New Unpublished Vascular Clinical Trial Results Announced at VIVA 18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, announces five more of the nineteen highly anticipated late-breaking clinical trial results at VIVA 18 hosted at the Wynn Las Vegas.

Below are highlights of this morning's late-breaking clinical trial presentations.

LUTONIX BELOW-THE-KNEE GLOBAL DCB IDE STUDY: PRIMARY ENDPOINT OUTCOMES AT 6 MONTHS
Presenter: J. A. Mustapha, MD

Patients with below-the-knee (BTK) critical limb ischemia (CLI) are the most complex subset of those with peripheral artery disease (PAD). Patients with CLI are treated with primary amputation in 25% to 33% of cases, which has a 1-year mortality rate of up to 40%.

The Lutonix BTK investigational device exemption clinical trial was conducted as a global multicenter prospective randomized study designed to evaluate the safety and efficacy of the Lutonix 014 DCB (BD Interventional) in the treatment of stenotic or occlusive infrapopliteal arteries as compared to standard percu­taneous transluminal angioplasty (PTA). Enrollment was completed in December 2017 with 442 randomized patients enrolled at 51 centers in the United States, Canada, Europe, and Japan.

A majority of the enrolled patients (90%) had CLI, presenting with Rutherford class 4 and 5 disease. The patient population also included 71.1%/68.4% diabetic, 92%/95.5% hypertensive, 78.4%/74.8% dyslipidemia, and 59.2%/57.4% smokers for DCB/PTA, respectively. The mean lesion lengths were 111.8 mm ± 92.6 mm and 94.7 mm ± 85.4 mm with a mean reference vessel diam­eter of 2.5 ± 0.6 and 2.6 ± 0.6 for DCB and PTA, respectively. The majority of lesions were calcified (59.9% DCB vs 54.2% PTA). Both arms had similar chronic total occlusions (36.1% DCB vs 33.3% PTA).

The noninferiority primary safety endpoint was met, with 99.3% of the patients in the DCB group free from safety events at 30 days compared to 99.4% in the control arm (P < .0001).

The primary efficacy endpoint was a composite of limb salvage and primary patency at 6 months, with 73.7% of the patients in the DCB arm free from primary efficacy events compared to 63.5% in the PTA arm, Δ10.2% (P = .0273, one-sided for superiority).

This is the first global, multicenter, randomized DCB trial to prove safety and show a benefit over PTA. The Lutonix BTK DCB offers a potential new treatment option for patients with CLI.

FIRST-IN-MAN EXPERIENCE WITH THE LARGE BORE CLOSER RESORBABLE VASCULAR SEALING SYSTEM
Presenter: Micah Watts, MD

The Large Bore Closer vascular sealing system (Rex Medical) delivers a fully resorbable sealing mechanism to the femoral arterial access site. The sealing mecha­nism consists of an intravascular patch and two extra­vascular spheres connected via two strands of suture. After deployment, the patch remains intravascular, and the two spheres remain extravascular until absorbed. Hemostasis is achieved by the mechanical means of the patch closing the arteriotomy from inside of the punc­ture. The Large Bore Closer system features an intuitive tightening mechanism that facilitates proper technique for delivery and deployment of the absorbable mecha­nism.

The Large Bore Closer first-in-man clinical trial is a study to assess the safety and effectiveness of the Large Bore Closer device in sealing femoral arterial access sites at the completion of percutaneous endovas­cular procedures performed through 10- to 16-F introducer sheaths in 23 patients at a single site. The primary safety endpoint is a composite of 60-day access site closure-related major complications.

An interim safety analysis was performed for the first 23 patients. The primary safety endpoint, freedom from 30-day major adverse events, was achieved in 23/23 of the intention-to-treat patients (100%). The primary effectiveness endpoint was mea­sured by time to hemostasis (TTH) after deployment of the device. Thirteen patients were treated without heparin with a mean TTH of 1:02 minutes (standard deviation [SD], 2:12 min) and 10 patients with IV heparin (mean activated clotting time at deployment, 218 seconds; SD 44.8) with a mean TTH of 2:12 minutes (SD 3:51). These findings confirm the safety and performance of the Closer Large Bore Vascular Sealing System as assessed in the study population. Preliminary results of the 23-subject Large Bore Closer first-in-man trial confirm safety and effectiveness of the device when used in subjects undergoing endovascular arterial procedures using 10 to 16-F introducer sheaths.

TWO-YEAR ANALYSIS OF THE PROSPECTIVE MULTICENTER SENTRY CLINICAL TRIAL: SAFETY AND EFFECTIVENESS OF THE BTG SENTRY BIOCONVERTIBLE IVC FILTER Presenter: Michael D. Dake, MD

The introduction of retrievable inferior vena cava (IVC) filters in the United States led to a growth in use between 2005 and 2010.¹ These retrievable filters have a high incidence of reported complications including device tilting, migration, embolization, fracture, or IVC perforation due to device design and prolonged implant time as a consequence of a low incidence of retrieval. Accordingly, the FDA advised physicians to retrieve IVC filters as soon as the risk of pulmonary embolism (PE) subsides, which contributed to a decline in IVC filter use from 2010.

However, used appropriately, IVC filters save lives and reduce both injury and cost related to PE. The literature confirms that the transient risk period for PE is short, and a publication by Morales et al in 2013 advises IVC filter removal between 29 and 54 days after implant.²

The BTG Sentry Bioconvertible IVC filter is designed to provide filtration for a period of transient PE risk and then bioconvert to a nonfiltering configuration, obviating the need to retrieve and avoiding typical filter-related complications. The safety and effectiveness of the Sentry filter were assessed in the SENTRY study at 23 sites in 129 patients requiring temporary protection against PE.

The primary endpoint was clinical success at 6 months and was achieved in 111 of 114 evaluable patients (97.4%). There were no instances of filter tilting, migration, emboliza­tion, fracture, or IVC perforation through 24 months, and there were no filter-related deaths. The rate of new symptomatic PE was 0% through 12 months and 2% through 24 months (none were device related). The rate of successful filter bioconversion was 95.7% (110/115) at 6 months, 96.4% (106/110) at 12 months, and 96.5% (82/85) at 24 months, which compares favorably with published retrieval rates.

1. Reddy S, Lakhter V, Zack CJ, et al. Association between contemporary trends in inferior vena cava filter placement and the 2010 US Food and Drug Administration advisory. JAMA Intern Med. 2017;177:1373-1374. doi:10.1001/ jamainternmed.2017.2719.
2. Morales JP, Li X, Irony TZ, et al. Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism. J Vasc Surg. 2013;1:376-384.

ALL-COMER PERFECT REGISTRY: PAN-PELVIC ENDOVASCULAR INTERVENTION FOR ERECTILE DYSFUNCTION: RESULTS OF CT ANGIOGRAPHY AND 12-MONTH CLINICAL FOLLOW-UP
Presenter: Tzung-Dau Wang, MD, PhD

Pelvic arterial stenotic disease is an essential cause of erectile dysfunction. The all-comer PERFECT registry studied clinical outcomes of pan-pelvic endovascular intervention in patients with erectile dysfunction.

The study enrolled patients with erectile dysfunc­tion and obstructive pelvic arterial lesions (unilateral diameter stenosis ≥ 70% or bilateral stenoses ≥ 50%) undergoing complete angioplasty and follow-up mul­tidetector pelvic CT angiography. The primary end­points included in-segment binary restenosis (diameter stenosis ≥ 50%) by follow-up pelvic CT angiography at 8 months and sustained clinical success in erectile func­tion (International Index for Erectile Function-5 [IIEF-5] score ≥ 22 or change in IIEF-5 ≥ 4 and without a later decline by ≥ 4) at 12 months.

A total of 182 consecutive patients (mean age, 62.6 ± 7.9 years) with 334 obstructive lesions (mean, 1.8 lesions per patient) and an average IIEF-5 score of 9.1 ± 4.4 were enrolled. At 8 months, CT angiographic binary restenosis occurred in 102 lesions (102/334, 31%) and 76 patients (76/182, 42%). For lesions located in the proximal internal pudendal artery and above, binary restenosis occurred in four of 113 lesions (3.5%), whereas for lesions located in the distal internal pudendal artery and beyond, binary restenosis occurred in 98 of 221 lesions (44%). Sustained clinical success in erectile function was achieved in 112 patients (62%) at 12 months, with an overall improvement in IIEF-5 of 5.7 ± 4.7 (P < .001). Among patients not developing any binary restenosis, 82% (87/106) achieved sustained clinical success in erectile function, whereas for patients with binary restenosis, 33% (25/76) achieved sustained improvement in erectile function. There were no signifi­cant adverse events during follow-up.

This study demonstrated the effectiveness of com­plete pelvic revascularization of arterial obstructive lesions in the amelioration of erectile dysfunction. The > 80% sustained clinical success rate in patients not developing restenosis is encouraging.

FULL-COHORT 12-MONTH SAFETY AND EFFICACY RESULTS OF THE VMI-CFA TRIAL Presenter: Koen Deloose, MD

Common femoral artery (CFA) atherosclerotic lesions currently remain one of the last limitations for adop­tion of endovascular repair as the first-line treatment. The bulky, eccentric, heavily calcified character of CFA plaques, frequent involvement of the femoral bifurca­tion, easy surgical accessibility, and favorable long-term outcomes continue to make CFA disease treatment part of the surgical domain. In the last 5 years, improve­ment of the endovascular equipment and technical skills of the operators have led to an increase in percu­taneous CFA procedures.

The multicenter prospective single-arm VMI-CFA trial evaluated the 1-year outcomes of treatment of symptomatic (Rutherford 2–4) CFA stenotic or occlu­sive lesions with the Supera vascular mimetic peripheral stent system (Abbott Vascular). The primary endpoint is core lab–adjudicated duplex ultrasound primary patency at 12 months, and the safety endpoint is absence of periprocedural adverse events up to 30 days postproce­dure. Four Belgian centers and three French centers enrolled 100 patients, all Rutherford 2, 3 or 4, with de novo lesions (> 50% ste­nosis) in the common femoral artery. There were 79 patients who were claudicants and 21 patients with critical limb ischemia. Procedural success rate, defined as < 30% residual stenosis, was 100%.

In the VMI-CFA trial, a 12-month cumu­lative primary patency rate of 95.2% was observed up to 365 days and the cumulative primary patency rate up to 395 days was 92.8%. The cumulative freedom from target lesion revascularization rate was 97.8%. There were no procedure- or device-related adverse events.

The 1-year data confirm the safety and feasibility of an endovascular approach with the Supera stent in the previously considered "no-stent zone" of the CFA. A head-to-head randomized controlled trial of Supera ver­sus endarterectomy seems to be a logical sequence to definitively clarify the CFA treatment discussion.

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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