Biotronik SCAI satellite session 6.30-6.45 pm Tuesday, May 21, 2019 Intro & Latest Contemporary DES Data and Clinical Implications Emmanouil S. Brilakis, MD, PhD Minneapolis Heart Institute
Disclosures • Consulting/speaker honoraria: Abbott Vascular, American Heart Association (associate editor Circulation), Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), CSI, Elsevier, GE Healthcare, InfraRedx, Medtronic • Research support: Regeneron, Siemens • Shareholder: MHI Ventures. • Board of Trustees: Society of Cardiovascular Angiography and Interventions
Orsiro Ultrathin Strut (BP SES) Stent System Stent Material L-605 Cobalt-Chromium Strut thickness 60 µm* Polymer material Poly-L-lactic acid (PLLA) Polymer type Bioresorbable, asymmetric circumferential thickness Passive coating Amorphous silicon carbide Sirolimus (1.4 µg/mm 2 ), >80% eluted in first Antiproliferative drug 90 days *For 2.25mm to 3.0mm diameter stents, 80 µm for >3.0 mm diameter stents
Orsiro DES: The only Ultrathin DES in the United States * Thin Strut Ultrathin Strut Drug-Eluting Stents Drug-Eluting Stent Abbott Medtronic Boston Scientific BIOTRONIK Xience Sierra 1 Resolute Onyx 2 Synergy 3 Orsiro CoCr-EES CoNi-ZES PtCr-EES CoCr-SES Polymer Bioabsorbable Durable Durable Bioabsorbable coating proBIO TM * ø 3.0 mm diameter, when compared to key competitors. BIOTRONIK data on file. 1. Xience and Xience Sierra are registered trademarks of Abbott Cardiovascular Systems. 2. Resolute Onyx is a registered trademark of Medtronic. 3. Synergy is a registered trademark of Boston Scientific Information on devices manufactured at companies other than BIOTRONIK was gathered from multiple sources. However, it has not been verified 4 by the vendors and we cannot guarantee its accuracy.
The Foundation of Orsiro is the Novel PRO-Kinetic Energy Stent Design Strong Cobalt Chromium (CoCr) alloy ▪ Double helix stent design for a smooth outer ▪ contour and outstanding flexibility . 3 Longitudinal connectors designed to resist ▪ longitudinal compression. 5 Source: BIOTRONIK data on file.
Double Helix Stent Design for a Smooth Outer Contour and Outstanding Flexibility 1 Smooth outer contour Wedge shaped transitions Ring element Consistent scaffolding through entire Defined stent length stent Orsiro Three longitudinal connectors per helix Two helical meanders Synergy Designed to minimize foreshortening Excellent flexibility and Boston Scientific* and resist longitudinal compression smooth crimped profile 1. BIOTRONIK Data on file *Synergy is a registered trademark of Boston Scientific. Disclaimer: Information on devices manufactured at companies other than BIOTRONIK was gathered from multiple sources. However, it has not 6 been verified by the vendors and we cannot guarantee its accuracy.
proBIO TM Passive Layer of Silicon Carbide Reduced nickel ion release compared to other stent platforms 1 60 Mass of Nickel release per surface area [ng/cm 2 ] -98% 50.8 50 Made of amorphous silicon carbide and is • responsible for the unique color of 40 BIOTRONIK stents 2 30 Intended to improve surface • characteristics and reduce nickel ion -94% release 2 20 14.9 -68% In vitro studies have shown up to a 98% • 10 6.4 reduction of nickel ion release when the 0.9 stent surface is coated with silicon 0 carbide. 1 TM CoNi PtCr CoCr CoCr with proBIO 1. BIOTRONIK data on file. 2. Rzany A, Schaldach M. Smart Material Silicon Carbide: Reduced Activation of Cells and Proteins on a-SiC:H-coated Stainless Steel. Progress in 7 Biomedical Research 2001; May: 182- 194
Visibility [Left] Radiopacity of crimped stents [Right] Radiopacity of expanded stents 1 Orsiro Orsiro ø3.0mm Orsiro Orsiro ø 4.0mm from left to right – Orsiro, Xience 2 , Synergy 3 , Resolute Onyx 4 BIOTRONIK data on file. 1. Expansion to Nominal Pressure; 2. 3.0mm: Xience Sierra, 4.0mm: Xience Alpine, Xience is a registered trademark of Abbott Cardiovascular Systems. 8 3. Synergy is a registered trademark of Boston Scientific 4. Resolute Onyx is a registered trademark of Medtronic.
Orsiro – Only Crossing Profile Under 1mm * Resolute Onyx 1 Lowest crossing Synergy 2 profile Xience Sierra 3 Orsiro on the US market 4 0.90 No Compromise on Radial Strength 5 Resolute Onyx 15% Synergy More radial strength 6,7 Xience** Orsiro *for selected diameters; **Xience Xpedition 1. Resolute Onyx is a registered trademark of Medtronic. 2. Synergy are registered trademarks of Boston Scientific. 3. Xience Sierra is a registered trademark of Abbott Cardiovascular Systems. 4. ø 3.0 mm diameter, when compared to key competitors. BIOTRONIK data on file. 5. ø 3.0 mm diameter, when compared to key competitors. BIOTRONIK data on file. 6. Compared to Xience Xpedition. 7. Expanded 3.0 mm diameter stents are radially compressed (15% of Ø) along full length. The force required to compress the stent is radial strength. BIOTRONIK data on file. 9 Disclaimer: Information on devices manufactured at companies other than BIOTRONIK was gathered from multiple sources. However, it has not been verified by the vendors and we cannot guarantee its accuracy.
Worldwide Orsiro Clinical Programs 2011 2012 2014 2015 2018 2013 2016 2017 2018 2018 2019 Studies ongoing, including all-comers 65 48,500+ patients enrolled 48k+ 70,000+ patients enrolled and 70k+ planned 10
Worldwide Orsiro Clinical Programs 2018 2011 2012 2013 2014 2015 2016 2018 2018 2017 2019 SORT OUT VII SORT OUT IX All Comers ORIENT BIO-RESORT BIOSCIENCE BIONYX Pivotal Europe Japan China USA Superiority BIOSTEMI Design 11
BIOFLOW V Trial Design • 1,334 patients randomized between May BIOFLOW-V N=1,334 2:1 Randomization 2015 and March 2016 884 BP SES, 450 DP EES ⎯ 884 Orsiro and 450 Xience 1 & 6-month follow-up • Patients enrolled in 13 countries in North America, Europe, Israel, Asia, and 1-year follow-up Australia and New Zealand TLF Primary Endpoint • Primary endpoint TLF at 1 year with 2-year follow-up planned follow-up through 5 years Pre-specified Analysis 3, 4, 5-year follow-up clinicaltrials.gov NCT02389946 Kandzari et al. Lancet 2017
Key Enrollment Criteria Inclusion Criteria Exclusion Criteria • • Recent (< 72 hours prior to procedure) STEMI or Age ≥ 18 years hemodynamically unstable NSTEMI/ ACS patients • IHD, stable or unstable angina, or silent • Chronic total occlusions, bypass grafts ischemia • Bifurcations with side branch > 2.0 mm • ≤ 3 de novo target lesions in ≤ 2 native target • In-stent restenosis or active stent thrombosis vessels (TV) • LVEF < 30% • RVD ≥ 2.25 mm and ≤ 4.0 mm • Prior PCI within 30 days (non-TV) or within 9 • months (TV) LL ≤ 36 mm • Planned staged PCI post-procedure • TIMI flow > 1 • Renal impairment > 2.5 mg/dL or 221 µmol/L or • Eligible for DAPT therapy (aspirin + P 2 Y 12 ) dialysis dependent • Provided informed consent • Excessively tortuous/ angulated or severely calcified (operator visual assessment) Doros et al. Am Heart J. 2017;193:35-45
Patient Disposition 1,334 randomized 884 BP SES 450 DP EES 52 Discontinued study 31 Discontinued study 13 Withdrew consent 9 Withdrew consent 12 Were lost to follow-up 4 Were lost to follow-up 11 Other 9 Other 16 Deaths 9 Deaths 848 (95.9%) active at 428 (95.1%) active at 2-Year Follow-up 2-Year Follow-up (807 completed visits; 25 missed visits) (401 completed visits; 18 missed visits)
Clinical Characteristics BP SES (N=884) DP EES (N=450) Age, years 64.5 ± 10.3 64.6 ± 10.7 Female 25.3% 27.1% Hypertension 79.7% 80.5% Hyperlipidemia 78.9% 82.4% Diabetes mellitus 34.0% 37.0% Prior MI 27.4% 25.9% Prior PCI 36.8% 33.0% Prior CABG 7.1% 5.2% Current smoking 23.6% 22.7% Clinical presentation Stable angina 48.4% 47.4% Acute coronary syndrome 51.4% 49.6%
Clinical Characteristics BP SES (N=1,051 Lesions) DP EES (N=561 Lesions) Target lesion vessel Left anterior descending 41.0% 41.2% Left circumflex 26.5% 26.0% Right 32.4% 32.8% Reference vessel diameter (mm) 2.59 ± 0.54 2.60 ± 0.58 Lesion length (mm) 13.3 ± 7.6 13.2 ± 7.7 Bifurcation lesion 14.8% 15.0% Calcification, moderate/severe 24.0% 26.7% Vessel tortuosity, moderate/severe 58.8% 61.5% ACC/AHA Lesion Class B2/C 72.6% 75.9% 1.2 ± 0.4 1.3 ± 0.5 Number of target lesions/patient * 1.3 ± 0.7 1.5 ± 0.9 Number of stents/patient * Total study stent length/patient (mm) * 26.8 ± 14.7 29.5 ± 17.5 Patients with overlapping stents * 9.4% (83/884) 15.0% (67/448) Stent length/lesion 20.8 ± 9.1 21.8 ± 10.5 * P <0.05
BIOFLOW V Primary Endpoint: Target Lesion Failure at 1 Year 8.92 5.92 Kandzari DE, et al. ESC 2017; Lancet 2017
BIOFLOW V Target Lesion Failure at 2 Years 8.92 5.92
BIOFLOW V 2 Year Outcomes Orsiro Xience BP SES P value DP EES (n=450) (n=884) Target lesion failure 7.5% 11.9% 0.015 Cardiac death 0.6% 0.5% 1.0 Target vessel MI 5.3% 9.5% 0.01 Ischemia-driven TLR 2.6% 4.9% 0.04 Cardiac Death/MI 7.0% 10.4% 0.047 All data represented as intention to treat
BIOFLOW V Target Vessel MI
BIOFLOW V Landmark Analysis: Target Vessel MI
BIOFLOW V Ischemia-Driven Target Lesion Revascularization Through 2 Years
BIOFLOW V Landmark Analysis: Ischemia-Driven Target Lesion Revascularization
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