ABSORB Extend 3-Year Clinical Outcomes in

ABSORB in daily practice
Prof Alfredo R Galassi MD, FACC, FESC, FSCAI
Director of Cardiac Catheterization and
Interventional Cardiology Unit
Department of Internal Medicine and Systemic Disease
Division of Cardiology, Cannizzaro Hospital,
University of Catania, Italy
Current PCI Options for Treating CAD
There is still room for improvement
Serruys, PW. PCR 2010
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BVS- Rationale and Goals
Rationale: Vessel scaffolding is only needed transiently
Goal: Revascularize the vessel like a metallic DES, then resorb
naturally into the body
Potential benefits:
 Restoration of natural physiologic vasomotor function in some patients
 Enable vascular remodeling and tissue adaptation
 Elimination of chronic sources of vessel irritation and sources for
chronic inflammation
 Possibly avoid current challenges with leaving a metal implant behind
 Potentially reduce the need for prolonged DAPT
 No permanent implant to complicate future interventions and reinterventions, particularly in younger patients
 Non-invasive imaging with MSCT or MRI without ‘blooming artifact’
Potential of a Fully Bioresorbable Vascular Scaffold
Bioresorbable
Vascular
Scaffold
Serruys, PW. PCR 2010
2
Abbott Vascular Everolimus-Eluting
BVS Components
Bioresorbable
Scaffold
• Poly (L-lactide)
(PLLA)
• Naturally
resorbed, fully
metabolized
Bioresorbable
Coating
• Poly (D,Llactide) (PDLLA)
coating
• Naturally
resorbed, fully
metabolized
XIENCE V
Delivery System
Everolimus
• Similar dose
density and
release rate to
XIENCE V
• World-class
deliverability
Bioresorbable Scaffold:
Three Phases of Functionality
Revascularization
Restoration
Resorption
0 to 3 months
3 to 12 months +
~12 months +
Performance should mimic
that of a standard DES
Transition from scaffolding
to discontinuous structure
Implant is discontinuous
and inert
•Gradually lose radial
strength
•Resorb in a benign
fashion
•Sufficient acute radial
strength
•Struts must be incorporated
into the vessel wall (strut
coverage)
•Allow the vessel to
respond naturally to
physiological stimuli
•Controlled delivery of
drug to abluminal tissue
•Become structurally
discontinuous
•Good deliverability
•Minimum of acute recoil
•Excellent conformability
3
Aligning Device Engineering with
Vascular Biology
Revascularization
Restoration
Resorption
Support
Full Mass Loss &
Bioresorption
Everolimus Elution
Mass Loss
1
3
6
Months
Platelet Deposition
Matrix Deposition
Leukocyte Recruitment
Re-endothelialization
SMC Proliferation and Migration
Vascular Function
2 Years
Forrester JS, et al., J. Am. Coll. Cardiol. 1991; 17: 758.
Oberhauser JP, et al., EuroIntervention Suppl. 2009; 5: F15-F22.
Absorb II Study Design
Prospective, randomized trial comparing Absorb to XIENCE in 501 patients
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Absorb II Angiography Assessment
More careful handling with Absorb led to slight differences in
Post-Procedure MLD. More vessel curvature with Absorb.
Procedural Assessment Pre and Post Procedure
p
Absorb
364 Lesions
Xience
182 Lesions
value
Procedural Details Per Lesion
Balloon dilatation prior to device implantation
%
100
98.9
0.11
Planned overlap with the same type of device
%
15.4
11.0
0.16
Unplanned/bailout implantation “same”
%
3.8
6.0
0.25
mm
3.01
3.05
0.10
%
60.7
58.8
0.67
mm
3.08
<
3.16
0.02
atm
14.23
<
15.03
0.01
mm
0.19
0.19
0.85
%
99.2
100
0.55
Acute Clinical Procedural
Success
%
96.1
98.8
an investigational
device. Limited by Federal (U.S.) law to investigational
use only.
Absorb BVS is currently CE marked.
Please
0.16
Nominal size of study device
Balloon dilatation after device implantation
Nominal diameter of last balloon used
Maximum last balloon pressure used
Acute recoil post device implantation
Acute Clinical Device Success
Abbott Vascular Confidential. INTERNAL USE only. Not to be reproduced, distributed or excerpted. CAUTION: Absorb BVS is
check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. ©2014
Abbott. All rights reserved. AP2940372-INT Rev. A 09/14
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Information contained herein for distribution outside the U.S. only. AP2940379-OUS Rev. A 09/14
5
Absorb II Clinical Outcomes
Absorb II Definite Scaffold Thrombosis
Absorb shows low rate of 0.6% Definite ST at 1 year, similar to XIENCE
6
Absorb II Angina Cumulative Rates
Absorb shows significantly lower rate of Post-PCI angina
ABSORB Cohort B
Non-Randomized, Single-Arm, First-in-Man Trial
101 subjects
(Non-randomized) 12 sites in Europe, Australia, New Zealand
Group B1 (n = 45)
Clinical Follow-up (months)
6
12
18
24
36
48
60
Group B2 (n = 56)
QCA, IVUS, OCT, IVUS VH follow up
MSCT follow up
Study Objective
Endpoints
FIM – safety/performance
Typical PCI clinical and imaging endpoints
Up to 2 de novo lesions in different epicardial vessels
Treatment
Device Sizes
Reference vessel diameter of 3.0 mm, lesions ≤ 14 mm in length
3.0 x 18mm devices
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ABSORB Extend
3-Year Clinical Outcomes in 250 Patients
Absorb shows strong safety and efficacy vs. XIENCE at 3 years in SPIRIT Trials
Absorb
EXTEND, 174
Pts
XIENCE V
SP123, 290
Pts
Cardiac Death %
0.6
1.4
0.65
Myocardial Infarction %
4.0
3.8
0.90
Ischemia Driven TLR %
P Value
NON-HIERARCHICAL
COMPONENTS
4.6
5.9
0.56
MACE %
7.5
10.0
0.36
TVF %
8.0
14.1
0.05
TLF %
6.9
9.7
0.31
Scaffold Thrombosis (ARC
Def/Prob) %
0.6
0.7
1.00
MACE is the composite of cardiac death, MI and ID-TLR ; TVF is the composite of cardiac
death, TV-MI and ID-TVR; TLF is the composite of cardiac death, TV-MI and ID-TLR
Adapted from Smits P. TCT 2014
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ABSORB Extend
3-Year Clinical Outcomes in 250 Patients
Absorb continues to show a comparable rate of MI at 3 years vs. XIENCE
Smits P. TCT 2014
ABSORB Extend
3-Year Clinical Outcomes in 250 Patients
Absorb continues to show a comparable rate of ST at 3 years vs. XIENCE
Smits P. TCT 2014
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ABSORB Extend
3-Year Clinical Outcomes in 250 Patients
**
Absorb continues to show a lower incidence of angina than XIENCE at 3 years
*
**
#
EXTEND excludes non-Japanese Asians, and SPIRIT IV non- complex subgroup
Includes in-hospital angina events; angina reported via AE forms.
Out of hospital to 3 years angina rates: 23.9% (Absorb) and 43.2% (XIENCE)
Smits P. TCT 2014
BVS in Diabetic patients
Diabetic patients treated with BVS showed similar rates of MACE
than those treated with EES
Muramatsu et al. JACC 2013
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Dzavik and Colombo JACC Intv 2014
Rules for Optimal BVS Implantation
5P
1. Proper Vessel Sizing
2. Preparation of the Lesion
3. Pay attention to Expansion Limits
4. Post dilatation with NC ballons
5. Prescribe DAPT
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Preparation of the Lesion

Assess the vessel proximal to the target lesion to ensure smooth
delivery to the lesion (problem of tortuosity)

Predilatation is strongly recommended

Quantitative imaging Is recommended for the assessment of
target vessel diameter at baseline for appropriate Absorb BVS
size selection (QCA, IVUS, OCT)

Confirm full expansion of the predilatation balloon – do not treat
patients with a greater than 40% residual stenosis after
predilatation (i.e., heavily calcified lesions)

It is recommended to administer a standard dose of
intracoronary nitroglycerin prior to finalize reference vessel
sizing
Pay attention to Expansion Limits
When expanding the scaffold, be sure to stay within the expansion
limits of the device:
Nominal Scaffold
Diameter
Maximum Dilatation
Limit
2.5 mm
3.00 mm
3.0 mm
3.50 mm
3.5 mm
4.00 mm
CAUTION: Do not dilate the scaffold beyond the maximum dilatation
limit. Expansion beyond the dilatation limits listed above, may result in
scaffold damage.
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BVS in Left Main Stenting:
Limitations
The largest BVS available is 3.5 mm which has
dilatation limit of 4.0mm and too small for many LM
Dilatation of struts into side branch (LCx) with > 2.5
mm balloon may result in scaffold disruption
When LCx is larger than 2.5 mm and needs
treatment at the ostium BVS on LM may not be
ideal (see bifurcation treatment)
Problems of Malapposition
Serruys TCT 2014
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Acute Disruption
Coronary Angiography
Target CTO vessel = RCA
Retrograde epicardial collateral (CC2) from LCx
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Approaching the epicardial collateral
Corsair (Asahi)
Sion (Asahi)
Advancing Corsair in the collaterals
Corsair (Asahi)
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Reverse CART
Antegradely
Finecross (Terumo)
Fielder XT (Asahi)
Retrogradely
Corsair (Asahi)
Confianza 12 (Asahi)
Reverse CART
Antegradely
Finecross (Terumo)
Fielder XT (Asahi)
Retrogradely
Corsair (Asahi)
Confianza 12 (Asahi)
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Externalization and Predilatation
Result after Predilatation
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Implantation of 5 BVS
Final result
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Take Home Messages
 Absorb proven safe and effective compared to a best in class DES
(XIENCE) (ABSORB II randomized trial)
 Lower rate of revascularization (ABSORB II randomized trial)
 Lower rate of angina (ABSORB II randomized trial, ABSORB Extend)
 Leaves no permanent implant behind: unique benefits as a result of
uncaging the vessel from the constraints of a permanent metallic
implant (ABSORB cohort B):
Future Treatment Options
Restoration of Vasomotion
Late Lumen Gain
Plaque Regression
Non-Invasive Imaging (MSCT or MRI without blooming artifact)
Un-jail Side Branches (long-term)
Take Home Messages
Proofs are established regarding feasibility and safety in
different patients and lesions subsets (Bifurcation, LM,
CTO)
Proper sizing of the lesion, predilatation, post-dilatation
may optimize its use but possibly avoiding over-dilatation
Few adverse events have been recorded ++ scaffold
thrombosis (initial results operator not used to these
different device)
Further randomized trials are needed to assess clinical
outcome in particular lesion subsets
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