Groundbreaking Endovascular Clinical Trial Results Announced at VIVA20

SAN JOSE, Calif., Nov. 6, 2020 /PRNewswire/ -- VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announced the first five of ten highly anticipated late-breaking clinical trial results presented at the VIVA20 virtual meeting.

Below are highlights of this afternoon's late-breaking clinical trial presentations:

IN.PACT Global Study Final Five-Year Outcomes Show Sustained Clinical Benefit
Presenter: Thomas Zeller, MD, PhD

This IN.PACT Global Study is the first presentation of 5-year data from a real-world, drug-coated balloon (DCB) global study. 

The IN.PACT Global Study was a large, prospective, multicenter, single-arm study conducted at 64 international sites. Subjects with bilateral disease, multiple lesions (de-novo or re-stenotic), TASC (A, B, C, D), in-stent restenosis, long lesions (≥15 cm) and chronic total occlusions (≥5cm) were enrolled. The 1406 intention-to-treat subjects with 1774 target lesions were treated with the IN.PACT Admiral DCB and analyzed as a part of the consecutively enrolled clinical cohort with safety and revascularization events reviewed by an independent Clinical Events Committee. Assessments through 5 years using the Kaplan-Meier (K-M) method included freedom from clinically-driven target lesion revascularization (CD-TLR), a safety composite (freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation through 5 years and clinically-driven target vessel revascularization through 5 years), and all-cause death.

The mean lesion length in this clinical cohort was 12.10 ± 9.54cm, with 18.0% in-stent restenosis, 35.5% total occlusions, and 68.7% calcification. The K-M estimate of freedom from CD-TLR through 5 years was 69.4%. The K-M estimated primary safety composite endpoint was 67.4% with a low major target limb amputation K-M cumulative incidence of 1.7%, through 5 years. The K-M estimate of freedom from all-cause death was 78.9%. This all-cause death rate was calculated after 96.4% vital status follow-up was collected through 5 years. 

Since the results of this real-world study were first published, safety and effectiveness through 5 years have been sustained. These outcomes support the use of the IN.PACT Admiral DCB for the management of real-world patients including complex femoropopliteal artery lesions.

REALITY Study: Directional Atherectomy Vessel Preparation Prior to DCB Angioplasty
Presenter: Krishna Rocha-Singh, MD

Drug-coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation.

REALITY (DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions) is designed to assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD.

The study prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and Clinical Events Committee-adjudicated events. 

The study enrolled 102 subjects; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm; 39% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); and, 86% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 9% (9/102) of subjects. Twelve-month primary patency rate was 77% (66/86) and freedom from CD-TLR rate was 93% (87/94). No device- or procedure-related deaths were reported; one index-limb major amputation was reported.

Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.

Standard versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism
Presenter: Efthymios Avgerinos, MD, PhD, MSc

Standard vs. UltrasouNd aSsisted cathEter-directed Thrombolysis in Submassive Pulmonary Embolism (SUNSET sPE) is a multicenter randomized trial that investigated whether ultrasound-assisted (USAT) is superior to standard-catheter (SCDT) thrombolysis in pulmonary arterial thrombus reduction.

Adults with sPE were randomized 1:1 to USAT or SCDT. Thrombolysis dose and duration were left to the operators' discretion. The primary outcome was 48-hour clearance of pulmonary thrombus assessed by pre- and post-procedure computed tomography angiography (CTA) using a refined Miller score. Secondary outcomes included right to left ventricular (RV/LV) ratio improvement, intensive care unit (ICU), bleeding and other serious adverse events.

81 patients with acute sPE were randomized and were available for analysis. Mean total dose of alteplase for USAT was 19 ± 7mg and 18 ± 7mg in SCDT (P=0.53) infused over 14 ± 6hours and 14 ± 5hours respectively (P=0.99).  In the USAT group (n=39), the mean raw pulmonary thrombus score was reduced from 31 ± 4 at baseline to 22 ± 7 (P<.001). In the SCDT group (n=41), the score was reduced from 33 ± 4 to 23 ± 7 (P<.001). There was no significant difference in mean thrombus score reduction between the two groups (P=0.76). The obstruction index reduction was also similar between groups: 21% and 22% for USAT and SCDT, respectively (P=0.77). The mean difference in RV/LV ratio from baseline (1.54 ± .30 for USAT, 1.69 ± .44 for SCDT) to 48 hours was 0.37 ± 0.34 in USAT versus 0.59 ± 0.42 in SCDT (p=0.01). In 5 USAT and 3 SCDT patients there was no RV/LV ratio improvement.  Major bleeding (one stroke with hemianopia and one vaginal bleed requiring transfusion) occurred in 2 patients both in the USAT group. The average ICU stay for the entire cohort was 3.2 ± 6.3, similar between groups.

In the SUNSET sPE trial, patients undergoing USAT had similar pulmonary arterial thrombus reduction compared to SCDT, using comparable mean lytic dose and duration of lysis.

VIVO Study 12-month Endpoint Results
Presenter: Anthony Comerota, MD

The VIVO Clinical Study evaluated the safety and effectiveness of the Zilver^® Vena Venous Stent in the treatment of patients with symptomatic iliofemoral venous outflow obstruction. 

Patients with symptomatic obstruction (CEAP clinical classification ≥3 or VCSS pain score ≥2) of one iliofemoral venous segment were included. The primary safety endpoint was 30-day freedom from major adverse events (MAE): procedural bleeding requiring transfusion, procedure- or device-related death, clinically-driven reintervention (reintervention with recurrent symptoms of venous outflow obstruction of the target lesion and a minimum lumen diameter [MLD] ≤50% of the immediate post-procedure MLD by venography), clinical migration, new symptomatic pulmonary embolism, or procedure-related perforation requiring open surgical repair or flow limiting dissection of the target vessel. The primary effectiveness endpoint was 12-month rate of primary quantitative patency (intervention-free, MLD >50% of the immediate post-procedure MLD by venography). The secondary endpoint was the change in VCSS from baseline to 1 month and 12 months. 

243 patients were enrolled (53 ± 15 years; 70% female). Iliac vein compression by the iliac artery (n=191; 78.6%) was the primary indication for stent placement. The mean lesion length at baseline was 98.6 ± 69.8 mm. Technical success (ability to deliver and place stent in intended location) was achieved for 97.3% of stents.  The 30-day freedom from MAE rate was 96.7%, exceeding the performance goal (PG) of 87% (95% CI: 93.5%-98.6%, p<0.0001). The 12-month primary quantitative patency rate was 89.9%, exceeding the PG of 76% (95% CI: 85.1%-93.4%, p<0.0001). Clinical improvement was demonstrated by the improvement in VCSS from baseline: -3.0 (95% CI: -3.5 to -2.6, p<0.0001) at 1 month and -4.2 (95% CI: -4.7 to -3.7, p<0.0001) at 12 months.

Study results support the safety and effectiveness of the Zilver^® Vena Venous Stent for the treatment of symptomatic iliofemoral venous outflow obstruction.

PROMISE I 1-Year Results
Presenter: Daniel Clair, MD

The multicenter PROMISE I trial represents the first human use in the US of a purpose-built percutaneous deep vein arterialization system for the treatment of no-option chronic limb-threatening ischemia (CLTI) patients. The LimFlow procedure permanently bypasses unreconstructible arteries and leverages healthier veins as a conduit to create new routes to perfuse tissue in the foot.  The purpose of the trial is to establish safety, effectiveness, and feasibility of the LimFlow System for use in the treatment of CLTI.

Thirty-two no-option CLTI patients (mean age, 71 ± 14 years; 66% male) were enrolled in a non-randomized manner at seven centers across the United States. All enrolled patients had Rutherford 5 or 6 class disease and deemed by a committee of experts to be ineligible for endovascular or surgical procedures to restore blood flow. Patients underwent percutaneous deep vein arterialization using the LimFlow System. The primary safety endpoint was above-ankle amputation-free survival (AFS) at 30 days, with a secondary endpoint of AFS at 6 months. Other secondary endpoints included technical success, vessel patency, and wound healing.

Technical success of the LimFlow procedure was 97%, with only one technical failure.  The primary safety endpoint of amputation-free survival (AFS) at 30 days was 91%. The secondary endpoint of AFS at 12 months was achieved in 70%. Core lab adjudicated wound healing categorized 75% of wounds as healed or healing.

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 and improve patient outcomes. 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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