1. DEFINITIVE AR - Acute Outcomes -
Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment
Prof. Thomas Zeller, M.D.
Universitaets-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, Germany

2. Contributors
Co-Sponsors: Covidien and Bayer HealthCare (formerly MEDRAD)
Principal Investigators: Prof. Thomas Zeller, MD & Prof. Gunnar Tepe, MD
Angiographic Core Lab: SynvaCor, Springfield, IL
Vascular 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
SC A

3. Study Design DAART* DCB
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
General and Angiographic Criteria Assessment
Lesion severely calcified?
Guidewire passage, enrollment & Randomization
DAART*
(N = 48)
DCB
(N = 54)
Guidewire Passage & Enrollment
(N=19) No
Yes
Yes
Severe Calcification: Dense circumferential calcification and calcification extending more than five (5) continuous centimeters of length prior to contrast injection or digital subtraction angiography
There was 6 month lag in ca++ arm due to prolonged enrollment period. Acute results from the ca++ arm will be presented soon.
The sample size difference between groups is attributed to the blocked randomized trial design.
Registry arm for severely calcified lesions created to limit bail-out stenting (and therefore variables) in randomized arm.
* Directional Atherectomy + Anti-Restenotic Therapy
SC A

4. Devices Bayer HealthCare’s Covidien’s Peripheral
SilverHawk ™ & TurboHawk™ peripheral plaque excision systems
Bayer HealthCare’s
Peripheral
Paclitaxel-coated
angioplasty catheter with Paccocath® Technology
SC A

5. Study Design Study Design and Oversight Primary Endpoint
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
SC A

6. Study Design Key Inclusion Criteria Key Exclusion 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
SC A

7. Baseline Demographics
DAART
(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 Factors
Angina
4.2%
9.3%
0.4425
Diabetes
27.1%
35.2%
0.4014
Hypertension
87.5%
81.5%
0.4300
Hyperlipidemia
70.8%
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
24.0% 3
74.1% 4
2.1%
1.9%
*No significant differences between groups
SC A

8. Baseline Lesion Characteristics Per 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
0.4794
Minimum lumen diameter (mm)
1.0
0.8
0.3372
Calcification
70.8%
74.1%
0.4758
*No significant differences between groups
SC A

9. 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
SC A

10. Minimum Lumen Diameters
DAART resulted in a significantly larger minimum lumen diameter (MLD) following the protocol-defined treatment (4.27 mm vs mm, P = 0.045)
P = 0.045
MLD = 4.27 mm
MLD = 3.78 mm
Min. Lumen Diameter (mm)
This slide shows the mean MLD at baseline and following each step of the protocol-defined procedure.
DAART Arm: 8 lesions were pre-dialated
DCB arm: 40 lesions were pre-dialated
SC A

11. 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
3.7% (2/54)
0.4968
The bail out stenting rate in this trial is considerably lower than the DCB studies published to date
Significantly higher rate of PTA following treatment with DCB in DCB arm
SC A

12. Residual Stenosis
Residual diameter stenosis was significantly lower in the DAART arm
P =
P =
SC A

13. Periprocedural Complications (Per CEC)
DAART
(N= 48)
DCB
(N = 54)
p-value
Distal Embolization
6% (3/48)
0/54
0.101
No Intervention 1
Surgical Intervention
Endovascular Intervention 2
Dissection (flow-limiting, Grade C/D)
2% (1/48)
19% (10/54)
0.009 6 4
Perforation
4% (2/48)
0.219
SC A

14. Functional Outcomes
Significant improvement in ABI & WIQ scores at 30 days in both cohorts
Mean ABI at Baseline and 30 Days
Percent of patients with Improvement in WIQ Scores at 30 days
P <
P <
No significant differences between groups
No significant differences between groups at baseline or at 30- days
Baseline 30 days
Baseline 30 days
SC A

15. 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
SC A