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DEFINITIVE AR - Acute Outcomes - Prof. Thomas Zeller, M.D. Universitaets-Herzzentrum Freiburg - Bad Krozingen Bad Krozingen, Germany Directional AthErectomy.

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Presentation on theme: "DEFINITIVE AR - Acute Outcomes - Prof. Thomas Zeller, M.D. Universitaets-Herzzentrum Freiburg - Bad Krozingen Bad Krozingen, Germany Directional AthErectomy."— Presentation transcript:

1 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

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 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 SC A

4 Devices Covidien’s 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 –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 –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 ± ± Male 64.6%68.5% History and Risk Factors Angina 4.2%9.3% Diabetes 27.1%35.2% Hypertension 87.5%81.5% Hyperlipidemia 70.8%68.5% Renal Insufficiency 12.5%14.8% Current/Previous Smoker50.0%63.0% Rutherford Clinical Category %24.0% %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) Diameter Stenosis 82%85% Reference vessel diameter (mm) Minimum lumen diameter (mm) Calcification 70.8%74.1% *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. DAARTDCBP 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) Min. Lumen Diameter (mm) MLD = 4.27 mm MLD = 3.78 mm P = 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) Bail-out Stent 03.7% (2/54) SC A

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

13 Periprocedural Complications (Per CEC) DAART (N= 48) DCB (N = 54) p-value Distal Embolization 6% (3/48)0/ No Intervention 10 Surgical Intervention 00 Endovascular Intervention 20 Dissection (flow-limiting, Grade C/D) 2% (1/48)19% (10/54)0.009 No Intervention 16 Surgical Intervention 00 Endovascular Intervention 04 Perforation 4% (2/48)0/ No Intervention 00 Surgical Intervention 00 Endovascular Intervention 20 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 Baseline 30 days P < No significant differences between groups 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


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