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Clinical evidence supports the benefits of using intravascular ultrasound (IVUS) throughout the PCI process, generating data and insights to improve both strategic approach and patient outcomes.
Randomized Controlled Trials (RCTs) collectively demonstrate the benefit of IVI (intravascular imaging, IVUS or OCT). In a network meta-analysis of 20 IVI randomized clinical trials, 16 of which included IVUS, IVI is associated with improved patient outcomes.1
In recent study results specific to IVUS, utilization of IVUS-guided PCI vs angiography-guided PCI alone leads to a statistically significant difference in major adverse cardiac events. Subcategories, including complex PCI, long coronary lesions, and acute coronary syndrome, demonstrated similar benefit. 2-5
IVUS-XPL TVF2 (n=1400)
Long lesions (>28mm)
ULTIMATE TVF3 (n=1448)
All-comers
RENOVATE-COMPLEX-PCI TVF4 (n=1639)
Complex lesions
IVUS-ACS TVF5 (n=3505)
Acute coronary syndrome
Using the three criteria below to assess PCI optimization, investigators identified the importance of adapting PCI strategy based on insights revealed through analysis of IVUS imaging.
| Study | Follow-up | Cumulative Incidence of TVF (%) | ||
|---|---|---|---|---|
| Angiography-guided PCI | Sub-optimal IVUS-guided PCI | Optimal IVUS-guided PCI | ||
| IVUS-XPL6 | 1 year | 5.8 | 4.6 | 1.5 |
| ULTIMATE7 | 1 year | 5.4 | 4.4 | 1.6 |
| RENOVATE- COMPLEX-PCI4 | 2.1 years | 12.3 | 8.9 | 6.0 |
| IVUS-ACS5 | 1 year | 7.3 | 7.1 | 3.2 |
Dr. Amit Amin and Dr. Laith Derbas shared late-breaking data at CRT 2024 highlighting the long-term benefits of IVUS use with PCI.8
For additional details and discussion of the findings, watch the video below.
Rafael Cavalcante, vice president Boston Scientific, Interventional Cardiology, Medical & Scientific Affairs speaks with Dr. Amit Amin on research he presented at CRT 2024, “IVUS Use and Long-Term PCI Outcomes in the US: Longest-term IVUS study with 10-year mortality data from the Premier Database.”
IVUS use was associated with lower rates of 1-year (p=0.002) and 10-years (p <0.0001) mortality.
The 2025 ACC Guidelines have designated intravascular ultrasound (IVUS) as a Class 1A recommendation for guiding PCI in ACS patients with complex coronary lesions. The ESC Guidelines implemented a Class 1A indication in 2024. The ACC recommendation is backed by significant clinical studies, including RENOVATE-Complex PCI, IVUS-XPL, and ULTIMATE, which demonstrate IVUS-guided PCI's efficacy in reducing restenosis, stent thrombosis, and major adverse cardiovascular events (MACE). The IVUS-ACS trial further supports these findings, showcasing improved target vessel failure rates and overall clinical outcomes.
Clinical data consistently shows the benefits of using IVUS with Percutaneous Coronary Intervention (PCI).1-8 IVI helps clinicians refine treatment strategy, guide vessel preparation and stent placement or other treatment, and assess procedural results, leading to improved patient outcomes. Though still underutilized, IVUS adoption and momentum continue to grow.
IVUS technology enhancements, including AI-enabled lesion assessment, make PCI optimization achievable, efficient, and, increasingly, a standard of care for Modern PCI. See why current IVUS users choose IVUS to improve their effectiveness and deliver exceptional results for PCI patients.
Learn how to incorporate IVUS insights in all phases of treatment with process guidance, training, and workflow efficiencies. Find the right tools and right support to help you do what’s right for your patients.
1. Stone GW, Christiansen EH, Ali ZA, et al. Intravascular imaging-guided coronary drug-eluting stent implantation: an updated network meta-analysis. Lancet. 2024;403(10429):824-837. doi:10.1016/S0140-6736(23)02454-6
2. 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. doi: 10.1016/j.jcin.2019.09.033
3. 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. doi: 10.1016/j.jcin.2020.10.001
4. Lee, JM, Choi, KH, Lee, JY, et. Al. Intravascular Imaging-Guided or Angiography-Guided Complex PCI. N Engl J Med 2023; 388:1668-1679. doi: 10.1056/NEJMoa2216607
5. Li X, Ge Z, Kan J, et al. Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial. Lancet. 2024;403(10439):1855-1865. doi:10.1016/S0140-6736(24)00282-4
6. Sung-Jin Hong, MD; Byeong-Keuk Kim, MD; Dong-Ho Shin, MD, MPH; et al. Effect of Intravascular Ultrasound–Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation The IVUS-XPL Randomized Clinical Trial. JAMA. 2015;314(20):2155-2163. doi:10.1001/jama.2015.15454
7. Zhang J, Gao X, Kan J, et al. Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial. J Am Coll Cardiol Intv. 2018;72(24):3126-3137. doi: 10.1016/j.jacc.2018.09.013
8. Amin, Amit. IVUS use and long-term PCI outcomes in the United States: Insights from the Premier Database. Presented at: CRT 2024. March 9, 2024. Washington, DC, USA.