Directional Atherectomy & Anti-restenotic Therapy (DAART): Hong Kong Experience & Update

Associate Professor Bryan Yan

Interventional Cardiologist

Prince of Wales Hospital

The Chinese University of Hong Kong

Disclosure

Speaker name:

..............................Bryan Yan...................................................

I have the following potential conflicts of interest to report:

Consulting: Medtronic, Boston Scientific, Cook Medical, OrbusNeich

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

x

Background

• Drug-coated balloons (DCB) have significantly changed the management of femoropopliteal disease

• Randomized controlled trials have demonstrated superior patency rates of DCB over PTA at 2- and 3-years1-3

• Beyond RCTs, real world registries with DCB use in more complex disease is associated with increased bail-out stenting (40% to 47%)1,4,5

1. “Lutonix 24-month Outcomes LEVANT 2 & Global Real World SFA

Registry” presented by Laurich C, SVS Chicago, 2015.

2. “Drug-coated Balloons Show Superior Three-Year Outcomes versus

Angioplasty: Results from the IN.PACT SFA Randomized Trial”

presented by Krishnan P, VIVA Las Vegas, 2016.

3. “ILLUMENATE European Randomized Trial: 2-Year Results”

presented by Brodmann M, VIVA Las Vegas, 2017.

4. “Drug Coated Balloon Treatment for Patients with Intermittend

Claudication: New Insights from the IN.PACT Global Study

Long Lesion (≥15cm) Imaging Cohort” presented by Scheinert

D, EuroPCR Paris, 2015

5. “IN.PACT Admiral Drug-Coated Balloon for Treatment of

Chronic Total Occlusions in the SFA” presented by Tepe G, CX

London 2016.

Known Limitations of DCB

• Calcium distribution & severity may affect late lumen loss (LLL) & primary patency

• Calcium may represent a barrier to optimal drug absorption

1. Fanelli F, et al. Cardiovasc Interv Radiol 37:898-907 (2014).

Is there a need for vessel prep?What does it mean?

• DCB as a ‘stand alone, leave nothing behind’ technology in ‘real world’ patients is questionable

• Vessel prep is improving the local environment prior to leaving something behind (DCB or stent)

• Debulking can increase luminal gain prior to DCB use?1,2

• Plaque modification can enhance drug uptake?3,4

• Plaque modification can reduce flow-limiting dissections?5

1. Zeller T, et al. Circ Cardiovasc Interv 2017;10:e004848.

2. Zeller T, et al. J Endovasc Ther 2004;11:676-85.

3. Tellez A, et al. EuroInterv 2014;10:1002-8.

4. Foley TR, et al. Cath Cardiovasc Interv 2017;89:10078-85.

5. Cioppa A, et al. Cardiovasc Revasc Med 2012;13:219-23.

Tools for Vessel Preparation

Balloons• Plain Old Balloon Angioplasty

• Cutting Balloons

• Scoring Balloons

• Controlled-inflation Balloon

Atherectomy Devices• Directional

• Orbital

• Rotational

• Photoablative

Directional atherectomy + DCB (DAART) combination therapy can overcome main limitations of stand-alone SFA therapies

• DA mechanically recanalize the vessel without overstretch

• DA remove perfusion barrier for better & more homogenous drug uptake

• DA reduce likelihood of bailout stenting & preserve native vessel

Existing DAART DataFew single-center studies & one randomized feasibility study

1. Presented by Zeller T, VIVA, Las Vegas, US (2014).

2. Cioppa A, et al. Cardiovasc Revasc Med 13:219-23 (2012).

3. Stavroulakis K, et al. J Endovasc Ther 22:847-52 (2015).

4. Stavroulakis K, et al. J Endovasc Ther; doi: 10.1177/1526602817748319 (2017).

5. Zeller, et al., defined dissection as ≥ Grade C while Cioppa, et al., defined dissection via chroma-flow involving more

than 60% of cross-sectional diameter with blood flow in the false lumen.

Study(* Core Lab) Type Patients Lesions Dissection5 BO Stent

30-day MAE 1-year >1-year

*DEFINITIVEAR1

DCB†

DAART†

DAART-Ca

544819

544819

19% (10/54)2% (1/48)

0%

3.7% (2/54)

0%5.3%

(1/19)

NR89.6%93.4%

---?

Cioppa2 DAART 30 306.7%

(2/30)6.7%

(2/30)

13% (4/30)

(1-year)90% ?

Stavroulakis3

(Popliteal)DAART 21 26 NR NR

14%(3/21)

95%90%

(18-mo)

Stavroulakis4

(CFA)DCBDAART

2621

2621

31% (8/26)5% (1/21)

4% (1/26)5% (1/21)

NR68%88%

?

Patency

DEFINITIVE AR1

• 121 subjects (10 sites)

• RCC 2-4; lesion lengths 7-15cm [excluding ISR, aneurysmal target sites and multi-lesion limbs]

• Independent CEC, angiographic & DUS core labs

• Pilot study designed to assess effect of DAART v DCB

1. “DEFINITIVE AR: A Pilot Study of Antirestenosis Treatment. 12-month Results: Directional Atherectomy Followed

by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency” presented by Zeller T, VIVA Las

Vegas 2014.

Prospective, multicenter, randomized (DAART v DCB); plus

non-randomized DAART arm for severely calcified lesions

DEFINITIVE AR1

1. “DEFINITIVE AR: A Pilot Study of Antirestenosis Treatment. 12-month Results: Directional Atherectomy Followed

by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency” presented by Zeller T, VIVA Las

Vegas 2014.

DEFINITIVE AR – 1 year1

1. “DEFINITIVE AR: A Pilot Study of Antirestenosis Treatment. 12-month Results: Directional Atherectomy Followed

by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency” presented by Zeller T, VIVA Las

Vegas 2014.

• Patency rates generally favorable

• Lower residual stenosis trended

toward higher patency rates

DEFINITIVE AR: 2-year Extension1

1. Presented by Tepe G at LINC, Leipzig, Germany 2017.

2. MAE (Major Adverse Event) defined as major unplanned amputation of the treated limb, all-cause mortality or

clinically-driven target lesion revascularization.

3. Clinically-driven TLR (target lesion revascularization) defined as any reintervention or artery bypass graft surgery

involving the target lesion in which the subject has a ≥ 70% diameter stenosis (Peak Systolic Velocity Ratio (PSVR) >

3.5 may substitute if a pre-intervention angiogram is not available) and at least two of the following: worsening RCC,

worsening WIQ score, or an ABI drop > 0.15 from baseline.

Freedom from MAE2 Freedom from Clinically-Driven TLR3

Fre

ed

om

Fro

m M

AE

DEFINITIVE AR: 2-year Extension

1. Presented by Tepe G at LINC, Leipzig, Germany 2017.

Trend towards lower TLR with ≤30% residual stenosis after DA1

– Multicenter, single-arm study– Target N ≤ 250

– ≤ 15 sites in US and Germany

– RCC 2-4, FPA lesions

– HawkOne / TurboHawk + IN.PACT Admiral

– Currently enrolling; target completion estimate 2018

– 4 Questions in need of answers– Is the directional atherectomy + DCB paradigm safe in long moderate-

severely calcified lesions?

– How effective is DA in removing calcified atheroma prior to DCB and what can IVUS teach us regarding optimal technique?

– Does a ≤30% %DS post-DA portend a favorable one year clinical outcome? How is this best assessed?

– What is the appropriate metric to assess ideal vessel prep (residual %DS by angio or luminal gain, residual plaque burden by IVUS)?

FU study to DEFINITIVE AR

DAART in Hong Kong

• DA & DCB readily available

– DCB (In.Pac Admiral) 2009

– Directional atherectomy (SilverHawl/TurboHawk) 2010

– Directional atherectomy (HawkOne) 2017

• DCB & atherectomy are not reimbursable items

– Package Deal: DA + DPD + DCB

• Uptake is slow

Case 1: HawkOne

Proximal SFA

Focal

Eccentric

Calcified

DPD + HawkOne

Spider Rx DPD

In.Pac Admiral 6 x 60mm

In.Pact Admiral

6 x 60mm

Case 2: Re-recurrent DES ISR

DA + DCB

9 months Angio FU

Case 3: Diffuse SFA Disease

Post DAART

Nasty!

Summary• DCB use in complex & long lesions is associated with

increasing provisional stent use (calcium is a potential barrier to DCB effectiveness)

• Vessel preparation with atherectomy can enhance DCB effectiveness by establishing lumen gain & potentially increase drug uptake

• Promise of directional atherectomy + DCB for femoropopliteallesions is demonstrated in a few studies (one multi-center core lab-adjudicated pilot study)

• Marriage of atherectomy + DCB may bring together the best of two worlds: effective plaque modification / debulkingpaired with sustained drug presence

Directional Atherectomy & Anti-restenotic Therapy (DAART): Hong Kong Experience & Update

Associate Professor Bryan Yan

Interventional Cardiologist

Prince of Wales Hospital

The Chinese University of Hong Kong