4)
Hybrid with DES, n(%)
0.18
0.03
TIMI Flow post, median [IQR]
3 [3-3]
3[3-3]
0.35 1
0.52
ISR, n(%)
3 (3)
5 (2)
0.63
0.5
CTO, n(%)
7 (6)
5 (4)
12 (5)
0.07
0.16
0.12
Complex Lesions B2/C, n(%)
39 (35)
73 (32)
28 (29)
0.38
0.98
Number of stents per lesion, mean±SD
1.3±0.7
1.1±0.4
1.2±0.6
1.2±0.5
0.04
0.14
0.55
Stent length per lesion, mm±SD
22.1±13.8
19.3±10.0
20.7±12.1
22.8±8.8
0.67
<0.01
0.08
Stent diameter per lesion, mm±SD
3.0±1.0
3.0±0.6
3.0±0.8
3.1±0.4
Maximum pressure per lesion, atm±SD
14.6±2.9
13.8±3.0
14.2±3.0
13.6±2.8
0.09
Overlapping stents per lesion, n(%)
26 (23)
14 (12)
40 (17)
16 (17)
0.24
0.33
0.86
Postdilatation per lesion, n(%)
35 (31)
35 (30)
70 (31)
33 (34)
0.49

8. Outcome at 9 months
Non-superiority of the metallic stents for the angiographic or any of the clinical end points
EES/BES n = 229
BVS n = 96
P Value
In-stent Late loss, mm±SD
0.25±0.39
0.28±0.39
0.30
n = 160
n = 78
Device-oriented composite 9%
12%
0.60
Patient-oriented composite
26%
27%
0.83
Definite Stent thrombosis 0%
A post-hoc non-inferiority analysis showed non-inferiority (p<0.001) of the BVS for the primary angiographic end point

9. 2-year Clinical Outcome
p-value
EES
BES
EES&BES
BVS
EES/BES
N=80
N=160
N=78
vs. BVS
Device-oriented MACE, n(%)
13 (16)
7 (9)
20 (13)
16 (21)
0.54
0.04
0.12
Cardiac death, n(%)
1 (1)
0 (0)
1.00
0.49
0.55
MI of TV n(%)
2 (3)
0.24
0.11
TLR, n(%)
12 (15)
19 (12)
14 (18)
0.67
0.10
0.23
clinically indicated, n(%)
8 (10)
4 (5)
12 (8)
11 (14)
0.47
0.06
0.16
Patient-oriented MACE
30 (38)
21 (26)
51 (32)
27 (35)
0.74
0.30
All cause mortality, n(%)
5 (3)
0.68
0.62
Any MI, n(%)
2 (1)
0.44
0.09
Any Revasc., n(%)
27 (34)
20 (25)
47 (29)
25 (32)
0.87
0.38
0.76
TVR, n(%)
17 (21)
28 (18)
18 (23)
0.85
0.15
10 (13)
18 (11)
13 (17)
0.51
0.25
0.31
ST (definite/probable), n(%)
0.33
ST (possible), n(%)

10. Survival free from DOCE
logrank p-value= 0.12

11. Landmark analysis DOCE
logrank p-value= 0.35
logrank p-value= 0.16

12. Survival free from POCE
logrank p-value= 0.67

13. Landmark analysis POCE
logrank p-value= 0.47
logrank p-value= 0.73

14. Subgroup analysis DOCE
In favour of
EES/BES
BVS
ACS
Diabetes
Complex
(B2/C)
p-value pinteraction
<0.05
0.66
0.44
0.80
0.07
0.24
0.69
0.09
0.78

15. Only one late scaffold thrombosis occurred throughout the trial
Conclusions
No significant differences with regard to clinical outcome between EES/BES and BVS
(Rates of the device-oriented composite end point were higher for pateints treated with BVS)
Only one late scaffold thrombosis occurred throughout the trial
(the mechanism of this thrombosis may be related to a process that manifests itself as PSLIA on OCT)

16. Cuculi et al. Circ Cardiovasc Interv. 2015 Oct;8(10):e002518.