Upload
scarlett-norton
View
214
Download
0
Tags:
Embed Size (px)
Citation preview
Klinikum RosenheimDepartment of Diagnostic and Interventional Radiology
LIN
C 2
01
4
DEFINITIVE AR Severe Ca++ Arm 30-Day Results
Gunnar Tepe, MDOn behalf of Prof. Thomas Zeller and
the DEFINITIVE AR Investigators
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
Study Design
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
Devices
Covidien’sSilverHawk ™ & TurboHawk™
peripheral plaque excision systems
Bayer HealthCare’sPeripheral
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
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
Baseline DemographicsDAART
Severe Ca++ Arm (N=19)
DAART (N= 48)
DCB (N = 54)
Age 69.7 ± 8.9 (19) 70.1 ± 9.7 69.0 ± 8.2
Male 73.7% (14/19) 64.6% 68.5%
History and Risk Factors
Angina 26.3% (5/19) 4.2% 9.3%
Diabetes 26.3% (5/19) 27.1% 35.2%
Hypertension 84.2% (16/19) 87.5% 81.5%
Hyperlipidemia 73.7% (14/19) 70.8% 68.5%
Renal Insufficiency 15.8% (3/19) 12.5% 14.8%
Current/Previous Smoker 36.8% (7/19) 50% 63%
Rutherford Category
2 15.8% (3/19) 27% 24%
3 84.2% (16/19) 70% 74%
4 0.0% (0/19) 2% 2%
Baseline Lesion CharacteristicsPer Core Lab Assessment
DAARTSevere Ca++ Arm
(N=19)
DAART(N= 48)
DCB (N = 54)
Lesion Length (cm) 11.9 10.6 9.7
Diameter Stenosis 88% 82% 85%
Reference vessel diameter (mm)
5.1 4.9 4.9
Minimum lumen diameter (mm)
0.7 1.0 0.8
Baseline Lesion CharacteristicsPer Core Lab Assessment
DAARTSevere Ca++
Arm (N=19)
DAART(N= 48)
DCB (N = 54)
Eccentric lesion 36.8% (7/19) 4.2% (2/48) 5.6% (3/54)
Ulcerated plaque 0.0% (0/19) 0.0% (0/48) 3.7% (2/54)
Calcification 94.7% (18/19) 70.8% (34/48) 74.1% (40/54)
Severe calcification* 89.5% (17/19) 25.0% (12/48) 18.5% (10/54)
TASC
A 31.6% (6/19) 33.3% (16/48) 48.1% (26/54)
B 42.1% (8/19) 56.3% (27/48) 42.6% (23/54)
C 26.3% (5/19) 10.4% (5/48) 9.3% (5/54)
D 0.0% (0/19) 0.0% (0/48) 0.0% (0/54)
*Defined as: dense circumferential calcification extending > 5 cm
Technical Success = 84.2%
•Defined as ≤ 30% residual stenosis following the protocol-defined treatment at the target lesion as determined by the Angiographic Core Laboratory.
DAARTSevere Ca++
DAART DCB P Value(DAART vs. DCB)
Technical Success 84.2% 89.6% 64.2% 0.004
Adjunctive Therapy (Post protocol-defined treatment)
DAARTSevere Ca++ DAART DCB
P Value(DAART vs. DCB)
Adjunctive Therapy
PTA (post-dil) 06.3%
(3/48)33.3% (18/54)
0.0011
Bail-out Stent5.3% (1/19)
0 3.7% (2/54) 0.4968
One bail-out stent placed in the DAART severe ca++ arm
Periprocedural Complications(Per CEC)
Severe Ca++ : DAART
DAART(N= 48)
DCB(N = 54)
P Value(DAART vs.
DCB)
Distal Embolization 5.3% (1/19) 6% (3/48) 0/54 0.101
No Intervention 1 1 0
Surgical Intervention 0 0 0
Endovascular Intervention 0 2 0
Dissection (flow-limiting, Grade C/D) 0% (0/19) 2% (1/48) 19% (10/54) 0.009
No Intervention 0 1 6
Surgical Intervention 0 0 0
Endovascular Intervention 0 0 4
Perforation 0% (0/19) 4% (2/48) 0/54 0.219
No Intervention 0 0 0
Surgical Intervention 0 0 0
Endovascular Intervention 0 2 0
Functional OutcomesSignificant improvement in ABI & WIQ scores at 30 days in all 3 cohorts
Mean ABI at Baseline and 30 Days
Percent of patients with Improvement in WIQ Scores at 30 days
Baseline 30 days Baseline 30 days
Conclusions• Acute results from the Severe Ca++ DAART Arm demonstrated high
technical success rate (84.2%) in complex calcified lesions with 1 bail-out stent placed and a low periprocedural complication rate
• Randomized Arm 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