October 6, 2021

New Round of Late-Breaking Clinical Trials Announced at VIVA21

LAS VEGAS, Oct. 5, 2021 /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 third round of highly anticipated late-breaking clinical trial results at VIVA21 hosted at Wynn Las Vegas.

VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present a variety of talks and live case presentations from clinical centers around the world. Attendees include an audience of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists.

Below are highlights of this morning's 4 late-breaking clinical trial presentations.

IN.PACT AV Access Study 24-Month Outcomes by Lesion Characteristics
Presented by Robert Lookstein, MD, MHCDL

There is a paucity of adjudicated effectiveness outcomes of drug-coated balloons (DCBs) to treat dysfunctional arteriovenous fistulas (AVFs) beyond 1 year, especially in subgroups that have high rates of reintervention.

IN.PACT AV Access is an independently adjudicated, prospective, global, multi-center, single-blinded study of the treatment of obstructive lesions of a native upper extremity AVF. Participants were randomized to treatment with IN.PACT AV DCB (Medtronic; n = 170) or standard uncoated percutaneous transluminal angioplasty (PTA; n = 160). The effective-ness outcome through 24 months was the rate of target lesion primary patency (TLPP), defined as freedom from clinically driven target lesion revascularization or access circuit thrombosis.

Several subgroups showed statistically significantly higher TLPP results with DCB compared to PTA based on time-to-event analyses through 24 months, including restenotic lesions (46.0% DCB vs 30.2% PTA), radiocephalic AVFs (53.6% DCB vs 43.0% PTA), brachiocephalic AVFs (48.5% DCB vs 27.3% PTA), anastomotic lesions (48.4% DCB vs 32.7% PTA), and lesions in the cannulation zone (74.2% DCB vs 18.9% PTA). TLPP was also observed to be significantly higher with DCB compared to PTA in subgroups determined by maximum treatment balloon diameters: > 6 mm subgroup (52.2% DCB vs 38.9%PTA) and ≤ 6 mm subgroup (52.1% DCB vs 32.6% PTA).

Overall, although sample sizes were small, superior TLPP through 24 months was observed with DCB in restenotic lesions, radiocephalic and brachiocephalic AVFs, and lesions in the anastomosis or in the cannulation zone. Benefits were seen in all other subgroups, although the treatment effect was not statistically significant. With regard to treatment balloon size, the greatest TLPP benefit was in lesions treated with smaller balloon diameters. These results demonstrate the sustained effectiveness of DCBs, suggesting the use of this therapy for patients at high risk of repeat interventions.

The EMINENT Study: Primary Results of the Randomized Trial of Eluvia DES vs Bare-Metal Stents
Presented by Yann Gouëffic, MD, PhD

The EMINENT study was designed to confirm the superior patency of the Eluvia drug-eluting stent (DES; Boston Scientific Corporation) compared with bare-metal stents (BMSs) for the treatment of femoropopliteal artery lesions. This is the largest randomized trial of device treatment for critical limb ischemia in this arterial segment to date.

A total of 775 patients from 58 centers in 10 European countries were randomly assigned to treatment with Eluvia DES (n = 508) or commercially available BMS (n = 267). Mean lesion length was 75.6 mm in the Eluvia arm and 72.2 mm in the BMS arm.

At 12 months, primary patency was statistically significantly greater in patients treated with Eluvia DES versus BMS (Kaplan-Meier estimates of 85.4% and 76.3% at 395 days, log-rank P = .0087), demonstrating the additional value of drug elution. A significantly greater proportion of patients treated with Eluvia DES demonstrated an improvement in Rutherford class by at least one category, without tar-get lesion revascularization (83.0% vs 76.6%; P = .0450). Twelve-month all-cause mortality did not differ significantly between patients treated with the Eluvia paclitaxel-eluting stent versus BMS (2.7% [13/474] vs 1.1% [3/263]; P = .1528). The primary end-point results demonstrate superior patency of the Eluvia DES compared with BMSs when treating femoropopliteal lesions, supporting the benefit of drug elution for increased patency through 1 year.

Utility of Sirolimus Drug-Eluting Balloons in the Treatment of Complex Below-the-Knee Atherosclerotic Disease in Patients With Chronic Limb-Threatening Ischemia: 18-Month Results From the PRESTIGE Study
Presented by Tjun Tang, MD

The use of sirolimus-eluting balloons (SEBs) to improve long-term tibial artery patency in the setting of chronic limb-threatening ischemia (CLTI) is novel. PRESTIGE investigated performance outcomes and the safety profile of the Selution SLR (sustained limus release) SEB (MedAlliance) for treatment of TransAtlantic Inter-Society Consensus (TASC) II C and D tibial occlusive lesions in patients with CLTI from Singapore. We report 18-month results.

PRESTIGE was a pilot, prospective, nonrandomized, single-arm, multi-investigator, single-center clinical study. Twenty-five patients (25 limbs; 33 lesions) with Rutherford class 5 wound severity were originally included. Of the 25 patients, 19 (76%) were available for 18-month analysis. Collected data included clinically driven target lesion revascularization (CD-TLR), amputation-free survival (AFS), change in Rutherford classification, wound status, EuroQoL five dimensions (EW-5D) quality-of-life survey, and Walking Impairment Questionnaire (WIQ).

Baseline demographics included 17 (68.0%) males and a mean age of 63.72 ± 9.73 years. Significant comorbidities included diabetes mellitus (n = 22; 88.0%) and end-stage renal failure (n = 11; 44.0%). Fifteen (45.5%) were TASC II D, and mean lesion length treated was 19 ± 11 cm. At the 18-month time point, AFS was 79.2% (19/24; four deaths and one major lower extremity amputation), the mortality rate was 16.7% (4/24), and freedom from CD-TLR was 88.0%. Mean Rutherford class improved from 5.00 at baseline to 1.42 ± 2.1 (P < .05) at 18 months. The wound healing rate was 78.9% (15/19). Mean EQ-5D improved from 58.0 ± 9.57 at base-line to 75.5 ± 12.0 (P < .001) at 18 months. WIQ (distance) and WIQ (stairs) generally decreased, albeit insignificantly from base-line to 18 months.

Selution SLR SEB remains a safe and efficacious modality in treating complex tibial arterial occlusive lesions in what is an otherwise frail cohort of CLTI patients, with a high prevalence of diabetes and end-stage renal failure. However, a trend of disease progression or recurrence was seen in medium-term outcomes, as reflected by worsening of the WIQ.

Intravascular Lithotripsy for Peripheral Artery Calcification: Interim Analysis of 752 Patients From the Disrupt PAD III Observational Study Presented by Ehrin Armstrong, MD

Disrupt PAD III is a prospective, multicenter, single-arm observational study designed to evaluate the acute safety and effectiveness of the Shockwave peripheral intravascular lithotripsy (IVL) system (Shockwave Medical) for the treatment of calcified peripheral artery disease (PAD) as determined by independent angiographic core lab assessment.

Between November 2017 and June 2019, 752 patients with 852 lesions were enrolled across 18 global sites. Diameter stenosis at baseline was 80.2% ± 18.1%, and 87.9% of lesions were determined to have moderate-severe calcification by Peripheral Academic Research Consortium criteria. IVL treatment was utilized primarily in femoropopliteal arteries (67.1%), followed by iliac (16.7%), common femoral (11.4%), and infrapopliteal arteries (4.8%). IVL treatment of complex lesions were evaluated: chronic total occlusion (CTO; 31.7%), eccentric (19.7%), and long lesions ≥ 15 cm (20.2%). Concomitant use of atherectomy or scoring/cutting balloon was at the discretion of the operator and was performed in 26.1% of treated lesions. Residual stenosis immediately after IVL treatment and at the end of the procedure was 32.3% ± 15.7% and 24.1% ± 11.7%, respectively. The flow-limiting dissection rate was 2.1% immediately following IVL treatment and 0.9% at the end of the procedure. Perforation was infrequent, with two (0.3%) events occur-ring immediately after IVL treatment, with a final perforation rate of 0.1%. There were no abrupt closure, distal embolization, or thrombotic events during any procedure. Safety and effectiveness outcomes were similar across vessel beds and complex lesions, including treatment of CTOs, eccentric lesions, and long lesions.

This study represents the largest analysis to date of periprocedural outcomes following IVL treatment of calcified, stenotic PAD in a “real-world” setting. Use of peripheral IVL demonstrated consistent procedural safety and effectiveness in complex lesions across multiple peripheral vascular beds.

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 have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about the VIVA Foundation, visit https://thevivafoundation.org/.