Experts "Live" CTO Workshop 2015 Septemper, 18th – 19th , 2014 in Istanbul, Turkey

1. BVS in CTO: Angiographic
and OCT follow-up data
Aylin Hatice Yamac, MD
Dogu Kilic
Omer Goktekin
Department of Cardiology
Bezmialem Vakif University
Istanbul, TURKEY

2. BVS for CTO lesions – potential benefits
• Avoidance of the risks inherited to “full metal jackets”, including late
restenosis and thrombosis.
• Unjail side branches long-term
• Restoration of the vessel’s biological properties: endothelial function and
vessel vasomotion
• Possible long-term favorable vessel remodeling with lumen enlargement
• Leaves potential of grafting the stented segment

3. MS # IC-15-00076, accepted for publication in Journal of Invasive Cardiology
Our CTO-BVS experience
Objectives:
To assess
• acute procedural success of BVS in CTO lesions
• early efficacy and safety of BVS by clinical monitoring

4. Seventy consecutive patients, who underwent successful recanalization of CTO with
BVS between September 13, 2012 and September 20, 2014 were included in this CTO
Registry.
Inclusion criteria:
• any CTO patient if symptomatic and/or with proven reversible ischemia (>10%)
and the presence of viable myocardium (Myocardial scintigraphy)
Endpoints analyzed:
• The composite of all-cause death and non-fatal myocardial infarction (MI)
• The composite safety endpoint of major adverse cardiovascular events (MACEs),
including death, MI and symptom-driven target lesion revascularization (TLR).
Our CTO-BVS experience

5. Patients demographics and clinical characteristics
70 Patients
76 CTOs

6. Angiographic characteristics

7. Procedural Variables

8. Clinical events and MACE at FU

9. • To assess early and long-term efficacy and safety of BVS
in CTO lesions (vessel patency, restenosis, re-occlusion
and scaffold thrombosis)
- Coronary Angiography and/or OCT at 1 year FU
• To demonstrate long-term clinical benefits of the use of
BVS for CTO lesions (clinical observation up to 5 years)
Our CTO-BVS experience
New objectives

10. Coronary Angiography QCA
Patients (n) 29
Age 58.03 ± 9.68
Male Gender (%) 25 (86.2 %)
Target vessel (LAD/LCX/RCA) 12/9/13
Side branch at occlusion
Provisional
Double stent (T stenting, both BVS)
6
4
2
No of total ABSORB BVS 71
No of ABSORB BVS per CTO 2.37 ± 0.94
Mean scaffold lenght (mm) 32.11 ± 5.17
Mean scaffold diameter 3.14 ± 0.41
Mean balloon diameter at postdilatation 3.3 ± 0.4
Inflation pressure (atm) 16.8 ± 4.1
Median time until Angiography 402 days.
34 CTOs

11. Coronary Angiography QCA
Post Procedure QCA
In-scaffold minimal luminal diameter (mm) 2.53 ± 0.42
In-scaffold minimal diameter stenosis (%) 14.0 ± 6.94
In-scaffold minimal area stenosis (%) 22.85 ± 9.30
FU QCA (n=)
In-scaffold minimal luminal diameter (mm) 2.25 ± 0.42
In-scaffold minimal diameter stenosis (%) 20.62 ± 3.12
In-scaffold minimal area stenosis (%) 36.53 ± 5.46
Late lumen loss 0.37 ± 0.25
Median time until Angiography 402 days.

12. Follow up OCT
Patient Age Gender Culprit
vessel
BVS
(n)
Balloon
predil.
(mm)
BVS
size
(mm)
Balloon
postdil.
(mm)
Side-
branch
dil.
Side
branch
stent
FU
(days)
MACE
1 41 m LCX 2 2.0x30 2.5x28
3.5x11
3.25x15 NO NO 376 NO
2a 55 m RCA 1 2.0x20
2.5x12
3.0x20
3.5x28 4.0x15 NO NO 517 NO
2b 55 m LCX 2 2.0x20
3.0x20
3.0x28
3.5x15
3.25x15 NO NO 517 TLR
3 66 m RCA 2 3.0x12 3.0x28
3.5x12
3.5x12 NO NO 781 NO
4a 49 m LCX 1 3.0x12 3.5x28 3.5x15 YES NO NO
4b 49 m RCA 2 3.0x12 3.5x28
3.5x18
3.5x12 NO NO 527 Dissect
ion
5 YU 55 m RCA 4 2.0x20
2.5x20
3.0x15
3.5x15
3.0x28
3.5x28
3.5x28
3.5x18
3.5x15 NO NO 745 NO

13. Follow up OCT
Patient Age Gender Culprit
vessel
BVS
(n)
Balloon
predil.
(mm)
BVS size
(mm)
Balloon
postdil.
(mm)
Side-
branch
dil.
Side
branch
stent
FU
(days)
MACE
6 60 m LAD 3 2.0x30 3.0x28
3.5x28
3.5x12
3.0x15
3.5x15
YES YES 332 NO
7 54 m RCA 1 2.5x15 3.5x28 4.0x15 NO NO 716 TVR
8 61 m RCA 2 2.5x30
3.0x15
3.5x28
3.5x28
4.0x15 NO NO 207 NO
9 60 m LAD 1 2.0x20
3.5x15
2.5x28
3.5x28*
3.5x14*
2.5x15 NO NO 278 TLR#
• *Desolve Stents
• # In stent restenosis of the Desolve stent was treated with a 2.5x28 mm
Absorb BVS

14. Follow up OCT
Patient Culprit
vessel
Mean
Prox Ref.
vessel
diameter
(mm)
Mean
Dist Ref.
vessel
diameter
(mm)
Minimal
lumen
diameter
(mm)
Minimal
lumen
area
(mm2)
Minimal
in
scaffold
lumen
diameter
(mm)
Minimal
in
scaffold
lumen
area
(mm2)
Lumen
diameter
stenosis
(%)
Area
stenosis
(%)
1 LCX 3.26 2.36 1.70 3.01 2.19 4.56 41.4 34.0
2a RCA 4.27 3.01 2.98 8.50 3.58 11.74 28.7 27.6
2b LCX 4.39 2.70 1.02 .90 2.34 4.83 69.5 79.0
3 RCA 3.14 2.08 1.93 3.42 2.42 4.79 20.3 28.6
4a LCX 3.04 2.30 1.93 3.46 2.36 5.10 31.3 34.9
4b RCA 3.39 3.02 2.35 4.72 2.74 6.35 27.7 25.7
5 RCA 3.28 2.70 2.13 4.17 2.56 6.55 22.7 36

15. Follow up OCT
Patient Culprit
vessel
Mean
Prox
Refer.
vessel
diameter
(mm)
Mean
Dist
Refer.
vessel
diameter
(mm)
Minimal
lumen
diameter
(mm)
Minimal
lumen
area
(mm2)
Minimal
in
scaffold
lumen
diameter
(mm)
Minimal
in
scaffold
lumen
area
(mm2)
Lumen
diameter
stenosis
(%)
Area
stenosis
(%)
6 LAD 3.41 1.94 1.50 2.22 1.83 3.25 37.6 31.7
7 RCA 3.65 3.20 2.50 5.86 2.77 7.50 20.3 21.9
8 RCA 3.81 2.94 2.67 7.65 2.85 9.25 13.2 17.1
9 LAD 3.58 2.27 1.47 2.13 2.16 5.44 43.9 60.8

16. Pre Procedure Post Procedure 1y FU

18. Clinical FU
In hospital Total FU
Overall death (%) 0 1 (3.0)
Cardiac death (%) 0 1 (3.0)
Target vessel MI (%) 0 0
TVR (%) 0 2 (6.1)
TLR (%) 0 3 (9.1)
BVS thrombosis (%) 0 0
Median time of clinical FU 542 days. IQR 366 (Range 175-961 days)

19. Absorb 3,0x28 mm
Pre Procedure Post Procedure

20. 1y FU

21. A 60 yrs. old male smoker patient presented with AP CCS III and NYHA FC III
• History of CX- and repeated LAD- PCI
• 2002 LAD PCI and CX PCI
• 2003 PCI to LAD due to restenosis
• 2006 PCI to LAD due to restenosis
• 2009 PCI to restenosis to restenosis
• 2011 PCI to restenosis
• Total 10 stents implanted to LAD
• 2012 CABG: two vessel (LAD and OM) with removement of the LAD stents
•  Coronary Angiography 2014: LIMA-LAD occluded
• PET/CT : viable tissue in the anterior wall, septum, inferoseptal and anteroapical wall

22. Coronary Angiography 2009

23. Pre Procedure

24. Post Procedure 1y FU
3,5x28; 3,5x18 mm Absorb

25. • Implantation of BVS after successful recanalization of even
complex CTO lesions is feasible with acceptable early results
• No in-hospital device-oriented complications were observed
• Mid-term clinical and angiographic outcomes are similar to
current DES
BVS for CTO lesions – Conclusions