DEFINITIVE AR - Acute Outcomes -

DEFINITIVE AR- Acute Outcomes -

Prof. Thomas Zeller, M.D.Universitaets-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany

Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and maintain Vessel

PatEncy: A Pilot Study of Anti-Restenosis Treatment

ContributorsCo-Sponsors: Covidien and Bayer HealthCare (formerly MEDRAD)

Principal Investigators: Prof. Thomas Zeller, MD & Prof. Gunnar Tepe, MDAngiographic Core Lab: SynvaCor, Springfield, ILVascular Ultrasound Core Lab: Vascore, Boston, MA

Sites: • Universitaets-Herzzentrum Freiburg - Bad Krozingen (Bad Krozingen)• Klinikum Rosenheim, Institut für Diagnostische und Interventionelle Radiologie• Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg• Vascular Centre Berlin, Ev. Hospital Königin Elisabeth Herzberge gGmbH • Heart Center Leipzig• St. Franziskus-Hospital Münster• Imelda Hospital Bonheiden• Angiomed Krakow• Universitäts-Spital Zürich, Klinik für Angiologie• Medizinische Universitätsklinik III

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Study Design

General and Angiographic

Criteria Assessment

Lesion severely calcified?

Guidewire passage,

enrollment & Randomization

DAART* (N = 48)

DCB(N = 54)

Guidewire Passage & Enrollment

DAART*(N=19)Yes

Registry arm for severely calcified lesions created to limit bail-out stenting (and therefore variables) in randomized arm.

* Directional Atherectomy + Anti-Restenotic Therapy

Purpose: Pilot study designed to assess and estimate the effect of treating a vessel with directional atherectomy + DCB (DAART) compared to treatment with DCB alone

No

Yes

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Devices

Covidien’sSilverHawk ™ & TurboHawk™

peripheral plaque excision systems

Bayer HealthCare’sPeripheral

Paclitaxel-coated angioplasty catheter with Paccocath® Technology

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Study Design

• Study Design and Oversight– Prospective, randomized (DAART vs. DCB alone)– 121 patients enrolled at 10 centers in Europe– CEC, DSMB, and Steering Committee oversight – Angiographic and Duplex Core Laboratory Analyses

• Primary Endpoint – Percent Stenosis at 1 Year

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Study Design• Key Inclusion Criteria

– RCC 2-4– Target lesion 7-15 cm in length– RVD 4-7 mm– Baseline stenosis ≥ 70%

• Key Exclusion Criteria– In-stent restenosis– Aneurysmal target vessel– 2 or more lesions that require treatment in the target limb

• Follow-up assessments – Pre-discharge, 30 days, 6 months, and 1 year post-procedure

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Baseline DemographicsDAART (N= 48)

DCB (N = 54) P Value*

Age 70.1 ± 9.7 69.0 ± 8.2 0.4383

Male 64.6% 68.5% 0.6807

History and Risk FactorsAngina 4.2% 9.3% 0.4425

Diabetes 27.1% 35.2% 0.4014

Hypertension 87.5% 81.5% 0.4300

Hyperlipidemia 70.8% 68.5% 0.8323

Renal Insufficiency 12.5% 14.8% 0.7807

Current/Previous Smoker 50.0% 63.0% 0.3076

Rutherford Clinical Category 0.9096

2 27.1% 24.0%3 70.8% 74.1%4 2.1% 1.9%

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Baseline Lesion CharacteristicsPer Core Lab Assessment

DAART(N= 48)

DCB (N = 54) P Value*

Lesion Length (cm) 10.6 9.7 0.3034

Diameter Stenosis 82% 85% 0.3468

Reference vessel diameter (mm) 4.9 4.9 0.4794

Minimum lumen diameter (mm) 1.0 0.8 0.3372

Calcification 70.8% 74.1% 0.4758

*No significant differences between groups

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Technical Success Defined as ≤ 30% residual stenosis following the protocol-defined treatment at the target lesion as determined by the Angiographic Core Laboratory.

DAART DCB P Value

Technical Success 89.6% 64.2% 0.004

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DAART Arm DCB Arm0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

0.96 0.78

0.23

1.39

2.16

0.92

1.61

DCBDAPre-DilatationBaseline

Minimum Lumen DiametersDAART resulted in a significantly larger minimum lumen diameter (MLD) following the protocol-defined treatment (4.27 mm vs. 3.78 mm, P = 0.045)

Min

. Lum

en D

iam

eter

(mm

)

MLD = 4.27 mm

MLD = 3.78 mm

P = 0.045

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Adjunctive Therapy (Post protocol-defined treatment)

DAART(N= 48)

DCB (N = 54) P Value

Adjunctive Therapy

PTA (post-dil) 6.3% (3/48) 33.3% (18/54) 0.0011

Bail-out Stent 0 3.7% (2/54) 0.4968

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Post-Protocol-Defined Treatment

Post-AdjunctiveTreatment

0

5

10

15

20

25

30

1817

28

22

DAARTDCB

Residual diameter stenosis was significantly lower in the DAART arm

P = 0.0002

Residual Stenosis

P = 0.0256

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Periprocedural Complications(Per CEC)

DAART(N= 48)

DCB(N = 54)

p-value

Distal Embolization 6% (3/48) 0/54 0.101

No Intervention 1 0Surgical Intervention 0 0Endovascular Intervention 2 0

Dissection (flow-limiting, Grade C/D) 2% (1/48) 19% (10/54) 0.009No Intervention 1 6Surgical Intervention 0 0Endovascular Intervention 0 4

Perforation 4% (2/48) 0/54 0.219

No Intervention 0 0Surgical Intervention 0 0

Endovascular Intervention 2 0

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Functional OutcomesSignificant improvement in ABI & WIQ scores at 30 days in both cohorts

Mean ABI at Baseline and 30 Days

Pain, aching or cramps in

calves or but-tocks

Walking Distance

Walking Speed

Stair Climbing

77%88% 83%

51%

76%

92%

75%

48%

Percent of patients with Improvement in WIQ Scores at 30 days

DAART DCB

0.66 0.69

0.94 0.92

Baseline 30 days Baseline 30 days

P < 0.0001 P < 0.0001 No significant differences between groups

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Conclusions• Acute results of DAART treatment show:

– Significantly higher technical success rate (DAART 89.6% vs. DCB 64.2%, P=0.004)

– Acceptable periprocedural complications– Significantly lower dissection rate (DAART 2% vs. DCB 19%,

P = 0.009)

• Long-term data to determine the durability of DAART vs. DCB are necessary and forthcoming

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