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IVUS-guided PCI did not significantly reduce target-vessel failure compared to angiography-guided PCITrial shows IVUS guidance does not reduce risk for heart patients

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Key Takeaway
Note that routine IVUS-guided PCI did not significantly reduce target-vessel failure compared to angiography-guided PCI.

This international, multi-center randomized controlled trial evaluated the efficacy of IVUS-guided PCI compared to angiography-guided PCI in 2020 patients undergoing complex PCI for coronary artery disease. The study aimed to determine if utilizing intravascular ultrasound (IVUS) with prespecified stent-optimization criteria would improve clinical outcomes over standard angiography guidance.

The intervention group received IVUS-guided PCI with specific optimization protocols, while the comparator group received angiography-guided PCI. The primary outcome was defined as target-vessel failure, a composite endpoint including death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-vessel revascularization. Patients were followed for a median of 19.0 months (IQR 15.2 to 23.4).

Regarding the primary outcome, target-vessel failure occurred in 13.9% of the IVUS group (140 patients) compared to 11.1% in the angiography group (112 patients). The hazard ratio was 1.25 with a 95% CI of 0.97 to 1.60 and a p-value of 0.08. These results indicate that while there was a numerical difference, the finding did not reach statistical significance.

Secondary outcomes included procedure duration, dilation with balloon angioplasty after stent implantation, and procedural complications. Regarding safety and tolerability, procedural complications occurred in 11.3% of the IVUS group versus 10.2% of the angiography group. The frequency of adverse events appeared similar between both groups, suggesting that the addition of IVUS did not significantly compromise patient safety during the procedure.

These results provide a nuanced perspective on the role of IVUS in complex PCI. While IVUS is often utilized to ensure optimal stent expansion and placement, this trial specifically found that routine IVUS-guided PCI was not associated with a lower risk of target-vessel failure than angiography-guided PCI alone in patients undergoing complex high-risk PCI. This finding suggests that while IVUS provides anatomical guidance, its impact on the primary composite endpoint of target-vessel failure did not reach statistical significance in this cohort.

The study noted limitations including limited evidence from current European practice prior to the trial. The trial was funded by Boston Scientific (IVUS-CHIP ClinicalTrials.gov number, NCT04854070). From a clinical standpoint, these results suggest that while IVUS is a viable tool for procedural guidance, it may not necessarily change the primary outcome of target-vessel failure compared to angiography alone in high-risk cases. Questions remain regarding whether specific sub-populations within the complex PCI group might benefit more from IVUS or if longer follow-up periods would reveal differences in late outcomes.

How this fits prior evidence

How this fits prior evidence: This study addresses a gap in understanding the impact of advanced imaging on procedural outcomes for coronary artery disease. While previous findings highlighted that colchicine reduces major adverse cardiovascular events in coronary artery disease and that polymer-free drug-eluting stents show comparable outcomes in PCI, this trial specifically evaluates the role of IVUS guidance versus angiography in high-risk cases.

When a person suffers from coronary artery disease, doctors often need to perform a procedure called PCI. This involves opening up blocked arteries in the heart to restore blood flow. In some cases, these procedures are very complex and high-risk. Because the stakes are so high, medical teams sometimes use advanced tools like IVUS. IVUS is a type of ultrasound that allows doctors to see inside the artery while they place a stent. The goal of using this extra imaging tool is to ensure the stent is placed perfectly, potentially reducing the risk of serious problems like heart attacks or death in these high-risk patients.

To test if this extra step actually helped, researchers conducted a large international study involving 2,020 patients undergoing complex PCI. They split the patients into two groups. One group received guidance from IVUS imaging to help optimize the stent placement. The other group received standard guidance using angiography, which is the traditional X-ray method doctors use to see the heart's blood vessels.

After following the patients for about 19 months, the researchers looked at the primary outcome: target-vessel failure. This term refers to a serious combination of events, including death from heart issues, having a heart attack in the treated area, or needing another procedure to fix the vessel. In the group using IVUS, 13.9% of patients experienced this failure. In the group using standard angiography, 11.1% experienced it. While the number was slightly higher in the IVUS group, the difference was not statistically significant. This means the data did not prove that one method was clearly better or safer than the other.

Regarding safety, the study found that procedural complications were very similar between both groups, occurring in about 11% of patients regardless of which imaging method was used. The procedure times and how well the balloons expanded also showed no major differences between the two methods.

It is important to keep these findings in perspective. While this was a large study with over 2,000 people, it only looked at one specific type of high-risk procedure. Additionally, there was limited evidence from European practices before this trial began. Because the results did not show a significant difference, doctors cannot say that adding IVUS provides an extra layer of safety for these patients right now. For now, both methods are used to manage complex heart conditions, but this study suggests that the advanced ultrasound tool does not currently change the overall success rate compared to standard imaging.

What this means for you:
Advanced ultrasound imaging did not show a significant reduction in risk for high-risk heart procedures.

Study Details

Study typeRct
Sample sizen = 2,020
EvidenceLevel 2
Follow-up828.0 mo
PublishedJun 2026
View Original Abstract ↓
BACKGROUND: Intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) has been associated with increased stent optimization and reduced adverse events among patients with complex coronary-artery lesions, but adoption of this strategy in Western countries remains low. Although practice guidelines recommend intracoronary imaging for anatomically complex lesions, evidence from current European practice is limited. METHODS: In this investigator-initiated, international, open-label, randomized, controlled trial, we assigned patients undergoing complex PCI to either IVUS-guided PCI, performed with the use of prespecified stent-optimization criteria, or angiography-guided PCI. The primary end point was target-vessel failure, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-vessel revascularization. RESULTS: Of the 2020 patients who underwent randomization, 1010 in the IVUS-guided PCI group and 1009 in the angiography-guided PCI group were included in the primary analysis. The mean age of the patients was 69 years, 79.4% were men, and 27.4% presented with an acute coronary syndrome. The mean procedure duration was 88.8 minutes with IVUS-guided PCI and 66.2 minutes with angiography-guided PCI. Dilation with balloon angioplasty after stent implantation was performed in 91.3% of the IVUS-guided PCI procedures and in 84.5% of the angiography-guided PCI procedures. At a median follow-up of 19.0 months (interquartile range, 15.2 to 23.4), target-vessel failure had occurred in 140 patients (13.9%) in the IVUS-guided PCI group and in 112 patients (11.1%) in the angiography-guided PCI group (hazard ratio, 1.25; 95% confidence interval, 0.97 to 1.60; P = 0.08). Procedural complications occurred in 11.3% of the IVUS-guided PCI procedures and in 10.2% of the angiography-guided PCI procedures. The frequency of adverse events appeared to be similar in the two groups. CONCLUSIONS: Among patients undergoing complex high-risk PCI, a strategy of routine IVUS-guided PCI performed with the use of prespecified stent-optimization criteria was not associated with a lower risk of target-vessel failure than angiography-guided PCI alone. (Funded by Boston Scientific; IVUS-CHIP ClinicalTrials.gov number, NCT04854070.).
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