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IVUS guidance
benefits patients
Clinical evidence
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.
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
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
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”.
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.
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
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
*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
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.
Clinical evidence slides for download
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Key thought leaders
Clinical expertise
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
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