Abstracts from the current literature By Ripal T. Gandhi, MD, FSIR, and Suvranu Ganguli, MD, FSIR
This column alerts SIR members to abstracts that may have an impact on their practice and how they converse with referring clinicians. If you would like to suggest abstracts you feel should be included, email us at
gandhi@baptisthealth.net or
suvranu.ganguli@
bmc.org.
JACC Cardiovasc Interv. 2022 Mar 14;15(5):536-546. doi: 10.1016/j. jcin.2022.01.001.
The impact of intravascular ultrasound on femoropopliteal artery endovascular interventions: A randomized controlled trial
Allan RB, Puckridge PJ, Spark JI, Delaney CL
Objectives: The aim of this study was to investigate whether the addition of intravascular ultrasound (IVUS) guidance during femoropopliteal artery interventions reduced the rate of binary restenosis within 12 months compared with angiographic guidance alone.
Background: IVUS is more accurate than angiography for assessment of vessel size and disease severity. Low-level studies suggest that the use of IVUS in femoropopliteal endovascular interventions improves outcomes, but currently, no level 1 evidence exists.
Methods: This was a prospective single-center trial of 150 patients undergoing femoropopliteal endovascular intervention, randomized (1:1) to guidance by angiography or angiography and IVUS. The primary outcome measure was freedom from binary restenosis, on duplex ultrasound, within 12 months. Secondary outcomes included clinically driven target lesion revascularization, disagreements in imaging findings between modalities, and changes in treatment caused by IVUS.
Results: Freedom from binary restenosis at 12 months was significantly higher in the IVUS group (72.4% vs. 55.4%; P = 0.008). There was no significant difference between groups for clinically directed target lesion revascularization (84.2% and 82.4%; P = 0.776). Mean vessel diameter was significantly larger with IVUS (5.60 mm vs. 5.10 mm; P < 0.001). A change in treatment occurred caused by IVUS in 79% of cases. Binary restenosis was lower in the IVUS group for cases treated with drug-coated balloons (9.1% vs. 37.5%; P = 0.001).
Conclusions: The use of IVUS resulted in a significant reduction in the rate of restenosis after endovascular intervention. This is the first randomized controlled trial to demonstrate that IVUS improves outcomes in femoropopliteal interventions. This benefit may primarily relate to cases treated with drug-coated balloons. (Does the use of intravascular ultrasound improve outcomes of endovascular interventional procedures for peripheral vascular disease of the superficial femoral artery or popliteal artery?; ACTRN12614000006640).
Radiology. 2022 Mar 8;211806. doi: 10.1148/radiol.211806. Online ahead of print.
Y-90 radioembolization versus drug-eluting bead chemoembolization for unresectable hepatocellular carcinoma: Results from the TRACE phase ii randomized controlled trial
Dhondt E, Lambert B, Hermie L, Huyuck L, Vanlangenhove P, Geerts A, Verhelst X, Aerts M, Vanlander E, Berrevoet F, Troisi RI, Vlierberghe HV, Defreyne L.
Background: Transarterial chemoembolization (TACE) is the recommended treatment for intermediate hepatocellular carcinoma (HCC) according to the Barcelona Clinic Liver Cancer guidelines. Prospective uncontrolled studies suggest that yttrium 90 (Y-90) transarterial radioembolization (TARE) is a safe and effective alternative.
Purpose: To compare the efficacy and safety of TARE with TACE for unresectable HCC.
Materials and Methods: In this single-center prospective randomized controlled trial (TRACE), Y-90 glass TARE was compared with doxorubicin drug-eluting bead (DEB) TACE in participants with intermediate-stage HCC, extended to Eastern Cooperative Oncology Group performance status 1 and those with early-stage HCC not eligible for surgery or thermoablation. Participants were recruited between September 2011 and March 2018. The primary end point was time to overall tumor progression (TTP) (Kaplan-Meier analysis) in the intention-to- treat (ITT) and per-protocol (PP) groups.
Results: At interim analysis, 38 participants (median age, 67 years; IQR, 63–72 years; 33 men) were randomized to the TARE arm and 34 (median age, 68 years; IQR, 61–71 years; 30 men) to the DEB-TACE arm (ITT group). Median TTP was 17.1 months in the TARE arm versus 9.5 months in the DEB-TACE arm (ITT group hazard ratio [HR], 0.36; 95% CI: 0.18, 0.70; P = .002) (PP group, 32 and 34 participants, respectively, in each arm; HR, 0.29; 95% CI: 0.14, 0.60; P < .001). Median overall survival was 30.2 months after TARE and 15.6 months after DEB-TACE (ITT group HR, 0.48; 95% CI: 0.28, 0.82; P = .006). Serious adverse events grade 3 or higher (13 of 33 participants [39%] vs. 19 of 36 [53%] after TARE and DEB-TACE, respectively; P = .47) and 30-day mortality (0 of 33 participants [0%] vs. three of 36 [8.3%]; P = .24) were similar in the safety groups. At the interim, the HR for the primary end point, TTP, was less than 0.39, meeting the criteria to halt the study.
Conclusion: With similar safety profile, Y-90 radioembolization conferred superior tumor control and survival compared with chemoembolization using drug-eluting beads in selected participants with early or intermediate hepatocellular carcinoma.
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