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
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:
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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
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
DAART*
No
General and
Angiographic
Criteria Assessment
Guidewire passage,
enrollment &
Randomization
Lesion severely
calcified?
(N = 48)
DCB
(N = 54)
Yes
Yes
Guidewire Passage
& Enrollment
DAART*
(N=19)
Registry arm for severely calcified lesions created to limit bail-out
stenting (and therefore variables) in randomized arm.
* Directional Atherectomy + Anti-Restenotic Therapy
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Devices
Covidien’s
SilverHawk ™ & TurboHawk™
peripheral plaque excision
systems
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Bayer HealthCare’s
Peripheral
Paclitaxel-coated
angioplasty catheter with
Paccocath® Technology
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 Demographics
Age
DAART
(N= 48)
70.1 ± 9.7
DCB
(N = 54)
69.0 ± 8.2
Male
64.6%
68.5%
0.6807
Angina
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
P Value*
0.4383
History and Risk Factors
Rutherford Clinical Category
0.9096
2
27.1%
24.0%
3
70.8%
74.1%
4
2.1%
1.9%
*No significant differences between groups
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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
4.9
0.4794
Minimum lumen diameter (mm)
1.0
0.8
0.3372
70.8%
74.1%
0.4758
Calcification
*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.
Technical Success
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DAART
DCB
P Value
89.6%
64.2%
0.004
Minimum Lumen Diameters
DAART 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. Lumen Diameter (mm)
4.5
MLD = 4.27 mm
4
0.92
P = 0.045
MLD = 3.78 mm
3.5
3
1.61
DCB
2.5
2.16
DA
2
Pre-Dilatation
1.5
1.39
1
0.23
0.5
0.96
0.78
DAART Arm
DCB Arm
0
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Baseline
Adjunctive Therapy
(Post protocol-defined treatment)
DAART
(N= 48)
DCB
(N = 54)
P Value
PTA (post-dil)
6.3% (3/48)
33.3% (18/54)
0.0011
Bail-out Stent
0
3.7% (2/54)
0.4968
Adjunctive Therapy
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Residual Stenosis
Residual diameter stenosis was significantly lower in the DAART arm
30
P = 0.0002
28
P = 0.0256
25
22
20
18
17
15
DAART
DCB
10
5
0
Post-Protocol-Defined
Treatment
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Post-Adjunctive
Treatment
Periprocedural Complications
(Per CEC)
DAART
(N= 48)
DCB
(N = 54)
p-value
6% (3/48)
0/54
0.101
No Intervention
1
0
Surgical Intervention
0
0
Endovascular Intervention
2
0
Dissection (flow-limiting, Grade C/D)
2% (1/48)
19% (10/54)
No Intervention
1
6
Surgical Intervention
0
0
Endovascular Intervention
0
4
4% (2/48)
0/54
No Intervention
0
0
Surgical Intervention
0
0
Endovascular Intervention
2
0
Distal Embolization
Perforation
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0.009
0.219
Functional Outcomes
Significant improvement in ABI & WIQ scores at 30 days in both cohorts
Mean ABI at Baseline and 30 Days
P < 0.0001
P < 0.0001
0.94
0.66
Percent of patients with Improvement in
WIQ Scores at 30 days
No significant differences between groups
0.92
92%
88%
77% 76%
0.69
83%
75%
51%
Baseline 30 days
Baseline 30 days
DAART
DCB
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Pain, aching or
cramps in
calves or
buttocks
Walking
Distance
Walking
Speed
48%
Stair
Climbing
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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