Three-Year Outcomes of a Randomized Controlled Trial Investigating the Use of Intravascular Ultrasound in Femoropopliteal Endovascular Interventions

Objective: To investigate whether there was a difference in the rate of binary restenosis at 36 months post-endovascular treatment between procedures guided by addition of intravascular ultrasound (IVUS) guidance and procedures guided by angiography alone. 

Materials and Methods: This was a prospective single-center trial of 150 patients undergoing femoropopliteal endovascular intervention, randomized (1:1) to a control group (guidance by angiography) or treatment group (guidance by IVUS and angiography). Follow-up of outcome measures was up to 36 months. The primary outcome measure was freedom from binary restenosis as defined by a peak systolic velocity ratio ≥ 2.4 on duplex ultrasound. Secondary outcomes included clinically-directed target lesion revascularization (cdTLR) and major adverse events (MAEs). Analysis of binary restenosis and directed target lesion revascularization by treatment subgroup was also performed. 

Results: Freedom from binary restenosis up to 36 months post-procedure was significantly higher in the treatment group (IVUS and angiographic guidance) (48.8% vs 34.7%, p=0.011). There was no difference between the groups in freedom from cdTLR (66.7% vs 64.9%, p=0.697) or MAEs (40.5% vs 32.9%, p=0.397). Freedom from binary restenosis was higher in the treatment group for cases treated with drug-coated balloons (68.2% vs 47.5%, p=0.005). 

Conclusions: Guidance with combined IVUS and angiography resulted in a higher proportion of cases remaining free of binary restenosis at 36 months compared with cases guided by angiography alone but no difference was seen between the groups for cdTLR. 

Clinical Trials Registry: ACTRN12614000006640 

Clinical Impact: This randomised controlled trial comparing 3 year outcomes for femoropopliteal endovascular procedures guided either by angiography or by angiography and intravascular ultrasound (IVUS) found that the binary restenosis rates was lower when IVUS guidance was included. This represents the longest duration prospective evidence supporting the use of IVUS. The long-term clinical benefit of IVUS are less clear as there was no difference in target lesion revascularisation rates. The benefit appears to be primarily related to drug-coated balloon treatment and further studies powered specifically for this treatment are required to confirm whether clinical benefits are present.