Five New Late-Breaking Endovascular Clinical Trial Results Announced at VIVA 16
LAS VEGAS, Sept. 20, 2016 /PRNewswire-USNewswire/ -- VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces highly anticipated late-breaking clinical trial results at VIVA 16 hosted at the Wynn Las Vegas.
Below are highlights of today's late-breaking clinical trial presentations. Full summaries and data can be found at viva.vporoom.com:
ENDOVASCULAR REPAIR IN ACUTE, COMPLICATED TYPE B AORTIC DISSECTION: 3-YEAR RESULTS FROM THE VALIANT US-IDE STUDY
Presenter: Ali Azizzadeh, MD
Patients with acute, complicated type B aortic dissections are reported to have a > 50% likelihood of dying from this disease. Patients in this category at 16 clinical sites in the United States were included in the Medtronic DISSECTION US IDE trial, a multicenter, prospective, nonrandomized, pivotal trial with planned 5-year follow-up. The primary safety endpoint was all-cause mortality within 30 days from the index procedure.
At 3 years, true lumen diameter over the endograft segment remained stable or increased in 92.3% of patients, false lumen diameter remained stable or decreased in 69.3%, and the false lumen was partially or completely thrombosed in 75% of patients. Midterm results of the Valiant thoracic stent graft in the treatment of acute, complicated type B aortic dissection are encouraging. Longer-term outcomes are needed to assess the durability of TEVAR in this indication.
FAST-TRACK ENDOVASCULAR AORTIC REPAIR: RESULTS FROM THE PROSPECTIVE LIFE REGISTRY
Presenter: Zvonimir Krajcer, MD, FACC
The Least Invasive Fast-Track EVAR (LIFE) study is a prospective, nonrandomized, postmarket registry demonstrating the clinical and cost benefits associated with the ultra-low profile Ovation Prime abdominal stent graft platform (Endologix, Inc.) under the least invasive conditions defined in the fast-track endovascular aneurysm repair (EVAR) protocol. Successful completion of the protocol required bilateral percutaneous access, avoidance of general anesthesia and intensive care unit admission, and next-day discharge.
The study enrolled 250 eligible patients at up to 40 centers in the United States. The protocol was successfully completed in 87% of patients. Comparing the fast-track cohort to the non–fast-track cohort, procedure time was 84 versus 110 minutes, use of general anesthesia was 0% versus 18%, need for intensive care unit stay was 0% versus 32%, and hospital stay was 1.2 versus 1.9 days. Patients were followed through 1 month after treatment.
Completion of the protocol was associated with over $21,000 in perioperative cost savings relative to standard EVAR, largely driven by differences in hospital stay costs. The 30-day hospital readmission rate was 1.6% compared to 8% reported for EVAR.
ARTERIOVENOUS FISTULA POST-CREATION INTERVENTIONS: COMPARISON BETWEEN TRADITIONAL SURGICAL AVF CREATION AND A NEW ENDOVASCULAR APPROACH
Presenter: Charmaine E. Lok, MD, FRCPC
Arteriovenous fistulas (AVF) created by traditional surgery (sAVF) are challenged by high failure rates. Post-creation interventions are often required to facilitate maturation and maintain function. This study compared AVF post-creation interventions between patients using sAVF and a new endovascular AVF (endoAVF).
Medicare Standard Analytical Files were used to determine patient demographic and clinical characteristics and identify and determine rates of sAVF post-creation interventions in patients with sAVF created from 2011 to 2013. Demographics and clinical information for patients with endoAVF were obtained from the single-arm Novel Endovascular Access Trial performed in Canada, Australia, and New Zealand. The technology used is not available in the United States and is pending US Food and Drug Administration review. Propensity score analysis was used to match key demographic and clinical characteristics between Medicare and NEAT patients.
In this propensity-score matched comparison, after AVF creation, patients with endoAVF required fewer interventions and had fewer health care costs than patients with sAVF.
2-YEAR RESULTS FROM THE MAJESTIC TRIAL OF THE ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Presenter: Stefan Müller-Hülsbeck, MD
The Eluvia drug-eluting vascular stent system (Boston Scientific Corporation) is composed of the Innova self-expanding nitinol stent platform with a fluoropolymer-paclitaxel coating. The MAJESTIC clinical study was designed to evaluate the Eluvia stent for treating femoropopliteal artery lesions up to 110 mm in length. MAJESTIC is a prospective, single-arm clinical trial with investigative sites in Europe, Australia, and New Zealand.
At 24 months, 91% of patients presented with no symptoms or minimal claudication. Mean age of the patients was 69 ± 9 years; 35% had diabetes. At baseline, 35% of patients had symptoms classified as Rutherford category 2, 61% were classified as category 3, and 4% as category 4. Mean lesion length was 70.8 ± 28.1 mm, 65% had severe calcification, and 46% of lesions were occluded.
MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent, including those with challenging baseline characteristics, sustained a high rate of clinical improvement, a good safety profile, and a low reintervention rate
TWO-YEAR RESULTS OF PACLITAXEL-COATED BALLOONS FOR LONG FEMOROPOPLITEAL ARTERY DISEASE: EVIDENCE FROM THE SFA-LONG STUDY
Presenter: Antonio Micari, MD, PhD
The SFA-Long study is an independent, prospective, multicenter, single-arm study to evaluate outcomes with the In.Pact Admiral paclitaxel-coated balloon (PCB)(Medtronic) in the treatment of long femoropopliteal artery disease.
Consecutive patients with disease due to femoropopliteal lesions > 15 cm long and with 4-to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. A total of 105 patients were enrolled and treated with the PCB. Primary patency rate at 24 months was 70.4%. By Kaplan-Meier estimate, patency in patients with stenotic versus occlusive lesions was 74% versus 68% (P = .42), respectively. Two-year results demonstrate durable safety and efficacy outcomes with the In.Pact Admiral PCB in patients with long femoropopliteal artery disease.
About VIVA Physicians
VIVA Physicians strive to be the premier educators in the field of vascular medicine and intervention. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field of vascular medicine with a spirit of collegiality by synergizing their 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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