The investigator-initiated, randomised-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 Prof. Young-Guk Ko (Severance Cardiovascular Hospital; Yonsei University, 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 2 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 haemodynamic results after the treatment,” stated Prof. 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). Prof. Ko pointed out that 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 clinically driven 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).
- 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.
Medical writing support was provided by Karin Drooff, MPHCopyright ©2024 Medicom Medical Publishers
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