COMPLEX CASES: LEFT MAIN

Transcription

1 COMPLEX CASES: LEFT MAIN Resolute Onyx DES Together are trademarks of Medtronic. * Third-party brands are trademarks of For distribution only in markets where the Resolute Onyx coronary stent has been

2 CONTINUOUS DESIGN INNOVATION FOR COMPLEX CASES RO RI R RO RI RO Resolute DES Safe, long-term drug elution with the BioLinx polymer specifically designed for DES Resolute Integrity DES Continuous Sinusoid Technology: A single wire in a helical pattern for greater flexibility and conformability Resolute Onyx DES Core Wire Technology for increased radiopacity, deliverability, and performance Broadest size matrix to optimize treatment of complex clinical scenarios

3 STENT DIAMETER (mm) RESOLUTE ONYX DES: EXPANDING TREATMENT OPTIONS STENT LENGTH (mm) COMPLEXLV 4.5 mm and 5.0 mm sizes expand treatment options for extra-large vessels and feature the same proven safety profile of Resolute Onyx DES. Left main Small vessels Long lesions CTOs Total occlusions AMIs ISR Multivessels Diabetes ACS UA Bifurcations DAPT: Low risk of ST after 1 month 1 First FDA-approved DES for patients with diabetes (Resolute Integrity DES) 1 One-year data from the RESOLUTE Clinical Program indicates low stent thrombosis rates for those that interrupted or discontinued DAPT any time after 1 month. While physicians should adhere to current ESC or ACC/AHA/SCAI Guidelines for PCI, patients who interrupt or discontinue DAPT medication 1 month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis. Early discontinuation of prescribed antiplatelet medication could result in a higher risk of thrombosis, MI, or death.

4 LEFT MAIN REVASCULARISATION IS CRITICAL AND REQUIRES A ROBUST SOLUTION LESION COMPLEXITY PRESENTS CHALLENGES Aorto-ostial lesion 5 7% of patients undergoing coronary angiography 1 HIGH mortality with medical therapy, requiring revascularisation 2 The left main is CRITICAL supplying % of left ventricular cardiac mass 1 Up to 80% of left main disease involves the bifurcation 3 Distal bifurcation Together are trademarks of Medtronic. * Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. For distribution only in markets where the Resolute Onyx coronary stent has been 1 Fajadet. Eur Heart J. 2012; 33: Bittl. Circ. 2013; 127: Windecker. Eur Heart J. 2014:

5 60% OF PATIENTS WITH LEFT MAIN DISEASE ARE ELIGIBLE FOR PCI 1,2 Breakdown of left main patients by SYNTAX score 2 Multi-vessel disease comprises a high proportion of low-intermediate SYNTAX score patients 3 100% 90% 80% SYNTAX > 32 40% SYNTAX 22 32% 70% 60% 50% 40% LM + 3VD LM + 2VD LM + 1VD LM Isolated 30% SYNTAX % 20% 10% 0 LOW SYNTAX INTERMEDIATE SYNTAX HIGH SYNTAX. 1 Windecker. Eur Heart J. 2014: Morice. Circ. 2010; 121: Fajadet. Eur Heart J. 2012; 33: >32

6 60% OF PATIENTS WITH LEFT MAIN DISEASE ARE ELIGIBLE FOR PCI 1,2 PCI has gained acceptance as a primary treatment modality for left main disease, especially for low-to-intermediate SYNTAX lesions 1 Outcomes in left main PCI continually improved with improved stent platforms 3 BMS First-generation DES MACE HR (95% CI) p-value n 0.33 ( ) < ( ) < Second-generation DES 1.01 ( ) NS CABG Better PCI Better 1 Windecker. Eur Heart J. 2014: Morice. Circ. 2010; 121: Park et al., Circ Cardiovasc Interv 2015; 8(3):e Includes n = 51 zotarolimus-eluting stent

7 RESOLUTE ONYX DES IS IDEALLY SUITED FOR LEFT MAIN STENTING SCAFFOLD INTEGRITY MAINTAINED IN LARGE VESSEL SUSTAINED RADIAL STRENGTH ACCURACY IN A CRITICAL LOCATION CONFORMABILITY IN BIFURCATION Together are trademarks of Medtronic. * Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. For distribution only in markets where the Resolute Onyx coronary stent has been

8 % Patients IMPORTANT CONSIDERATIONS FOR LEFT MAIN STENTING SCAFFOLD INTEGRITY MAINTAINED IN LARGE VESSEL 100 SCAFFOLD INTEGRITY MAINTAINED IN LARGE 80 VESSEL 60 SUSTAINED 75% of RADIAL left main STRENGTH diameters are mm ,0 3,5 4,0 4,5 5,0 5,5 6,0 6,5 7,0 7,5 ACCURACY IN A CRITICAL LOCATION Left Main Diameter (mm) CONSIDERATION: Appropriate stent sizing to achieve vessel apposition without compromising scaffold or coating integrity CONFORMABILITY IN BIFURCATION Together are trademarks of Medtronic. * Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. For distribution only in markets where the Resolute Onyx coronary stent has been 1 Analysis of 125 patients, Shand CCI 2014; 84:351-58

9 % Patients IMPORTANT CONSIDERATIONS FOR LEFT MAIN STENTING SCAFFOLD INTEGRITY MAINTAINED IN LARGE VESSEL ,0 3,5 4,0 4,5 5,0 5,5 6,0 6,5 7,0 7,5 Left Main Diameter (mm) 75% of left main diameters are mm 1 CONSIDERATION: Appropriate stent sizing to achieve vessel apposition without compromising scaffold or coating integrity 1 Analysis of 125 patients, Shand CCI 2014; 84:351-58

10 MAINTAINS SCAFFOLDING AND COATING INTEGRITY AT LARGE-VESSEL DIAMETER RETAINS STRUCTURE AT MAXIMUM OVEREXPANSION SCAFFOLD INTEGRITY MAINTAINED IN LARGE VESSEL Resolute Onyx 5.0 mm x 18 mm DES Synergy 4.0 mm x 20 mm DES 1.62 mm 1.87 mm Promus Premier 4.0 mm x 20 mm DES 1.85 mm Deployed to 5.75 mm (maximum labeled overexpansion) Maximum distance between stent struts Bench test data on file at Medtronic.

11 IMPORTANT CONSIDERATIONS FOR LEFT MAIN STENTING Elastic artery Tunica externa Tunica media Tunica intima The left main has the highest elastic content of any coronary artery 2 SUSTAINED RADIAL STRENGTH Muscular artery Tunica externa Tunica media CONSIDERATION: Sustained radial force to prevent recoil Tunica intima 1 OpenStax College, Anatomy & Physiology. 25 April Bergelson Am Heart J 1995; 129:350-9 Representative images of LM vs. other CA 1

12 SUSTAINED RADIAL STRENGTH FOR LARGE VESSELS SUPPORT FOR CRITICAL REPERFUSION Resolute Onyx DES with Core Wire technology provides sustained radial strength at larger diameter Resolute Integrity DES 3.0 mm x 18 mm Resolute Onyx DES 3.0 mm x 18 mm Resolute Onyx DES COMPLEXLV 5.0 mm x 18 mm SUSTAINED RADIAL STRENGTH Radial Strength (Higher Is Better) Compression Resistance (N/mm per mm) /91 µm (Not swaged) /81 µm (Swaged) /91 µm (Swaged) Strut Dimensions Bench test data on file at Medtronic.

13 IMPORTANT CONSIDERATIONS FOR LEFT MAIN STENTING Aorto-ostial lesions have complex geometry and are difficult to visualize 1 ACCURACY IN A CRITICAL LOCATION Distal geographic miss of aorto-ostial stent 1 CONSIDERATION: High radiopacity with minimal foreshortening for accurate delivery 1 Jaffe Int J Cardiol 2015; 186:61-66

14 ACCURACY IN A CHALLENGING RADIOGRAPHIC ENVIRONMENT HIGH RADIOPACITY AND MINIMAL FORESHORTENING FOR PRECISE DEPLOYMENT Resolute Onyx DES 5.0 mm x 18 mm Deployed to 5.75 mm 0.8% foreshortening 0.1 mm Unshielded 0.75 mm Pb Shield Synergy * DES 4.0 mm x 20 mm Deployed to 5.75 mm 14.7% foreshortening 2.9 mm Material Density (g/cc) Higher Is Better Pt-10lr Core Wire alloy 21.5 ACCURACY IN A CRITICAL LOCATION Promus Premier * DES 4.0 mm x 20 mm Deployed to 5.75 mm 16.6% foreshortening 3.3 mm MP35N Cobalt alloy L605 Cobalt alloy PtCr Platinum chromium alloy 9.9 Bench test data on file at Medtronic.

15 IMPORTANT CONSIDERATIONS FOR LEFT MAIN STENTING Up to 80% of left main lesions involve the bifurcation 1 Fajadet Eur Heart J 2012; 33: CONSIDERATION: Cell design for large side branch access Conformability to maintain vessel apposition CONFORMABILITY IN BIFURCATION 1 Windecker Eur Heart J 2014:

16 ADAPTABILITY FOR BIFURCATION STENT GEOMETRY FACILITATES SIDE BRANCH ACCESS AND VESSEL APPOSITION Open cell design expandable for large-vessel side branch access Resolute Onyx DES Excellent flexibility and conformability contribute to superior strut apposition Resolute Onyx DES 3.0 x 18 mm Strut malapposition: 3.7 ± 1.4% Synergy DES 3.0 x 20 mm Strut malapposition: 10.7 ± 0.2% 2.9 mm 2.9 mm 2.75 mm 2.75 mm Resolute Onyx DES 4.5 x 18 mm Synergy * DES 4.0 x 20 mm 3.8 mm 3.8 mm Modeling method per Mortier. JACC: Cardiovasc Interv 2014; 7(3): CONFORMABILITY IN BIFURCATION 4.93 mm 3.79 mm Stents deployed to 4.5 mm and cell area expanded with a 4.5 mm balloon inflated to RBP. Bench test data on file at Medtronic. These tests and models may not be indicative of clinical performance.

17 RESOLUTE ONYX DES IS IDEALLY SUITED FOR LEFT MAIN STENTING SCAFFOLD INTEGRITY MAINTAINED IN LARGE VESSEL SUSTAINED RADIAL STRENGTH ACCURACY IN A CRITICAL LOCATION CONFORMABILITY IN BIFURCATION

18 Europe Medtronic Intl. Trading SARL Route du Molliau 31 Case Postale CH-1131 Tolochenaz Switzerland Tel: Fax: Asia Pacific Medtronic Intl. Ltd. 49 Changi South Avenue 2 Nasaco Tech Centre Singapore Singapore Tel: Fax: Latin America Medtronic USA, Inc. Doral Corporate Center II 3750 NW 87 th Avenue, Suite 700 Miami, FL USA Tel: Fax: their respective owners. All other brands are trademarks of a Medtronic company. For distribution only in markets where the Resolute Onyx coronary stent has been approved. Not for distribution in the USA, Japan or France. UC ML 1/16