Ultrasound-guided angioplasty beneficial in symptomatic peripheral artery disease
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Key takeaways:
- IVUS-guided angioplasty for peripheral artery disease improved procedural outcomes vs. an angiography-guided approach.
- IVUS also conferred higher 12-month patency and less target lesion revascularization.
ATLANTA — IVUS-guided angioplasty was superior to an angiography-guided approach for improving immediate procedural outcomes and 12-month patency in patients with symptomatic femoropopliteal artery disease, a speaker reported.
The results of the IVUS-DCB trial were presented at the American College of Cardiology Scientific Session.
“Drug-coated balloons have shown favorable outcomes in various studies in treating femoropopliteal artery disease. However, if you use a drug-coated balloon, there are challenges such as vessel recoil, residual stenosis and arterial dissection,” Young-Guk Ko, MD, cardiologist in the division of cardiology at Severance Hospital and Yonsei University in Seoul, South Korea, said during a press conference. “We need to have proper vessel preparation prior to DCB use and also after DCB use, we need to have good optimization to improve DCB outcomes.
“IVUS provides a cross-sectional image of a vessel so we can precisely measure the vessel dimensions and explore the plaque characteristics,” Ko said. “In the field of coronary intervention, similar studies have already shown that IVUS has clinical benefit, especially in complex lesions; however, although there is increased use in the field of peripheral artery intervention, there is still limited clinical data reporting the benefit of IVUS use.”
For the present study, Ko and colleagues enrolled 237 patients with symptomatic femoropopliteal artery disease (mean age, 70 years; 85% men; 80% with hypertension; 60% with diabetes) from seven centers in South Korea to assess outcomes after IVUS-guided paclitaxel-coated balloon angioplasty compared with an angiography-guided approach. All participants were treated with a DCB (IN.PACT Admiral, Medtronic) and were Rutherford category 2 to 5.
Participants were randomly assigned to IVUS- or angiography-guided DCB angioplasty. The primary endpoint was 12-month DCB patency, defined as freedom from restenosis and target lesion revascularization.
Ko said the lesions treated in this study were complex, with an average length of more than 200 mm. He also noted that pre-balloon diameter and maximal pressure were higher in the IVUS arm compared with angiography (P for all < .001). Similarly, additional post-dilation was more frequent (P = .03) and post-dilation pressure was higher (P = .02) in the IVUS group.
Angiography success, defined as absence of residual stenosis less than 30% or flow compromise, was achieved in 76.5% of the IVUS arm and 61% of the angiography arm (P = .001).
“I think in the IVUS group, we treated the target lesion better compared with the angiography group, and this was translated to better outcomes at the 12-month follow-up,” Ko said.
Primary patency of DCB treatment for symptomatic femoropopliteal artery disease at 12 months was 83.8% in the IVUS group compared with 70.1% in the angiography group (HR = 0.46; 95% CI, 0.25-0.85; log-rank P = .01).
In a subgroup analysis, the observed improvement in 12-month primary patency in the IVUS group was mainly driven by higher patency for patients with the more complex TransAtlantic Inter-Society Consensus (TASC) document type C and D lesions compared with angiography (84.8% vs. 58.7%; HR = 0.33; 95% CI, 0.17-0.67; log-rank P = .002), Ko said, noting that in patients with TASC II type A and B lesions, there was no difference between the groups in 12-month patency.
Moreover, 12-month freedom from clinically driven target lesion revascularization was also higher in the IVUS group compared with angiography (92.4% vs. 83%; HR = 0.41; 95% CI, 0.19-0.9; log-rank P = .03).
“IVUS guidance significantly enhanced both the immediate procedural outcomes as well as the 12-month primary outcomes, such as primary patency and freedom from clinically driven target lesion revascularization, and also sustained clinical and hemodynamic outcomes in comparison with angiography guidance,” Ko said during the press conference.
Reference:
- Intravascular ultrasound outperforms angiography for peripheral artery disease treatment. https://www.acc.org/About-ACC/Press-Releases/2024/04/08/14/38/intravascular-ultrasound-outperforms-angiography-for-peripheral-artery-disease-treatment. Published April 8, 2024. Accessed April 16, 2024.
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Ko YG, et al. Late-breaking clinical trials V. Presented at: American College of Cardiology Scientific Session; April 6-8, 2024; Atlanta.
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