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.
The impact of intravascular ultrasound on femoropopliteal artery endovascular interventions: A randomized controlled trial
JACC Cardiovasc Interv. 2022 Mar 14;15(5):536-546. doi: 10.1016/j.jcin.2022.01.001.
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).
Y-90 radioembolization versus drug-eluting bead chemoembolization for unresectable hepatocellular carcinoma: Results from the TRACE phase ii randomized controlled trial
Radiology. 2022 Mar 8;211806. doi: 10.1148/radiol.211806. Online ahead of print.
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.
Pain outcomes following mechanochemical ablation vs. cyanoacrylate adhesive for the treatment of primary truncal saphenous vein incompetence: The MOCCA randomized clinical trial
JAMA Surg. 2022 May 1;157(5):395-404. doi: 10.1001/jamasurg.2022.0298.
Belramman A, Bootun R, Tang TY, Lane TRA, Davies AH
Importance: Endovenous thermal ablations (ETAs) are recommended as first-line treatment for truncal vein reflux, have a short recovery time and are cost-effective. However, ETAs are associated with discomfort during tumescent anesthesia infiltration. To minimize discomfort, nonthermal, nontumescent ablation techniques had emerged in the form of mechanochemical ablation (MOCA) and cyanoacrylate adhesive injection (CAE).
Objective: To assess pain scores immediately after truncal ablation using a 100-mm visual analog scale and 10-point number scale to compare pain-related outcomes following mechanochemical ablation vs. cyanoacrylate adhesive treatment.
Design, setting and participants: The Multicenter Randomized II Clinical Trial Comparing Mechanochemical Ablation vs. Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Veins Incompetence study was a prospective multicenter randomized clinical trial conducted at three sites between November 2017 and January 2020. Inclusion criteria were primary great or small saphenous varicose veins; exclusion criteria included recurrent varicose veins, current deep venous thrombosis or serious arterial disease. There were 392 participants screened, 225 were excluded and 167 participants underwent randomization. Four participants did not receive allocated intervention and were included in the intention-to-treat analysis. Follow-up took place at 2 weeks and 3, 6, and 12 months.
Interventions: Patients with primary truncal vein incompetence were randomized to receive either MOCA or CAE.
Main outcomes and measures: The primary outcome measure was pain score immediately after completing truncal ablation using a 100-mm visual analog scale (VAS) and a 10-point number scale. Secondary outcome measures included degree of ecchymosis, occlusion rates, clinical severity, and generic and disease-specific quality of life (QoL) scores.
Results: Of 167 study participants, 99 (59.3%) were women, and the mean (SD) age was 56 (15.8) years. Overall, 155 truncal veins treated (92.8%) were great saphenous veins. Demographic data and baseline status were comparable between treatment groups. A total of 73 patients (47%) underwent adjunctive treatment of varicosities. Overall median (IQR) maximum pain score after truncal treatment was 23 mm (10–44) on the VAS and 3 (2–5) on the number scale, showing no significant difference in median (IQR) pain measured by VAS (MOCA, 24 [11.5–44.7] mm vs. CAE, 20 [9.0–42.0] mm; P = .23) or by number scale (MOCA, 4 [2–5] vs. CAE, 3 [2–4]; P = .18). Both groups demonstrated significant and comparable improvement in clinical severity, generic and disease-specific QoL scores, and complete occlusion rates. Four patients treated with CAE developed minor complications (superficial thrombophlebitis and thrombus extensions).
Conclusions and relevance: To our knowledge, this was the first randomized clinical trial directly comparing nontumescent ablation techniques. The study demonstrated that the MOCA and CAE techniques have a similar periprocedural pain score.
Utility and outcome of angioembolization for high-grade renal trauma management in a large hospital-based trauma registry
J Urol. 2022 May;207(5):1077-1085. doi: 10.1097/JU.0000000000002424. Epub 2022 Jan 4.
Hakam N, Amend GM, Nabavizadeh B, Allen IE, Shaw NM, Cuschieri J, Wilson MW, Stein DM, Breyer BN
Purpose: We evaluated angioembolization (AE) use for high-grade renal trauma (HGRT) management and compared AE vs. surgical repair (SR) in requiring nephrectomy.
Materials and methods: Using National Trauma Data Bank® 2013–2018, we identified patients with HGRT who underwent AE or SR as initial management. Therapy failure was defined as performing subsequent nephrectomy, partial nephrectomy, SR or AE. Logistic regression was performed to assess the association between intervention type (AE vs. SR) and nephrectomy. Analysis was repeated in a propensity score-matched cohort constructed by matching AE to SR patients on American Association for the Surgery of Trauma (AAST) grade, injury mechanism (blunt vs. penetrating) and hemodynamic instability (systolic blood pressure <90 mmHg).
Results: There were 266 patients in the AE group and 215 in the SR group. Median age was 29.5 years and 212 patients (44.1%) had penetrating injuries. AE was successful in 94.2% and 85.3% of grade IV and V injuries, respectively, whereas SR was successful in 82.1% and 56%, respectively. Grade V injury was associated with AE failure in the adjusted analysis (OR 3.55, 95% CI 1.22–10.2, p=0.02). Nephrectomy was less likely to be performed after AE vs. after SR in HGRT (6.4% vs. 17.2%, p=0.01), AAST grade IV (4.2% vs. 13.7%, p=0.001) and AAST grade V (12% vs. 44%, p=0.001). The matched cohort comprised 528 patients. In post-match regression, AE, compared to SR, was associated with lower odds of nephrectomy (OR 0.18, 95% CI 0.04–0.70, p=0.013).
Conclusions: AE achieved superior kidney salvage compared to SR in this observational cohort. These results inform both clinical practice and future prospective trials.
