Recent discussions about myocardial infarction have frequently become trending topics online. As a warning sign for heart attacks, the assessment and treatment methods for myocardial ischemia are also drawing significant attention. One diagnostic tool, known as Intravascular Ultrasound (IVUS), has become widely adopted across various levels of medical institutions in recent years, with several Chinese domestic manufacturers entering the field to develop their own IVUS systems.
However, two large-scale European clinical studies recently published in *The New England Journal of Medicine* (NEJM) have challenged the application of IVUS. The trials, named OPTIMAL and IVUS-CHIP, focused on left main coronary artery disease and patients undergoing complex high-risk percutaneous coronary intervention (PCI), respectively. Both studies consistently showed that using IVUS to guide PCI procedures did not significantly reduce the risk of major adverse clinical events for patients compared to guidance by coronary angiography alone.
In China, significant coronary stenosis with typical myocardial ischemia symptoms is a clinical indication for PCI. However, for some "borderline lesions," the traditional coronary angiography's assessment of the degree of vascular stenosis is easily influenced by factors such as projection angle and the physician's subjective judgment, which can lead to overestimation or underestimation of the condition, resulting in either overtreatment or delayed care.
With advancements in medical imaging technology, clinicians now have multiple methods to assess the severity of myocardial ischemia and determine the need for PCI. In this context, numerous past clinical studies have demonstrated that IVUS, as an intravascular imaging modality, can act as a "third eye" for cardiovascular physicians. It compensates for the limitation of coronary angiography, which only provides a two-dimensional "vascular silhouette," by clearly displaying the cross-sectional structure of the vessel wall. By measuring the lumen area and diameter, IVUS allows for precise determination of the indication for PCI. Its role as a "recommended intravascular imaging guidance for complex lesions" with Class IA evidence has been included in global clinical guidelines.
The recent European studies have颠覆ed long-standing beliefs in the medical community, leading to a reassessment of IVUS's clinical value. Several chief cardiovascular physicians expressed that these two European trials have caused "great surprise" within the industry.
Some experts analyze that the controversial results might stem from the fact that the participating clinical centers and operators were highly experienced. Even with angiography alone, they could achieve high-quality surgical outcomes based on their expertise, thereby diminishing the relative advantage of IVUS.
Professor Zhang Yi, Director of the Pan-Vascular Center at Shanghai Tenth People's Hospital, commented on the OPTIMAL study: "The study yielded an unexpected 'negative' result, which is highly颠覆ive and challenges the conventional belief that 'IVUS is essential for left main PCI.' Its core clinical significance is that in the hands of highly skilled and experienced operators, guidance by high-quality angiography alone can achieve comparable clinical outcomes for patients with left main coronary artery lesions." However, he emphasized the need for individualized assessment of each patient's specific condition, building on the insights from studies like OPTIMAL.
Another chief physician from a top-tier hospital's cardiology department noted that many factors can lead to different outcomes in clinical studies, closely related to the trial design itself and the patient population. Therefore, it is possible for studies to reach inconsistent conclusions. He added, "This conversely suggests that the guiding value of IVUS might be even more critical for centers or operators with relatively less experience."
Liu Xuebo from the Department of Cardiology at Tongji Hospital affiliated with Tongji University previously wrote in an article for the *Chinese Journal of Cardiology*: "IVUS can provide a comprehensive assessment of the entire vessel wall, defining the lumen contour and the external elastic membrane, and quantifying plaque burden. As most aneurysms exhibit complex plaque characteristics, and adjacent normal vessels can show pseudo-significant stenosis, analyzing the basic vascular structural morphology is quite necessary. IVUS is the preferred method for assessing aneurysms with a diameter exceeding 5 mm." He also stated that challenges such as aneurysm stenosis, thrombus causing myocardial ischemia, calcification, and difficulty in accurately assessing lumen size present significant hurdles for clinical intervention, and the use of IVUS should be considered.
Furthermore, compared to guidance by coronary angiography alone, IVUS-guided PCI can significantly reduce the risk of post-operative cardiovascular adverse events and the need for repeat procedures, with benefits being particularly clear for patients with complex coronary lesions.
The annual volume of PCI procedures in China has now reached approximately 2 million. In recent years, with the continuous development of domestic IVUS equipment, the penetration rate of IVUS in PCI procedures is in a period of rapid growth, although the overall level remains relatively low, with significant regional disparities.
According to data from Frost & Sullivan, China's IVUS market size was approximately 3 billion yuan in 2023 and is projected to nearly double, reaching close to 6.7 billion yuan by 2030.
Several domestic IVUS products have now received approval for market release. Major manufacturers include LifeTech Scientific (Beixin Shenming), Healium Medical (Hengyu Yiliao), SonoScape Medical (Kaili Yiliao), and Panovision Ascend (Quanjing Hengsheng). The industry landscape, once dominated by multinational giants like Boston Scientific and Philips, is being reshaped.
Regarding the cost of IVUS, with consumables being included in centralized procurement programs in various regions, there has been a significant price reduction. For example, in top-tier hospitals in Shanghai, the cost of IVUS consumables ranges from 4,000 to 5,000 yuan, which remains significantly higher than the cost of coronary angiography consumables, which are around 2,000 yuan.