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Peripheral artery disease: procedure-guidance by IVUS superior to angiography

Presented by
Prof. Young-Guk Ko, Severance Cardiovascular Hospital; Yonsei University, South Korea
ACC 2024
Using intravascular ultrasound (IVUS) as guidance for endovascular treatment in patients with femoropopliteal artery disease primary patency outperformed angiography alone in the IVUS-DCB study.

“IVUS provides detailed information on vessel dimensions and plaque characteristics; however, there has been limited clinical data on the benefit of IVUS in the endovascular treatment of femoropopliteal artery disease using drug-coated balloons (DCBs),” Prof. Young-Guk Ko (Severance Cardiovascular Hospital; Yonsei University, South Korea) explained the study background [1].

The investigator-initiated, randomised-controlled IVUS-DCB trial (NCT03517904) compared IVUS-guided with angiography-guided angioplasty with DCB for patients with femoropopliteal artery disease. The main study outcome was defined as primary patency (i.e. absence of clinically driven target lesion revascularisation [CD-TLR] or binary stenosis on imaging) at 12 months. The 237 participants were predominantly men (85%) and had a mean age of around 70 years. The average lesion length was between 204.9 mm and 214.5 mm with about two-third being complex lesions of TransAtlantic Inter-Society Consensus (TASC)2 type C/D.

The immediate procedural outcomes included technical success in 76.5% on IVUS and 61% on angiography (P=0.02) and procedural success in 73.9% compared with 60.2% (P=0.03), respectively. “In the IVUS group, the post-procedural ankle-brachial index was significantly higher, reflecting better haemodynamic results after the treatment,” stated Prof. Ko.

In the intention-to-treat analysis at 12 months, the primary outcome results showed superiority for IVUS guidance with patency rates of 83.8% compared with 70.1% in the angiography group (HR 0.46; 95% CI 0.25–0.85; P=0.01). The per-protocol analysis showed similar results. “When we broke down the target lesions according to their complexity into the TASC2 A/B subgroup and the TASC2 C/D subgroup, the clinical benefit in terms of primary patency was evident only in complex lesions,” Prof. Ko added.

The percentage of participants free from CD-TLR, a secondary endpoint, was 92.4% compared with 83.0% (HR 0.41; 95% CI 0.19–0.90; P=0.03). Among the significant predictors of re-stenosis identified by a univariate model were lesion length ≥200 mm (P=0.002) and post-procedural minimal lumen diameter (P<0.001).

  1. Ko YG. Comparison of Intravascular Ultrasound-guided versus Angiography-guided Angioplasty for the Outcomes of Drug-coated Balloon in the Treatment of Femoropopliteal Artery Disease. LB5, Session 412, ACC 2024 Scientific Session, 6–8 April, Atlanta, USA.

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