VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announced the next four of 19 highly anticipated late-breaking clinical trial results at VIVA 18 hosted at the Wynn Las Vegas.
PERCUTANEOUS BYPASS FOR THE TREATMENT OF COMPLEX, LONG-SEGMENT PERIPHERAL ARTERY DISEASE WITHIN THE FEMOROPOPLITEAL ARTERY: 18-MONTH PRELIMINARY RESULTS FROM THE DETOUR I TRIAL
Presenter: Ehrin Armstrong, MD
The DETOUR I trial was designed to evaluate the safety and effectiveness of the Detour procedure for percutaneous femoropopliteal bypass. Percutaneous femoropopliteal bypass is achieved using the PQ Detour system (PQ Bypass), including a specialized crossing device, radiopaque snare, and the Torus stent graft. When used in combination, these tools create a path for arterial flow originating in the superficial femoral artery, which then travels through the femoral vein and re-enters in the popliteal artery at the site of reconstitution.
DETOUR I is a prospective, single-arm, multicenter study that enrolled 77 patients and 81 limbs across Europe, New Zealand, and Chile. Inclusion criteria for this clinical evaluation required de novo, in-stent restenotic, or chronic total occlusion lesions that were ≥ 10 cm in length, as well as a femoral vein with a diameter of ≥ 10 mm or the presence of a duplicate femoral vein. Follow-up visits occurred at 30 days, and 3, 6, 12, and 18 months, and will continue through 36 months. Independent review of the data is performed by the Cleveland Clinic core lab and Syntactx clinical events committee at key evaluation points.
Results of the study at 12 months were presented at the Society for Vascular Surgery meeting in June 2018. At 18 months, average lesion length was 37 cm, rate of primary patency was 67.6%, freedom from death was 98.5%, freedom from amputation was 98.6%, and freedom from target lesion revascularization was 74.6%. Rutherford improvement ≥ 1 class was seen in 98.5% of limbs, and ≥ 2 classes in 94%. Additional data evaluating the safety and effectiveness of the Detour procedure will be collected through 36-month follow-up in the DETOUR I trial, and in the DETOUR II United States investigational device exemption study, which is currently enrolling patients. The Detour procedure earned CE Mark approval in February 2017.
ZILVER PTX GLOBAL DATA ANALYSIS FROM FIVE STUDIES AND NEARLY 2,400 PATIENTS HIGHLIGHTS DES BENEFITS IN CHALLENGING PATIENT POPULATIONS
Presenter: Michael D. Dake, MD
A pooled analysis combined all available data from five global studies of the Zilver PTX drug-eluting stent (DES, Cook Medical) including three premarket studies in North America, Asia, and Europe and two postmarket studies in the United States and Japan. Patient and lesion factors impacting freedom from target lesion revascularization (TLR) were evaluated.
Kaplan-Meier analyses were performed with all available data through 5 years. A classification tree analysis was used to rank patient and lesion factors for their impact on TLR. All factors in the classification tree analysis were then evaluated using a Cox proportional hazards ratio model. Clinically driven TLR was defined in all studies as reintervention performed for ≥ 50% diameter stenosis after recurrent clinical symptoms.
In total, nearly 2,400 patients were included in the analysis. There was a high incidence of diabetes (49%); average lesion length was 11.1 ± 8.7 cm; 36% of lesions were totally occluded; and 13% of lesions were treated for in-stent restenosis (ISR). From this pooled analysis, the DES had a 1-year rate of freedom from TLR of 91%. The classification tree analysis revealed that ISR, long lesions (> 15 cm), reference vessel diameter (RVD), and total occlusions were the factors with the most impact on TLR. The Cox proportional hazards ratio model revealed that ISR (P < .001) and total occlusions (P < .001) were significant factors affecting freedom from TLR through 1 year. Lesion length is significant in non-ISR lesions; RVD is significant in nonoccluded lesions. Furthermore, sex, calcification, and diabetes had no significant impact on TLR.
This global analysis of the Zilver PTX DES is the largest dataset reporting 5-year results for endovascular intervention of the superficial femoral artery. The impact of these patient and lesion factors on outcomes can help inform optimal patient selection and treatment algorithms.
PREVEIL EARLY FEASIBILITY STUDY: 12-MONTH DATA ON THE SAFETY AND FUNCTIONALITY OF THE SURMODICS SURVEIL DRUG-COATED BALLOON FOR FEMOROPOPLITEAL LESIONS
Presenter: D. Christopher Metzger, MD
PREVEIL is a United States-based prospective multicenter single-arm study designed to assess the safety and feasibility of the Surmodics SurVeil drug-coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease in de novo lesions of the femoropopliteal arteries. The 12-month results included 13 patients at three clinical sites utilizing the SurVeil DCB in lesions < 90 mm. Clinical assessments include plasma paclitaxel levels over 30 days, primary patency and late lumen loss through 6 months, and changes in Rutherford classification, ankle-brachial index/toe-brachial index, 6-minute walk test, and walking impairment questionnaire (WIQ) at 1, 6, 12, 24, and 36 months. Key secondary safety endpoints included freedom from major vascular complications and evidence of paclitaxel toxicity.
The 12-month data demonstrated that the prespecified safety endpoint was achieved in all subjects. One of 13 patients met duplex ultrasound criteria for restenosis (peak systolic velocity ratio > 2.5). All patients had significant improvement in Rutherford classification, resting ankle-brachial index/toe-brachial index, 6-minute walk test, and WIQ at 12 months. Previously presented data demonstrated that median paclitaxel plasma concentration peaked immediately postprocedure (Cmax 1.07 ng/mL) and was undetectable at 30 days. Secondary technical, device, and procedure success criteria were achieved.
The ongoing positive results from this study demonstrate that the SurVeil DCB has the potential to be a next-generation DCB with improved efficacy of drug transfer.
The SurVeil device includes a proprietary drug-excipient formulation for balloon coating and is manufactured using processes designed to improve coating uniformity. Preclinical data have shown three to five times higher target tissue drug concentration, more evenly distributed and durable drug effect, and lower incidence of downstream drug concentrations compared to control DCBs.
MIMICS-3D REGISTRY INVESTIGATING THE BIOMIMICS 3D STENT IN PATIENTS WITH REAL-WORLD FEMOROPOPLITEAL DISEASE
Presenter: Thomas Zeller, MD, PhD
The BioMimics 3D (Veryan Medical Limited) is a nitinol stent designed to provide optimal radial support, flexibility, durability, visualization, and delivery accuracy for femoropopliteal intervention. Addition of a unique 3D helical centerline provides the advantages of biomechanical stability and swirling blood flow. BioMimics 3D was evaluated in the MIMICS randomized controlled trial (RCT), in which subjects received either a BioMimics 3D helical stent or a straight stent control. Those treated with BioMimics 3D had better primary stent patency at 24 months (P < .05). A second study, MIMICS-2, conducted in the United States, Japan, and Europe, met 30-day safety and 12-month primary patency endpoints, and longer-term outcome data are accruing in the ongoing follow-up through 3 years.
A European registry (MIMICS-3D) is now investigating outcomes in a population consisting of sicker patients with longer, more complex lesions; complementary use with drug-coated balloons occurred in 50% of procedures. MIMICS-3D enrolled 505 subjects at 23 sites. The primary safety endpoint is a composite of major adverse events (MAEs) or clinically driven target lesion revascularization (CD-TLR) through 30 days. Primary outcome measure for effectiveness is freedom from CD-TLR though 12 months. An independent clinical events committee adjudicates MAEs.
Technical success of the BioMimics 3D procedure as assessed by the operator for the entire enrolled population was 98%. Interim data on the first 200 enrolled patients showed that the percentage of subjects with improvement of at least one Rutherford category or more compared to baseline was 88.5% (115/157); 12-month freedom from TLR is 90%, which closely tracks the values for the MIMICS RCT and MIMICS-2 study, despite treatment of more complex disease. In all three studies, there have been no confirmed stent fractures. These emerging data continue to support the hypothesis that intentionally rendering the stented femoropopliteal artery segment helical (and thus imparting swirling blood flow) improves the outcome of peripheral intervention.