Experts "Live" CTO Workshop 2014 26th Septemper 2014 in Madrid, Spain

1. The role of BVS in CTO PCI :
Mid-term Clinical Outcomes with
Multi-imaging Techniques.
Antonio Serra M.D.
aserrap@santpau.cat

2.  Is one of the most challenging scenarios to
test, due to long fibrocalcified lesions with
high plaque burden 1, 2
 In this setting is where “vessel reparation”
might be most needed.
 Avoid a “full metal jacked”, precluding future
CABG
Rationale: BVS in CTOs
1.- Rubartelli A , et al. Eur Heart J 2010
2.- Galassi AR, et al. EuroIntervention 2011

3. Objectives
 CTO-ABSORB pilot study is a prospective,
observational, single-center registry designed to :
 Assess the safety and performance of the Absorb
everolimus-eluting scaffold BVS, in unselected
consecutive patients undergoing PCI for CTO, under
guidance of imaging techniques
 To provide preliminary observations and generate
hypotheses for future studies with large proportion of
patients.

4. Objectives
All comers registry with few exclusion criteria :
- Patient or refering physician refusal
- Extremely calcified lesions + tortuosity
- True Bifurcated lesions with SB > 2.5 mm
- Reference vessel diameter < 2.5 mm or
< 4.5 mm (out of the Absorb measures)
- Complications treated with metallic stents

5. Methods
Wire Crossing
1st dilatation small balloon 1.5- 2.0mm
NTG 400 mcgr
IVUS analysis
Further dil. with NC /Cutting/ Rota + cutting
IVUS analysis
BVS implantation
OCT analysis
Further dil with NC if needed
Renal function &
CK, US Troponin
- Pre & 6, 12 & 24
hours post-PCI

6. Follow-up
Clinical FU by Phone Call: 1 month
Angio FU & OCT: 12 months
Clinical Visit & MSCT: 18 months
Clinical Visit & MSCT/MRI: 6-8 month
Clinical FU by Phone Call: 24 months, 3, 4 and 5 years

7. 67 succeed CTOs (2013-2014)
49 clinical eligible CTOs
38 Absorb CTO cases
35 Absorb CTO cases
7 patients excluded:
Patient or referent physician refuse
6 patients excluded:
Live CTO courses with other DES
5 patients excluded:
Old patients with comorbilities
Clinical criteria (n=18)
5 patients excluded:
Angio Calcium + tortuosity
4 patients excluded:
True bifurcated lesions + SB ≥ 2.5mm
2 patients excluded:
Reference vessel diameter < 2.5 (n=1)
or ≥ 4mm (n=1)
Angiographic criteria (n=11)
Bail-out stent (DES) used (n=3)
(1) Coronary perforation after
balloon: stent graft
(1) Aorto-ostial disection after
rotational atheretomy: 4mm DES
(1) Distal coronary disection after
BVS: 2.25mm DES
28.5% of clinical eligible CTOs were excluded due to
predefined-angio criteria or PCI related complications
Study Profile

8. Pre-procedure
RCA CTO.
J- CTO Score Complexity 2
1
1
4
4
3
3
2
2
IVUS pre- BVS
implantation
Side branch
Cutting
balloon pre-
dilatation
After wiring &
pre-dilatation
21mm

9. 3 overlapped BVS Absorb 3.0 x 28; 3.5 x 28 & 3.5 x 28 mm (84 mm length)
+ drug-eluting balloon 2.25 x 20 mm in LPD
Post-BVS implantation

10. Final OCT1.
1.
2*
.
2*
.
3.
3.4*
.
4*
.
5.
5.
OCT post-BVS implantation
After NC balloon
post-dilatation

11. LAO 30º/ CRAN 12º
6-months MSCT FU 12-months Angio FU
* *
*
*

12. 1.
1.
2.
2.
3*
.
3*.4*.
4*
.
5.
5.
OCT 12 months post-BVS

13. Results

14. • Age (years) (mean±SD) 60.7 + 9.7
• Male gender 80.0 (28)
Risk Factors
 Diabetes 20.0 (7)
 Hypertension 60.0 (21)
 Dyslipidemia 74.3 (26)
 Current Smoker 20.0 (7)
Clinical Presentation
 Silent ischemia/Stable angina 85.7 (5/25)
• Baseline cMRI 48.6 (17)
• Baseline MSCT 88.0 (31)
• LVEF (≤ 50%) 22.9 (8)
• 3 vessel disease 25.0 (5)
Unless specified otherwise, values are % and (n) of patients
Clinical Characteristics (n=35)
History of
 Myocardial Infarction 28.6 (10)
 PCI 37.1 (13)

15. Unless specified otherwise, values are % and (n) of patients
Target Vessel:
- RCA 45.7% (16)
- LAD 40.0% (14)
- LCx/Marginal Branch 11.4% (4)
CTO location:
- Ostial/proximal 28.6% (10)
- Mid 65.7% (23)
CTO involving bifurcated lesion 20.0% (7)
In-stent restenosis (Class IV) 5.7% (2)
Lesion Characteristics (n=35)

16. CTO angiographic characteristics
• Blunt stump type* 40.0 (14)
• Severe Tortuosity (Bending)* 11.4 (4)
• Significant Calcification* 34.3 (12)
• Previously Failed Lesion* 8.6 (3)
• Occlusion length ≥ 20mm* 31.4 (11)
CTO complexity (J-CTO Score)
• Easy (score of 0) 25.6 (9)
• Intermediate (score of 1) 48.6 (17)
• Difficult (score of 2) 8.6 (3)
• Very difficult (score of ≥3) 17.2 (6)
• Occlusion length (mm) 18.6 + 12.5
• Target Lesion length (mm) 35.9 + 15.8
Unless specified otherwise, values are % and (n) of patients
CTO complexity (n=35)

17. • Radial or bi-radial approach 60.0 (21)
• 6- Sheath Size 51.4 (18)
• Antegrade Strategy 85.7 (30)
• Number of GW used per lesion 1.8 + 1.1
• Number of pre-dilatation balloons used per lesion 2.6 + 0.97
• Plaque modification:
 Cutting balloon pre-dilatation 71.4 (25)
 Rotational Aterecthomy 8.6 (3)
• Number of scaffolds used per lesion 2.2 + 0.89
• Total scaffold lenght implanted per lesion, mm 52.5 + 22.9
• Post-dilatation (0.5mm bigger NC balloon / scaffold) 62.9 (22)
Unless specified otherwise, values are % and (n) of patients
Procedural Characteristics (n=35)

18. Immediate Results (n=35)
• Total number of visible analyzed SBs covered by BVS(n) 109
 Mean number/lesion 3.2  1.4
 SB < 0.5mm 41.3 (45)
 SB ≥ 0.5mm 58.7 (64)
• Post-BVS SBO 6.4 (7)
 SB < 0.5mm 3.7 (4)
 SB ≥ 0.5mm 2.7 (3)
• All scaffolds were successfully delivery and deployed
• Side Branch Occlusion (SBO)6: as a reduction in TIMI flow to grade 0 or 1.
Accordingly, side branches with pre-BVS implantation TIMI flow grade 0 or 1, were excluded
6.- Muramatsu T, et al. JACC Cardiovasc Interv. 2013
• Dissection before BVS was observed in (4/7) 57% of all SBO cases
(100% of SBO with bigger SB ≥ 0.5mm)

19. • Contrast-induced nephropathy 0 (0)
• Peri-PCI Myocardial damage (only markers) 8.6 (3/30)
• Peri-PCI Myocardial infarction 0 (0)
• Vascular access site complication 2.8 (1)
7.- Kristian Thygesen K, et al. Eur Heart J 2012
In-Hospital Results (n=35)
Peri-PCI myocardial damage: CPK ≥3 times the upper limit of normal (ULN) & US troponin
≥5 times ULN. In case of symptoms and/or electrocardiogram changes suggesting MI, was
defined as Myocardial infarction7
A procedure-related contrast-induced nephropathy (CIN) was defined as an increase of
25% or 0.5 mg/dl in serum creatinine at 24-48 hours after PCI comparing baseline values8
8.- Mehran R, et al. J Am Coll Cardiol 2004
Blood test was performed pre and 6, 12, 24h post-PCI

20. 1-month FU (n=35) 6-months FU (n=35)
Overall Death 0 0
Cardiac 0 0
MI 0 0
TLR 0 0
MACE 0 0
BVS Thrombosis* 0 0
In-scaffold re-occlusion** (2) 5.7%
ARC definition*
Results (n=35)
MSCT** (100% FU completed)

21. Pre-PCI Post-PCI
6 mo MSCT6 mo MSCT

22. 1.
1.
2.
2.
3.
4.
4.
3.
12 months OCT

23. Conclusions
 We reported excellent mid-term patency and safety by
6-8 months clinical and MSCT follow-up
 The ABSORB-CTO pilot study demonstrated the safety
and feasibility of PCI of CTO lesions with the fully
bioresorbable Absorb® BVS, under imaging guidance
techniques.
 Further clinical and imaging follow-up at future time
points is required to extend the significance of the
current findings.