VIVA 2017 Late-breaking Clinical Trial Presentations

September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials presented at VIVA 2017 this week. The large vascular conference is sponsored by VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research. 

First Prospective Multicenter Study Evaluating Outcomes Following EVAR in Women vs Men: Early Results From the LUCY Study

Presented by Jennifer Ash, M.D., the LUCY study is the first prospective multicenter study to assess outcomes in women compared to men treated with the Ovation stent graft system (Endologix) for elective abdominal aortic aneurysm repair. The 30-day results of the 76 women and 149 men enrolled show that compared to men, women had more complex anatomy. Technical success was achieved in 100% of the women and 98.6% of the men. No women underwent a secondary intervention for endoleak, occlusion/stenosis, or migration compared to two reinterventions in the male arm for type Ia endoleak. The early results of the LUCY study show that women derive similar benefits with the Ovation system compared to men.

Six-Month Results of the PREVEIL Early Feasibility Study for the SurVeil DCB 

Presented by Gary Ansel, M.D., PREVEIL was a prospective, United States, multicenter, single-arm trial to assess the safety and feasibility of the SurVeil drug-coated balloon (DCB) (Surmodics) in the treatment of subjects with de novo lesions of the femoropopliteal artery. The study enrolled 13 patients at three clinical sites with symptomatic femoropopliteal lesions ≤90 mm in length. Acute success measures of safety were achieved in 100% of subjects. At 6 months, subjects treated with the SurVeil DCB demonstrated primary patency of 100 percent and mean late lumen loss of 0.27 ± 0.54 mm. Subjects experienced significant improvement in Rutherford classification, ankle-brachial/toe-brachial index, 6-minute walk test, and walking impairment questionnaire at 30 days and six months. Median plasma concentration peaked immediately postprocedure (Cmax 1.07 ng/mL) and was undetectable at 30 days. Secondary technical, device, and procedural success criteria were achieved. 

The PRELUDE Study: Prospective Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator Device 

Presented by Marianne Brodmann, M.D., this study evaluates the safety and efficacy of the Serranator Alto percutaneous transluminal angioplasty (PTA) serration balloon catheter (Cagent Vascular) in subjects with atherosclerotic disease of the superficial femoral and popliteal arteries. The device has four external metal serrated strips embedded on a semi-compliant balloon to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion. Subjects with stenosis >70%, lesion length ≤10 cm, and reference vessel diameters of 4 to 6 mm were included. Occlusions were allowed up to 6 cm in length. The primary safety endpoint was a composite of major adverse events plus peri-operative death 30-days post-procedure. The primary efficacy endpoint is defined by device success with a final diameter stenosis <50%. Twenty-five patients were enrolled at four study centers. The average pretreatment stenosis was 88% with a posttreatment stenosis of 23%. Only one stent was placed (4%) post-Serranator. There were no major adverse events or perioperative deaths at 30 days.

Use of a DCB to Treat Obstructive Lesions in the Superficial Femoral and Popliteal Arteries: Preliminary Results from the SAFE-DCB Trial 

Presented by Edward Woo, M.D., the SAFE-DCB is a prospective, United States multicenter study designed to assess the on-label use of the Lutonix 035 drug-coated balloon (DCB) catheter (Bard Peripheral Vascular) for the treatment of de novo or restenotic lesions in the native superficial femoral or popliteal arteries in a real-world patient population. A total of 968 patients at 74 centers fulfilled all the study requirements. This per-protocol group had symptoms of intermittent claudication or critical limb ischemia, obstructive lesions up to 150 mm in length, and reference vessel diameters of 4 to 7 mm. To date, 627 per-protocol patients have reached the 12-month follow-up, and all evaluable 12-month data are included in this analysis. An early look at the primary endpoints showed the 30-day freedom from safety events was 98.5%, while 12-month freedom from target lesion revascularization was 90.8%.

First-in-Human Experience With Endovascular Aneurysm Repair Using the Ovation Alto Stent Graft 

Presented by Sean Lyden, M.D., this case review evaluated the first-in-human experience with the newest-generation Ovation stent graft, the Ovation Alto (Endologix), intended to accommodate the widest range of anatomies for on-label endovascular aneurysm repair (EVAR) compared to other commercially available devices. Described in the review are the first seven patients treated with the Ovation Alto stent graft at a single center from August 2016 to February 2017. The ability of the Ovation Alto to fundamentally expand EVAR indications mainly relate to the unique sealing mechanism and the delivery system. Ovation Alto was successfully delivered and deployed in all patients with 100% technical success. At 30-day follow-up, no type I or III endoleaks, stent graft migrations, abdominal aortic aneurysm rupture, abdominal aortic aneurysm–related mortality, or secondary intervention were reported.

Comparison of Particulate Embolization After Femoral Artery Treatment with IN.PACT Admiral, Ranger, and Stellarex DCBs in Healthy Swine 

Presented by Aloke Finn, M.D. Different combinations of carrier excipients and drug crystallinity unique to individual drug-coated balloons (DCBs) may influence embolic safety characteristics in peripheral vascular territories through embolization of released particulates. This has the potential to cause damage to nontarget tissues downstream of the treated area. A comparator study of three DCBs (3x dosing) in healthy swine was performed to assess the vascular response of the treated vessel and non-target tissues (embolic effects) at 28 days. Paclitaxel was detected in downstream tissues for all DCBs and followed a similar trend.

CAS Benefit: Subgroup Analysis of ACT 1 

Presented by Gary Ansel, M.D., the ACT I clinical trial, a prospective, multicenter, randomized study to support the approval of the Xact rapid exchange carotid stent system (Abbott Vascular) in conjunction with Emboshield embolic protection systems (Abbott Vascular) in the treatment of standard carotid endarterectomy (CEA) risk, asymptomatic extracranial carotid atherosclerotic disease subjects. The current analysis evaluates the performance of carotid artery stenting (CAS) versus CEA out to 5 years in the subgroups of gender (212 women and 278 men) and different atherosclerotic disease burdens. Carotid plus coronary artery disease plus peripheral artery disease was the only subgroup in which patients treated with CAS versus CEA had a higher freedom from death, stroke, or myocardial infarction within 30 days or ipsilateral stroke between 31 days and 5 years and a higher freedom from ipsilateral stroke between 31 days and 5 years. In select subgroups of ACT I, CAS treatment resulted in fewer long-term clinical events at five years compared to CEA. 

MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia in Subjects with Severe PAD: 24-Month Results from the MOBILE Trial 

Presented by John Laird, M.D., the phase 3 MOBILE multicenter study sought to determine if autologous bone marrow–derived progenitor cells (MarrowStim, Zimmer Biomet) could decrease major amputation in patients with critical limb ischemia (CLI). This is the first phase 3 trial in the United States to study bone marrow cell therapy for CLI. There were 152 patients enrolled at 24 sites. The rationale and design of this trial was based on a previous phase 1 trial and used a 3:1 treatment-to-placebo randomization scheme. At 24 months, 71 patients were eligible for analysis. Amputation-free survival was 73.6% in the MarrowStim arm and 50% in the control arm. Cell therapy appears to be durable through 24 months and improved amputation-free survival rates compared to placebo, although analysis is limited by sample size. 

ILLUMENATE European Randomized Trial: Two-Year Results 

Presented by Marianne Brodmann, M.D., the ILLUMENATE European trial was conducted to demonstrate the safety and effectiveness of the 0.035-inch Stellarex DCB (Spectranetics Corporation) for femoropopliteal revascularization. In total, 294 patients were randomized to treatment with the Stellarex DCB or an uncoated PTA balloon at 18 sites in Europe. Patients treated with the DCB maintained a significantly higher primary patency rate of 75.9% versus 61%. In conjunction with the higher patency rate, the rate of clinically driven target lesion revascularization was significantly lower in the DCB group (12.1 vs. 30.5%). Functional outcomes, such as walking impairment questionnaire scores and walking distance, were similar between groups despite there being 60% fewer revascularizations in the DCB group.

Five-year EVAR Outcomes are Equivalent Between Genders: Results from the ENGAGE Registry 

Presented by Mark L. Schermerhorn, M.D., this study compared gender-specific outcomes after endovascular aneurysm repair (EVAR) from a large global registry. There were 133 women (10.5%) and 1,130 men (89.5%) with infrarenal aneurysms treated with the Endurant stent graft (Medtronic) enrolled and followed clinically and radiographically. Women in the registry were older and had smaller aneurysms, narrower proximal aortic neck diameters, shorter nonaneurysmal aortic neck lengths, greater infrarenal angulation, and smaller bilateral iliac artery diameters. Successful delivery and deployment of the Endurant stent graft was achieved in equal numbers of women and men. Through 5 years, there were no aneurysm-related mortalities or ruptures in women; and the rate of freedom from secondary endovascular procedures was similar between the two genders (women, 85.6%; men, 84.1%). At 5 years, the combined rate of abdominal aortic aneurysm diameter stability and shrinkage was similar between genders (women, 89.6%; men, 89.4%). 

DANCE Trial: Two-year Outcomes from the 157-Limb Atherectomy Cohort
    
Presented by George Adams, M.D., the DANCE enrolled 262 subjects, with 157 limbs revascularized using atherectomy and 124 limbs receiving angioplasty. The preliminary two-year primary patency rate is 72.8% and freedom from CD-TLR was seen in 85.2% of subjects. There was no loss of patency seen between months 24 and 25 as the analysis window was closed. Two-year results from the DANCE trial ATX group provide the largest, long-term data set of patency rates in atherectomy subjects with adjunctive local drug therapy. 

Twenty-Four-Month Results of AcoArt I DCB Catheter: Randomized, Multicenter, Controlled Clinical Study in Femoropopliteal Arteries       

Presented by Wei Guo, M.D. Two hundred Chinese patients with peripheral artery occlusive disease were prospectively randomized to treatment with the Orchid drug-coated balloon (DCB) or an uncoated balloon catheter. The primary endpoint was angiographic late lumen loss at six months, which was 0.05 ± 0.73 mm for the DCB group and 1.15 ± 0.89 mm for the uncoated balloon group. After 24 months, the freedom from CD-TLR rate was 86.5 vs. 58.6% (P < .05). There were no significant between-group differences in the rates of death and major amputation (9.4 vs. 9.6%, P = .98). AcoArt I demonstrates safety and efficacy of Orchid DCB in treating femoropopliteal artery disease.

Safety and Efficacy of a Novel Percutaneous Bypass Procedure for Long-Segment Femoropopliteal Lesions > 25 cm: A Sub-Analysis From the PQ Bypass DETOUR I Trial 

Presented by Sean Lyden, M.D., this prospective, multicenter, nonrandomized, single-arm trial is one of the largest prospective series to evaluate the percutaneous treatment of femoropopliteal blockages with lengths of 25 to 45 cm. The primary patency rate was 88.9% at six months with optimal device placement, and an overall primary patency rate of 76.9%. Delivery of devices and removal of the delivery system was successful in 100% of lesions. Improvement in Rutherford class of at least two grades was observed in 92% of patients; 94% of subjects improved ≥ one class over baseline at six months.

Clinical Outcomes Among Vascular Procedure Patients Receiving Suture-Mediated vs. Surgical Cutdown for Closure of Large-Bore Arterial Access 
     
Presented by Darren Schneider, M.D., this retrospective study utilized the IBM Explorys research database, which contains longitudinal patient data for approximately 55 million U.S. patients since 2012. Clinical outcomes and complication rates were compared among patients undergoing closure of large-bore arterial access using the Perclose ProGlide suture-mediated closure system (Abbott Vascular) versus surgical cutdown. A multivariate analysis showed significantly lower complication rates for Perclose patients. During the hospital admission for the procedure, Perclose patients were 80% less likely to require a blood transfusion and 41% less likely to have an infection. In addition, the mortality rate at 30 days was 70% lower among these patients. The average hospital length of stay during the index procedure was significantly shorter for Perclose patients (5.1 days vs. 9 days; P < .001). 

Interim 18-Month Results of the AV Trial: A Randomized Trial of DCB's in Hemodialysis Arteriovenous Fistulae  

Presented by Scott Trerotola, M.D., this randomized trial enrolled 285 patients with dysfunctional AVF. After successful percutaneous transluminal angioplasty, lesions were treated with either a Lutonix DCB (Bard Peripheral Vascular) or a control uncoated balloon. The primary safety endpoint was met and did not differ between groups. The six-month efficacy endpoint was not met with target lesion primary patency (TLPP) of 71% for DCB and 63% for control; however, at the end of the 6-month window, TLPP was superior for DCB (64 vs. 53%, P = .024). Interventions to maintain target lesion patency were fewer for DCB at six months (44/patient vs. 64/patient; 31.3% fewer reinterventions). At interim 18 months, the survival curves remain separated with a 37% improvement in TLPP over control. 

A Unique Bioconvertible Inferior Vena Cava (IVC) Filter: 1-Year Results from the SENTRY Trial

Presented by Michael Dake, M.D. In the SENTRY trial, 129 patients requiring temporary pulmonary embolism (PE) protection were enrolled across 23 sites. The rate of new symptomatic PE through 12 months was 0 percent (0/129). There were no instances of filter tilting, migration, embolization, fracture, IVC perforation through 12 months or device-related deaths. The rate of successful Sentry bioconversion was 95.7 percent at six months and 96.4 percent at 12 months, an improvement over published retrieval rates.

Two-Year Results from the IN.PACT Global Study

Presented by Thomas Zeller, M.D. IN.PACT Global is a multicenter, international, prospective, single-arm study designed to expand on clinical evidence with the In.Pact Admiral drug-coated balloon (DCB) (Medtronic) for the treatment of real-world patients with symptomatic femoropopliteal disease. To date, IN.PACT Global is the largest independently adjudicated DCB study of real-world patients with femoropopliteal artery disease. Two-year results demonstrate consistent and durable clinical performance, and confirm the positive results observed in the IN.PACT SFA randomized trial. 

Insights from the Zilver PTX Study in Japan

Presented by Michael Dake, M.D. The first 900 patients in Japan treated with drug-eluting stents were enrolled in the Zilver PTX study. Nine hundred and five patients with 1,080 lesions were enrolled at 95 institutions. Comorbidities included a high incidence of chronic kidney disease (44 percent) and critical limb ischemia (21 percent). The current study continues to show positive outcomes through four years. For the challenging subgroups evaluated, results were similar and favorable through two years, indicating that the Zilver PTX drug-eluting stent (DES) may be a valid treatment option for patients with these difficult-to-treat lesions. 

Primary Patency of the BioMimics 3D Helical Stent: Significant Outcome from the Mimics Study

Presented by Thomas Zeller, M.D. The BioMimics 3D helical stent (Veryan Medical Ltd.) has a 3-D helical centerline designed to impart nonplanar curvature to the vessel, promoting swirling blood flow. The study randomized 76 patients with symptomatic peripheral artery disease 2:1 to either BioMimics 3D or LifeStent (Bard Peripheral Vascular). A statistically significant difference was observed in primary patency through 24 months. These data support the BioMimics 3D helical stent in primary stenting of complex lesions and point to potential for complementary use with DCBs.

Four-Year Results of the IN.PACT SFA Trial: Drug-Coated Balloon Catheter vs. an Uncoated Balloon Catheter in Femoropopliteal Lesions

Presented by Peter Schneider, M.D. The IN.PACT SFA Trial enrolled 331 patients with symptomatic femoropopliteal lesions. Four-year results demonstrated sustained treatment effect in maintaining significantly higher freedom from CD-TLR by KM estimate in patients treated with the In.Pact Admiral drug-coated balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) despite a late catch-up effect. Among patients requiring re-intervention, the mean time to the first event was significantly longer in the DCB group.

Watch a VIDEO with VIVA Steering Committee member Krishna Rocha-Singh, M.D., explaining advancements in device therapy for hypertension. 
 

Watch the VIDEO “State of Therapy for Critical Limb Ischemia,” with VIVA founding member Michael Jaff, M.D., explaining the current trends and technologies in critical limb (CLI) ischemia. 

For more information: www.vivaphysicians.org

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