1. Clinical Restenosis and its Predictors after implantation of BRS: results from the German-Austrian-ABSORB RegIsteR
Julinda Mehilli, MD, FESC
on behalf of GABI-R Study Group
Munich University Clinic
Ludwig Maximilians University, Munich, Germany

2. Potential conflicts of interest
Speaker's name: Julinda Mehilli
I have the following potential conflicts of interest to report:
Lecture fees:
Abbott Vascular, Biotronik, Daiichi Sankyo, Edwards Lifesciences , Eli-Lilly, Terumo
Receipt of institutional grants:
Abbott Vascular, Boston Scientific, Edwards Lifesciences

3. GABI-Registry Structure
Principal Investigator (PI)
Prof. Dr. C. Hamm
(Gießen und Bad Nauheim)
prospective multicenter registry
n= 93
CO-PIs Prof. Dr. J. Kastner (Wien) Prof. Dr. J. Wöhrle (Ulm) Prof. Dr. R. Zahn (Ludwigshafen) Steering Committee Prof. Dr. S. Achenbach (Erlangen) Prof. Dr. J. Mehilli (München) Prof. Dr. T Münzel (Mainz) PD Dr. C. Naber (Essen) Prof. Dr. H. Nef (Gießen) Prof. Dr. T. Neumann (Essen) Prof. Dr. G. Richardt (Bad Segeberg) Prof. Dr. A. Schmermund (Frankfurt) Critical Event Committee (CEC) Prof. Dr. N. Werner (Bonn) Prof. Dr. N. Frey (Kiel) Prof. Dr. B. Rauch (Ludwigshafen)
Universitätsklinikum Rostock
Segeberger Kliniken Herzzentrum
Elisabethkrankenhaus Essen
Universitätsklinikum Giessen
Universitätsklinikum Mainz
Kerckhoff-Klinik Bad Nauheim
Universitätsklinikum Erlangen
Rems-Murr-Kliniken Winnenden
Herz- und Gefäßzentrum Oberallgäu Kempten
Klinikum der Universität München Großhadern 3

4. Aims of GABI-Registry Documentation
of all consecutive pts undergoing ABSORB system implantation in clinical routine
of indications, procedural results, and BVS technical performance
of outcomes in-hospital, at 30 days and at 2 and 5 years after BVS implantation
Gathering
of data on quality of life
of health economics data before and after ABSORB BVS implantation
Nef et al., Cardiovasc Revasc Med 2015

5. GABI-Registry Population
3264 BVS-treated patients enrolled between 11/ / month follow-up rate, 97%
Target lesion failure at 6-mo FU
Ischemic events at 6-mo FU 5 % 4 3
2.45%
2,01
1,86 2
1,23
0,98 1 ST
Death MI
TLR

6. Aim of the current analysis of GABI-R
To assess clinical restenosis and its predictors after implantation of Absorb BVS
N=3264
undergoing BVS implantation 11/2013 to 01/2016
86 patients (2.6%) unknown vital status
N=3178 (97.4%)
known vital status at 6-mo FU
Clinical BVS restenosis:
clinically-indicated
32 patients (1.0%) unknown clinical status
target lesion revascularization unrelated to BVS thrombosis
N=3146 (96.4%)
known clinical status at 6-mo FU
N=24
with
clinical BVS restenosis
N=3146
without clinical BVS restenosis

7. Baseline Characteristics
treated patients
clinical BVS restenosis
n=24
without clinical BVS restenosis
n=3122
P value
Age, yrs
63.4±9.9
60.9±11.0
0.29
Women, %
25.0
23.1
0.82
Diabetes, %
27.3
21.1
0.48
Current smoker, %
18.2
35.1
0.10
Hypertension, %
66.7
73.2
0.47
Hypercholesterolemia, %
56.3
0.31
Chronic kidney disease, %
4.2
8.0
0.49
History of MI, %
29.2
22.2
0.42
History of PCI, %
27.8
0.76
ACS at presentation, %
33.3
51.8
0.07

8. Angiographic and Procedural Data
treated patients
clinical BVS restenosis
n=24
without clinical BVS restenosis
n=3122
P value
Procedure duration, min.
70.2±44.0
58.7±28.8
0.33
Radiation time, min.
15.0±8.7
11.8±8.2
<0.05
Amount of contrast medium, ml
194.6±88.5
174.7±74.4
0.40
LVEF, %
53.6±9.5
56.1±10.5
0.30
Three-vessel CAD, %
29.2
27.1
0.82
LAD, %
40.9
45.8
0.52
Treated lesion/patient
1.83±1.0
1.36±0.7
<0.01

9. Lesion Characteristics
Treated lesions
clinical BVS restenosis
n=44
without clinical BVS restenosis
n=4239
P value
Complex (B2/C), %
52.3
36.2
<0.05
De novo, %
97.7
94.2
0.32
Ostial, %
0.0
0.9
0.54
Bifurcation, %
3.0
0.25
mild-to-moderate calcified,%
66.0
60.6
Initial TIMI < 2 flow, %
9.1
21.4
Final TIMI 3 flow, %
100.0
98.1
0.35

10. Procedural Data Treated lesions clinical BVS restenosis n=44
without clinical BVS restenosis
n=4239
P value
Predilatation performed, %
100.0
99.9
0.88
Debulking device use, %
9.3
8.7
0.89
BVS overlapping , %
22.2
10.8
<0.05
Implanted BVS size, mm
3.0±0.4
3.1±0.6
0.53
Total implanted BVS length, mm
40.0
23.0
<0.001
BVS implantation pressure, atm.
12.7±2.8
13.5±2.7
0.12
Additional DES implantation, %
4.5
2.9
0.51
Postdilatation performed, %
75.0
72.2
0.68
Postdilation balloon size, mm
3.2±0.5
3.3±0.5
0.69
Postdilation balloon pressure, atm.
16.2±3.8
16.7±4.1

11. Clinical Outcomes at Follow-up
Ischemic events at 6-months 50
with
clinical BVS restenosis
without
clinical BVS restenosis % 40
p<0.001
29,2
p=0.59
p<0.001
p=0.26 30 25 20 10
4,2*
1,2
1,7
1,3 1
Death
* 1pts. with thrombosis after TLR MI
TV-MI
BVS thrombosis 11

12. Clinical BVS Restenosis clinically-indicated TLR unrelated to thrombosis
Target lesion-related events
Multivariable analysis
HR 95% CI
p value
BVS length
1.02 1.01 – 1.04
<0.001
calcified lesions
0.41 0.12 – 1.41
0.16
complex lesions
0.90 0.38 – 2.12
0.81
BVS size
0.79 0.23 – 2.73
0.71
diabetes mellitus
1.48 0.58 – 3.78
0.41
0.76%
clinical BVS
restenosis 12

13. Angiographic and Clinical Pattern of BVS restenosis
Angiographic pattern
16,6
focal body
Clinical presentation
100
20,8
SAP 80
37,5 60
(N)STEMI 50
focal margin
diffuse intra-BVS
29,2 40
41,7
UAP 20
4,2
occlusion 13

14. Conclusion
In GABI-Registry, clinically-indicated TLR at 6 months after BVS implantation, is a rare event and associated with a greater length of implanted BVS.
Longer-term follow-up within the setting of adequately powered randomized trials is required to verify the observed higher risk of myocardial infarction related to BVS restenosis 14

15. euro
PCR

16. euro
PCR

17. Scaffold Thrombosis and Restenosis
AIDA trial – Absorb BVS vs. EES in all-comers n=1845
Definite stent thrombosis at 30-mo FU
Target lesion revascularization at 12-mo FU 5 %
Absorb BVS EES (Xience) % 4
p=0.01
p=0.87 3
2,4
2,5
1,8 2 1
0,4
Thrombosis-related TLR Restenosis-related TLR
Wykrzykowska et al., New Engl J Med 2017