November 2, 2022

Final Round of Late-Breaking Clinical Trial Results Announced at VIVA22

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 final Late-Breaking Clinical Trials session at the VIVA22 conference, 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 summaries of this morning's 5 late-breaking clinical trial presentations.

The AFX2 Anatomically Fixated Endograft Has Similar Outcomes to Commercially Available Proximally Fixated Endografts: 5-Year Results of the LEOPARD Trial
Presented by Christopher J. Kwolek, MD, MBA

The LEOPARD (Looking at EVAR Outcomes by Primary Analysis of Randomized Data) trial is the first prospective randomized clinical trial designed to compare relevant clinical outcomes after endovascular aneurysm repair using contemporary commercially available devices.

A total of 455 patients were randomized. 235 patients were treated with a stent graft using anatomic fixation and the AFX/AFX2 device (Endologix) with Duraply, and 220 patients were treated with a stent graft using proximal fixation (91 Endurant [Medtronic], 72 Gore Excluder [Gore & Associates], and 57 Zenith [Cook Medical]). Demographic and anatomic characteristics were similar between the groups.

Patients were followed for 5 years, and an independent core lab was utilized. All device-related events and major adverse events were reviewed and adjudicated by an independent physician.

At 5 years, there was no difference between the anatomic and proximal fixation groups with respect to aneurysm-related mortality, aneurysm rupture, all-cause mortality, reintervention, or limb occlusion. Freedom from open conversion was statistically lower for the AFX group at 5 years at 100% versus 98% for the proximal fixation group (P = .0142).

The primary endpoint was aneurysm-related complications (ARCs) combined with the following: periprocedural death, aneurysm rupture, open conversion, any type of endoleak (I, II, III, IV), limb occlusion, migration > 10 mm, sac enlargement > 5 mm, and device-related reintervention.

Freedom from ARCs was higher at 5 years for the AFX group at 63.8% versus 55.5% for the proximal fixation group and was predominantly driven by the higher type II endoleak rate noted in the proximal fixation group.

In summary, all four devices were effective for preventing aneurysm rupture and aneurysm-related death in over 97% of patients out to 5 years. There was no difference in type I or type III endoleaks noted, and reintervention was required in 15% of patients in both groups at 5 years with minimal need for open conversion. 70% of patients were still alive at 5 years, and thus further follow-up will be necessary to determine long-term outcomes.

Utility of Sirolimus Drug-Eluting Balloons in the Treatment of Complex Below-the-Knee Atherosclerotic Disease in Patients With Chronic Limb-Threatening Ischemia—24Month 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 chronic limb-threatening ischemia (CLTI) is novel. The PRESTIGE study investigated performance outcomes and safety of the Selution sustained limus release (SLR) SEB (MedAlliance SA) for treatment of TASC II C and D tibial occlusive lesions in patients with CLTI from Singapore. We report 24-month results.

PRESTIGE was a prospective, nonrandomized, single-arm, multi-investigator, single-center clinical pilot study. 25 patients (25 limbs; 33 lesions) with Rutherford class 5 wound severity were originally included, and 18/25 (72%) patients were available for 24-month analysis. Collected data included clinically driven target lesion revascularization (CD-TLR), amputation-free survival (AFS), change in Rutherford class, wound status, EQ-5D quality-of-life survey, and Walking Impairment Questionnaire (WIQ).

Baseline demographics included 17 (68.0%) males; mean age was 63.7 ± 9.7 years. Significant comorbidities included diabetes mellitus (n = 22; 88.0%) and end-stage renal failure (n = 11; 44.0%). Fifteen (45.5%) patients had TASC II D lesions, and mean lesion length treated was 19 ± 11 cm. At 24 months, AFS was 75.0% (18/24 patients; 4 deaths and 2 major lower extremity amputations), and freedom from CD-TLR was 87.0%. Mean Rutherford class improved from 5.00 at baseline to 0.44 ± 1.33 (P < .05) at 24 months. The wound healing rate was 94.4% (17/18). Mean EQ-5D visual analogue scale improved from 58.0 ± 9.57 at baseline to 76.7 ± 11.1 (P < .001) at 24 months. WIQ (distance) and WIQ (stairs) generally decreased, albeit insignificant from baseline to 24 months.

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

ELEGANCE: Increasing Diversity in Peripheral Artery Disease Trials
Presented by Maureen P. Kohi, MD

Despite the high prevalence of peripheral artery disease (PAD) in women and underrepresented minorities (URMs), these groups are infrequently included in PAD trials. The ELEGANCE registry is a global, nonrandomized, open-label, prospective, multicenter registry actively collecting real-world data on outcomes following endovascular treatment of PAD, with an emphasis on enrolling diverse patients treated with drug-eluting devices (DEDs). Inclusion criteria included age ≥ 18 years, written informed consent, and treatment with any commercially available Boston Scientific Corporation DEDs marketed for lesions in peripheral artery circulation. ELEGANCE aims to enroll at least 40% each of women and URMs. Patients enrolled will be followed up to 5 years post–index treatment.

As of July 28, 2022, 579 patients (710 lesions) have been enrolled across 46 activated sites in the United States, China, Germany, and Thailand. Mean age is 69.6 years (SD ± 9.7 years); 241 (41.6 %) are female and 235 (40.6%) are URMs. Of these, 117 (20.2%) are Black or of African heritage, 55 (9.5%) are Asian, and 47 (8.1%) are Hispanic/Latino. Comorbidities and risk factors include current (156 [27.4%] patients) or past smoking (292 [51.3%] patients); type 2 diabetes mellitus (305 [52.7%] patients); and history of hyperlipidemia (468 [82.2%] patients) and/or history of hypertension (515 [90.5%] patients) requiring medication. Treatment indications include claudication (370 [66.3%] patients) and chronic limb-threatening ischemia (143 [25.6%] patients). Median lesion length was 100 mm (IQR, 60-200 mm). Of 710 treated lesions, 513 (72.7%) were de novo and 193 (27.3%) were restenotic. Calcification was moderate or severe in 178 (25.3%) and 225 (32.0%) patients, respectively. Among the 538 patients with available Rutherford classification at baseline, 204 (37.9%) were ≥ class 4.

By emphasizing diversity of patients studied, ELEGANCE will improve therapeutic decision-making and clinical outcomes for the management of PAD with DEDs in all populations, including those uncommonly included in PAD trials.

Revascularization Therapy for Femoropopliteal Disease With a Novel Intra-Arterial Stent Graft: 12-Month Results of the TORUS-2 Study
Presented by Ehrin J. Armstrong, MD

The Torus stent graft system (Endologix) represents the first covered stent for the superficial femoral artery (SFA) introduced in nearly 20 years. The goal of the TORUS 2 study is to investigate both the safety and effectiveness of this potential covered stent graft option by comparing results to preestablished performance goals.

The TORUS 2 study is a prospective, single-arm, multicenter, international trial. Follow-up was scheduled at 30 days, 6 months, and then annually through year 3. The primary effectiveness endpoint assesses primary patency at 12 months, which is defined as absence of clinically driven target lesion revascularization (CD-TLR) and recurrent target lesion diameter stenosis > 50% with a peak systolic velocity ratio of > 2.5. The primary safety endpoint is a composite outcome of several major adverse event (MAE) types through 30 days, consisting of all-cause mortality, CD-TLR, and amputation of the target limb.

A total of 188 patients were enrolled and treated with the Torus stent graft system across 34 sites. The mean age is 69.7 ± 8.4 years, 72% are male, and 84% had a Rutherford class ≥ 3. The mean lesion length as assessed by the core lab is 118 ± 44 mm and ranges up to 275 mm. 52% had moderate to severe calcification. Mean maximum stenosis was 89%, ranging from 50% to total occlusion, and 36% of patients presented with a total occlusion of the diseased vessel. Technical success was achieved in 100% of patients. 13% of patients underwent atherectomy. The 30-day MAE rate (141 patients) was 1.4% (2 CD-TLRs were reported at day 14 and 18). Through 1 year, there were four (2.8%) deaths, 24 (17.0%) CD-TLRs, and one (0.7%) target limb amputation. At 1 year, the freedom from CD-TLR was 75.7%.

A Registry-Based Study of Paclitaxel Drug-Coated Balloon Angioplasty for the Treatment of In-Stent Restenosis of the Femoral-Popliteal Artery
Presented by Daniel J. Bertges, MD

The Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) conducted a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) (In.Pact Admiral, Medtronic) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR). The study included 43 sites across the United States and evaluated 300 patients.

Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints included technical success, target vessel revascularization (TVR), major limb amputation, and all-cause mortality.

Patients were typical of the peripheral artery disease population with a mean age of 68 years, 58% male, and 56% with diabetes. The majority had claudication (80% Rutherford class 2-3), while 20% had ischemic rest pain (Rutherford class 4). Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. Mean lesion length was 17.8 ± 11.8 cm. Occlusions were treated in 43% of lesions (mean occluded length, 16 ± 10 cm). Type by TransAtlantic Inter-Society Consensus (TASC) included: TASC A, 17%, TASC B, 29%; TASC C, 38%; and TASC D, 15%.

Based on interim Kaplan-Meier estimates at 12 and 24 months, freedom from any TLR was 90% and 72%, freedom from any TVR was 88% and 68%, freedom from major target limb amputation was 99% and 99%, and all-cause survival was 95% and 89%.

This postmarket registry-based study of the In.Pact Admiral paclitaxel DCB shows promising results in treating femoropopliteal ISR with freedom from TLR of 90% at 1 year. These results demonstrate the ability of the SVS VQI to conduct postmarket evaluation of peripheral devices in partnership with industry and federal regulators.

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