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IVUS Data

IVUS Guidance Elevates Coronary Outcomes

The Importance of IVUS-Guided PCI

The Path to Modern PCI

Intravascular ultrasound (IVUS) is a medical imaging methodology for Percutaneous Coronary Intervention (PCI). Clinical data consistently shows the benefits of IVUS to determine treatment strategy, guide stent placement, and assess procedural results for optimized long-term outcomes.¹ IVUS is a cornerstone of the SYNTAX II study design and was used 84.1% of the time. This trial demonstrates the importance of IVUS use to ensure the effectiveness of PCI.

Adequate stent expansion and apposition

IVUS usage post stent implantation led to further optimization of the stented lesion in 30.2% of lesions, predominantly further post-dilatation.

Visualization of a larger minimal stent area

Larger post-procedural MSA, evaluated by IVUS, was independently associated with the lower rate of Target Lesion Revascularization (TLR) at 2 years.

American College of Cardiology logo

ACC imaging recommendations

In February 2023, The American College of Cardiology (ACC) Interventional Council released the recommendation that all cardiac cath labs should have imaging capabilities. The review proposes PCI best practices and advocates for broader use of IVI technologies.

Modern PCI gives you inside knowledge to improve the long-term outcomes in patients’ lives

Coronary angiography

Coronary angiography has limitations

See

IVUS defines the extent and type of disease

SEE

PREP

IVUS confirms lesion modification

PREP

Treat

IVUS confirms optimal stent deployment

TREAT


Pre-Procedure: Standardize your approach & remove the guesswork

Using IVUS to inform treatment planning and guide DES implantation.

The ADAPT-DES² study evaluated outcomes in patients undergoing PCI with IVUS use versus no IVUS use. IVUS guidance led to the use of larger stents or balloons, more post-dilatation, additional stents, or higher pressures in 74% of patients. The IVUS use group reported a significant reduction in MI (38%), ST (53%), MACE (35%), and TLR (20%). IVUS use was identified as an independent predictor of lower ST incidence.

Changes to procedure plan after IVUS:

IVUS guidance chart

IVUS use changed the procedure 74% of the time.


PCI procedures have significantly worse outcomes when stent strength is compromised.

The IVUS sub study of the EXCEL trial³, found that stent deformation was present in nearly 7% of all patients, and stent deformation detected by IVUS was strongly associated with LM-related MACE during 3-year follow-up.

  • Statistically higher MACE rates when stent deformation occurred 
  • Stent deformation at 3 years: 28% MACE 
  • No stent deformation at 3 years: 13% MACE

Post-Procedure: Verify results for predictable & durable outcomes 

Utilization of IVUS-guided PCI vs angiography-guided PCI alone leads to a statistically significant difference in major adverse cardiac events.

ULTIMATE TVF⁴ (n=1448)

ULTIMATE TVF (n=1448)

RENOVATE-COMPLEX-PCI TVF⁵ (n=1639)

RENOVATE-COMPLEX-PCI TVF (n=1639)

IVUS guidance to assess lesion morphology during stent implantation will improve both immediate and long-term clinical outcomes.

The IVUS-XPL⁶ Study found that, among patients with long coronary lesions (defined as greater than 28mm), IVUS- versus angiography-guided stent implantation led to an immediate divergence of clinical events at stent implantation that continued out to five years post procedure.

IVUS-XPL TVF (n=1400)

IVUS-XPL TVF (n=1400)

Data from the 2023 randomized controlled trial RENOVATE-COMPLEX-PCI⁷ proved an optimal procedure can reduce restenosis significantly a sub-optimal one. Stent optimization was defined as sufficient stent expansion without major stent malapposition to the vessel wall or edge dissection. 

Only 45.4% of patients received stent optimization

Only 45.4% of patients received stent optimization

Developed in partnership with physicians to simplify IVUS workflow, IVUS 123 Essentials is a step-by-step guide that shows you how to easily incorporate imaging throughout every PCI procedure. Optimize outcomes by incorporating these 3 simple steps in your post PCI workflow.

  1. Geographic miss and edge dissection: No edge dissection involving the media with length more than 3mm
  2. Malapposition: Plaque burden 5mm proximal or distal to the stent edge <50%
  3. Stent Expansion: Minimum lumen area in the stented segment more than 5.00mm2 or 90% of the minimal lumen area at the distal reference segments

A network meta-analysis presented by Dr Gregg W. Stone, MD  at European Society of Cardiology congress 2023 showed reduced all-cause mortality and myocardial infarction (MI) rates with percutaneous coronary intervention (PCI) guided by intravascular imaging than with angiography guidance alone.⁸ This includes 20 randomized trials covering 12,428 patients with a mean follow-up of 26.4 months. 16 out of the 20 trials studied in this meta-analysis performed intra-vascular ultrasound (IVUS). Intravascular imaging (IVUS or OCT) guidance of PCI compared with angiography guidance of PCI resulted in​

  • 31% reductions in the primary composite outcome of target lesion failure ​

  • 46% reductions in cardiac death ​

  • 20% reductions in target vessel myocardial infarction ​

  • 29% reductions in target lesion revascularization by 29%,​

  • 52% reduction in stent thrombosis

Intravascular Imaging Guidance for PCI: A Network Meta-analysis

TLF (Direct Evidence): IV Imaging (OCT or IVUS) vs. Angio​ ​

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1. Banning AP, Serruys P, et al. Five-year outcomes after state-of-the-art percutaneous coronary revascularization in patients with de novo three-vessel disease: final results of the SYNTAX II study. Eur Heart J. 2022 Mar 31;43(13):1307-1316. doi: 10.1093/eurheartj/ehab703. PMID: 34617993; PMCID: PMC8970987.

2. Maehara A, Mintz GS, et al. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents. Circ Cardiovasc Interv. 2018 Nov;11(11):e006243. doi: 10.1161/CIRCINTERVENTIONS.117.006243. PMID: 30571206.

3. Fujino A, Maehara A, Mintz G, et al. PREDICTORS OF LEFT MAIN CORONARY ARTERY STENT DIMENSIONS: AN EXCEL TRIAL INTRAVASCULAR ULTRASOUND SUBSTUDY. J Am Coll Cardiol. 2018 Mar, 71 (11_Supplement) A1451. https://doi.org/10.1016/S0735-1097(18)31992-2

4. Gao X, Ge Z, Kong X, et al. 3-Year Outcomes of the ULTIMATE Trial Comparing Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation. J Am Coll Cardiol Intv. 2021 Feb, 14 (3) 247–257. https://doi.org/10.1016/j.jcin.2020.10.001

5. Lee JM, Choi KH, Song YB, et al., on behalf of the RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging– Guided or Angiography-Guided Complex PCI. N Engl J Med 2023; 388:1668-79.

6. Hong S, Mintz G, Ahn C, et al. Effect of Intravascular Ultrasound–Guided Drug-Eluting Stent Implantation. J Am Coll Cardiol Intv. 2020 Jan, 13 (1) 62–71. https://doi.org/10.1016/j.jcin.2019.09.033

7. Lee JM, Choi KH, Song YB, et al., on behalf of the RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging– Guided or Angiography-Guided Complex PCI. N Engl J Med 2023; 388:1668-79.

8. Stone GW. Intravascular imaging guidance for PCI: a “real-time” updated network meta-analysis. Presented at: ESC 2023. August 27, 2023. Amsterdam, the Netherlands.