Objectives: Although the clinical utility of intravascular ultrasound (IVUS)-guidance during lower-extreme peripheral vascular interventions (LE-PVI) is well-established, there remains a paucity of long-term outcomes data among patients with peripheral arterial disease (PAD) in Asia. Current evidence suggest that IVUS-use significantly reduces the short-term incidence of vascular complications and major limb events. This study investigates the long-term comparative clinical effectiveness of IVUS-guidance during LE-PVI using real-world evidence (RWE) from Japan, where IVUS has been separately and non-discriminatorily reimbursed since 1994.

Methods: A retrospective, observational study was designed using data from the Medical Data Vision (MDV) database, which included health insurance claims data of inpatient and outpatient episodes from >400 acute-care hospitals in Japan, since April 2008. The analysis includes adult PAD patients undergoing an index LE-PVI between April 2009 to July 2019, who had a pre-existing record in the MDV database. The study population as well as pre-specified patient characteristics, and clinical endpoints are defined using ICD-10 and related disease- and procedure codes. Patient follow-up is censored at either the end of follow-up (July 2020), at repeat LE-PVI event, or at death. The study population is categorized into two groups: index LE-PVI with- and without-IVUS-guidance; latter defined as angiography-alone with no other imaging modalities. The impact of IVUS-guidance on endpoints such as all-cause-mortality, repeat LE-PVI, stroke, acute myocardial infarction, stent thrombosis, major amputations, and composite major adverse limb and cardiac events, are investigated using descriptive statistics, and competing risk survival analysis techniques. Adjustment for potential confounding factors is made through multivariate analyses and propensity-score matching techniques. Sub-group analyses are performed according to critical limb ischemia indication, and by arterial segment of the index LE-PVI.

Conclusions: To our knowledge, this is the first large-scale (N>9,000), RWE study performed to validate the clinical utility of IVUS-guidance during LE-PVI among PAD patients in Asia.