Late-Breaking Clinical Trial Results Announced at The VEINS 2024

LAS VEGAS, Nov. 3, 2024 /PRNewswire/ -- The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the results for the Late-Breaking Clinical Trials presented at The VEINS conference, at Wynn Las Vegas.

The VEINS (Venous Endovascular INterventional Strategies) is an annual venous education symposium that brings together a global, multispecialty faculty to present a comprehensive variety of lectures and case presentations focused on venous care. The audience is comprised of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists. Below are highlights of this morning's 4 late-breaking clinical trial presentations.

 Clot Burden Reduction With a Novel Thrombectomy Device for the Treatment of Acute Pulmonary Embolism: RV/LV ratio and MMS Reductions Observed in the Pilot ENGULF Trial
Presented by Julie Bulman, MD

The ENGULF trial is a two-phase, prospective, single-arm study assessing the safety, feasibility, and efficacy of the novel Hēlo PE Thrombectomy System (Endovascular Engineering), a moderate-bore catheter with a flexible and expandable funnel and an internal agitator for the treatment of acute pulmonary embolism (PE). In the feasibility phase, core lab–adjudicated right ventricular/left ventricular (RV/LV) ratio and modified Miller score (MMS) reductions were reported in 25 patients, along with the primary safety endpoints. Patients with intermediate-risk PE underwent a preprocedural and 48-hour postprocedural CT scan. The primary efficacy outcome was the core lab–adjudicated difference in the pre- to postprocedural RV/LV ratio. Pre- and post-CTA scans were also reviewed for a reduction in MMS. Primary and secondary safety outcomes were all-cause mortality, major life-threatening bleeding, device-related serious adverse events, pulmonary or cardiac injury, and clinical decompensation at 48 hours and 30 days postprocedure.

Of 25 patients from eight centers, baseline CT scans revealed a mean RV/LV ratio of 1.53 ± 0.27 and MMS of 15.68 ± 0.95. Embolectomy was successfully performed in all patients. The postprocedure mean RV/LV ratio was 1.15 ± 0.18, representing a 23.2% ± 12.81% reduction, and postprocedure MMS reduction was -2.6 ± 2.4, representing a 16.5% ± 15.3% reduction. Reduction in clot burden was measured and core lab adjudicated, demonstrating a 83.8% ± 22.4% reduction in targeted vessels. There were no major adverse events at 48 hours and no deaths at 30 days. Anemia requiring transfusion but not meeting major bleeding criteria occurred in two patients postprocedure. The novel Hēlo PE Thrombectomy System was safe and effective in treating acute PE and provides a notable reduction in core lab–adjudicated CTA thrombus burden.

Randomized Controlled Trial Comparing Cyanoacrylate Closure to Surgical Stripping: Spectrum Program Secondary Outcomes Through 6 Months
Presented by: Manj Gohel, MD

The VenaSeal Spectrum Surgical Stripping study is a randomized controlled trial comparing cyanoacrylate closure (CAC) using VenaSeal (Medtronic) to surgical stripping (SS), the standard care in several countries. At six sites in three countries, participants with CEAP (clinical, etiology, anatomy, pathophysiology) C2 to C5 disease were included, and multiple clinical, patient-reported anatomic and safety outcomes were assessed through 6 months.

Previously presented early outcomes demonstrated higher patient satisfaction at 30 days in participants randomized to CAC compared to SS. At 30 days, improvements in revised Venous Clinical Severity Score (rVCSS) and Aberdeen Varicose Vein Questionnaire (AVVQ) trended in favor of CAC (P = .0086 and P = .0039, respectively) and were similar at 6 months. Postprocedure pain scores were similar in the CAC and SS groups, although general anesthesia was commonly used for SS. Changes in EuroQoL five dimensions and 36-Item Short Form Health Survey from baseline to 6 months were similar between groups. No physicians using CAC expressed neutrality or dissatisfaction, whereas 20.9% of SS physicians were neutral and 7% were dissatisfied with the procedure. Hypersensitivity to CAC occurred in 11.3% of participants, with most being self-limiting. There were no cases of granuloma or endovenous glue-induced thrombosis. Serious adverse event rates were low, with one event (1.9%) after CAC and two events (3.8%) after SS. More participants receiving CAC returned to work through 6 months compared to SS (85.7% [30/35] vs 73.7% [28/38]). Technical success in both groups was 100%.

Participants treated with CAC showed trends toward greater improvements in rVCSS and AVVQ at 30 days compared to SS. The safety profile was good in both groups.

Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the Duo Venous Stent System: 24-Month Results from the VIVID Trial
Presented by: Mahmood Razavi, MD

The VIVID study investigated the safety and efficacy of the Duo Venous Stent System (Philips) for the treatment of patients with nonmalignant iliofemoral occlusive disease. VIVID was a prospective, multicenter, single-arm study conducted in the United States and Poland. Study centers enrolled patients with nonthrombotic, acute thrombotic or chronic postthrombotic clinically significant venous outflow obstruction. The primary safety endpoint was freedom from major adverse events at 30 days postindex procedure. The primary efficacy endpoint was primary patency of the stented segment at 12 months. The 12-month primary endpoints were met and presented previously.

The purpose of this study is to report the 24-month outcomes. Secondary and observational endpoints collected through 24 and 36 months include primary patency, primary assisted patency, secondary patency, clinically driven target lesion revascularization (CD-TLR), clinically driven target vessel revascularization (CD-TVR), major adverse events, and patient-reported outcomes. Primary patency at 24 months was 89.9%. The Kaplan-Meier estimates of freedom from CD-TLR and CD-TVR were 94.1% and 93.4%, respectively. Primary assisted patency and secondary patency were 95.7% and 96.5%, respectively. The 24-month Kaplan-Meier estimate of freedom from major adverse events was 92.7%. There were no reports of stent fracture, migration, or embolization through 24 months.

These data confirm the safety and efficacy of the Duo Venous Stent System in treating patients with nonthrombotic, acute thrombotic or chronic postthrombotic venous outflow obstruction.

Intra-Venous Fluid Challenge Results in Significant Change to Deep Pelvic Vein Cross-Sectional Area
Presented by: Khanjan Nagarsheth, MD, MBA

Raju et al described the 200-150-125 rule for the cross-sectional area (CSA) of the common iliac, external iliac, and common femoral veins (CIV, EIV, CFV).¹ This study assessed the effects of intravascular volume expansion on deep pelvic vein size.

Between August 2021 and April 2024, 73 patients underwent diagnostic venography with intravascular ultrasound (IVUS) for suspected deep pelvic vein stenosis. Patients received 500 mL of intravenous fluid, followed by a 20-minute wait. IVUS measurements were taken before and after hydration in the left CIV, EIV, and CFV.

Of these patients, 87.6% were female, with a mean age of 31.8 ± 11.2 years and a mean body mass index of 29.3 ± 7.8 kg/m². The left lower extremity was affected in 75.3% of cases.

Statistically significant changes in CSA were observed in all vein segments after fluid administration:

• Left CIV: 149.7 mm² to 191.6 mm² (P < .001)
• Left EIV: 115.8 mm² to 138.8 mm² (P < .001)
• Left CFV: 91.9 mm² to 109.1 mm² (P < .001)

Left CIV stenosis (≥ 50% stenosis compared to adjacent reference area) was seen in 28.8% of patients. In this subset, CSA changed from 62.9 mm2 to 95.8 mm² (P < .001), with 76.2% of cases changing to < 50% stenosis after fluid administration.

Intravascular volume expansion prior to venography with IVUS shows an increase in deep pelvic vein CSA. A hypovolemic state, which may exist in patients receiving nothing by mouth before venography, may underestimate deep pelvic vein size.² Patient fluid status should be considered before performing these studies and intervening for deep pelvic vein stenosis.

1. Raju S, Davis M. Anomalous features of iliac vein stenosis that affect diagnosis and treatment. J Vasc Surg Venous Lymphat Disord. 2014;2:260-267. doi: 10.1016/j.jvsv.2013.12.004
2. Lee JS, Song Y, Kim JY, Park JS, Yoon DS. Effects of preoperative oral carbohydrates on quality of recovery in laparoscopic cholecystectomy: a randomized, double blind, placebo-controlled trial. World J Surg. 2018;42:3150-3157. doi: 10.1007/s00268-018-4717-4

About the VIVA Foundation
The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide.

SOURCE The VIVA Foundation