Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 1 Abbott.

Slides:



Advertisements
Similar presentations
“Real World”: SVG, De Novo or Restenotic Coronary Artery Lesions Chronic Stable Angina, Silent Ischemia, Acute Coronary Syndromes Vessel Diameters:
Advertisements

Bioresorbeerbare “stents”
Www. Clinical trial results.org The RAVEL Study A RAndomised (double blind) study with the Sirolimus coated BX™ VElocity balloon expandable stent (CYPHER™)
Bioabsorbable stents: early clinical results Dr Angela Hoye MB ChB, PhD Senior Lecturer in Cardiology Hull & East Yorkshire Hospitals.
3rd CEEGI Advisory Board1 Resolute in the DES era: Indications & Limitations Georgios I. Papaioannou, MD, MPH, FACC, FSCAI Athens Medical Center Cardiac.
2 Year Clinical Outcomes from the Pivotal RESOLUTE US Study Laura Mauri MD, MSc on behalf of the RESOLUTE US Investigators Brigham and Women’s Hospital.
Le stent biobasorbable Bernard Chevalier ICPS Massy / GCS Creil.
University Hospital La Paz
Dr. V.K.AJIT KUMAR PROFESSOR, DEPT. of CARDIOLOGY, SCTIMST, TRIVANDRUM STENT CHOICE IN AMI.
DIABETES trial P Jiménez-Quevedo, M Sabaté, DJ Angiolillo, JA Gómez-Hospital, R Hernández-Antolín, J Goicolea, F Alfonso, C Bañuelos, J Escaned, R Moreno,
Clinical Result Overview
Chaim Lotan MD, Yaron Almagor MD, Karel Kuiper MD, M.J. Suttorp MD, William Wijns MD The SICTO Study CYPHER TM Sirolimus-eluting stent in Chronic Total.
As presented by Patrick W. Serruys, MD, PhD, FACC Principal Investigator Thoraxcentre - Erasmus University Rotterdam, The Netherlands PISCES Paclitaxel.
BIOSENSORS-CLINICAL UPDATE “LEADERS AND BEYOND” John E Shulze, CTO BIOSENSORS INTERNATIONAL GROUP Jan 29, 2010.
Trial Vignettes Contemporary trials 3: DES
HORIZONS AMI Trial H armonizing O utcomes with R evascular IZ ati ON and S tents In A cute M ycoardial I nfarction H armonizing O utcomes with R evascular.
The REALITY Study Results. REALITY Study Design The REALITY Study : Prospective randomized clinical trial to evaluate the safety and efficacy of CYPHER®
Giuseppe Biondi Zoccai, MD, FSICI-GISE University of Turin, Turin, Italy.
NOBORI New Generation Drug Eluting Stent Clinical Data Danny Detiege Clinical Manager - Cardiology Terumo Europe N.V. Leuven, Belgium.
1 of Presented by Gregg W. Stone, MD, ACC PROMUS Stent is a private-labeled Xience V Everolimus Eluting Coronary Stent System manufactured.
A Randomized Comparison of Everolimus-­ Eluting Absorb Bioresorbable Vascular Scaffolds vs. Everolimus-Eluting Metallic Stents: One-Year Angiographic and.
Upendra Kaul, MD for the TUXEDO INDIA Investigators Paclitaxel Eluting Versus Everolimus Eluting Stents in Patients with Diabetes Mellitus and Coronary.
Slow-rate release polymer-based paclitaxel- eluting stent compared with bare stent in patients with single complex coronary lesions TAXUS V Presented at.
Treatment of bifurcation lesions is a complex problem Different techniques are commonly used (Y-/T-stenting, „culotte“ technique, „kissing stent“ technique…)
The Endeavor Zotarolimus-Eluting Stent: Device Description and Comprehensive Update of the Clinical Trial Program.
Clinical Experience with the Bio Active Stent (BAS) in FINLAND 9 e CFCI Hotel Meridien Etoile Paris, France 10 Octobre 2007 Pasi Karjalainen, MD, PhD.
Www. Clinical trial results.org Cypher sirolimus-eluting stent Primary Endpoint:  In-stent and late lumen loss at 9 months (determined by QCA) Secondary.
Effect of Intravascular Ultrasound- Guided vs. Angiography-Guided Everolimus-Eluting Stent Implantation: the IVUS-XPL Randomized Clinical Trial Myeong-Ki.
For OMA distribution only. © 2014 Medtronic, Inc. All rights reserved DOC_1A 03/14 Four-Year Outcomes Following Resolute Zotarolimus-Eluting Stent.
Disclosure Statement of Financial Interest
Columbia University Medical Center Cardiovascular Research Foundation New York City, NY Akiko Maehara, MD Use of IVUS Reduces Stent Thrombosis and Myocardial.
RAVEL 4 YEAR FOLLOW-UP - Cordis Cardiology / Cardialysis – Euro-PCR – Sousa – 24 May 2005 RAVEL A RAndomised, double-blind study with the Sirolimus-eluting.
©2012 Abbott. All rights reserved. AP Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized.
Everolimus-eluting Bioresorbable Vascular Scaffolds in Patients with Coronary Artery Disease: ABSORB III Trial 2-Year Results Stephen G. Ellis, MD,
My initial ABSORB experience Assoc. Prof. I. Petrov
Latvian Centre of Cardiology real-life registry
New Generation Resolute Integrity Drug-Eluting Stent Superior to Benchmark Xience Drug-Eluting Stent: Primary Endpoint Results from the PROPEL Study –
The Abbott Vascular DES Pipeline
on behalf of the ABSORB II Investigators
Novel Stent Technologies: Update on Bioresorbable Stents
Bioabsorbable Stent: Unsolved Issues and Challenges
For the HORIZONS-AMI Investigators
Harmonized Assessment by Randomized Multicenter Study of OrbusNEich’s COMBO StEnt Japan-USA HARMONEE: Primary Report of A Randomized Trial of a Bioabsorbable.
ABSORB Japan: 3-year Clinical and Angiographic Results of a Randomized trial Evaluating the Absorb Bioresorbable Vascular Scaffold vs. Metallic Drug-eluting.
Clinical outcomes after implantation of Absorb BVS in small vessels
Bioresorbable scaffold: the advent of a new era in percutaneous coronary revascularisation Clinical Data Update Ron Waksman, MD, FACC Director, Cardiovascular.
On behalf of all principal COMPARE II investigators:
DES Should be Used as the Default Stent in ACS!
on behalf of the ABSORB II Investigators
on behalf of the ABSORB II Investigators
Early strut coverage in patients receiving new-generation drug-eluting stents and its implications for dual antiplatelet therapy: a randomized clinical.
Two-Year Extended Follow-up in Patients Receiving a Zotarolimus-eluting Stent in the E-Five Registry Martin T. Rothman, Ian T. Meredith, Keyur Parikh,
TAXUS II and IV: two-year follow-up
Long-term follow-up of the DIABETES I (DIABETes and sirolimus Eluting Stent) trial: P Jiménez-Quevedo, M Sabaté, DJ Angiolillo, JA Gómez-Hospital, R Hernández-Antolín,
3-Year Clinical Outcomes From the RESOLUTE US Study
ENDEAVOR IV: 5 Year Final Outcomes
For the HORIZONS-AMI Investigators
For the HORIZONS-AMI Investigators
On behalf of all principal COMPARE II investigators:
FOR DISTRIBUTION BY MEDTRONIC OFFICE OF MEDICAL AFFAIRS ONLY.
12-month clinical and 13-month angiographic outcomes from a randomized trial evaluating the Absorb Bioresorbable Vascular Scaffold vs. metallic drug-eluting.
Gregg W. Stone, MD Columbia University Medical Center
ENDEAVOR III Multicenter Randomized Trial Clinical/MACE Angio/IVUS
Updated 3-Year Meta-Analysis of the TAXUS Clinical Trials Safety and Efficacy Demonstrated in 3,445 Randomized Patients Time allocation for this talk.
Martin B. Leon, David R. Holmes, Dean J. Kereiakes, Jeffrey J
Long Term Clinical Results from the Endeavor Program: 5-Year Follow up
Maintenance of Long-Term Clinical Benefit with
Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents: First Report of the Five-Year Clinical Outcomes from.
MACE: Death, MI or TLR at 5 years
TYPHOON Trial Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON) Trial Presented at.
Presentation transcript:

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 1 Abbott Vascular's Bioresorbable Scaffold Programme, a new paradigm in PCI Richard J. Rapoza, PhD Divisional Vice President of R&D

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 2 MY CONFLICTS OF INTEREST ARE: Full time employee of Abbott Vascular

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 3 The Evolution of PCI Treatment Options BenefitsDetrimentsTLR PTCA 1970s Minimally invasive alternative to CABG Excellent long-term durability of results for patients who did well through ~6 months Acute/sub-acute closure High restenosis rates due to negative vessel remodeling 30 – 50% BMS 1980s Eliminated abrupt and sub-acute closure Reduced restenosis rates compared to PTCA Neointimal hyperplasia resulting in in-stent restenosis 15 – 30% DES 2000s Significantly reduced neointimal hyperplasia Reduced restenosis rates compared to BMS Late and very late stent thrombosis Dependence on long-term DAPT 5 – 10% Each of these new technologies addressed the shortcomings of the previous technology, but with their introduction arrived new, significant concerns

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 4 A New Therapy?: Vascular Restoration Therapy Medical Therapy PCI CABG PTCAStenting VRT Devices Used: BDC BMS DES BVS

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 5 Vascular Restoration Therapy (VRT) Restoration ResorptionRevascularization Restore vasomotor function Restore natural vessel structure Restore flow BMS & DES only accomplish this Only possible in the absence of a permanent implant Vessel is restored to a more natural state, capable of natural vascular function

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A Mos Support Mass Loss Tie chains                                 Molecular Weight 1218 Polylactide Degradation vs Lumen Support Data on file at Abbott Vascular.

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 7 Model derived from Prabhu S and Hossainy S, J. Biomed. Mater. Res., Pt. A 2007; 80: 732. Tests were performed by and data are on file at Abbott Vascular. BVS Resorption in Healthy Porcine Model month 1 6 months 2 1 year 3 18 months 10X Magnification 4 2 years 5

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 8 Photos taken by and on file at Abbott Vascular. 2 years3 years 4 years Tests performed by and data on file at Abbott Vascular. 1.5 years % Mass Remaining Long Term Biological Response

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 9 ■ BVS Cohort A (n = 26) ■ BVS Cohort B1 (n = 42 ITT) ▲ EES (n = 22)*  BMS (n = 27)* ABSORB Cohort B 6-Month QCA Cumulative Incidence Curve for Late Loss Adapted from Serruys, PW. PCR 2010 BMS LL = 0.85 ± 0.36 mm BVS Cohort A LL = 0.44 ± 0.35mm BVS Cohort B1 LL = 0.19 ± 0.18 mm EES LL = 0.10 ± 0.23 mm * SPIRIT-FIRST ABSORB is a trademark of the Abbott Group of Companies

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 10 ABSORB Cohort A Clinical Results – Intent to treat Hierarchical 6 Months (n = 30) 12 Months (n = 29)* 24 Months (n = 29)* 36 Months (n = 29)* 48 Months (n = 29)* Ischemia Driven MACE 1 (3.3%)**1 (3.4%)** Cardiac Death0 (0.0%) MI1 (3.3%)**1 (3.4%)** Q-Wave MI 0 (0.0%) Non Q-Wave MI 1 (3.3%)**1 (3.4%)** Ischemia Driven TLR0 (0.0%) by PCI 0 (0.0%) by CABG 0 (0.0%) No new MACE between 6 and 48 months * One patient withdrew consent and missed the 9, 12, 18 month and 2, 3 and 4 year visits **This patient also underwent a TLR, not qualified as ID-TLR (DS = 42%) followed by post-procedural troponin qualified as NQMI and died from Hodgkin’s disease at 888 days post-procedure Serruys, PW., AHA No thrombosis up to 4 years (all patients off clopidogrel) ABSORB is a trademark of the Abbott Group of Companies

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 11 ABSORB Cohort B Clinical Results - Intent to treat, Group 1 No thrombosis by ARC or Protocol Non-Hierarchical Cardiac Death (%) Myocardial Infarction n (%) Q-wave MI Non Q-wave MI Ischemia Driven TLR n (%) PCI CABG Hierarchical MACE n (%) Hierarchical TLF n (%) 30 Days 6 Months N = (2.2) (4.4) 1 (2.2) 2 (4.4) MACE: cardiac death, MI, ischemia-driven TLR TLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR 9 Months N = (2.2) (4.4) Serruys, PW., TCT 2010 Ormiston, J., TCT 2010 ABSORB is a trademark of the Abbott Group of Companies

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 12 ABSORB Cohort B Clinical Results - Intent to treat, Group 1&2 No thrombosis by ARC or Protocol Non-Hierarchical Cardiac Death (%) Myocardial Infarction n (%) Q-wave MI Non Q-wave MI Ischemia Driven TLR n (%) PCI CABG Hierarchical MACE n (%) Hierarchical TLF n (%) 30 Days 6 Months N = (2.0) 3 (3.0) (2.0) 3 (3.0) 2 (2.0) (5.0) 2 (2.0) 5 (5.0) MACE: cardiac death, MI, ischemia-driven TLR TLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR Serruys, PW., AHA Months N = (3.0) 0 2 (2.0) 0 5 (5.0) ABSORB is a trademark of the Abbott Group of Companies

Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 13 Baseline6 mo follow up Baseline MLA: 7.39 mm 2 Follow up MLA: 8.18 mm 2 Coverage: 60 μm ABSORB Cohort B: OCT example ABSORB is a trademark of the Abbott Group of Companies Serruys, PW. PCR 2010 Serruys, PW. CCT 2010