definitive ar - acute outcomes -
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DEFINITIVE AR - Acute Outcomes -. D irectional Ath E rectomy F ollowed by a Pacl I taxel -Coated Balloo N to I nhibi T Restenos I s and maintain V essel Pat E ncy : A Pilot Study of A nti- R estenosis Treatment. Prof. Thomas Zeller, M.D. - PowerPoint PPT PresentationTRANSCRIPT
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%
*No significant differences between groupsSC1206092013A
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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