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Insights into using intravascular ultrasound as a guide for endovascular treatment for patients with femoropopliteal artery disease.

Using intravascular ultrasound (IVUS) as guidance for endovascular treatment in patients with femoropopliteal artery disease outperformed angiography in the IVUS-DCB study. The achievement of primary patency was significantly higher with 83.3% versus 70.1% in favor of IVUS.

The investigator-initiated, randomized-controlled IVUS-DCB trial (NCT03517904) compared IVUS-guided with angiography-guided angioplasty with drug-coated balloons for patients with femoropopliteal artery disease [1]. The main study outcome, presented by Young-Guk Ko, MD, from the Severance Cardiovascular Hospital at Yonsei University in South Korea, was defined as primary patency at 12 months. The 237 participants with femoropopliteal artery disease were predominantly men (85%) with a mean age of around 70 years. The average lesion length was between 204.9 mm and 214.5 mm with about two-third 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 hemodynamic results after the treatment,” stated Dr Ko.

In the intention-to-treat analysis at 12 months, the primary outcome results showed superiority for ultrasound guidance with patency rates of 83.8% in the IVUS group compared with 70.1% on angiography (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,”Dr Ko pointed out.

The percentage of participants free from clinically driven toll-like receptors, 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).

Medical writing support was provided by Karin Drooff, MPH
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