Drug-coated balloons (DCBs) have shown promising efficacy in the endovascular treatment of femoropopliteal artery disease. However, problems such as vascular recoil, residual stenosis and arterial dissection may be encountered during treatment, and there is an urgent need to improve the vascular preparation process and post-treatment techniques for DCB. Intravascular ultrasound (IVUS) can provide detailed information on vessel size and plaque characteristics. However, there are limited data on whether the use of IVUS improves DCB outcomes.
On April 8, local time, Professor Young-Guk Ko from Severance Cardiovascular Hospital in Seoul, South Korea, announced the results of the IVUS-DCB study at the "Late-Breaking Clinical Trials" session of the 73rd American College of Cardiology Annual Meeting (ACC.24). The results of the study showed that IVUS-guided treatment of popliteal artery disease with DCB could achieve significant and long-lasting clinical benefits.
Study design
The IVUS-DCB trial is a prospective, multicenter, randomized study conducted in South Korea to compare the clinical efficacy of IVUS and angiography-guided angioplasty with DCB for popliteal artery disease. A total of 237 patients with symptomatic popliteal artery disease were randomly assigned to IVUS-guided (n=119) and angiography-guided (n=118) in a 1:1 ratio. The primary endpoint was primary patency at 12 months (Figure 1).
Fig.1 Study design
Findings:
The baseline characteristics and lesion characteristics of the two groups were well matched. There are differences in surgical characteristics (Table 1).
Table 1 Surgical features
Immediate surgical results showed that the IVUS-guided group performed better in terms of technical success, surgical success rate, and postoperative ankle-brachial index (ABI) compared with the angiography-guided group (Table 2).
Table 2 Immediate surgical results
Primary patency at 12 months was significantly higher in the IVUS-guided group than in the angiography-guided group (83.8 versus 70.1 percent; P=0.01; Figure 2).
Figure 2 Primary patency rate at 12 months
The IVUS-guided group was significantly better than the angiography-guided group in terms of freedom from clinically driven target lesion revascularization (92.4% vs. 83.0%, P=0.03) and sustained clinical improvement (89.1% vs 76.3%, P=0.02) (Fig. 3).
Fig.3 Freedom from clinically driven target lesion revascularization (left) and sustained clinical improvement (right)
In patients with TASC II lesion class C/D, the primary patency rate at 12 months was significantly higher in the IVUS-guided group than in the angiography-guided group (84.8 versus 58.7 percent; P = 0.002), but in patients with TASC II lesion type A/B, there was no significant difference in major patency rates at 12 months between the IVUS-guided and angiography-guided groups (96.9 versus 94.1 percent; P = 0.52) (Figure 4).
Fig. 4 Primary patency rate at 12 months based on TASC II lesion type
Predictors of increased restenosis include lesion length ≥ 200 mm and subintimal recanalization, and IVUS guidance is associated with a reduced risk of restenosis (Table 3).
Table 3 Restenosis prediction
Conclusions of the study
Compared with the angiography-guided group, IVUS-guided treatment significantly improved the clinical outcome of DCB in the treatment of popliteal artery disease, especially in terms of primary patency at 12 months, freedom from clinically driven target lesion revascularization, and sustained clinical improvement. In complex popliteal artery disease, the benefit of IVUS guidance on primary patency after DCB therapy is more pronounced.
The researchers said
Professor Young-Guk Ko, principal investigator of the study, noted that IVUS is more accurate than angiography in measuring vessel size, helps to obtain sufficient vascular lumen diameter, and helps to assess the response of the target lesion to treatment. Although IVUS may increase the complexity of the procedure, it may benefit patients by improving the outcome of treatment.
Professor Ko said that compared to the angiography group, the IVUS group used a larger pre-dilation balloon diameter and higher pressure before the application of DCB, as well as more frequent post-dilation and higher post-dilation pressure after the application of DCB. These optimizations, based on IVUS assessments, may increase the final lumen diameter and better maintain target vessel patency at 12-month follow-up.
It is important to note that most of the femororopopliteal artery lesions treated in this study are complex and extensive, with an average length of more than 20 cm, and it is unclear whether IVUS has the same benefit for patients with shorter and milder lesions. In addition, the researchers said that the study is only applicable to femoropopliteal artery surgery involving DCB, and further studies are needed to elucidate the possible benefits of IVUS in guiding other types of devices, such as stents, as well as in other peripheral arteries.
Source: ACC official website
Yimaitong is a professional online doctor platform, and the mission of the platform is to "sense the pulse of the world's medicine and help China's clinical decision-making". Yimaitong has a series of products such as "Clinical Guidelines", "Medication Reference", "Medical Literature King", "Yizhiyuan", "eYantong" and "ePulse", which fully meet the needs of medical workers in clinical decision-making, obtaining new knowledge and improving scientific research efficiency.