Impact of intravascular ultrasound on limb events in endovascular therapy for patients with peripheral arterial disease: insights from the TOMA-CODE registry.

Intravascular ultrasound (IVUS) has become a standard procedure for performing coronary intervention, but its impact on peripheral endovascular therapy (EVT) remains unclear. To assess the usefulness of IVUS during EVT, this study analyzed over 2000 consecutive patients from the TOkyo-taMA peripheral vascular intervention research COmraDE (TOMA-CODE) registry with peripheral arterial disease (PAD) in Japan. The primary outcome was chronic limb events (a composite of clinically driven target lesion revascularization (cTLR) and major amputation) during a two-year follow-up period. The secondary outcomes included the procedural success rate, in-hospital major adverse limb events (MALE), and major cardiac and cerebrovascular events (MACCE). Patients with and without IVUS were compared using propensity score matching. Among the 2227 eligible cases enrolled, with a median follow-up period of 10.4 months, there were no significant differences in limb events between IVUS (784 patients) and non-IVUS (1443 patients) groups during the follow-up period (15.4% vs. 14.4%, P = 0.53, unadjusted; 14.8% vs. 15.4%, P = 0.77, adjusted). In contrast, the IVUS group had higher procedural success rates (98.7% vs. 96.7%, P = 0.02) and lower in-hospital MALE (1.6% vs. 4.1%, P = 0.01), even after multiple adjustments. Additionally, there was no significant difference in the MACCE incidence (10.9% vs. 12.2%, P = 0.47) between the groups. This study demonstrated that IVUS usage did not reduce the occurrence of limb events among EVT patients in the chronic phase, but IVUS may improve in-hospital outcomes. Further research is necessary to verify these findings.