Three-Year Outcomes of a Randomized Controlled Trial Investigating the Use of Intravascular Ultrasound in
Richard B Allan1,2, Phillip J Puckridge1,2, Christopher L Delaney1,2
1Department of Vascular and Endovascular Surgery, Flinders Medical Centre, Bedford Park, SA, Australia.
Insights
Intravascular ultrasound (IVUS) guidance combined with angiography significantly reduced binary restenosis rates at 36 months after femoropopliteal endovascular treatment compared to angiography alone. However, no significant differences were observed in clinically-directed target lesion revascularization or major adverse events.
Area of Science:
- Cardiovascular Interventions
- Vascular Surgery
- Medical Imaging
Background:
- Femoropopliteal endovascular procedures are common treatments for peripheral artery disease.
- Binary restenosis remains a significant challenge, impacting long-term outcomes.
- Intravascular ultrasound (IVUS) is an imaging modality that can provide detailed vessel information during interventions.
Purpose of the Study:
- To compare the rate of binary restenosis at 36 months following femoropopliteal endovascular treatment.
- To evaluate the impact of intravascular ultrasound (IVUS) guidance in addition to angiography versus angiography alone on restenosis rates.
- To assess secondary outcomes including clinically-directed target lesion revascularization (cdTLR) and major adverse events (MAEs).
Main Methods:
- A prospective, single-center randomized controlled trial involving 150 patients undergoing femoropopliteal endovascular intervention.
- Patients were randomized 1:1 to receive guidance by angiography alone (control) or by IVUS and angiography (treatment).
- Primary outcome was freedom from binary restenosis (peak systolic velocity ratio ≥ 2.4) at 36 months, with secondary outcomes including cdTLR and MAEs.
Main Results:
- Freedom from binary restenosis at 36 months was significantly higher in the IVUS guidance group (48.8%) compared to the angiography alone group (34.7%) (p=0.011).
- No significant differences were found between the groups for freedom from cdTLR (66.7% vs 64.9%, p=0.697) or MAEs (40.5% vs 32.9%, p=0.397).
- In subgroup analysis, freedom from binary restenosis was notably higher with IVUS guidance for procedures using drug-coated balloons (68.2% vs 47.5%, p=0.005).
Conclusions:
- Combined IVUS and angiography guidance leads to a higher proportion of patients free from binary restenosis at 36 months post-femoropopliteal endovascular treatment.
- While IVUS guidance improves restenosis rates, it did not demonstrate a significant difference in cdTLR or MAEs compared to angiography alone.
- The benefit of IVUS guidance appears particularly pronounced in procedures utilizing drug-coated balloons, warranting further investigation.
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:
ACTRN12614000006640Clinical ImpactThis 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.
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