1. 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

2. No disclosures

3. 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

4. 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

5. 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: Resolution of QCA: Dahm, J. and van Buuren, F. Int J Vasc Med Offset and variability of visual estimate: data on file at Abbott Vascular.
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6. 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

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

8. 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

9. 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 ; 123: / Wijns, W, et al., European Heart Journal ; 31: / Levine, GN, et al., Circulation ; 124: / Steg, PG, et al., European Heart Journal ; 33: / O’Gara, PT, et al., Circulation ; 127:

10. 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 ; 123: / Wijns, W, et al., European Heart Journal ; 31: / Levine, GN, et al., Circulation ; 124: / Steg, PG, et al., European Heart Journal ; 33: / O’Gara, PT, et al., Circulation ; 127:

11. 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

12. 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

13. 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

14. 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: ;
kim et al. Circ Cardiovasc Interv Jul;8(7)

15. n=31,283 patients

16. Results
n=31,283 patients

17. 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

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

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

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

22. ILUMIEN III: OPTIMIZE PCI
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.

23. ILUMIEN III: OPTIMIZE PCI
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.

24. ILUMIEN III: OPTIMIZE PCI

25. ILUMIEN III: OPTIMIZE PCI
PRIMARY ENDPOINT

26. 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