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For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved. 10129897DOC_1A.

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Presentation on theme: "For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved. 10129897DOC_1A."— Presentation transcript:

1 For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved DOC_1A 03/2014 Bioabsorbable Stents (BAS) & Drug-Eluting Stents (DES) Angina Status & TLF Creep

2 For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved DOC_1A 03/2014 Hypothesis: Can BVS Implantation Reduce Angina? Are ABSORB angina rates lower than 2 nd generation DES? Stone TCT 2013

3 For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved DOC_1A 03/2014 Variation of Angina Rates from Recent 2 nd Gen DES Trials There is a wide variation in angina status from 10.5% to 28% at 1 YearThere is a wide variation in angina status from 10.5% to 28% at 1 Year On-label patient data from the RESOLUTE Trials were analyzed based on reported angina status between follow up intervals. Xience and ABSORB data presented at TCT Event rates are expressed as KM estimates. Change in Angina Status may not be product specific Variation in Angina Status 10.5% 18.0% % 28.1% 2 Yeung AC, et al. JACC. 2011;57: Serruys PW, et al. N Engl J Med. 2010;363:

4 For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved DOC_1A 03/2014 Does an increase in TLF over time always occur in 2 nd Gen DES? Is TLF Creep a real phenomenon with all DES studies? Stone TCT 2013

5 For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved DOC_1A 03/2014 Careful vessel preparation can influence TLF The RESOLUTE Japan Trial was conducted using careful lesion preparation and extensive imaging.The RESOLUTE Japan Trial was conducted using careful lesion preparation and extensive imaging. Months Number at risk Target Lesion Failure (%) 4.0% The 3-year TLF rate from RESOLUTE Japan was 4.0%The 3-year TLF rate from RESOLUTE Japan was 4.0% No TLF creep was seen in the RESOLUTE Japan trialNo TLF creep was seen in the RESOLUTE Japan trial RESOLUTE Japan Lesion Prep/Imaging IVUS Use (%)99 Pre-Dilation Pressure Range (min, max) 6.00, Post-Dilatation (%)78 RESOLUTE Japan TLF to 3 Yrs

6 For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved DOC_1A 03/2014 Insights on angina status and TLF creep from recent 2 nd generation DES trials Angina status may not be product specific as varying low angina rates have been shown by recent 2 nd generation DES trials.Angina status may not be product specific as varying low angina rates have been shown by recent 2 nd generation DES trials. TLF creep can be influenced and reduced in 2 nd generation DES trials with enhanced vessel/lesion prep and use of imaging as seen with the RESOLUTE Japan clinical trial.TLF creep can be influenced and reduced in 2 nd generation DES trials with enhanced vessel/lesion prep and use of imaging as seen with the RESOLUTE Japan clinical trial.


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