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    IVUS guidance
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    IVUS icon

    IVUS imaging helps you decide, guide and confirm the right interventional treatment for each patient. IVUS-guided strategies are backed by various studies and The Society for Cardiac Angiography and Interventions (SCAI) expert consensus statement states that IVUS is “definitely beneficial”.1 Explore the various studies below to learn more.

    Intravascular imaging-guided coronary drug-eluting stent implantation: an updated network meta-analysis

    For this systematic review and updated meta-analysis, investigators searched the publication databases from inception through August 30, 2023, for studies that randomly assigned patients undergoing PCI with drug-eluting stents to either IVUS or OCT, or both, or to angiography alone to guide their interventions.

    • 22 trials were identified in which 15,964 patients were randomized
    • Compared with angiography guidance, intravascular imaging guidance of coronary stent implantation with OCT or intravascular ultrasound enhances both the safety and effectiveness of PCI, reducing the risks of death, myocardial infarction, repeat revascularization, and stent thrombosis.

    Meta analysis of 22 randomized controlled trials with nearly 16,000 patients reinforces the benefits of image-guided PCI
    Imaging improves outcomes and saves lives14

    Imaging improves outcomes

    RENOVATE-COMPLEX-PCI

    Intravascular image–guided PCI with IVUS or OCT versus angiography-guided PCI in patients with complex coronary-artery lesions 

    • 1639 patients with complex coronary-artery lesions randomized 2:1 to undergo either intravascular image–guided PCI or angiography-guided PCI 
    • IVI could be used at any time during the PCI procedure but was mandated after stent implantation
    • 2.1-year median follow-up


    Conclusion: Intravascular image-guided PCI was associated with a lower incidence of a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization compared to angiography guided PCI.

    Renovate Complex PCI
    Renovate Complex PCI

    ULTIMATE RCT 3-year outcome data

    Intravascular ultrasound-guided versus angiography-guided implantation of drug-eluting stent in all-comers.6

    “Routine IVUS-guided DES implantation is associated with fewer major adverse cardiac events (MACE) compared with angiography guidance for patients with individual lesion subset. However, prior to the ULTIMATE trial the beneficiary effect on MACE outcome from IVUS-guidance over angiography-guidance in all-comers who undergo DES implantation remained understudied.”
    — Zhang J et al 6

    Compared to angiography-guided PCI alone, in all comer patients, ULTIMATE shows that IVUS-guided PCI significantly reduces clinically driven Target Lesion Revascularization (TLR). This benefit was sustained over three years. Only 1.6% TVF* at 12 months and 4.2% TVF at 3 years when optimal IVUS-guided PCI criteria was met.

    Primary endpoint based on patient-level comparison

    Primary endpoint on patient level comparison
    86 percent l m

    54% reduced rate of TVF at 3-years when optimal IVUS-guided PCI criteria was met.

    Imaging standardization with 3 IVUS defined

    criteria to achieve optimal PCI

    3 IVUS defined criteria

    Plaque burden at the 5-mm proximal or distal to the stent edge <50%.

    Expansion satisfactory: Minimal lumen CSA in stented segment >5mm2, or 90% of distal reference lumen CSA.

    No edge dissection involving media with length >3mm.

    IVUS-XPL 5-year outcomes

    Reduction in MACE2


    The IVUS-XPL study was a prospective, multi-center, randomized trial resulting in:

    • 1,400 patients receiving Xience Prime stents ≥28 mm randomized (700 IVUS-guided, 700 angiography-guided) at 20 centers.
    • “Sustained 5-year clinical benefits resulted from both within 1 year and from 1 to 5 years’ post-implantation”.

    Ivus xpl
    Reduction in mace
    Reduction in mace graph

    ADAPT-DES

    PCI strategy changed 74% of the time3


    The ADAPT-DES study reported that IVUS guidance was associated with a change in PCI strategy 74% of the time.3 Most often, the impact was a larger sized stent or balloon, higher inflation pressures or post-dilation. Furthermore, the study reported that larger stent areas resulted in cases where both pre-and post-PCI IVUS were performed compared to when only post-PCI IVUS was performed.

    PCI strategy graph
    PCI strategy graph

    34% reduction in MACE5

    The ADAPT-DES study reported that IVUS guidance was associated with a 34% reduction in major adverse cardiac events (MACE) at 2 years (4.9% vs 7.4%, p < 0.001).5

    Reduction in mace graph

    34%

    reduction in MACE associated with IVUS guidance
     

    Relationship between IVUS use and MACE (definite/probable ST, cardiac death, MI) within 2 years

    Meta-analysis


    Meta-analyses of a combined 39 distinct studies and more than 36,000 patients show that IVUS-guided DES stenting is associated with reduced MACE. 7,8,9,10,11

    Ahh meta analysis table

    *Duplicated patients participating in the studies have been removed.

    Source

    The American Journal of Cardiology

    Circulations Cardiovascular Interventions

    International Journal of Cardiology

    EuroIntervention

    JACC Cardiovascular Interventions

    Total

    Author

    Ahn JM

    Elgendy IY

    Klersey C

    Zhang YJ

    Jang JS

    IVUS patients

    12499

    1593

    9965

    8102

    11793

    15469*

    Total DES patients

    26503

    3192

    18707

    19619

    24849

    36831*

    *Duplicated patients participating in the studies have been removed.

    Meta-analysis

    Meta-analyses of a combined 39 distinct studies and more than 36,000 patients show that IVUS-guided DES stenting


    is associated with reduced MACE 7,8,9,10,11

    Source

    Author

    IVUS patients

    DES patients

    The American Journal of Cardiology

    Ahn JM

    12499

    26503

    Circulations Cardiovascular Interventions

    Elgendy IY

    1593

    3192

    International Journal of Cardiology

    Klersey C

    9965

    18707

    EuroIntervention

    Zhang YJ

    8102

    19619

    JACC Cardiovascular Interventions

    Jang JS

    11793

    24849

    Total

    15469

    36831

    *Duplicated patients participating in the studies have been removed.

       

    Samsung registry 
    43% lower risk of cardiac death12

     

    6,005 patients who had at least one complex lesion undergoing PCI with drug-eluting stents were enrolled in a prospective institutional registry. IVUS guidance was used on 1,674 enrolled patients. IVUS-guided PCI was associated with 43% lower risk of cardiac death during 64 months of median follow-up compared with angiography-guided PCI.12

    Clinical outcomes

    Clinical outcomes
    Samsung registry table

    Economic impact of IVUS
    IVUS-guided PCI with DES is a dominant treatment option vs. angiography13

    An analysis of IVUS-guided PCI and angiography-guided PCI from an Italian healthcare payer perspective found that IVUS-guided PCI with DES is a dominant treatment option compared to angiography-guided PCI with DES.13


    • The analysis modeled incremental cost effectiveness based on DRG tariffs and outcomes data from the Ahn meta-analysis.

    • Most data points are in the south-east quadrant indicating better outcomes and lower costs with IVUS-guidance versus angiography alone.
    • Cost savings increased in patients with diabetes, renal insufficiency, or ACS and were associated with less MI and revascularization.

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    Philips elite academy logo

    Philips ELIITE Academy is focused on delivering high value and real-time strategic educational programs that meet the evolving needs of our customers. For more information on the available courses, please visit www.igtdacademy.philips.com.

    Keythought leaders icon

    Key thought leaders

    Clinical expertise icon

    Clinical expertise

    Product knowledge icon

    Product knowledge 

    1. Klersey C, et al. Use of IVUS guided coronary stenting with drug eluting stent: A systematic review and meta-analysis of randomized controlled clinical trials and high quality observational studies. Int J Cardiol. 2013 Dec 5;170(1):54-63.

    2. Hong S-J, et al. “Effect of Intravascular Ultrasound-guided Drug-Eluting Stent Implantation: Five-Year Follow-Up of the IVUS-XPL Randomized Trial, JACC: Cardiovascular Interventions (2019), doi: https://doi.org/10.1016/j.jcin.2019.09.033

    3. Witzenbichler B, Maehara A, Weisz G, et al. Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: the assessment of dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study. Circulation. 2014;129(4):463-470.

    4. A. Maehara, ADAPT-DES IVUS Substudy: Utility of IVUS in delineating the Mechanism of and Preventing Stent Thrombosis, TCT Presentation October 24, 2012

    5. Maehara A. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents. Circ Cardiovasc Interv. 2018 Nov;11(11):e006243

    6. Zhang J et al. The ULTIMATE trial. Journal of the American College of Cardiology (2018), doi.org/10.1016/j.jacc.2018.09.013

    7. Ahn JM, Kang SJ, Yoon SH, et al. Meta-analysis of outcomes after intravascular ultrasound-guided versus angiography-guided drug-eluting stent implantation in 26,503 patients enrolled in three randomized trials and 14 observational studies. Am J Cardiol. 2014;113:1338-1347.

    8. Elgendy IY et al. Outomes with Intravascular Ultrasound-Guided Stent Implantation: A Meta-Analysis of Randomized Trials in the Era of Drug-Eluting Stents. Circ Cardiovasc Interv. 2016;9:e003700

    9. Jang JS, et al. Intravascular Ultrasound-Guided Implantation of Drug-Eluting Stents to Improve Outcome, A Meta-Analysis. J Am Coll Cardiol Intv. 2014;7(3):233-243

    10. Zhang YJ, et al. Comparison of intravascular ultrasound versus angiography-guided drug-eluting stent implantation: a meta-analysis of one randomized trial and ten observational studies involving 19,619 patients. EuroIntervention. 2013;9:891-892

    11. Klersey C, et al. Use of IVUS guided coronary stenting with drug eluting stent: A systematic review and meta-analysis of randomized controlled clinical trials and high quality observational studies. Int J Cardiol. 2013 Dec 5;170(1):54-63.

    12. Choi KH, Song YB, Lee JM, et al. Impact of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention on Long-Term Clinical Outcomes in Patients Undergoing Complex Procedures. JACC Cardiovasc Interv. 2019;12:607–20.

    13. Alberti. Understanding the economic impact of intravascular ultrasound. Eur J Health Econ (2016) 17:185–193

    14. G.W. Stone et al.  https://doi.org/10.1016/S0140-6736(23)02454-6

    15. Lee, J.M et al published on March, 5 2023, at NEJM.org DOI: 10.1056/NEJMoa2216607

     

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