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

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

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

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 Over-Estimates Under-Estimates Inter/Intra-Observer Variability Most Accurate Margin of Error* 3.0 mm 3.1 mm 2.8 mm 2.7 – 3.3 mm To be updated * 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 relevant imaging variables use for PCI-guidance Clinical evidence of IVUS-guided PCI

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% of the average reference lumen area or ≥100% of lumen area of the reference segment with the lowest lumen area Average is weigth average

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 Accurately size the vessel Select appropriate scaffold for “best fit” 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.

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 IVUS: Plaque morphology 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.

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 Accurately size the vessel Select appropriate scaffold for “best fit” IVUS: Plaque morphology Proximal Lesion Distal Proximal Lesion Distal Gray scale IVUS

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

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

2014 ESC/EACTS Guidelines on Myocardial Revascularization Background IVUS may be used for optimization of DES deployment Guidelines endorse use of IVUS based on previous MA Use of IVUS has 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. 2014 ESC/EACTS Guidelines on Myocardial Revascularization Hong et al. JAMA. 2015;314(20); Tian et al. EuroIntervention 2015;10:1409-1417; kim et al. Circ Cardiovasc Interv. 2015 Jul;8(7)

n=31,283 patients

Results n=31,283 patients

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

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

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

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/S0140-6736(16)31922-5 Figure. Trial profileIVUS=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/S0140-6736(16)31922-5 Figure. Trial profileIVUS=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 PRIMARY ENDPOINT

Conclusions IVUS is easy to use and widely available. Clinical evidence showing the benefits of IVUS-guided 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