My 2nd talk related to the recent advances and new trial w/ BRS was a hit!

2. Bioresorbable Coronary
Scaffolds
Bill D Gogas
Habib Samady
33
Textbook: Interventional Cardiology, 2nd Edition 2016
CE mark FDA, CE mark
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mark
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mark

3. Strut coverage is
delayed in
segments treated
with overlapping
Absorb scaffolds
Strut coverage is
comparable
among segments
treated with
overlapping
Absorb scaffolds
and metallic stents
Lumen and vessel
enlargement
initiation
Scaffold’s strut core
sites remain
acellular
JACC Cardiovasc Interv. 2016Apr 25;9(8):852-5
Restoredvasomotor
function of Absorb
treated segments
Restoredpulsatility
of Absorb treated
segments
Scaffold’s strut core
sites have
“preserved box”
appearance and
polymer isbeing
replaced by matrix
Gene levels of
Cx43 are
increased in
Absorb treated
arterial segments
Light intensity of
strut core sites surges
due to gradual
cellularization by
connective tissue
Late lumen
enlargement
The Absorb BVSis
completely
degraded
Thinningof vessel
wall attributed to late
lumen enlargement
Restoredvasomotor
function of Absorb
treated segments
Resorption siteshave
>50% of collagen-
rich connective
tissue and are fully
integrated in the vessel
wall

4. 0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
-0.8 -0.3 0.2 0.7
501 patients were randomly assigned to the Absorb group or the Xience group.
At 3 year follow-up, the primary endpoint was superiority of the Absorb BVS vs. the XV
stent in angiographic vasomotor reactivity after administration of intracoronary nitrate.
Absorb BVS n=258 0.047±0.109 mm
XIENCE n=130 0.056±0.117 mm
Vasomotion (mm)
Cumulativefrequency
Psuperiority
= 0.49
Lancet. 2016 Nov 19;388(10059):
2479-2491

5. J Am Coll Cardiol Intv 2016;9:728–41
- A total of 15 Absorb BVS (3.0x18.0-mm) and 14 XV (3.0x18.0-mm or 3.0x12.0-mm) stents were
randomly implanted in the main coronaries of 12 non-atherosclerotic swine.
- Vasomotor performance (constrictive and expansive) was measured in the stented/scaffolded
segments and the 5-mm proximal and distal adjacent segments at 1 year (n=6) and 2 years (n=6)

6. 35.91 +/- 24.74% vs. 1.20 +/- 3.79% (p < 0.01)
0
5
10
15
20
25
30
35
40
Absorb BVS Xience V
J Am Coll Cardiol Intv 2016;9:728–41
% Relaxation Assessed w/ Substance P
(Endothelial Dependent Vasorelaxation)

7. 35.91 +/- 24.74% vs. 1.20 +/- 3.79% (p < 0.01)
0
5
10
15
20
25
30
35
40
Absorb BVS Xience V
J Am Coll Cardiol Intv 2016;9:728–41
% Relaxation Assessed w/ Substance P
(Endothelial Dependent Vasorelaxation)

8. 501 patients were randomly assigned to the Absorb group or the Xience group.
At 3 year follow-up, the co-primary endpoint was the non-inferiority angiographic LLL.
Lancet. 2016 Nov 19;388(10059):2479-2491
Cumulativefrequency
Pnon-inferiority
= 0.78
Absorb n=298 0.37±0.45 mm
XIENCE n=151 0.25±0.25 mm
Late Luminal Loss: In-stent/ In-scaffold (mm)

9. 8 definite scaffold thromboses (one acute, one subacute, six very late) and 1 late probable
scaffold thrombosis in the Absorb BVS group (3%), and no definite or probable stent
thrombosis in the XV group (p=0.0331) over the course of 3 years
Lancet. 2016 Nov 19;388(10059):2479-2491
Angiographic, in-stent/scaffold assessment

10. Optimal Implantation Technique is Imperative for
Good Clinical Outcomes:
“The PSP Rule for Absorb BVS Deployment”
1. Prepare the lesion to receive scaffold w/ NC balloon sized 1:1
2. Facilitate delivery
3. Enable full expansion of pre-dilatation balloon to facilitate full scaffold
expansion and improve vessel compliance
1. Accurately size the vessel (2.5-3.75 mm) w/ intracoronary imaging
2. Select appropriate scaffold for “best fit”
1. Mandatory post-dilatation w/ NC balloon
2. Achieve <10% final residual stenosis
3. Ensure full strut apposition

11. 1. Prepare the lesion to receive scaffold w/ NC balloon sized 1:1
2. Facilitate delivery
3. Enable full expansion of pre-dilatation balloon to facilitate full scaffold
expansion and improve vessel compliance
LesionAssessmentin2projectionsafterNTL
LesionPreparationw/2.5x10NCinflated@16Atm
AngiographicResultafterOptimalLesionPrep.
Optimal Implantation Technique is Imperative for
Good Clinical Outcomes:
“The PSP Rule for Absorb BVS Deployment”

12. AbsorbBVS2.5x12-mmdeployed@14-Atm:
2-Atmevery5sec
FinalAngiographicResultafterAbsorbBVSDeployment
1. Accurately size the vessel (2.5-3.75 mm) w/ intracoronary imaging
2. Select appropriate scaffold for “best fit”
Optimal Implantation Technique is Imperative for
Good Clinical Outcomes:
“The PSP Rule for Absorb BVS Deployment”

13. 1. Mandatory post-dilatation w/ NC balloon
2. Achieve <10% final residual stenosis
3. Ensure full strut apposition
*
*
*
*
*
Optimal Implantation Technique is Imperative for
Good Clinical Outcomes:
“The PSP Rule for Absorb BVS Deployment”

14. 8 definite scaffold thromboses (one acute, one subacute, six very late) and 1 late probable
scaffold thrombosis in the Absorb BVS group (3%), and no definite or probable stent
thrombosis in the XV group (p=0.0331) over the course of 3 years
Lancet. 2016 Nov 19;388(10059):2479-2491
Angiographic, in-stent/scaffold assessment
Conclusion
The trial did not meet its co-primary endpoints of superior vasomotor reactivity
and non-inferior late luminal loss for the Absorb BVS with respect to the
metallic stent, which was found to have significantly lower late luminal loss
than the Absorb BVS.
The PSP Rule for Absorb BVS Deployment in AB II was implemented in 6.5%

15. 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to
receive an Absorb BVS (1322 patients) or an XV stent (686 patients).
The primary end point, which was tested for both non-inferiority and
superiority, was Target-Lesion Failure (cardiac death, target-vesselmyocardialinfarction, or ischemia-
driven target-lesion revascularization) at 1 year.
N Engl J Med. 2015 Nov 12;373(20):1905-15

16. Target Lesion Failure @ 1Y:
7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7
percentage points; 95% confidence interval, -0.5 to 3.9; p=0.007 for noninferiority and
p=0.16 for superiority).
N Engl J Med. 2015 Nov 12;373(20):1905-15

17. N Engl J Med. 2015 Nov 12;373(20):1905-15
0%
2%
4%
6%
8%
10%
0 100 200 300 400
Days Post Index Procedure
(N=1623)
All RVD ≥2.25 mm
0.8%
0.5%
Definite/ProbableST(%)
Device thrombosis within 1y occurred in 1.5% of patients in the Absorb group
and in 0.7% of patients in the Xience group (P=0.13).
N Engl J Med. 2015 Nov 12;373(20):1905-15

18. N Engl J Med. 2015 Nov 12;373(20):1905-15
0%
2%
4%
6%
8%
10%
0 100 200 300 400
Days Post Index Procedure
(N=1623)
All RVD ≥2.25 mm
0.8%
0.5%
Definite/ProbableST(%)
Device thrombosis within 1y occurred in 1.5% of patients in the Absorb group
and in 0.7% of patients in the Xience group (P=0.13).
(N=375)
Any RVD <2.25 mm
4.6%
1.5%
Absorb
Xience
Absorb
Xience
Definite/ProbableST(%)
Days Post Index Procedure

19. N Engl J Med. 2015 Nov 12;373(20):1905-15
0%
2%
4%
6%
8%
10%
0 100 200 300 400
Days Post Index Procedure
(N=1623)
All RVD ≥2.25 mm
0.8%
0.5%
Definite/ProbableST(%)
Device thrombosis within 1y occurred in 1.5% of patients in the Absorb group
and in 0.7% of patients in the Xience group (P=0.13).
(N=375)
Any RVD <2.25 mm
4.6%
1.5%
Absorb BVS
XV
Absorb BVS
XV
Definite/ProbableST(%)
In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease
with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting
cobalt–chromium stent, was within the prespecified margin for noninferiority with respect to
TLF @ 1 year.
N Engl J Med. 2015 Nov 12;373(20):1905-15

20. A total of 480 patients were randomized (241 BVS vs. 239 CoCr-EES).
The primary endpoint of in-segment LL @ 1 year was 0.19±0.38 mm for BVS vs. 0.13±0.38 mm for CoCr-EES
achieving non-inferiority ofBVS compared with CoCr-EES
BVS and CoCr-EES also had similar 1-year rates of TLF: 3.4% vs. 4.2%, p=0.62 and definite/probable scaffold/stentthrombosis
(0.4% vs. 0.0%, respectively; p=1.00)

21. 400 patients were randomised in a 2:1 ratio to BVS (N=266) or CoCr-EES (N=134).
The 2-year TLF rates were 7.3% and 3.8% in the BVS and CoCr-EES arms (p=0.18), respectively.

22. 400 patients were randomised in a 2:1 ratio to BVS (N=266) or CoCr-EES (N=134).
VLST beyond 1-year was observedin 1.6% of the BVS arm, while there was no VLST in the CoCr-EES arm.

23. TLF @ 1, 2 & 3 Years
based on PSP Implementation in the ABSORB Trials
AB II
AB III
AB Extend
AB Japan
AB China
AB II
AB Extend
AB Japan
AB China
non-PSP:
11.9%
PSP:
5.4%
AB II

24. Scaffold Thrombosis @ 1, 2 & 3 Years
based on PSP Implementation in the ABSORB Trials
AB II
AB III
AB Extend
AB Japan
AB China
AB II
AB Extend
AB Japan
AB China
non-PSP:
3.4%
PSP:
0.7%
AB II

25. 2nd Generation Everolimus-Eluting Absorb BVS
GT1
Post-PCIData on file of

26. DESolveTM CX Novolimus-Eluting BRS
Novolimus-eluting scaffold
Thickness: 120 μm
Crossing Profile: 1.3 mm
DESolve Cx Trial
Primary Endpoint @ 6m: Efficacy,
In-scafold LL= 0.18 ± 0.29 mm
Primary Endpoint @ 6m: Clinical,
MACE: 0%
6m30d 12m 24m
DESolveTM NXT Novolimus-Eluting BRS
DESolve NXT Trial
Primary Endpoint @ 6m:
In-scafold LLL
& TLF: TLR, MI, Cardiac Death
Secondary Endpoint:
TLF @ 30d, 1Y, 2Y, 3Y
In-segmentLLL
IVUS-derived in-scaffold%
obstruction
OCT-derivedstrutcoverage
6m30d 12m 24m 36m

27. Fantom® Sirolimus-Eluting BRS
FANTOM II
PrimaryEndpoint:MACE&LL@6m
SecondaryEndpoint:MACE&LL@9m
6 month Primary Endpoint
(n=100)
MACE
(%)
2.1%
LL
(mm)
0.25 ± 0.40
9 month Secondary
Endpoint
MACE
(%)
Ongoing
LL
(mm)
Ongoing

28. RENUVIA Everolimus-Eluting Abluminal Coating BRS
Data on file of
Material: PLLA
Design: Zig-Zag hoops
Thickness: 120-μm
Abluminal
Everolimus Coating
RENUVIA EES
30Days90Days
FAST FIM, Efficacy of RENUVIA BRS
Angiographic endpoint:
In-scaffold Late Lumen Loss
Experimental Study
30Days
OCT
FIM: N=30
30d
6m
12m
24m
-
60m

29. Conclusions:
Although the promising field of VRT was designed to eliminate many of the long-term limitations of
contemporary metallic drug-eluting stents, recent randomized trials have raised concerns related to the
rates of very late scaffold thrombosis and the degree of functional restoration following scaffold
resorption.
The increasing adoption of optimal scaffold deployment techniques including optimal lesion
preparation, precise vessel sizing and post-dilatation indicates that late and very late clinical events are
dramatically decreased, encouraging the utilization of bioresorbable scaffolds for coronary
revascularization in selected clinical subsets.
Further design iterations of current generation bioresorbable scaffolds are expected to improve clinical
outcomes compared to current generation metallic drug-eluting stents, a hypothesis that remains to be
elucidated following completion of the ongoing clinical studies utilizing 2nd
generation poly-L-lactic acid
scaffolds.