Final Five Unpublished Vascular Clinical Trial Results Announced at VIVA 18

LAS VEGAS, Nov. 7, 2018 /PRNewswire/ -- VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announced the final five of 19 highly anticipated late-breaking clinical trial results at VIVA 18 hosted at the Wynn Las Vegas.

Below are highlights of this afternoon’s late-breaking clinical trial presentations.

TREATMENT OF VENOUS ILIOFEMORAL OCCLUSIVE DISEASE WITH A SELF-EXPANDING VENOUS STENT: 12-MONTH RESULTS FROM THE PROSPECTIVE, MULTICENTER VERNACULAR TRIAL
Presenter: Michael D. Dake, MD

VERNACULAR is a prospective multicenter single-arm clinical trial designed to assess the performance of the Venovo venous stent (BD Interventional), a self-expanding stent for the treatment of iliac and femoral vein occlusive disease. A total of 170 patients were treated at 22 centers in the United States, Europe, and Australia.

The primary efficacy measure was 12-month primary patency, defined as freedom from target vessel revascularization and freedom from thrombotic occlusion and stenosis > 50% (duplex ultrasound–derived). Secondary outcomes included the Venous Clinical Severity Score (VCSS) pain assessment and Chronic Venous Insufficiency Quality-of-Life Questionnaire (CIVIQ-20), both hypothesis-tested for improvement at 12 months compared to baseline values. One hundred fifty-six patients completed 12-month follow-up, including 84 patients with post-thrombotic syndrome (PTS) and 72 patients with nonthrombotic iliac vein lesions.

All stents (219) were deployed successfully to the intended location. The 12-month primary patency rate was 88.3%, which was significantly better than a performance goal (74%) derived from the venous stent literature (P < .0001). The VCSS pain score at 12 months improved significantly from baseline, with a mean improvement in the pain score of –1.7 (P < .0001). CIVIQ-20 scores also improved significantly at 12 months from baseline, with a mean improvement of –15.7 (P < .0001). Additional observations included a 12-month freedom from target lesion revascularization of 92.6% (95% CI, 87.5%, 96.1%). Radiographs were assessed by the Yale core lab for stent fractures, with no fractures reported at 12-month follow-up.

One-year results from the VERNACULAR trial demonstrated that the Venovo venous stent could be deployed successfully in obstructive iliac and femoral vein lesions, including acute or chronic deep vein thrombosis, postthrombotic syndrome, or venous compression syndrome (eg, May-Thurner), with a primary patency rate of 88.3%, a low reintervention rate of 7.4%, and no core-lab–assessed stent fractures.

UTILIZING A NOVEL DEVICE TO TREAT BTK DISEASE: DEEPER FIRST-IN-HUMAN RESULTS
Presenter: John R. Laird Jr, MD

The purpose of this trial is to evaluate the safety and efficacy of a novel device, the Reflow Medical Temporary Spur stent system, in conjunction with a drug-coated balloon (DCB). The primary efficacy endpoint of the trial is binary arterial flow of treated lesion sites by continuous wave Doppler through 6 months. The dual primary safety endpoints are freedom from device- and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months postprocedure.

This trial is a prospective single-center nonrandomized single-arm study. Trial enrollment began in October 2017 and was completed in May 2018, with 21 patients having completed trial and procedure enrollment and undergoing follow-up. Twelve patients have completed follow-up through 6 months, and all 21 have completed follow-up out to at least 3 months.

All 21 enrolled patients have met the safety endpoints of the trial to this date, with no clinically driven target lesion revascularization in the group, no major adverse limb events, and freedom from device- and procedure-related death through 30 days postprocedure.

Out of the group that has completed 6-month follow-up, 11 patients (92%) were found to have patent flow by waveform Doppler through 6 months, the primary efficacy endpoint, confirmed by ultrasound/angiogram for Spur/DCB-treated areas. Adjudication of the Doppler ultrasound results and angiographic follow-up results has been conducted with a core lab. The majority of patients in this trial have seen an improvement in clinical outcomes, with an average decrease in Rutherford class score by two classes (max –4, min 0) at 6 months. Of patients with wounds, 88% saw complete wound healing at 6 months and all saw improvement.

SIX-MONTH INTERIM RESULTS FROM THE COPPER BTK COHORT: UTILIZATION OF THE OCCLUSION PERFUSION CATHETER TO ADMINISTER ANTIPROLIFERATIVE MEDICATIONS FOR PAD
Presenter: Pradeep K. Nair, MD, FACC, FSCAI

The study objective was to assess the safety and efficacy of paclitaxel administration using a novel drug delivery catheter (Occlusion Perfusion Catheter, Advanced Catheter Therapies) for the prevention of restenosis in infrapopliteal de novo and restenotic lesions. Restenosis continues to be a great challenge after percutaneous revascularization procedures for peripheral artery disease, particularly for below-the-knee (BTK) applications.

A prospective nonrandomized open-label multicenter registry of a novel delivery catheter delivering liquid paclitaxel after atherectomy and percutaneous transluminal angioplasty was conducted in 35 patients. The primary efficacy endpoint at 6 months is defined as freedom from clinically driven target lesion revascularization (CD-TLR) and target lesion patency as evaluated by duplex Doppler ultrasound. The primary safety endpoint at 1 month is freedom from major adverse events, defined as target limb–related death, major amputation in the target limb, or target lesion revascularization (TLR). A total of 35 patients enrolled in the study, with a lesion length of 111.9 +/– 80.4 mm and a diameter stenosis of 93.7 +/– 8.81%. All patients tolerated the procedure well, with no reports of adverse procedural events. Thirty-one patients have completed their 1-month follow-up, 28 patients have completed their 3-month follow-up, and 21 patients have completed their 6-month follow-up. All subjects are expected to return for 6-month follow-up by January 2019.

In all follow-up cases, only one CD-TLR (4%, N = 24) has been observed. Primary patency at 6 months was 85.7% (N = 21). Additionally, no patients (0%) have experienced major adverse events through 1-month follow-up. The feasibility and initial efficacy of this device is encouraging for this new technique, with the potential as an alternative approach for infrapopliteal revascularization. In particular, the ability to treat very long or multiple lesions with a single device provides a more economical option. The safety profile in this small-cohort study is particularly favorable in view of recent concerns regarding adverse events with DCBs for BTK applications.

STOP-PAD TRIAL: JVS-100 AS AN ADJUNCT TO REVASCULARIZATION FOR NONHEALING WOUNDS
Presenter: Mehdi H. Shishehbor, MD

Efficacy of biologic therapies for critical limb ischemia (CLI) remains elusive, in part due to limitations in trial design and patient selection. Using a novel design, the STOP-PAD trial examined the impact of complementing revascularization therapy with intramuscular JVS-100 (Juventas Therapeutics), a nonviral gene therapy that activates endogenous regenerative repair pathways, on wound healing.

In this double-blind placebo-controlled phase 2B trial, we randomized 109 patients with CLI (Rutherford 5 or 6) to 8-mg or 16-mg intramuscular injections of placebo versus JVS-100. Patients were eligible if they persistently had reduced forefoot perfusion by toe-brachial index (TBI) or skin perfusion pressure (SPP) after successful revascularization with angiographic demonstration of tibial arterial flow to the ankle.

The primary efficacy endpoint was 6-month wound healing score assessed by an independent wound core laboratory. The primary safety endpoint was major adverse limb events (MALE). The mean age was 71 years; 33% were women; 79% had diabetes; and 8% had end-stage renal disease. TBI after revascularization was 0.26, 0.27, and 0.26 among the three groups (placebo, 8-mg, and 16-mg injections, respectively). Only 32% of wounds completely healed at 6 months, without any differences between the three groups (31%, 33%, and 33%, respectively). Similarly, there were no significant changes in TBI at 6 months. Six (5.5%) patients died and four (3.6%) had major amputation. Rates of MALE at 6 months were 24%, 29%, and 11%, respectively.

Although safe, JVS-100 failed to improve wound healing or hemodynamic measures at 6 months. Only one-third of CLI wounds healed at 6 months despite successful revascularization, highlighting the need for additional research in therapies that can improve microcirculation in these patients.

EU STUDY RESULTS OF THE B-LASER ATHERECTOMY CATHETER
Presenter: John R. Laird Jr, MD

The purpose of the study was to evaluate the B-Laser (Eximo Medical) for the treatment of infrainguinal peripheral artery disease. The B-Laser is a novel atherectomy device using an array of optical fibers transmitting short (approximately 10 ns) pulses of 355-nm waves (small solid-state Nd:YAG laser) surrounded by a blunt blade. The catheter has a three-fold higher affinity for ablation of fibrotic material than endothelium, is indifferent to contrast media presence, has aspiration (with the 2-mm and 2.35-mm catheters) and off-centering mechanisms (with the 2.35-mm catheter), and works efficiently in all types of lesions, including calcification.

There were 50 patients with peripheral artery disease (38 were men; mean age, 64 years [45, 82]; Rutherford 2–4 disease) enrolled, with a total of 53 B-Laser treated lesions. Calcification was seen in 88% of lesions and was graded as mild (27%) and moderate/severe (61%). Forty-three (78%) were chronic total occlusions. Average lesion length was 7.4 cm; 45 of 53 (84.9%) lesions were in the superficial femoral artery, and eight (15.1%) were in the superficial femoral/popliteal artery, popliteal artery, and tibioperoneal trunk.

Clinical success was achieved in 100% (53/53) of lesions. There were no perioperative device-related perforations, dissections, or distal embolizations, nor any other device-related complications. Core lab evaluation of baseline stenosis, post–B-Laser and residual stenosis, and average reduction in residual stenosis post B-Laser, were 93.6% ± 13.6%, 58.7% ± 15.1%, and 35.04% ± 14.78%, respectively. Only two target lesion revascularizations were noted at 1-year follow-up (2/46, 4.3%).

The B-Laser is a promising technology for atherectomy of complex heterogeneous lesions. Additional studies are underway.

About VIVA Physicians

VIVA Physicians, 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 for optimal patient care. Educational events presented by VIVA Physicians 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 VIVA Physicians, visit www.vivaphysicians.org.

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