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DEFINITIVE AR - Acute Outcomes -

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.

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DEFINITIVE AR - Acute Outcomes -

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  1. DEFINITIVE AR- Acute Outcomes - Directional AthErectomyFollowed by a PaclItaxel-Coated BallooN to InhibiTRestenosIs 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) KlinikumRosenheim, InstitutfürDiagnostische und InterventionelleRadiologie Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg Vascular Centre Berlin, Ev. Hospital Königin Elisabeth HerzbergegGmbH Heart Center Leipzig St. Franziskus-Hospital Münster Imelda Hospital Bonheiden AngiomedKrakow Universitäts-Spital Zürich, KlinikfürAngiologie MedizinischeUniversitätsklinik III

  3. 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 No Yes Yes Registry arm for severely calcified lesions created to limit bail-out stenting (and therefore variables) in randomized arm. * Directional Atherectomy + Anti-RestenoticTherapy

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

  5. Study Design • Study Design and Oversight • Prospective, randomized (DAART vs. DCB alone) • 121 patients enrolled at 10centers in Europe • CEC, DSMB, and Steering Committee oversight • Angiographic and Duplex Core Laboratory Analyses • Primary Endpoint • Percent Stenosis at 1 Year

  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

  7. Baseline Demographics *No significant differences between groups

  8. Baseline Lesion CharacteristicsPer Core Lab Assessment *No significant differences between groups

  9. Technical Success Defined as ≤ 30% residual stenosis following the protocol-defined treatment at the target lesion as determined by the Angiographic Core Laboratory.

  10. 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) P = 0.045 MLD = 4.27 mm MLD = 3.78 mm Min. Lumen Diameter (mm)

  11. Adjunctive Therapy (Post protocol-defined treatment)

  12. Residual Stenosis Residual diameter stenosis was significantly lower in the DAART arm P = 0.0002 P = 0.0256

  13. Periprocedural Complications(Per CEC)

  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 < 0.0001 P < 0.0001 No significant differences between groups Baseline 30 days Baseline 30 days

  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

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