Overview of the Clinical Utility of IVUS to

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Overview of the Clinical Utility of IVUS to Optimize PCI Hector M. Garcia-Garcia MD,

Overview of the Clinical Utility of IVUS to Optimize PCI Hector M. Garcia-Garcia MD, MSc, Ph. D, FESC, FACC Director, Angio and IVUS/NIRS corelab Chairman, Clinical Event Committee Confidential 2016

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Outline • Technical comparison of Angio, OCT and IVUS. • Methods of analysis of

Outline • Technical comparison of Angio, OCT and IVUS. • Methods of analysis of relevant imaging variables use for PCIguidance • Clinical evidence of IVUS-guided PCI

Outline • Technical comparison of Angio, OCT and IVUS. • Methods of analysis of

Outline • Technical comparison of Angio, OCT and IVUS. • Methods of analysis of relevant imaging variables use for PCIguidance • Clinical evidence of IVUS-guided PCI

Technical considerations: QCA/IVUS/OCT Accurately size the vessel • Sizing Variability: – Sizing accuracy can

Technical considerations: QCA/IVUS/OCT Accurately size the vessel • Sizing Variability: – Sizing accuracy can vary by 0. 3 mm depending on imaging modality used – Recognize the risk of under/over-estimating vessel size by visual estimation Actual Size OCT IVUS QCA Visual Estimate 3. 0 mm 3. 1 mm 2. 8 mm 2. 7 – 3. 3 mm Most Accurate Over-Estimates Under-Estimates Inter/Intra-Observer Variability Margin of Error* * Margin of error estimates based on resolution for each imaging modality: Resolution of OCT and IVUS: Bezerra, H. G. , J Am Coll Cardiol. : Cardiovasc Interv. 2009; 2: 1035. Resolution of QCA: Dahm, J. and van Buuren, F. Int J Vasc Med. 2012. Offset and variability of visual estimate: data on file at Abbott Vascular. 5 of 31

Outline • Technical comparison of Angio, OCT and IVUS. • Methods of analysis of

Outline • Technical comparison of Angio, OCT and IVUS. • Methods of analysis of relevant imaging variables use for PCIguidance • Clinical evidence of IVUS-guided PCI

IVUS Quali-/Quantitative Measurements • • Intra-Stent Tissue Protrusion/Thrombus Stent Strut Malapposition Edge Dissection Expansion

IVUS Quali-/Quantitative Measurements • • Intra-Stent Tissue Protrusion/Thrombus Stent Strut Malapposition Edge Dissection Expansion Tissue Protrusion Malapposition Edge Dissection

IVUS Quali-/Quantitative Measurements • Optimal stent expansion defined by - In-stent MLA > 90%

IVUS Quali-/Quantitative Measurements • Optimal stent expansion defined by - In-stent MLA > 90% of the average reference lumen area or ≥ 100% of lumen area of the reference segment with the lowest lumen area

P S P IVUS/OCT to Optimize Stenting OBJECTIVE • • • Prepare lesion to

P S P IVUS/OCT to Optimize Stenting OBJECTIVE • • • Prepare lesion to receive scaffold Facilitate delivery Enable full expansion of pre-dilatation balloon to facilitate full scaffold expansion OBJECTIVE • • Accurately size the vessel Select appropriate scaffold for “best fit” OBJECTIVE • • Achieve <10% final residual stenosis Ensure full strut apposition Wright, RS, et al. , Circulation. 2011; 123: 2022 -2060. / Wijns, W, et al. , European Heart Journal. 2010; 31: 2501 -2555. / Levine, GN, et al. , Circulation. 2011; 124: 2574 -2651. / Steg, PG, et al. , European Heart Journal. 2012; 33: 2569 -2619. / O’Gara, PT, et al. , Circulation. 2013; 127: 529 -555.

P S P IVUS/OCT to Optimize Stenting OBJECTIVE IVUS: Plaque morphology • • •

P S P IVUS/OCT to Optimize Stenting OBJECTIVE IVUS: Plaque morphology • • • Prepare lesion to receive scaffold Facilitate delivery Enable full expansion of pre-dilatation balloon to facilitate full scaffold expansion Wright, RS, et al. , Circulation. 2011; 123: 2022 -2060. / Wijns, W, et al. , European Heart Journal. 2010; 31: 2501 -2555. / Levine, GN, et al. , Circulation. 2011; 124: 2574 -2651. / Steg, PG, et al. , European Heart Journal. 2012; 33: 2569 -2619. / O’Gara, PT, et al. , Circulation. 2013; 127: 529 -555.

P S P IVUS/OCT to Optimize Stenting OBJECTIVE IVUS: Plaque morphology • • •

P S P IVUS/OCT to Optimize Stenting OBJECTIVE IVUS: Plaque morphology • • • Prepare lesion to receive scaffold Facilitate delivery Enable full expansion of pre-dilatation balloon to facilitate full scaffold expansion OBJECTIVE • • Accurately size the vessel Select appropriate scaffold for “best fit” Proximal Gray scale IVUS Proximal Lesion Distal

P S P IVUS/OCT to Optimize Stenting OBJECTIVE • • One frame every 1

P S P IVUS/OCT to Optimize Stenting OBJECTIVE • • One frame every 1 mm Achieve <10% final residual stenosis relative to the closest reference segment Ensure full strut apposition

Outline • Technical comparison of Angio, OCT and IVUS. • Methods of analysis of

Outline • Technical comparison of Angio, OCT and IVUS. • Methods of analysis of relevant imaging variables use for PCIguidance • Clinical evidence of IVUS-guided PCI

Background • IVUS may be used for optimization of DES deployment • Guidelines endorse

Background • IVUS may be used for optimization of DES deployment • Guidelines endorse use of IVUS based on previous MA 2014 on Myocardial Revascularization • Use of. ESC/EACTS IVUS has. Guidelines been limited by – Perceived extra time and cost of the procedure – Lack of uniform accepted standards for stent optimization – Limited number of adequately powered RCT • Since the latest MA new RCT have been published – IVUS XPL n = 1400 – AIR CTO, CTO IVUS. Hong et al. JAMA. 2015; 314(20); Tian et al. Euro. Intervention 2015; 10: 1409 -1417;

n=31, 283 patients

n=31, 283 patients

Results n=31, 283 patients

Results n=31, 283 patients

Results Study Year Design Sample Size P Agostoni 2005 Observational 24/34 P Roy 2008

Results Study Year Design Sample Size P Agostoni 2005 Observational 24/34 P Roy 2008 Observational 884/884 SJ Park 2009 Observational 145/145 SH Kim 2010 Observational 308/112 J Jakabcin 2010 RCT 105/105 JS Kim 2011 Observational 487/487 BE Claessen 2011 Observational 631/873 SH Hur 2011 Observational 2765/1816 KW Park 2012 Observational 619/802 SL Chen 2012 Observational 324/304 ADAPT-DES 2013 Observational 3349/5234 AVIO 2013 RCT 142/142 RESET 2013 RCT 269/274 YJ Youn 2011 Observational 125/216 YW Yoon 2013 Observational 662/912 SG Ahn 2013 Observational 49/36 IRIS-DES 2013 Observational 1616/1628 Hernandez 2014 Observational 505/505 SJ Hong 2014 Observational 206/328 XF Gao 2014 Observational 337/679 AIR-CTO 2015 RCT 115/115 CTO-IVUS 2015 RCT 201/201 HU Yazici 2015 Observational 30/30 Q Tan 2015 RCT 61/62 IVUS-XPL 2015 RCT 700/700

Summary results Entire cohort MACE DEATH MI ST TLR TVR Favors IVUS Favors ANGIO

Summary results Entire cohort MACE DEATH MI ST TLR TVR Favors IVUS Favors ANGIO n=31, 283 patients

n=10, 486 patients RCT + Propensity matched Summary results RCT + Propensity MACE DEATH

n=10, 486 patients RCT + Propensity matched Summary results RCT + Propensity MACE DEATH MI ST TLR TVR Favors IVUS Favors ANGIO

These findings must be interpreted only for complex lesions, because all identified patients had

These findings must be interpreted only for complex lesions, because all identified patients had long lesions or chronic total occlusions.

ILUMIEN III: OPTIMIZE PCI http: //dx. doi. org/10. 1016/S 0140 -6736(16)31922 -5 Figure. Trial

ILUMIEN III: OPTIMIZE PCI http: //dx. doi. org/10. 1016/S 0140 -6736(16)31922 -5 Figure. Trial profile. IVUS=intravascular ultrasound. OCT=optical coherence tomography. PCI=percutaneous coronary intervention. *These non-randomly allocated patients were used to show investigators’ ability to follow the prescribed OCT guidance procedure.

ILUMIEN III: OPTIMIZE PCI http: //dx. doi. org/10. 1016/S 0140 -6736(16)31922 -5 Figure. Trial

ILUMIEN III: OPTIMIZE PCI http: //dx. doi. org/10. 1016/S 0140 -6736(16)31922 -5 Figure. Trial profile. IVUS=intravascular ultrasound. OCT=optical coherence tomography. PCI=percutaneous coronary intervention. *These non-randomly allocated patients were used to show investigators’ ability to follow the prescribed OCT guidance procedure.

ILUMIEN III: OPTIMIZE PCI

ILUMIEN III: OPTIMIZE PCI

ILUMIEN III: OPTIMIZE PCI PRIMARY ENDPOINT

ILUMIEN III: OPTIMIZE PCI PRIMARY ENDPOINT

Conclusions • IVUS is easy to use and widely available. • Clinical evidence showing

Conclusions • IVUS is easy to use and widely available. • Clinical evidence showing the benefits of IVUSguided PCI is overwhelming • All relevant measurements can be easily obtained by IVUS analysis • IVUS should remain the imaging modality of choice for all coronary interventions