alien vs terminator? by stephan windecker, md pcr 2014. resolute all comers 5-year tlf ... arroyo...

11/30/2016

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Absorb vs Synergy

Clinical Efficacy -Review of Absorb 3 and

Evolve 2 Trials

Dr. Marc Litt

Director Cardiac Cath Lab Baptist Medical Center

Jacksonville,Flordia

SYNERGY™

Everolimus-Eluting Platinum Chromium Stent System with Abluminal Bioresorbable PLGA Polymer

ABSORB BVS GT 1 Bioresorable PLLA scaffold with a Bioresorable PLLA

Polymer with Everolimmus

VS

Alien vs Terminator?

11/30/2016

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Why develop bioresorable stents or polymers?

5

Event rates persist beyond 1 year with current PERMANENT Polymer DES

Presented by Stephan Windecker, MD PCR 2014.

Resolute All Comers 5-year TLF

TLF (target Lesion Failure) is defined as cardiac death, TVMI, of clinically driven TLR.

Why develop bioresorable

stents or polymers?

• Lower late event rates - late TLF ,late ST

• Improve vasomotion

• Reduce need for prolonged DAPT

• Reduce delayed healing/incomplete endothelial coverage

• Reduce inflammation,foreign body giant cell reaction

• Reduce risk negative vessel remodeling

• Reduce late stent malapposition

• Reduce neoatherosclerosis i

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Circulation. 2016;134:168–182. DOI: 10.1161/CIRCULATIONAHA.116.021539

DES stent platforms

Stent Xience Resolute Synergy BVS

Structure CoCr/EES CoNi/ZES PtCr/EES PLLA/EES

Strut

Thickness

81 um

91um

74um

150um

Polymer BVDF Biolink PLGA PDLLA

Distribution/

Thickness

conformal/7

-8 um

conformal/6

um

abluminal/4

um

conformal/

7 um

9

Ultrathin Abluminal Coating

Bioabsorbable Polymer Coating (PLGA) • Abluminal • 4µm thick • 85:15 ratio • <4 month absorption time

Everolimus-Eluting • 100μg/cm2

• 3 month release time

Platinum Chromium Platform • 74μm (0.0029in) strut thickness Visibility Strength Flexibility Conformability Recoil

SYNERGY Stent Technology Design

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© 2015 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners.

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SYNERGY™ Stent Clinical Program


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Randomized Cohort (RCT)

SYNERGY™ Stent

n = 846

PROMUS Element™ Plus

Stent System

n = 838

RCT Design

Multicenter noninferiority trial

Pivotal, single-blind, 1:1 randomization

Primary Endpoint: TLF (CD, TV-MI, or TLR)

at 12 months

Follow-up through 5 years

Patients with ≤3 native coronary artery lesions in ≤2 major epicardial vessels; lesion length ≤34 mm, RVD ≥2.25 mm ≤4.0,

%DS> 50 <100 (excluded LM disease, SVG, CTO, ISR or recent STEMI)

SYNERGY Stent

n = 21

Diabetes Substudy

PK

Substudy

125 global sites Single-arm

Diabetes Study

n = 203

SYNERGY Cohort

EVOLVE II RCT

n = 263

EVOLVE II Diabetes Substudy Design

Consecutive, multicentre, single-arm, non-

randomised

1° Endpoint: TLF at 12 mo

Kereiakes et al. The EVOLVE II T rial. Circ Cardiovasc Interv. 2015.

EVOLVE II DM Substudy. Presented by Stephan Windecker, MD at PCR 2015.wing the index procedure.

Per protocol, patients were treated with one of the following P2Y12 inhibitors (clopidogrel, ticlopidine, prasugrel, or ticagrelor) for at least 6 months follo

Most complex patient population ever studied in a U.S. Pivotal Trial

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EVOLVE II Clinical Trial Design First Successful U.S. Pivotal Trial of a Bioabsorbable Polymer Technology


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SY

NE

RG

Y™

Ste

nt

Arm

Po

pu

latio

n (

%)

25.9

33.9

76.8

23.9

31.1

0

18

36

54

72

90

NSTEMI Unstable Angina B2/C Lesions <2.25 mm DM Medically Treated

Broadest and most complex patient population

ever studied in a U.S. Pivotal Trial

12

EVOLVE II Clinical Trial Baseline Patient Characteristics – A More Comers Study

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EVOLVE II Clinical Trial 2-Year Results

8.5

1.5

5.4

3.1

6.2

9.4

1.0

5.5

4.3

6.7

0

4

8

12

16

20

TLF Cardiac Death TV-MI TLR TVR

Incid

en

ce

Ra

te (

%)

SYNERGY™ Stent System Promus Element™ Plus

Stent System (PP-DES)

Components of TLF

SYNERGY™ Stent System

BP-DES (n=816)

Presented by D. Kereiakes, MD at ACC 2016

ITT Population; Patients who did not receive a study stent were censored at 1 year; KM Event Rates; Per protocol spontaneous MI is defined as rise and/or fall of cardiac biomarkers with ≥1 value >99th percentile of the URL + evidence of myocardial ischemia.

1. TLF: ischemia-driven TLR, MI related to the target vessel, or any cardiac death. The study primary endpoint was the rate of 12-month TLF by both intent-to-treat and per-protocol analyses.

2. Peri-PCI MI is defined as ≥1 of the following: i) biomarker elevations within 48 hours of PCI (based on CK-MB >3X URL), ii) new pathological Q waves, or iii) autopsy evidence of acute MI

P=0.57 P=0.35 P=0.89 P=0.17

Primary Endpoint of Target Lesion Failure (TLF) Met

TLF Cardiac Death Target Vessel MI2 TLR

P=0.57

PROMUS Element™ Plus Stent System

PP-DES (n=796)

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ST Landmark Analysis Definite/Probable ST after 24 hours to 2-Years


‡Day 715 – Definite ST: Patient was not compliant to aspirin and was not taking at P2Y12 inhibitor at time of presentation

ST occurring between 0 and 1 years have been previously reported in Kereiakes et al. Circ Cardiovasc Interv 2015

ITT; Patients who did not receive a study stent were censored at 1 year; KM Event Rate; log-rank P values

NNumerically lower ARC Definite/Probable ST with the SYNERGY BP-DES compared to

the PROMUS Element PP-DES

SYNERGY™ Stent System

BP-DES


PP-DES

14

P=0.056


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PROMUS Element Plus

SYNERGY

Subacute (2-30 days) Late (30 days – 1 year)

0.8%

(N=6)

0.4%

(N=3)

P=0.31

Acute (≤1 day)

N=1 (Prob)

N=5 (2 Definite/3 Probable)

N=2 (Definite)

Very Late (1 year – 2 years)

N=1 (Def)

ZERO Definite ST in the SYNERGY arm after 24 hours


PROMUS

Element Plus™

Stent System

PP-DES

SYNERGY™

Stent System

BP-DES

EVOLVE II Clinical Trial Exceptionally Low Stent Thrombosis

15

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SWEET

Registry

Fribourg

Experience

Belfast

Experience

EVOLVE II

Trial

EVOLVE

Trial

EVOLVE

China

EVOLVE II

QCA Study

SCAAR

Registry

N: 820 671 100 846 94 205 100 7880

Acute 1.5% 0.3% 0% 0.2% 0% 0% 0%

Sub-

acute 0.1% 0.3% 0% 0% 0% 0% 0%

Late 0.1% 0.1% 0% 0% 0% 0% 0% 0.1%*

Acute: ≤ 1 day

Subacute: 2 – 30 days

Late: 30 days – 1 year

*Cumulative adjusted ARC def ST

SWEET Registry: Cook TCT 2015., Fribourg Experience: Arroyo CRT 2016. Belfast Experience: Noad TCT 2015., EVOLVE II: Kereiakes, et al. Circ Cardiovasc Interv. 2015;8:e002372.DOI:10.1161/CIRCINTERVENTIONS.114.002372.,EVOLVE FHU:

Meredith et al. J Am Coll Cardiol. 2012; 59 (15):1362., EVOLVE II QCA: Meredith ACC 2015., SCAAR Registry: James TCT 2015.

0.2%*

16

ARC ST (Def) Rates for the

SYNERGY™ Stent at 1-Year


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Arterial Wall

Promus PREMIER™ Stent Conformal Permanent Polymer

SYNERGY Stent Abluminal PLGA

Bioabsorbable Polymer

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*Strut thickness for small vessel model is 74μm, Workhorse model is 79μm and large vessel is 81μm. Boston Scientific data on file.

78 µm* Strut + Polymer

97 µm Strut + Polymer

SYNERGY™ Stent Abluminal Coating


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96.9

98.3

90.

100.


SYNERGY Stent System

Series 1


1 Technical Success is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% in 2 near-orthogonal projections with T IMI 3 flow in the target lesion, as visually assessed by

the physician. Summarized per lesion

(n = 838) (n = 846)

P = 0.04

Te

ch

nic

al S

ucce

ss (

%)

SYNERGY Stent displayed greater technical success1 with delivery and deployment

18

EVOLVE II Clinical Trial SYNERGY™ Stent System Technical Success

11/30/2016

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19

Summary

• Positive clinical performance of SYNERGY supported by:

• 2-year EVOLVE II Trial data proving non-inferiority to the Promus Element Plus Stent for TLF in a diverse population (>60% ACS, >25% MI, 31% diabetes, smaller vessels, longer lesions, ≥75% AHA/ACC B2/C lesion morphology)

• 2-year EVOLVE II Trial data with no definite ST after 24 hours

• Bioabsorbable polymer-coated DES may enhance healing and improve late outcomes (ST, TLR).

Everolimus/PDLLA (1:1) matrix coating

• 7 µm

• Conformal coating

• Controlled drug release similar to Xience CoCr-EES

PLLA Backbone

• Semi-crystalline

• Circumferential sinusoidal rings connected by linear links

• Strut thickness 150 µm

• Platinum markers in each end ring

Fully

Bioresorbable

Absorb BVS

The current available technology: The reabsorption process

Hydrolysis occurs via random chain scission of the ester bond

1 3 6 24

Support

Mass Loss

Tie

chains Initially, hydrolysis preferentially cleaves amorphous tie

chains, leading to a decrease in molecular weight without

altering radial strength

When enough tie chains are broken, the device

begins losing radial strength

Molecular Weight

12 18

� �

� �

�

� �

�

� � �

�

36 Months

Abbott Vascular.

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See Important Safety Information referenced within. ©2016 Abbott. All rights reserved. AP2942359-US Rev. A 22

ABSORB IS BUILT ON PROVEN XIENCE TECHNOLOGY

INDICATIONS: The XIENCE Family of Everolimus Eluting Coronary Stent Systems are indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions for XIENCE V (length ≤ 28 mm), XIENCE Prime, XIENCE Xpedition and XIENCE Alpine (lengths ≤ 32 mm) with reference vessel diameters of ≥2.25 mm to ≤ 4.25 mm. Additionally, the entire XIENCE Family is indicated for treating de novo chronic total coronary occlusions.

ABSORB: Extensive Clinical Program Real World and Complex Patient Populations

GABI-R Design: All-comers registry

N=~5000 1˚: Safety & efficacy

ABSORB FIRST Design: Prospective, multi-center, global registry

N= ~1800

1˚: ST, CD, MI, revascularization, MACE, TLF, & TVF

BVS EXPAND* Design: All-comers registry

N=~300 1˚: 1-year MACE

GHOST EU Design: All-comers registry N=continuous enrollment

1˚: TVF

FRANCE ABSORB Feasibility: De novo lesions

N=~2000 1˚: 1-year MACE

AIDA Design: RCT vs. XIENCE

N=~1850 1˚: 2-year TVF

REPARA Design: All-comers registry

N=~1500 1˚: 1-year MACE

EVERBIO II Design: Non-inferiority

RCT EES vs. BES vs. BVS

N=~240

1˚: Late lumen loss at 9 months

ASSURE Design: All-comers registry

N=180 1˚: Safety & efficacy

ALL-COMERS

POLAR-ACS Design: ACS registry

N=94 1˚: Safety, clinical device, procedure, success & in-

hospital MACE

TROFI II Design: STEMI vs. XIENCE

N=190 1˚: 6-months,

neo-intimal healing score

PRAGUE 19 Design: STEMI (STEMI Killip I/II)

N=79 1˚: Clinical outcomes

ISAR ABSORB MI Design: Non-inferiority vs. EES

N=260 1˚: % diameter stenosis at 6-8 months

ABSORB CTO Feasibility: CTO

N=35 1˚: Safety & performance

PABLOS Feasibility: Bifurcations

N=30 1˚: Device, procedural, main & side branches

IT-DISAPPEARS Design: MVD and Long Lesion Registry

N=~1000 1˚: Safety & efficacy

ABSORB II Design: Randomized 2:1 Absorb BVS:XIENCE

N=501

1˚: Vasomotion & lumen diameter

after the index procedure & at 3 years

SIMPLE TO MODERATELY COMPLEX POPULATIONS

ABSORB EXTEND Design: Prospective, single-arm, open-label

clinical study

N=812

1˚: ID-MACE

ABSORB COHORT B Design: Allocated (non-randomized)

N=101

1˚: Safety & performance

ABSORB III Design: RCT. N= ~2250

1˚: TLF at 1 year

ADDITIONAL LARGE RCTs

ABSORB JAPAN Design: RCT. N= ~400

1˚: TLF at 1 year

ABSORB CHINA Design: RCT. N= ~440

1˚: In-segment late loss at 1 year

ABSORB IV Design: RCT. N= ~3000

1˚: Angina within 1 year

COMPLEX POPULATIONS

*Excludes STEMI patients. ACS, acute coronary syndrome; MVD, multi -vessel disease; CTO, chronic total occlusion; MI, myocardial infarction RCT, randomized controlled trial; OMT, optimal medical therapy; EES, everolimus-eluting stents; BVS, bioresorbable vascular

scaffold; STEMI, ST-segment–elevation myocardial infarction; MACE, major adverse cardiac events; ID-MACE, ischemia-driven major adverse cardiac events; TLF, target lesion failure; IVUS MLA, intravascular ultrasound minimal lumen area; TVF, target vessel failure; LAD,

left anterior descending; FIM, first-in-man.

UK REGISTRY Design: Prospective, single-arm, multi center,

observational registry N= 1005

1˚: RDS < 50% at procedure conclusion, MACE

FEAST Russia Registry Design: All-comers registry

N=2500

1˚: 1-year MACE, TVF, Revascularization, ST, Peri-procedural

MI, Angina

COMPARE ABSORB Design: High risk for ISR

N=~2100 1˚:TLF Kuwait Registry

Design: All-comers registry N=200

1˚: Safety & efficacy PROSPECT ABSORB Design: RCT BVS vs. OMT in unstable asymptomatic

pts N=900

1˚: 2-Yr IVUS MLA

BVS STEMI First Design: STEMI

N=151 1˚: Safety & performance

RAI Registry Design: All-comers registry


Retrospective Multicentric/MICAT Registry Design: All-comers registry


UNDERDOGS Design: Long Lesions/Overlap

N=314 DOCE at 1 Year

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Primary Endpoint

Target Lesion Failure at 1 year (CD,TV-MI,ID-TLR), powered for non-inferiority in 2000 clinical follow-up subjects

Power Secondary Endpoints

1.Angina at 1 year for superiority test of Absorb to Xience

2.ID-TVR at 1 year for superiority test

3.All Revascularization at 1 year for superiority test

Treatment Up to 2 de novo lesions in different epicardial vessels. No planned overlap; RVD (site) 2.5-3.75mm; LL ≤ 24mm

25

30 d 6 mo 12 mo 24 mo 36 mo 48 mo 60 mo

Clinical Follow-up

Prospective, multicenter, single blind, randomized 2:1

Absorb vs. Xience, in ~2000 patients

ABSORB III Study Design

Randomized 2:1

N=2008 (ITT)

ABSORB

N=1322

ABSORB

N=1312

Xience

N=677

99.2% Complete 98.7% Complete

N=4 lost to follow-up

N=6 withdrew consent

N=6 lost to follow-up

N=3 withdrew consent

Xience

N=686

12-month Follow-up

Study Flow and Follow-up

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1-Year TLF Components

7.8

0.6

6.0

3.0

6.1

0.1

4.6

2.5

0.

2.

4.

6.

8.

10.

TLF Cardiac death TV-MI ID-TLR

1-Y

ea

r T

LF

(%

)

Absorb (N=1322)

Xience (N=686) P=0.16

P=0.29

P=0.18

P=0.50

Absorb

(N=1322)

Xience

(N=686) p-value

Angina 18.3% 18.4% 0.93

All Revascularization 9.1% 8.1% 0.50

ID-TVR 5.0% 3.7% 0.21

Powered Secondary Endpoints

Absorb

(N=1322)

Xience

(N=686) p-value

Device Thrombosis (def/prob) 1.54% 0.74% 0.13

- Early (0 to 30 days) 1.06% 0.73% 0.46

- Late (> 30 to 1 year) 0.46% 0.00% 0.10

- Definite* (1 year) 1.38% 0.74% 0.21

- Probable (1 year ) 0.15% 0.00% 0.55

*One “definite ST” in the Absorb arm by ITT

was in a pt that was treated with Xience

Device Thrombosis to 1 Year

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12.9%

10.0%

4.6%

6.7%

5.2%

0.9%

8.3%

4.5%

1.5%

5.5% 4.6%

0.6% 0%

5%

10%

15%

20%

TLF TVMI ST TLF TVMI ST

Absorb Xience

RVD <2.25 mm (median 2.09 mm)

1-Y

ea

r E

ve

nts

(%

)

Median based on pooled Absorb and Xience

RVD ≥2.25 mm (median 2.74 mm)

Outcomes by QCA RVD 2.25 mm

TLF: Pint diff = 0.31

TVMI: Pint diff = 0.09

ST: Pint diff = 0.12

# Event 31 11 24 6 11 2 71 30 55 25 9 3

# At risk 241 133 241 133 238 133 1067 542 1067 542 1058 540

ABSORB III Acute Device Success and Post Dilatation

p<. 001

94.3

65.5

99.3

51.3

40.

52.

64.

76.

88.

100.

Device Success Post Dilatation

Absorb Xience

p<. 001

• ABSORB BVS was non-inferior to Xience CoCr-

EES for TLF at 1 year (primary endpoint met)

• TLF components (cardiac death, TV-MI, ID-TLR)

were not significantly different between devices

• Angina, all revascularization and ID-TVR were

similar between devices

• No statistically significant differences in device

thrombosis were present

Summary and Conclusions

11/30/2016

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• The ABSORB III trial has demonstrated safety and

efficacy of Absorb BVS at 1 year in patients with

stable CAD and stabilized ACS

• Longer term evaluation is ongoing to determine if

ABSORB improves late outcomes compared to

Xience

Summary and Conclusions

Absorb Meta-analysis 1 year

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Absorb II

Absorb China

Absorb Japan

Absorb III

Summary

20/331

8/238

11/265

102/1313

141/2147

1-Year DoCE (TLF): Cardiac Death,TV-MI or ID-TLR

DoCE = Device-oriented composite endpoint

0.1 0.5 5.0 10.0 1.0

Absorb BVS Better

Xience CoCr-EES Better

Test for heterogeneity: I2=0%; P=0.78

Test for overall effect: Z=1.36; P=0.18

7/165

10/237

5/133

41/677

63/1212

1.42 [0.61, 3.30]

0.80 [0.32, 1.98]

1.10 [0.39, 3.11]

1.28 [0.90, 1.82]

1.22 [0.91, 1.64]

Study Absorb BVS

XIENCE CoCr-EES

RR [95% CI] RR [95% CI]

ABSORB 1-Year Meta-analysis

5.7

1.3

4.

0.5

0.

2.

4.

6.

8.

10.

MI ST

1-Y

ear

TLF (

%)

Absorb Xience

P<.08 P<.08

1 Year Absorb Meta-analysis

ABSORB II: Three-year Clinical Outcomes from a

Prospective, Randomized Trial of an Everolimus-

Eluting Bioresorbable Vascular Scaffold vs. an

Everolimus-Eluting Metallic Stent in Patients with

Coronary Artery Disease

PW Serruys, B Chevalier, D Dudek, et al.

A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1

Lancet, 385 (2015), pp. 43–54

11/30/2016

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Absorb n=258 0.047±0.109 mm

XIENCE n=130 0.056±0.117 mm

Absorb n=298 0.371±0.449 mm XIENCE n=151 0.250±0.250 mm

0.

0.25

0.5

0.75

1.

-0.8 -0.35 0.1 0.55 1. 0.

0.25

0.5

0.75

1.

-0.8 -0.35 0.1 0.55 1.

Late luminal loss (in-stent/scaffold) (mm)

Vasomotion (mm)

Absorb 2 Trial

3 year endpoints NOT MET

No Late lumen loss was larger among patients in the Absorb arm (0.37 mm vs 0.25 mm; P = 0.78 for noninferiority

Vasmotion was not superior to Xience

Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-

eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a

3 year, randomised, controlled, single-blind, multicentre clinical trial

Serruys, Patrick W et al.

The Lancet , Volume 388 , Issue 10059 , 2479

11/30/2016

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Composite secondary endpoints

Cardiac death,TV-MI,TVR !0% Absorb 5% Xience P<.04

Absorb 2 -three year results

PW Serruys, B Chevalier, D Dudek, et al.

A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1

Lancet, 385 (2015), pp. 43–54

Stent Thombosis Definite Scaffold or stent thrombosis

8/320 (3%) Absorb 0/159 (0) Xience P<.06

6 in Absorb group very late ST >365 days !

Intraluminal scaffold dismantling (ILSD)- the

protrusion of sections of the scaffold into the

lumen due to segmental bulk erosion, which may

occur when little neointimal tissue is present to

otherwise restrain the scaffold struts

J Am Coll Cardiol Intv. 2015;8(13):1768-1769. doi:10.1016/j.jcin.2015.06.026

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Perfect Stent Material ??

polymimetic alloy

Or one that dissolves

The Future of Bioresorbable Vascular Scaffolds (BVS):

James C Blankenship MD MHCM MACC M-SCAI

Director, Cardiology and Cardiac Cath Labs

Geisinger Medical Center, Danville PA

No Conflicts of Interest Relevant to this Topic

Principle Investigator at Geisinger

Medical Center for multi-center trials

funded by

Astra-

Zeneca

Boston

Scientific

Abbott

Vascular

Medinal

Stentys Inc

St Jude Medical

Regado

Biosciences

Medinal LTD

GlaxoSMithKline

Takeda

Pharmaceuticals

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Problems with First Generation BVS

Strut Absorption Time Radial (Hoop) Strength

Strut Thickness and Width Strut Fracture Resistance

Visibility

Strut Absorption Time

Radial (Hoop) Strength Strut Thickness and Width Strut Fracture Resistance

Visibility


Kereiakes DJ, Onuma Y, Serruys PW, Stone GW. Bioresorbable vascular scaffolds for coronary revascularization.

Circulation. 2016 Jul 12;134(2):168-82.

Supportive

Role of BVS is

Short-Lived

BVS Struts Persist

Long After They Are

Functional

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Poly-Lacti

des

Decompos

e at

Different

Rates

Biodegradable magnesium alloy

and polymer

Maintains mechanical integrity for 6

months, totally degrades by 12

months.

Slide

courtes

y of

Chaud

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Strut Absorption Time

Radial (Hoop) Strength


Visibility


Polymer (PLLA) stents have poor radial (hoop) strength

--Therefore lesion preparation is essential

Metal stents have much better radial strength (Mg, Fe)

“Self-Correction”: some stents (e.g., DESolve) expand

.3 mm in the days after implantation


Strut Thickness and Width

Strut Fracture Resistance Visibility


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Scaffold strength depends on:

Strut width (exponentially)

Strut thickness (directly)

Shape of hoops, and

# hoops per unit length,

Strut Thickness

89 157 150 120 150

Strut Width

89-112 191 165 30 20

Strut Dimensions of 4 BVS (in microns)

Crossing profile depends on strut width

more than thickness (width limits

crimping).

Stent

Strut Thickness (microns)

FANTOM/ReZolve 125

DeSolve CX 120

DREAMS 2G/Magmaris

120

ReZolve 2 100

MeRES 100

Absorb next 100

Reduced Strut Thickness in Latest Generation Stents

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Strut Thickness and Width

Strut Fracture Resistance Visibility


Expansion

Limits

Stent

Over-Expansion Limit (mm)

Absorb next generation

.75

FANTOM 1.0

DESolve 1.5

Newer BVS are More Expandable (More Fracture Resistant)

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Stent

Over-Expansion Limit (mm)

Absorb next generation

.75

FANTOM 1.0

DESolve 1.5

DREAMS 2.3

https://www.researchgate.net/figure/261254372_fig8_Fig-8-

Post-dilatation-capability-of-a-30-mm-DREAMS-2nd-

generation-The-device-is

Newer BVS are More Expandable (More Fracture Resistant)



Visibility


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Abizaid A, Ribamar Costa J.

The unmet needs: How future

technologies will address

current limitations of

bioresorbable scaffold

technology. Catheterization

and Cardiovascular

Interventions. 2016 Nov

1;88(S1):54-9.

Polyester

carbonate

scaffold with

iodinated

tyrosine

molecules.

Iodine gives it

radiovisibility

11/30/2016

24

Next-Generation BVS

Faster Strut Absorption Better Radial Strength

Thinner Struts More expandable, Fracture-

Resistant Better Angiographic Visibility

Kereiakes DJ, Onuma Y, Serruys PW, Stone

GW. Bioresorbable vascular scaffolds for

coronary revascularization. Circulation. 2016

Jul 12;134(2):168-82.

The Race to Create the

Better Bioabsorbable

Vascular Scaffold

19 companies

23 stents

The Race to Create the

Better Bioresorbable

Vascular Scaffold

Euro Heart J. 2014;35:765-

11/30/2016

25

Strut Material Company Stent Name

PLLA Abbott Vascular

Absorb

Magnesium alloys

Biotronik DREAMS/Magmaris

Tyrosine polycarbonate

Reva Fantom/ReZolve

Nitride Iron Lifetech Lifetech Nitride Iron Stent

Alternative BVS Strut Materials

Stent Name Trial Name

Strut Trial n

Angio Outcom

es

Clinical Outcomes

FANTOM FANTOM II PLLA 240 good good

MeRes100 MeRes 1 PLLA 108 good good

Firesorb FUTURE1 PLLA 45 good good

Amaranth BVS

FORTITUDE PLLA 63 good good

MMRES MIRAGE PLLA 60 good good

DESolve DESolve PLLA 120 good good

DESolve CX DESolve CX PLLA 25 good good

DREAMS 2G

BIOSOLVE II

Mg 123 good good

ABSORB Absorb- PLLA 467 good good

BVS Reports at TCT-2016

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26

Summary: The Future of BVS Efficacy of 1st-generation BVS is uncertain

2nd-generation BVS are addressing problems of 1st-gen BVS

All versions are drug-eluting, made of polymer or metal

19 companies are competing

Uncertain if BVS can rival current DES short-term

outcomes

Long-term benefits of BVS are attractive but unproven

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