Mode
Text Size
Log in / Sign up

IVUS-guided PCI shows no significant difference over angiography-guided PCI for primary outcomesTrial shows ultrasound imaging adds no benefit for heart surgery

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Note that IVUS-guided PCI provides no additional benefit over angiography-guided PCI for the primary endpoint.

This multicenter randomized controlled trial evaluated 806 patients with unprotected left main coronary artery disease to compare the efficacy of IVUS-guided PCI versus angiography-guided PCI. The study followed patients for a median of 2.9 years to assess a patient-oriented composite primary outcome including stroke, myocardial infarction, revascularization, or death.

The primary endpoint occurred in 33.7% (135) of the IVUS group compared to 30.9% (125) of the angiography group. The hazard ratio was 1.11 (95% CI, 0.87 to 1.42; P = 0.40), indicating no statistically significant difference between the two guidance methods.

Regarding safety, procedure-related and overall safety events were reported as similar in both groups. No specific data on serious adverse events or discontinuations were provided.

A primary limitation of this study is that the certainty of evidence was not reported. Clinical practice suggests that IVUS-guided PCI does not provide additional benefit over angiography-guided PCI for the primary endpoint in patients with unprotected left main coronary artery disease.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap regarding procedural guidance techniques in patients with left main coronary artery disease. While previous coverage identified an inverse triglyceride relationship with mortality in left main coronary artery disease, this study focuses on the technical comparison of IVUS versus angiography-guided PCI, showing no significant difference in primary outcomes.

When doctors treat a serious blockage in the left main coronary artery, they need to know which tools provide the best results. Some experts suggested that using an ultrasound device (called IVUS) to guide the procedure might offer better precision than traditional X-ray imaging alone. This study aimed to see if that extra technology actually changed patient outcomes.

Researchers followed 806 patients who underwent procedures for this specific heart condition. They split the group into two: one and received ultrasound guidance, while the other used standard angiography (X-ray) guidance. The team looked at a combination of serious events including stroke, heart attack, death, or the need for more surgery over a period of about three years.

Ultimately, the results showed no significant difference between the two methods. Patients in the ultrasound group had a 33.7% rate of major issues compared to 30.9% in the X-ray group, but this gap was not statistically significant. Safety events were also similar for both groups. For now, this suggests that while ultrasound is an option, it does not provide extra protection or better results than standard imaging for these patients.

What this means for you:
Ultrasound guidance did not show any additional benefit over standard X-ray imaging for treating left main artery disease.

Common questions

Does using ultrasound during the procedure make it safer?

The study found that procedure-related and overall safety events were similar for both patients who received ultrasound guidance and those who did not. Because there was no significant difference in safety outcomes between the two groups, the extra imaging step did not provide additional protection.

How many people were involved in this study?

The trial included a total of 806 patients with unprotected left main coronary artery disease. This group was split into two: 401 patients received IVUS-guided procedures, and 405 patients received angiography-guided procedures.

What were the results for heart attacks or strokes?

The primary outcome measured stroke, heart attack, death, or the need for more surgery. The rate of these events was 33.7% in the ultrasound group and 30.9% in the angiography group. This difference was not statistically significant, meaning both methods performed similarly.

Study Details

Study typeRct
Sample sizen = 806
EvidenceLevel 2
Follow-up128.4 mo
PublishedJun 2026
View Original Abstract ↓
BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly used for revascularization of unprotected left main coronary artery disease. Whether intravascular ultrasonographic (IVUS) guidance during PCI results in better clinical outcomes than conventional angiographic guidance alone is uncertain. METHODS: In an international, multicenter, open-label trial, we randomly assigned patients with unprotected left main coronary artery disease in a 1:1 ratio to undergo either IVUS-guided PCI or angiography-guided PCI. The primary end point was a patient-oriented composite of any stroke, any myocardial infarction, any revascularization, or death from any cause at the longest follow-up. RESULTS: A total of 806 patients underwent randomization; 401 were assigned to undergo IVUS-guided PCI and 405 to undergo angiography-guided PCI. The mean (±SD) age of the patients was 71.4±10.7 years, 78.4% of the patients were men, and 34.7% had diabetes. At a median follow-up of 2.9 years, a primary end-point event had occurred in 135 patients (33.7%) in the IVUS-guided PCI group and in 125 patients (30.9%) in the angiography-guided PCI group (hazard ratio, 1.11; 95% confidence interval, 0.87 to 1.42; P = 0.40). The incidence of death, myocardial infarction, or revascularization appeared to be similar in the two groups. The percentages of patients with procedure-related and overall safety events also appeared to be similar in the two groups. CONCLUSIONS: Among patients with unprotected left main coronary artery disease, IVUS-guided PCI showed no additional benefit over angiography-guided PCI with respect to the incidence of stroke, myocardial infarction, any revascularization, or death from any cause at a median follow-up of 2.9 years. (Funded by Philips Image Guided Therapy Devices and Boston Scientific; OPTIMAL ClinicalTrials.gov number, NCT04111770.).
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.