Angina Status TLF Creep Bioabsorbable Stents BAS DrugEluting
Angina Status & TLF Creep Bioabsorbable Stents (BAS) & Drug-Eluting Stents (DES) For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved. 10129897 DOC_1 A 03/2014
Hypothesis: Can BVS Implantation Reduce Angina? Are ABSORB angina rates lower than 2 nd generation DES? Stone TCT 2013 For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved. 10129897 DOC_1 A 03/2014
Variation of Angina Rates from Recent 2 nd Gen DES Trials Variation in Angina Status 28. 1% Change in Angina Status may not be product specific % 18. 0% 10. 5% 1 2 • There 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 2013. Event rates are expressed as KM estimates. 1 Serruys PW, et al. N Engl J Med. 2010; 363: 136 -46 2 Yeung AC, et al. JACC. 2011; 57: 1778 -83. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved. 10129897 DOC_1 A 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 For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved. 10129897 DOC_1 A 03/2014
Careful vessel preparation can influence TLF • The RESOLUTE Japan Trial was conducted using careful lesion preparation and extensive imaging. RESOLUTE Japan TLF to 3 Yrs 10 RESOLUTE Japan Lesion Prep/Imaging IVUS Use (%) Pre-Dilation Pressure Range (min, max) Post-Dilatation (%) Target Lesion Failure (%) 12 99 6. 00, 24. 00 78 8 6 4 4. 0% 2 4. 0% 0 0 4 8 12 16 20 24 28 32 36 94 93 91 91 Months Number at risk 100 96 95 95 94 94 • The 3 -year TLF rate from RESOLUTE Japan was 4. 0% • No TLF creep was seen in the RESOLUTE Japan trial For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved. 10129897 DOC_1 A 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. • 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. For OMA distribution only. Trademarks may be registered and are the property of their respective owners. © 2014 Medtronic, Inc. All rights reserved. 10129897 DOC_1 A 03/2014
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