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LightLab Clinical Initiative data demonstrate OCT benefits for PCI

LightLab is a multicenter, prospective, observational clinical initiative designed to evaluate the impact of using a routine OCT workflow, MLD MAX, on physician decision-making and procedural efficiency during PCI with the goal of improving cath lab workflow, safety and efficiency.

Percutaneous coronary intervention (PCI) is most commonly guided by angiography which offers a two-dimensional view of the three-dimensional structure.1 It can’t depict the arterial vessel wall, and thus evaluate vessel dimensions and plaque characteristics, nor directly assess the results of stent implantation.2 Recent LightLab data give further insights into the limitations of angiography in the cath lab and highlights the benefits of using OCT.

OCT reduced ambiguities impacting decisions on vessel prep, stent sizing, and expansion3
 

OCT changed angio-based decisions3

 OCT changed angio-based morphology assessment3

Pre-PCI OCT changed angio-based
diagnosis and treatment decisions 5

OCT changed angio-based
vessel prep strategy4

Achieved when following LL
OCT workflow, MLD MAX3

1. OCT changed angio-based decisions in 88% of lesions3

When physicians used the full range of information from OCT with the MLD MAX workflow they changed decisions in 88% of lesions over their angiographic assessment. The largest impact was observed prior to stenting, in decisions involving morphology assessment, vessel preparation and stent sizing, key decisions which may influence final stent expansion. Achieving optimal expansion is proven to reduce rates of major adverse cardiac events during PCI.2

88% of lesions impacted

2. OCT changed angio-based assessment of morphology in nearly 1 in 2 lesions3

When physicians used OCT to assess lesion morphology and composition of the plaque, they changed their angiographic-guided assessment in about half of lesions or in 48% of lesions. Due to the high resolution images, OCT provides additional information on lesion morphology which is important to determine how to prepare and treat the vessel appropriately, especially when calcification is present. Extensive calcification may adversely impact PCI procedure and final stent expansion.2
 

 OCT changed assessment of morphology in 48% of lesions

 

3. OCT changed angio-based vessel prep strategy in nearly 1/3 of lesions4

Proper vessel evaluation, lesion preparation, and sizing are essential to achieve optimal stent expansion.

When physicians assessed lesion morphology and severity with OCT, they changed vessel prep strategy. When a change in vessel prep strategy occurred, calcification was the predominant morphology as seen with OCT. Angiography underestimates morphological lesion severity which impacts treatment strategy.
 

  OCT changed angio-based vessel prep strategy

4. Pre-PCI OCT changed angio-based diagnosis and treatment decisions5

When physicians used OCT pre-PCI in ISR lesions, they changed their angiographic diagnosis and treatment strategy in 91% of lesions. OCT can diagnose ISR and accurately identify the mechanism of stent failure which impacts ISR treatment strategy. In LightLab, OCT changed angio assessment of ISR mechanism in 48% of lesions with a quarter of these lesions missed as ISR by angiography.

Identifying the mechanism of stent failure is paramount to planning treatment as treatment strategy differs for ISR due to stent underexpansion and due to neointimal hyperplasia.2 Analysis of ISR by intravascular imaging is essential to understand the mechanism of failure and OCT is a preferred technique.2

 ISR algorithm
Algorithm adapted from: Ziad Ali, MD. CHIP guided by OCT, A Case Based Discussion, TCT 2017

5. Optimal stent expansion achieved with MLD MAX workflow3

Achieving optimal expansion is proven to reduce rates of major adverse cardiac events during PCI.2 Operators achieved 80% minimal stent expansion on average when following LightLab workflow, MLD MAX.

OCT makes it easy to detect underexpansion. Using Tapered Reference Mode, which is based on the natural tapering of vessels and factoring in side branches, OCT software automatically calculates expansion percentage % and highlights regions of underexpansion in red, well-expanded in white, see below.
 

 OCT software

Example 1: OCT software detected 67% stent expansion (A) meaning the stent is underexpanded based on the recommended expansion targets2 of MSA ≥ 80% or >90%. The software highlighted underexpansion in red, and well-expanded areas in white which can also be seen on the angio co-registration feature (B) and on the rendered stent feature (C).

 

  OCT Software

Example 2: OCT software detected 86% stent expansion (A) and it is highlighted in white to indicate well-expanded stent based on the recommended expansion targets2 of MSA ≥ 80% or >90%. The software highlighted well-expanded stent in white on angio co-registration feature (B) and rendered stent feature (C).

References

  1. Reyes, M. The next innovation in PCI is not a stent. The value of OCT. CathLab Digest. Oct 6, 2019. Volume 27, Issue 10.
  2. 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.
  3. Bezerra, H. et al: Analysis of changes in decision-making process during OCT-guided PCI -Insights from the LightLab Initiative. EuroPCR2020 Presentation.
  4. Croce, K. et al: Optical Coherence Tomography Influences Procedure and Vessel Preparation Decisions During Percutaneous Coronary Intervention– Insights from the LightLab Initiative. TCTConnect2020 Presentation.
  5. Croce, K. et al: Effect of a Prescriptive Optical Coherence Tomography Guided Strategy on Treatment of In-Stent Restenosis– Insights from the LightLab Initiative. TCTConnect2020 Presentation.

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