Vessel prep is the key…to extending the role of DCBs to more challenging lesions and to optimize the

outcome of stenting

Peter A. Schneider, MD

Kaiser Foundation Hospital

Honolulu, Hawaii

Disclosure

Peter A. Schneider

.................................................................................

I have the following potential conflicts of interest to report:

Scientific Advisory Board (non-paid): Cardinal, Abbott, Medtronic

Royalty (modest): Cook

Co-founder and Chief Medical Officer: Intact, Cagent

Enter patients into studies: NIH, Bard, Gore, Medtronic, BSI,

Silk Road (no financial relationship).

VIVA Board member (nonprofit)

Vessel Preparation

Technologies that Benefit

• Drug coated balloon

• Woven nitinol stent

• Bioabsorbable vasc scaffold

• Stent-graft

• Self expanding nitinol stent

Tools for Vessel Preparation

• PTA

• Modified angioplasty balloons

• Atherectomy

• Lithoplasty

Sustained lumen gain that permits definitive treatment.

Finished result must be without surface irregularities.

Vessel Prep=Drug Uptake

• Calcium limits drug uptake

• 5-20% of Paclitaxel taken up by artery wall.

• Uneven distribution of drug

• More drug into the artery wall is key, but must be done in a uniform manner, both longitudinally and circumferentially

• Better delivery=lower dose on the balloon?

Presentation Charing Cross Meeting 2016

“Drug needs to enter the medial layer within the first 3 days”,

R. Virmani, MD

IN.PACT DCB vs PTA Trial Design

1. With symptoms of claudication and/or rest pain and angiographic evidence of SFA/PPA stenosis

2. Pre-dilatation mandatory for all subjects in IN.PACT SFA II phase only

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12 Month

Follow-up

PTA Pre-Dilatation

With 1mm undersized Uncoated Balloon

Randomize 2:1

Test Arm:

Dilatation with Drug Coated Balloon

Control Arm:

Dilatation with Uncoated Balloon

Suboptimal PTA:

Major flow limiting dissection

OR >70% residual stenosis

Treat per standard practice

30 day follow-up for safety

Study Designed to Reduce Bias Against Control Group

CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use

12 Month

Follow-up

Successful

Pre-Dilation

Anterior tibial artery

dissection after long

segment recanalization

Above knee popliteal artery

dissection at re-entry site

SFA dissections

Post-PTA Dissection

Balloon angioplasty causes too much acute injury

Why do we think that balloon angioplasty

will be the best way to prepare the lesion,

deliver the medication and treat the lesion,

all at the same time?

Scheinert Levant II Subgroup Analysis LINC Jan 2016

Overexpansion Results in Improved 1-year Patency

Clinical Limitations & Unmet Needs

Calcium as a Barrier Longer Lesion Length

Calcium Limits Vessel Expansion1

Calcium May Limit Drug Effect2

Increased lesion length is an

independent predictor of decreased

patency5.

1Freed MS, Manual of Interventional Cardiology, 2Fanelli DEBELLUM, 3Laird, CCI, June

2010, 4SMART Control IFU, 5Matusumura, DURABILITY IIJVS, July 2013, 6Davaine,

European Journal of Vascular and Endovascular Surgery 44 (2012)

Courtesy: L Garcia

Provisional Stenting in Randomized Controlled Trials may not be representative of actual stenting in studies due to study design

FEMPAC1

PACIFIER2

THUNDER3

IT Registry4

IN.PACT SFA5

Bad Krozingen6

Leipzig Registry7

Illumenate FIH8

In.PACT Global Reg9

In.PACT Global LL10

(15-25 mm)

In.PACT Global LL10

(>25 mm)

1Werk M et al. Circulation 2008; 2Werk et al. Circ Cardiovasc Interv 2012; 3Tepe G et al. N Engl J Med 2008; 4icari A Et al. J Am Coll Cardiol Intv

2012; 5Tepe et al. Circulation 2015; 6Zeller T et al. J Endovasc Therapy 2014; 7Schmidt A. LINC 2013; 8Schroeder H et al. Catheter Cardiovasc

Interv 2015; 9Laird J. Endovacsular Today Feb 2015. 10Ansel G. TCT 2015.

Challenges with DCB and Long LesionsNeed for Dissection Repair

Full wall to wall

balloon inflation:

no waist

Inadequate

stent

expansion

due to

calcium-

mediated

recoil

Final Result

Limite

d flow

throug

h stent

Supera Stent

6.5mm

Compliments M Razavi

Stent DeploymentPre-dilatation

SFA

Chronic Total Occlusion

220mm lesion length

POBA 6mm X 120mm

balloon

Vessel Prep Prior to Stent Placement

Superb TrialDeployment Technique and 12-Month Patency

90.583.3 81.8

73.7 74.4

57.7

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Nominal MinimalCompression

ModerateCompression

MinimalElongation

ModerateElongation

SevereElongation

(±10%) (11-20%) (21-40%) (11-20%) (21-40%) (>40%)

L Garcia VIVA 2016

Jetstream™ Atherectomy

System(Boston Scientific)

Peripheral Rotablator™ Rotational

AtherectomySystem(Boston

Scientific)

Diamondback 360™, Stealth

360™ Atherectomy

System(Cardiovascular

Systems, Inc)

SilverHawk™, TurboHawk™

Plaque Excision System

(Covidien)

Turbo-Elite™ Laser

AtherectomyCatheter

(Spectranetics)

Front-Cutting N/A

Differential Cutting N/A

Active Aspiration

Concentric Lumens

Lesion Morphology:

Calcium

Soft/Fibrotic Plaque

Thrombus (indicated for thrombectomy and

atherectomy)

Atherectomy Devices

Sources: Endovascular Today Buyer’s Guide 2014. JETSTREAM System Brochure, Boston Scientific Website, 2014. Peripheral Rotablator product website, Boston Scientific, 2014.

Diamondback 360 product website, CSI, 2014. Covidien website, Directional Atherectomy products, 2014. Turbo-Elite Laser Atherectomy Catheter Instructions for Use, May 2014.

Courtesy: L Garcia

DEFINITIVE AR at 12 Months Angiographic Patency

82.4

90.9

58.3

71.8 68.8

42.9

0102030405060708090

100

All Patients Lesions > 10 cm All Severe Ca++

DAART

DCB

N = 34 N = 39 N = 22 N = 16 N = 24 N = 7

Results for all patients who returned for

angiographic follow-upUp next: REALITY Trial

Lithoplasty

• Shockwave technology (Shockwave Medical)

• 35 patients Europe 30 day safety

• 87% achieved <50% stenosis with lithotripsy alone

• Average stenosis 23% post ShockWave

• Familiar Balloon-based endovascular technique

• “Front-line” balloon strategy (.014”compatible)

• Disrupts both deep & superficial calcium pre dilation

• Normalizes vessel wall compliance

• Ultra-low pressure

• Minimized effect on healthy tissue

Serration Technology

Micro-Serration Scoring Technology: simple easy to use angioplasty balloon designed to provide controlled, predictable results in lumen gain.

“From an aspect of safety the device shows evidence of early intimal healing.”

Michael Joner, MD/CVPath Institute

Acute Animal Study: SEM Chronic Animal Study

* Scanning Electron Microscopy

Documented Linear Interrupted Scoring

Pre-Clinical: SEM Porcine Model*

Disclosure: Co-Founder

How do you know vessel is adequately prepared?

?

Vessel Prep Is the KeyConclusion

• Evidence of need for and results of vessel prep are all indirect at present.

• Vessel prep will likely be the key to optimizing the use of drug coated balloons

– Deliver more medication

– Avoid stenting

Vessel prep is the key…to extending the role of DCBs to more challenging lesions and to optimize the

outcome of stenting

Peter A. Schneider, MD

Kaiser Foundation Hospital

Honolulu, Hawaii