BRS in Small Vessels and

Diffuse Disease: Managing

Overlapping Scaffolds; When
to Use DES or Balloon Only

Jorge Belardi, MD
Director of the Cardiology Department
Instituto Cardiovascular de Buenos Aires - ICBA
 Disclosure Statement of Financial Interest

I, Jorge Belardi 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.
 Case

16
4 54 y/o man, Hypertension
Recent onset angina NYHA II
Severe anterior ischemia

5
Syntax score 28
2

?
 Diffuse Coronary Artery Disease
Definitions
• Stenosis length > 20 mm (type C-AHA/ACC)
• Multiple significant stenoses separed by
segment of apparently normal (but probably
diseased) vessel in the same artery
• Significant narrowing involving the whole
length of the coronary artery
• Distal narrowed segments/vessel diameter <
2mm (SYNTAX Trial)
PCI in Difusse Coronary Disease
What we know?

Most powerful predictors

of definite or probable
stent thrombosis

F. D'Ascenzo et al. / International Journal of Cardiology 167 (2013) 575–584

MACCE by Number of Stents in the
SYNTAX Trial
 SCAAR Registry

Restenosis Definite Stent Thrombosis

BMS (n 64631), DES 1gen (n19202), DES 2 gen (n 10551)

Samo G et al. EHJ 2012

 Absorb III Trial
1 EP: Target Lesion Failure

Ellis SG et al. NEJM 2015;373:1905-15

 Absorb III Trial
1 – year Device Thrombosis by RVD Quintiles

Stone GW - TCT 2015

 Absorb III Trial
Device Thrombosis by Vessel Size
Any QCA RVD < 2.25 mm vs. all RVD ≥ 2.5 mm

Stone GW - TCT 2015

Absorb III Trial
TLF by Vessel Size

Stone GW - TCT 2015

 ABSORB Optimal Implantation

1. Prepare the Lesion

2. Properly Size the Vessel

3. Pay attention to expansion limits

4. Post-dilate with NCB

5. Adecuate DAPT duration

 Overlap

150 μm=0.15 mm x 2

12%

2.5 mm
0.3 mm struts
Endothelization patterns of overlapping
segments: BVS vs. Xience

Absorb Xience

28 days

90 days

Farooq et al. JACC Interv 2013; 6:523-32

 Scaffold overlap considerations

Marker to Marker Scaffold to Scaffold

Distal balloon marker aligned with Distal balloon marker proximal to

The proximal marker beads of the the proximal marker beads of the
implanted scaffold implanted scaffold

The markers of the second 1 mm of space between the markers

scaffold will be adjacent to the of the second scaffold and the
markers of the deployed scaffold markers of the deployed scaffold

1 mm overlap No or Minimal Overlap

 COMPARE-ABSORB

BVS vs. Xience for prevention of restenosis

in patients at high risk of restenosis
Hybrid Strategy

BVS

DES DEB
 Avoid full metal jacket

DES 2 Gen
Final Result & 10 month follow up

10 month fo
»THANK YOU
BVS Free metallic strategy
DEB

• The common advantage of these devices is that

no metallic cages are left behind which could
potentially have long-term benefits

• Possible Indications:
 Diffuse disease: BRS proximally & DCB distally
 Bifurcations: BRS on MB & DCB on SB
 Restenosis + de novo disease in same vessel
DES DEB

Costopoulos et al. JACC Intv. 2013;6:1153-9

 BVS

DES
 Absorb III Trial
1 – year TLF Components

Ellis SG et al. NEJM 2015;373:1905-15

 ABSORB III Analysis
In very Small Vessels

• Additional subgroup analyses were conducted to

explore the differences in event rates between
Absorb and Xience
• Given the thicker struts of Absorb, a biologically
relevant analysis was to examine outcomes in
smaller vessels
• Detailed analyses according to reference vessel
diameter by QCA

• QCA underestimates visually assessed vessel

diameter: 2.5 mm by visual is 2.25 mm by QCA
 DES Evolution

Older DES Newer DES

TAXUS CYPHER RESOLUTE PROMUS XIENCE
 Absorption and Vessel Remodeling

Krebs  Lactic Acid Lactate
Cycle  H2 O

CO2
Lactate

Soporte

Mole

Mass Loss

1 3 6 12 18 24 Month

Luz Luz Luz

 ABSORB Optimal Implantation

1. Prepare the Lesion

• Pre-dilate always preferably use of a NC

balloon, shorter than the scaffold

In 1:1 ratio

For resistant/calcified lesions – MODIFY them

first
 ABSORB Optimal Implantation
5. Adecuate DAPT duration
To AVOID Scaffold Thrombosis

• 150 𝝁m struts take slightly longer to be covered with

endothelium

• Try not to use BVS in patients who are at risk of

stopping DAPT (Scaffold gone at 3 years and not in
a couple of months)
 ABSORB Optimal Implantation

2. Properly Size the Vessel

Upsize the scaffold for any given diameter but AVOID OVERSIZING
Recommended
Reference Vessel Size (mm) by Visual Estimation Scaffold Size
(mm)

2.25 2.5 2.5 mm

> 2.5 3 3 mm

>3 3.5 3.5 mm

If visually estimating vessel size, for vessels that appear

to be > 3.5 mm, consider using a metallic DES
Device oversizing and incidence of MACE
according to the device type
BVS Metallic EES
A
A’
BVS MACE EES MACE

Cum ula tiv e incide nce of ca rdia c

Cum ula tiv e incide nce of ca rdia c

ov e r size
ov e r size

de a th, M I a nd ID -T LR (% )
non-ov er size
de a th, M I a nd ID -T LR (% )

non-ov e r size 12%

12%
9 .3

8% 8%
P =0 .0 4 3 4 .2
4% 4%
3 .7
P =0 .6 6 5 2 .8
0% 0%
0 30 18 0 360 0 30 180 3 60
T im e a fte r in de x proc e dure ( da y s ) T im e a fte r inde x proce dure (da y s)

BVS MI at 37 days and 393 days

B’
EES MI at 37 days and 393 days

Cum ula tiv e incide nce of ta rg e t

Cum ula tiv e incide nce of ta rg e t

ov e r size ov e r size
non-ov e r size non-ov er size
12% 12 %

v es s e l M I (% )
8 .4
v e ss el M I (% )

8 .4
8%
8% A t 3 7 d ays A t 3 9 3 d ays
A t 3 7 d ays A t 3 9 3 d ays P =0 .5 6 P =0 .5 6
4% P =0 .0 2 4 P =0 .0 4 7
4% 2 .1 2 .1
3 .2
2 .6
0% 0% 0 .9 0 .9
0 30 1 80 360 0 30 180 360
T im e a fte r inde x proce dure T im e a fte r inde x proce dure
C’
BVS ID-TLR EES ID-TLR

Cum ula tiv e incide nce of ID -T LR (% )

Cum ula tiv e incide nce of ID -T LR (% )

ov er size
ov e r s ize
non-ov e r size
non-ov e r s iz e
12 % 12%

8% 8%

4% 2 .8 4% 2 .1
P= 0.0 9 4 P = 0 .9 3 4 1 .9
0% 0%
0 .5
0 30 1 80 360 0 30 180 360

T im e a fter inde x proce dure T im e a fte r inde x pro ce dure P. Suwannasom et al.
Submitted
 ABSORB Optimal Implantation

#3 Pay Attention to Expansion Limi

3. Pay attention
so astonot
expansion limits
to fracture the scaffold
Delivery Balloon
Avoid Inflation
scaffold fracture – Compliance charts

2.5 mm 3.0 mm 3.5 mm

Clinical Trial
Average
Deployment
Pressure*

*Average Absorb scaffold deployment balloon pressures from pooled ABSORB II and ABSORB EXTEND clinical trial data. Data on file at Abbott Vascular:
 ABSORB Optimal Implantation
4. Post-dilate with NCB

• Don´t leave the scaffold under-deployed

• Consider using a NCB that is up to + 0.5 mm larger

than the nominal Scaffold diameter

• In complex lesions consider intravascular imaging with

OCT in the beginning
 Absorb III Trial
2.5 mm Device Treatment
Events by QCA/RVD

Stone GW - TCT 2015

 Absorb III Trial
1 year ST in Very Small Vessels
Impact of post-dilatation and pressure

Stone GW - TCT 2015

 Absorb III Trial
TLF by Vessel Size
Any QCA RVD < 2.25 mm vs. all RVD ≥ 2.5 mm

Stone GW - TCT 2015

 Conclusiones Absorb III a 1 año
Esto para ud solo
• For treatment of simple and moderately complex lesions
in pts with stable CAD and stabilized ACS, the ABSORB
BVS, results in similar 1-year rates of patient-oriented
and device-oriented composite endpoints as Xience
CoCr-EES, consistent with comparable overall
outcomes.
• Absorb BVS was highly effective, with ID-TLR rates
comparable to Xience
• When implanted in appropriately sized vessels (RVD 2.5-
3.75 mm(, the safety profile of ABSORB was similar to
Xience. In contrast, in very small vessels (those smaller
than intended for this device) a strong signal for
increased thrombosis was observed.
 Absorb III Trial
Device Thrombosis by Timing and Vessel Size

Stone GW - TCT 2015

Absorb Extend Overlap Subset
Clinical Outcomes