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OCT Intravascular Imaging

OPTIS™ Imaging Systems
Clinical Outcomes

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Clinical Outcomes

Limitations of angiography and the rise of intravascular imaging

The use of intracoronary imaging (IVI) during percutaneous coronary interventions (PCI) has been associated with improved clinical outcomes compared to angiography alone as demonstrated in multiple trials and studies.1-3

PCI, which is still most commonly guided by angiography, has well-established limitations which impact patient outcomes.4

  • Angiography can't depict the arterial vessel wall, and thus evaluate vessel dimensions and plaque characteristics5—information physicians need to properly prepare the vessel and plan a treatment strategy to achieve optimal stent expansion.
  • Angiography can't directly assess the results of stent implantation5—post-stent assessment when physicians check for medial dissections, stent malapposition and stent underexpansion to ensure optimal stent expansion.
     
Absence of Intravascular Imaging Results

Why Stent Expansion Matters?

Achieving optimal stent expansion is proven to reduce rates of adverse cardiac events.5 Stent underexpansion is an indicator of adverse events, such as stent thrombosis and restenosis.5

How do professional societies support IVI?
  • The AHA/ACC 2021 Guidelines for use of intravascular imaging were updated and now recommend OCT imaging to guide stent implantation and to determine mechanism of stent underexpansion.6
  • 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology now require the knowledge of imaging and physiology devices, how to perform imaging-guided PCI as well as the outcomes data to support the use.7
  • ACC recommends that operators use IVI as an essential adjunct to angiography, that all US cardiac catheterization labs have IVI capability and national training programs provide training on IVI.8

Which Contemporary Image-Guided Studies Support Improved Clinical Outcomes?

  1. IVUS-XPL, ULTIMATE, and the recently published RENOVATE-COMPLEX-PCI all consistently show that the use of IVI improves patient outcomes long term.1-3

Intravascular Imaging vs Angiography Studies
STUDYSIZEREGIONOUTCOMES
IVUS-XPL, 2019
(IVUS vs Angio-guided PCI)		N=1,400
1:1 randomization		KoreaIVUS-guided stent implantation in a significantly lower rate of major adverse cardiac events up to 5 years, compared with angiography-guided stent implantation.2
ULTIMATE, 2021
(IVUS vs Angio-guided PCI)		N=1,448
1:1 randomization		ChinaIVUS-guided DES implantation was associated with significantly lower rates of TVF and ST during a 3-year follow-up among all comers.1
RENOVATE-COMPLEX-PCI, 2023
(Angio-guided PCI vs Image-guided PCI)		N=1,689
2:1 randomization between imaging & angio		KoreaIntravascular imaging-guided PCI was linked to a 37% lower incidence of target-vessel-related myocardial infarction or death from cardiac causes than angiography-guided PCI.3

RENOVATE-COMPLEX-PCI

View the data

Target Vessel Failure

IVUS-XPL

View the data

Primary Endpoint at 5 Years

ULTIMATE

View the data

Angiography vs IVUS Guidance
  1. OCT-guided PCI vs. Angiography Studies


Multiple studies of OCT-guided PCI vs. angiography alone suggest that intravascular imaging with OCT is associated with better clinical performance.9,11,13
 

STUDYSIZEOUTCOMES
CLI-OPCI I
(EuroIntervention, 2012)		335 pts OCT guided vs 335 pts angio-guidedReduced rate of cardiac death and MACE in patients who underwent OCT-guided intervention.9
ILUMIEN I
(EHJ, 2015)		418 ptsOCT imaging influenced physician decision-making pre-PCI in 57% and post-PCI in 27% of all cases.10
ILUMIEN III
(LANCET, 2016)		450 pts (158 OCT, 146 IVUS, 146 ANGIO)OCT-guided PCI resulted in superior stent expansion and procedural success compared to angiography-guided PCI.11
DOCTORS
(CIRC 2016)		240 pts NSTEMIIn patients with non–ST-segment elevation acute coronary syndromes, OCT-guided PCI is associated with higher post-procedure FFR than angio-guided PCI.12
PAN-LONDON
(JACC CARD INT, 2018)		1,149 pts OCT, 10,971pts IVUS 75,046 pts angio.OCT-guided PCI was associated with improved procedural outcomes, in-hospital events, and long-term survival compared with standard angiography-guided PCI.13
  1. ILUMIEN IV (Coming Soon)


ILUMIEN IV is one of the most anticipated clinical trials of 2023. It is the largest imaging randomized clinical trial with n=2,487 patients in 80 global centers. The trial will compare OCT-guided stent implantation vs. angiography guided in high-risk or complex lesions in achieving larger post-PCI lumen dimensions and improving clinical outcomes.14
 

ILUMIEN IV Overview


Previously, the ILUMIEN III trial showed that OCT-guided PCI resulted in superior stent expansion and procedural success as compared to angiography-guided PCI.11

ILUMIEN I showed that OCT imaging changed physician decision-making pre- and post-PCI.10 These results are consistent with the most recent LightLab, iOPTICO and TACTICS global studies where each has shown that OCT changed angio-based decisions—decisions that influence treatment strategy.4,15,16


Pre- and Post-PCI OCT Changed Physicians Decision-Making Over Angiography
 
LightLab4
N=925
LightLab Study
iOPTICO15
N=480
iOPTICO Study
TACTICS16
N=702
TACTICS
  1. LightLab, iOPTICO, TACTICS demonstrate that OCT with MLD MAX impacts procedural decision-making.


These three studies conducted across the globe demonstrated that when physicians use OCT-guidance before stent implantation, it changed their angio-based treatment strategy.

In the LightLab study, multicenter, prospective, observational clinical initiative (N=925) conducted in the US, designed to evaluate the impact of a routine MLD MAX workflow on physician decision-making and procedural efficiency, OCT guidance changed physician decisions in 86% of lesions.4
 

OCT changed physician decision-making during PCI in 86% of lesions
OCT changed physician decision making during PCI in 86% of lesions


Source: Bergmark et al: Decision-Making During Percutaneous Coronary Intervention Guided by Optical Coherence Tomography: Insights From the LightLab Initiative.


In the TACTICS registry, investigator-initiated, prospective, multicenter, observational study (N=702) conducted in Japan, OCT-guidance affected PCI strategy in 58% of patients.15
 

Impacts of OCT-Guidance on PCI
Frequency of PCI strategy changes based on OCT findings
Impacts of OCT-Guidance on PCI

Source: Shinke, Toshiro. Impact of Underlying Causes of Acute Coronary Syndrome on 1-Year Outcomes After Percutaneous Coronary Intervention: Results from OCT Guided Primary PCI Registry -TACTICS Registry. TCT2022.


In the iOPTICO study, a multicenter, prospective study designed to determine the impact of real time optical coherence tomography and with angiography co-registration (ACR) conducted in South Asia (N=480), OCT + ACR guidance changed decisions in 90% of lesions.16
 

OCT+ACR changes angiographic based decision in 90% of lesions
OCT+ACR changes angiographic based decision in 90% of lesions

ACR: Angio co-registration

Source: Mathew, R. et al. Impact of Real-Time Optical Coherence Tomography-Angio Co-Registration (OCT-ACR) on Physician Decision Making During Percutaneous Coronary Intervention: A Multicenter, Prospective Study (iOPTICO study). 

All these data further highlight the limitations of angiography-based lesion assessment and preparation, and therefore, its impact on treatment strategy and patient outcomes. Intravascular imaging with OCT has been shown to change physicians angio-based decisions which impact treatment strategy,4,10,16 reduced rate of cardiac death and MACE.9

Connect With Us

Learn more about OCT and MLD MAX workflow, explore educational content or learn how to perform OCT-guided PCI with Ultreon™ 1.0 Software.

OCT and MLD MAX Workflow

References

  1. Zhang J, et al. Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial. J Am Coll Cardiol. 2018;72(24):3126-3137.
  2. Hong M et al., IVUS-XPL 5 Year Outcomes, TCT 2019.
  3. Lee J.M. et al. Intravascular Imaging–Guided or Angiography-Guided Complex PCI. NEJM DOI: 10.1056/NEJMoa2216607.
  4. Bergmark B, et al. Decision-Making During Percutaneous Coronary Intervention Guided by Optical Coherence Tomography: Insights From the LightLab Initiative. Circ Cardiovasc Interv. 2022;15(11):872-881.
  5. Räber L, et al. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018;39(35):3281-3300.
  6. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145:e18–e114. DOI: 10.1161/CIR.0000000000001038.
  7. 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions): A Report of the ACC Competency Management Committee | Circulation: Cardiovascular Interventions. 2023;0:e000088 https://doi.org/10.1161/HCV.0000000000000088.
  8. Truesdell AG, Alasnag MA, Kaul P, et al. Intravascular Imaging During Percutaneous Coronary Intervention: JACC State-of-the-Art Review. J Am Coll Cardiol. 2023;81(6):590-605. doi:10.1016/j.jacc.2022.11.045.
  9. Prati F., et al. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: (CLI-OPCI) study. EuroIntervention, 2012.
  10. ILUMIEN I European Heart Journal (2015) 36, 3346–3355 doi:10.1093/eurheartj/ehv367.
  11. ILUMIEN III: Lancet: https://doi.org/10.1016/S0140-6736(16)31922-5.
  12. DOCTORS: https://doi.org/10.1161/CIRCULATIONAHA.116.024393 Circulation. 2016;134:906–917.
  13. Pan London: JACC Cardiovasc Interv. 2018 Jul 23;11(14):1313-1321. doi: 10.1016/j.jcin.2018.01.274.
  14. ILUMIEN IV Trial. Clinical Trials. https://clinicaltrials.gov/ct2/show/NCT03507777.
  15. Mathew, R. et al. Impact of Real-Time Optical Coherence Tomography-Angio Co-Registration (OCT-ACR) on Physician Decision Making During Percutaneous Coronary Intervention: A Multicenter, Prospective Study (iOPTICO study). J Am Coll Cardiol. 2020 Oct 27; 76(17): B176.
  16. Shinke, T. Impact of Underlying Causes of Acute Coronary Syndrome on 1-Year Outcomes After Percutaneous Coronary Intervention: Results from OCT Guided Primary PCI Registry -TACTICS Registry. TCT2022.

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