1. On behalf of all principal COMPARE II investigators:
COMPARE II trial: 1-Year Clinical Data of the Treatment of Long Lesions (>20 mm)
Pieter Cornelis Smits
On behalf of all principal COMPARE II investigators:
Ad van Boven, Jean-Jaques Goy, Peter den Heyer, Antonio Serra, Ton Slagboom, Mario Togni, Ramiro Trillo Nouche, Mariano Valdés, Andre Vuillomenet, Jose Vázquez, Vassilis Voudris 1

2. Potential conflicts of interest
Speaker’s name: Pieter Cornelis Smits
 I have the following potential conflicts of interest to report:
 Research contracts: Boston Scientific, Abbott Vascular, Terumo  Consulting: Blue Medical
 Employment in industry; none
 Stockholder of a healthcare company; none
 Owner of a healthcare company; none
 Other(s): travel and speaking fees from Abbott Vascular 2

3. Biolimus Eluring Stent (BES) Everolimus Eluting Stent (EES)
COMPARE II trial
a large scale, multicenter, prospective,
randomized (2:1) study, N=2707
Biolimus Eluring Stent (BES)
N=1795
Everolimus Eluting Stent (EES)
N=912
abluminal, biodegradable
polymer
biolimus-eluting stent
durable polymer
everolimus-eluting stent
ClinicalTrials.gov Identifier: NCT

4. Endpoints Primary endpoint Major secondary endpoints COMPARE II trial
Composite of cardiac death, non-fatal myocardial infarction and target vessel revascularization
Major secondary endpoints
Composite of cardiac death, non-fatal myocardial infarction and clinically indicated target lesion revascularization
Stent thrombosis (def/prob) according to ARC
Dual antiplatelet therapy was 12 months for each treatment arm
The primary hypothesis was non-inferiority of BES vs EES.
Data were independently monitored and adverse events were adjudicated by an independent clinical event committee.

5. COMPARE II trial Long Lesion Subgroup
BACKGROUND AND AIM
Treatment of long lesions (LL) remains a challenge in interventional cardiology, with a high propensity to restenosis.
Our aim was to evaluate the clinical outcomes of the patients with long lesions treated with the Nobori biolimus eluting stent (BES) versus patients treated with Xience/Promus everolimus eluting stent (EES) in a real world / all-comer situation as a substudy of the COMPARE II trial.

6. COMPARATORS Xience / Promus Nobori COMPARE II trial
Everolimus 1.0 µg/mm2
Fluoropolymer
Vision multilinkTM
Nobori
Biolimus 15,6 µg/mm
Poly-lactic acid
S-StentTM

7. Methodology COMPARE II trial Long Lesion Subgroup 12 sites
Total Population: patients
Randomization 2 : 1
Non Inferiority Design
DAPT up to 12 months
12 sites
PI: Dr. P. Smits
BES
n = 1795
EES
n = 912
Patients with Long Lesions (>20 mm) treated
BES (LL)
n = 403
EES (LL)
n =224
Clinical Follow-up 0d
30d
12mo
3yr
5yr
Primary endpoint at 12 months　: Composite of cardiac death, non-fatal myocardial Infarction and clinically indicated target vessel revascularization

8. Baseline Characteristics
COMPARE II trial Long Lesion Subgroup
Baseline Characteristics
Baseline demographics
BES
403 pts
EES
224 pts
P-value
Age (mean ± SD)
63.1 ± 11.3
63.0 ± 10.7 NS
Male, %
81.4
77.7
Cardiovascular history
Previous MI, %
20.3
23.3
Previous PTCA, %
14.1
16.1
Previous CABG, %
5.5
6.7
Previous stroke, %
5.3
4.9
Peripheral artery disease, %
7.3
6.3

9. Baseline Characteristics
COMPARE II trial Long Lesion Subgroup
Baseline Characteristics
Risk Factors
BES
403 pts
EES
224 pts
P-value
Smoker, %
Previous smoker
35.8
36.2 NS
Current smoker
31.1
23.2
0.04
Hypertension, %
54.1
58.9
Liver insufficiency (%)
0.3
0.5
Renal Failure (%)
6.1
7.7
COPD (%)
6.6
6.8

10. Baseline Characteristics
COMPARE II trial Long Lesion Subgroup
Baseline Characteristics
Clinical Presentation
BES
403 pts
EES
224 pts
P-value
Stable Angina (%)
39.9
38.4 NS
Unstable Angina (%)
9.7
10.7
STEMI (%)
20.8
17.9
NSTEMI (%)
26.1
28.6

11. Lesion Characteristics
COMPARE II trial Long Lesion Subgroup
Lesion Characteristics
BES
(738 lesions)
EES
(433 lesions) p %
Ostial lesion
13.0
11.3 NS
Thrombus present
16.8
13.9
Moderate or severe
calcified lesion
39.4
39.3
CTO lesion
4.7
4.2
Bifurcation
7.1
5.5
Mean ± SD
Lesion length
24.6 ± 12.3
25.2 ± 12.6
Lesion per patient treated
1.8 ±1.9
1.9 ±1.2
Stent per lesion
1.67 ± 0.90
1.57 ± 0.80

12. Lesion Characteristics
COMPARE II trial Long Lesion Subgroup
Lesion Characteristics
BES
EES
P=NS
Type A
Type B1
Type B2
Type C
B2/C: 77.2%
B2/C: 75.3%

13. Cardiac Death, MI, Clinically Indicated TVR
COMPARE II trial Long Lesion Subgroup
Primary Endpoint
Cardiac Death, MI, Clinically Indicated TVR
P = NS

14. Cardiac Death, MI, Clinically Indicated TLR
COMPARE II trial Long Lesion Subgroup
Secondary Endpoint
Cardiac Death, MI, Clinically Indicated TLR
P = NS

15. Stent Thrombosis (ARC)
COMPARE II trial Long Lesion Subgroup
Stent Thrombosis (ARC)
P = NS
Definite/Probable ST, ARC

16. COMPARE II trial Long Lesion Subgroup
Conclusions
Despite high complexity of lesions in the LL subgroup, good clinical outcomes and a low rate of revascularization were observed at 12 months post-procedure with both types of DES.
Stent thrombosis was relatively low despite multiple overlapping stents.
Our findings confirm the safety and efficacy of both BES and EES for treatment of patients with LL in coronary arteries.