Physicians and researchers from the United States and around the world presented groundbreaking research from late-breaking clinical trials, follow-up data from major randomized trials and registries, and first-in-man experiences with novel devices or drugs. The VIVA19 trial results are listed below in the order they were presented on November 5-6, 2019.
Additionally, all press releases for this year's trials can be found in our News section.
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No Increased Long-Term All-Cause Mortality for the Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Compared to Uncoated Devices
Presenter: Michael D. Dake, MD
The final long-term patient-level data for the Zilver PTX drug-eluting stent (DES) (Cook Medical) were evaluated to determine if there is an increased mortality risk due to paclitaxel. Because risk factors common in patients with peripheral artery disease may collectively contribute to patient prognosis, the contribution of baseline patient risk factors to mortality and freedom from target lesion revascularization (TLR) were also investigated.
Mortality through 5 years was compared for the primary randomization groups, which included 40% DES patients in the control group, as well as for the actual treatment groups. Actual treatment analysis compared patients treated with the DES to patients treated with nonpaclitaxel therapies. Imbalances in patient risk factors were considered. Mortality and freedom from TLR were evaluated for DES and percutaneous transluminal angioplasty (PTA)/bare-metal stent (BMS) risk factor groups.
Final 5-year mortality data were available for 94% of patients. The intent-to-treat mortality analysis comparing the DES primary randomization group to the PTA primary randomization group was not significant (P = .08). Despite randomization, combinations of risk factors were more prevalent in the DES primary randomization group compared to the PTA primary randomization group (P < .01); the numeric difference in mortality rates between groups may be due to the imbalance of risk factors at baseline. When stratified by number of risk factors, patients with fewer risk factors had a decreased mortality rate.
When comparing actual treatment groups, there was no difference in the 5-year mortality rates for the DES group compared to the PTA/BMS group (19.1% vs 17.1%; P = .60). When evaluating potential risk factors for freedom from TLR, the DES showed benefit across the different risk factor groups; a greater relative benefit was observed in groups with fewer risk factors. Analyses of the Zilver PTX DES demonstrated no increase in long-term mortality and support a benefit across different risk factor groups.
A Novel Sustained Limus Release Eluting Balloon: 2-Year Data From the SELUTION SFA Trial
Presenter: Thomas Zeller, MD, PhD
Historically, paclitaxel has been the drug of choice for use in drug-coated balloons (DCBs). The drawback of limus drugs compared with paclitaxel in DCBs has been the difficulty in transfer—because limus drugs have a relative lack of lipophilicity compared with paclitaxel, they have lower bioavailability when only short-term tissue contact is provided. The SELUTION SLR (MedAlliance) is based on microreservoir balloon coating technology, which provides controlled and sustained sirolimus release with a therapeutic effect for over 60 days. The cell adherent technology is a proprietary amphiphatic lipid technology that binds microreservoirs to the balloon surface, and it contains and protects microreservoirs during insertion and inflation. Also, it facilitates higher drug transfer efficiency, allowing for low drug dose (1 µg/mm2) on the balloon surface, and maximizes the drug bioavailability.
SELUTION SFA is a prospective, controlled, multicenter, open-label, single-arm clinical trial treating superficial femoral artery (SFA) lesions (lesion length, 51.3 ± 40.3 mm; 34% moderate-severe calcification). The trial enrolled 50 patients in four German centers between November 2016 and May 2017. Patients enrolled were symptomatic with de novo or restenotic lesions with ≥ 70% diameter stenosis or occlusion.
The primary endpoint was defined as late lumen loss (LLL) evaluated by angiography at 6 months. Duplex ultrasound and clinical endpoints were evaluated at 6, 12, and 24 months. Main secondary endpoints are primary patency, target lesion revascularization (TLR), change in Rutherford classification, and change in ankle-brachial index (ABI).
The SELUTION SFA trial met its primary endpoint and demonstrated an LLL of 0.19 mm. Excellent freedom from clinically driven TLR was achieved through 24 months in 87.5%, with no primary TLR event observed after month 11.
Clinical improvements were seen in Rutherford classification, ABI, and walking impairment at 6 months and were further improved to 12 months and maintained to 24 months. This initial first-in-human trial demonstrates that SELUTION SLR is a viable option to treat lesions in the SFA. It is the first demonstration of a sirolimus safety and efficacy in peripheral intervention.
RANGER II SFA: Randomized Trial of RANGER DCB Versus PTA in the SFA
Presenter: Ravish Sachar, MD
The global RANGER II SFA randomized (3:1) study compared treatment with the Ranger drug-coated balloon (DCB; paclitaxel dose density, 2 µg/mm2) (Boston Scientific Corporation) with standard percutaneous transluminal angioplasty (PTA) in the femoropopliteal segment. Baseline characteristics were similar between the Ranger DCB (n = 278, 37.8% women, 42.4% with diabetes) and standard PTA control groups (n = 98, 31.6% women, 43.9% with diabetes). Mean lesion length was 82.5 ± 48.9 mm for the Ranger DCB group and 79.9 ± 49.3 mm for the control group. The first 306 patients to complete 12-month follow-up were included in the primary endpoint analysis according to the prespecified interim analysis plan. Follow-up is ongoing for the remaining patients.
Ranger DCB met the study endpoint criterion for superior effectiveness at 12 months with primary patency of 82.0% vs 68.8% for PTA (P = .013) and demonstrated noninferior safety with a major adverse event–free rate of 93.5% vs 82.1% (noninferiority P < .0001). The Kaplan-Meier estimate of primary patency was 89.2% at 12 months for Ranger DCB vs 72.9% for PTA (log rank P = .002). The target lesion revascularization rate was significantly lower in the Ranger DCB group as compared with the PTA group (6.0% vs 17.9%; P = .002). There was no difference in all-cause death between groups (2.3% vs 2.5%; P > .99).
In this primary endpoint analysis of interim data, the low-dose Ranger DCB demonstrated primary patency superior to standard PTA through 1 year, with fewer reinterventions and a good safety profile.
4-Year Outcomes From the IN.PACT Global Study
Presenter: Thomas Zeller, MD, PhD
The IN.PACT Global Study is a prospective, multicenter, single-arm study conducted at 64 international sites. Patients with complex lesions were enrolled, including bilateral disease, multiple lesions, TASC A through D, de novo, in-stent restenosis, long lesions, and chronic total occlusions. The 1,406 intent-to-treat patients (1,773 lesions) were treated with the In.Pact Admiral drug-coated balloon (DCB) (Medtronic) 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 48 months were freedom from clinically driven target lesion revascularization (CD-TLR) and the safety endpoint, which was a composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation, and clinically driven target vessel revascularization through 48 months after the index procedure.
The mean patient age in the clinical cohort was 68.6 ± 10.1 years, and 67.8% were male. The mean lesion length was 12.09 ± 9.54 cm, including 18% in-stent restenosis, 35.5% total occlusions, and 68.7% calcified lesions. The Kaplan-Meier estimate of freedom from CD-TLR through 48 months was 73.4%. The cumulative incidence of the safety composite endpoint was 71.9%, with a low major target limb amputation rate (1.1%) through 48 months. The Kaplan-Meier estimate of freedom from all-cause death through 48 months was 83.5%. In an additional analysis, the Kaplan-Meier estimate of freedom from CD-TLR was 74.5% for claudicants and 64.8% for critical limb ischemia (CLI) patients.
Results from this real-world study demonstrate long-term, sustained clinical benefit and safety with low amputation and mortality rates in patients treated with the In.Pact Admiral DCB. Furthermore, the results demonstrate long-term effectiveness in claudicants and CLI patients through 4 years and support the use of a DCB for the treatment of femoropopliteal disease.
DCB Versus POBA After B-Laser Atherectomy
Presenter: John H. Rundback, MD
The B-Laser (AngioDynamics/Eximo Medical) represents a new atherectomy device utilizing a 355-nm laser with a very short pulse width to selectively ablate mixed-morphology plaque including calcification. Outcomes were compared for patients treated in the European Union CE Mark and United States investigational device exemption studies with B-Laser, followed by either plain old balloon angioplasty (POBA; n = 46) or drug-coated balloon (DCB) angioplasty (n = 51).
Clinical characteristics were similar between the two groups. POBA patients had more popliteal and tibial lesions treated (77.8% and 84.2% vs 11.1% and 15.8% in the DCB group), but other lesion characteristics were similar. There were no major procedural complications, including no embolization and no grade C–E dissections. Core lab–adjudicated duplex patency at 6 months was 89.5% in the POBA group and 85.2% in the DCB group. One-year clinical improvement (ankle-brachial index, Rutherford score) were the same.
These preliminary data indicate no differences in measurable short-term outcomes following B-Laser atherectomy regardless of subsequent mode of angioplasty. The characteristics of plaque modification following B-Laser atherectomy may impact outcomes and mitigate previously noted patency and clinical benefits of DCB angioplasty.
Two-Year Outcomes From the IMPERIAL Randomized Trial of Eluvia and Zilver PTX
Presenter: Osamu Iida, MD, on behalf of the IMPERIAL investigators
The global IMPERIAL randomized controlled trial (N = 465) was designed to compare performance of the Eluvia paclitaxel-eluting nitinol stent (Boston Scientific Corporation) with the Zilver PTX paclitaxel-coated stent (Cook Medical) for treatment of femoropopliteal artery lesions.
Multiple challenging lesion and disease characteristics were represented in the study, with mean lesion lengths of 86.5 ± 36.9 mm and 81.8 ± 37.3 mm for Eluvia and Zilver PTX groups, respectively; 42% and 44% had diabetes, and 31% and 30% had occlusions, respectively.
At 24 months, the Kaplan-Meier estimates of primary patency were 83% and 77.1% for patients treated with Eluvia and Zilver PTX, respectively (log-rank P = .10). The clinically driven target lesion revascularization rate was significantly less for patients treated with Eluvia (12.7% vs 20.1%; P = .0495).
Full Cohort 24-Month Safety and Efficacy Results of the VMI-CFA Trial
Presenter: Koen Deloose, MD
Although common femoral artery (CFA) endarterectomy is still considered the gold standard treatment for patients with CFA stenosis, 12-month follow-up results of the VMI-CFA study showed that endovascular repair is a safe and effective alternative. The repuncturable Supera vascular mimetic peripheral stent system (Abbott Vascular) can manage bulky, heavily calcified CFA disease due to its extreme crush resistance.
The multicenter, prospective, single-arm VMI-CFA trial evaluated the outcomes of treatment of symptomatic (Rutherford class 2–4) CFA stenotic or occlusive lesions with the Supera stent in 100 patients. All patients had de novo lesions (> 50% stenosis). The primary efficacy endpoint was core lab–assessed duplex ultrasound primary patency at 12 months, and the primary safety endpoint was the absence of periprocedural adverse events up to 30 days postprocedure. The cumulative primary patency rates up to 365 and 395 days were 95.2% and 92.8%, respectively. The cumulative freedom from target lesion revascularization (TLR) rate was 97.8%. No procedure- or device-related adverse events were reported.
To investigate the longer-term durability of the endovascular approach, the 24-month VMI-CFA study results were prospectively analyzed. No new loss of primary patency or TLR was reported, resulting in a cumulative primary patency rate of 92.8% and a freedom from TLR rate of 97.8% at 730 days. The cumulative survival rate was 85.5%. The tremendous shift from Rutherford class 3–4 toward Rutherford class 0–1 was sustained at 2 years.
These 2-year data confirm that CFA disease can be treated endovascularly with the Supera stent with great outcomes and a very good safety profile. A head-to-head randomized controlled trial of Supera vs endarterectomy (SUPERSURG RCT) will be launched in 2020 to further clarify the CFA treatment discussion.
Nexus Arch Branch Stent Graft System—Mid-Term Results
Presenter: Daniel Clair, MD
The Nexus aortic arch stent graft is a CE Mark–approved, off-the-shelf system for endovascular treatment of pathologies extending or involving the aortic arch. Two-year results from a prospective multicenter premarket study including 25 patients (mean age, 73 years) treated with Nexus are presented.
Nexus is a modular stent graft introduced via a 20-F delivery system with double flushing ports, which allows efficient de-airing. The main module is deployed over an axillofemoral guidewire to extend from the brachiocephalic trunk to the descending aorta and is combined with a precurved ascending module that conforms to the ascending aorta.
All patients had aneurysm size > 55 mm and were considered high risk for conventional open arch surgery by a multidisciplinary team. Indications for treatment were aneurysm (15 [60%] patients) or dissection (10 [40%] patients), including seven patients previously treated surgically for type A dissection. Thirteen (52%) patients had prior thoracic aortic surgery. Supra-aortic bypasses were performed prior to Nexus implantation.
Technical success was achieved for all intended Nexus introductions and deployments (100%). At 30 days, two (8%) patients died from cardiac causes and two (8%) patients showed nondisabling stroke, which resolved completely within 30 days. During a mean follow-up of 25 months, there was one additional procedure-related mortality from stroke, and one patient was converted to open surgery following retrograde type A dissection. During follow-up, aneurysm size decreased or remained stable in 96% of the patients, with no aneurysm-related deaths.
The Nexus system is the first CE Mark–approved branched stent graft for the aortic arch. Design features that assist in minimizing manipulations may explain the high technical success, low rate of neurologic complications, and durability, allowing safe endovascular repair.
Mid-term results at a mean 25-month follow-up are stable without any material failure or stent graft issues. However, more experience and longer follow-up are necessary to confirm these promising mid-term results.
Revolution Rotational Atherectomy System IDE Experience
Presenter: Jeff Carr, MD
The Revolution rotational atherectomy system (Rex Medical) incorporates continuous aspiration and has a dual indication for atherectomy and thrombectomy. The device is intended for atherectomy of the peripheral vasculature in patients with obstructive atherosclerotic disease both above and below the knee. No capital equipment is required. The spheroid-shaped burr rotates at 140,000 rpm to ablate plaque, which is aspirated into the catheter.
The primary objective of the REVEAL trial was to evaluate the safety and effectiveness of the Revolution peripheral atherectomy system in patients with symptomatic infrainguinal lower extremity arterial obstructive disease. One hundred twenty-one patients were enrolled at 17 U.S. sites. Patients with Rutherford category 2 to 5 disease and lesions with ≥ 70% stenosis were eligible. The primary safety endpoint was a composite of 30-day major adverse events, including all-cause mortality, clinically driven target lesion revascularization, amputation, vessel perforation, and embolization. The primary effectiveness endpoint was technical success, defined by core laboratory–assessed ≤ 50% diameter stenosis after treatment prior to adjunctive therapy.
The 30-day primary safety and effectiveness endpoints were met, with freedom from 30-day major adverse events in 110 of 113 (97.3%) intention-to-treat patients at 30 days (both distal embolizations were clinical events committee–adjudicated as nondevice-related) and technical success in 111 of 123 (90.2%) target lesions. Excluding lesions that were treated with a burr not appropriately sized for the vessel diameter from the data set in which the postatherectomy stenosis was > 50%, the technical success rate was 95.7% (111 of 116 patients) (nonimputed). The procedural success rate was 93.7% (119 of 127 patients). The 6-month outcomes were also favorable.
The REVEAL study findings confirm a favorable safety and effectiveness profile through 6 months for the Revolution peripheral atherectomy system.
1-Year Results From the MIMICS-3D Registry: Investigating the BioMimics 3D Stent
Presenter: Michael Lichtenberg, MD
BioMimics 3D (Veryan Medical) is a nitinol stent designed to provide optimal radial support, flexibility, durability, visualization, and delivery accuracy for femoropopliteal intervention. The addition of a unique three-dimensional (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 patients received either a BioMimics 3D helical stent or a straight stent control. The Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) at 1 year for those treated with BioMimics 3D was 91%. A second study, MIMICS-2, conducted in the United States, Japan, and Europe, met 30-day safety and 12-month primary patency endpoints, and the 1-year Kaplan-Meier estimate of freedom from CD-TLR was 88%.
A European registry (MIMICS-3D) is now investigating outcomes in patients with longer, more complex lesions; complementary use with drug-coated balloons occurred in 50% of procedures. MIMICS-3D enrolled 507 patients at 23 sites. The primary safety end-point is a composite of major adverse events (MAEs) or CD-TLR through 30 days. The primary outcome measure for effectiveness is freedom from CD-TLR through 12 months. An independent clinical events committee adjudicated MAEs.
Technical success of the BioMimics 3D procedure as assessed by the operator was 98%. The percentage of patients with improvement of ≥ 1 Rutherford category at 1 year compared to baseline was 87% (322/370); 12-month freedom from CD-TLR was 89%, which aligns with results from the MIMICS RCT and MIMICS-2 studies, despite treatment of more complex disease. For patients treated with or without a drug-coated balloon and BioMimics 3D, there was no difference in CD-TLR (89.5% and 88.5%, respectively; P > .88).
These three studies confirm that imparting a helical shape onto the vessel with BioMimics 3D and imparting swirling flow improves outcomes and suggest that swirling flow is nature’s alternative to drug elution.
Treatment of BTK Disease With a Novel Device: Update on the DEEPER OUS Trial
Presenter: Thomas Zeller, MD, PhD
Peripheral artery disease (PAD) of the infrapopliteal arteries is associated with decreased quality of life and increased morbidity and mortality. Several factors contribute to high restenosis rates in the infrapopliteal arteries, and new devices continue to be developed to address these challenges.
The purpose of the DEEPER OUS study is to evaluate the safety and efficacy of a novel device, the Temporary Spur stent system (Reflow Medical, Inc.), in conjunction with a commercially available drug-coated balloon. An angiographic substudy examining recoil will be conducted on the first 10 patients from each site.
This trial is a prospective, multicenter, nonrandomized, single-arm study. Trial enrollment began in July 2019 and is presently ongoing, with anticipated completion in 2020. The study will consist of 100 patients in New Zealand, Germany, and Switzerland.
Acute technical and procedural success are presented for patients enrolled through October. Ultrasound and clinical data from the first enrolled patients are presented.
The Temporary Spur stent system appears to be a feasible and safe method for the treatment of disease in the infrapopliteal arteries. Examination of patency rates and long-term safety data is ongoing in the DEEPER OUS trial.
6-Month Results of TOBA II BTK
Presenter: George Adams, MD
Dissection is a frequent and clinically problematic outcome of percutaneous transluminal balloon angioplasty (PTA). There is no current safe and efficacious solution because revascularization of below-the-knee (BTK) arteries is dependent upon PTA, and there are no FDA-approved implants for use BTK. TOBA II BTK, a prospective, multicenter, single-arm global pivotal study, is the first investigational device exemption clinical trial approved to investigate safety and effectiveness of a permanent implant to repair dissections in BTK arteries. The study evaluated the Tack endovascular system (4 F) (Intact Vascular) in 233 patients who had ≥ 1 dissection requiring repair after PTA in the mid/distal popliteal, tibial, and/peroneal arteries. There were 918 Tacks implanted from the mid popliteal to 1 cm above the tibiotalar joint, with 122 placed in the distal third of the vessels.
The Tack system has four preloaded self-expanding nitinol implants on a single catheter. Each implant is 6 mm long and self sizes to vessels ranging from 1.5 to 4.5 mm in diameter, using sufficient radial force to appose dissected tissue against the vessel wall. Primary safety and efficacy endpoints were analyzed at 6 months and compared with performance goals derived from the critical limb ischemia (CLI) literature.
TOBA II BTK met both primary endpoints (P < .0001) of safety (30-day major adverselimb event or perioperative death) and efficacy (6-month major adverse limb event or 30-day perioperative death). All (100%) dissections were resolved following Tack implantation, with 92.0% 6-month Kaplan-Meier freedom from clinically driven target lesion revascularization (CD-TLR), 87.3% 6-month Kaplan-Meier target lesion patency, and 95.7% 6-month Kaplan-Meier amputation-free survival. Wounds were healed or improved in 73.8% and Rutherford category was ≤ 3 at 6 months in 74% of CLI patients.
TOBA II BTK met all endpoints in a 100% dissected vessel population. High rates of dissection resolution, wound improvement, and freedom from CD-TLR support the Tack endovascular system as an ideal adjunct to PTA and potentially as the first permanent vascular implant to improve results of infrapopliteal angioplasty.
5-Year ABSORB BTK Trial Results
Presenter: Ramon L. Varcoe, MBBS, MS, PhD
The ABSORB BTK trial is a prospective, nonrandomized, single-center study designed to evaluate a novel bioresorbable, drug-eluting scaffold used for the treatment of peripheral artery disease below the knee. There were 71 scaffolds utilized in 55 limbs of 48 patients who fulfilled the inclusion criteria (72.7% with critical limb ischemia). Most scaffolds were implanted in arteries of the proximal half of the calf, and the mean lesion length was 20.1 mm (range, 5–50 mm). There was 100% procedural and technical success.
Over the 5-year follow-up period, 38% of patients had died, all from causes unrelated to the procedure or study device; 95% of patients had sustained clinical improvement. Complete wound healing occurred in 90% of those treated for tissue loss, with no major amputations and a limb salvage rate of 100%. Primary patency (defined as freedom from peak systolic velocity ratio > 2.0 or target vessel occlusion) and freedom from clinically driven target lesion revascularization rates were estimated at 89.2%/80.3%/72.9% and 97.2%/90.7%/90.7% at 12, 36, and 60 months, respectively, using the Kaplan-Meier method. No late or very late scaffold thromboses were observed.
This novel bioresorbable, drug-eluting scaffold has several inherent advantages over stents, related to its biological resorption. These results represent best-in-class durability for a stent-like device in this challenging vascular territory.
Results of the LimFlow System in the PROMISE I Trial
Presenter: Daniel Clair, MD
The multicenter PROMISE I trial represents the first human use in the United States 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 PROMISE I trial is to establish the safety, effectiveness, and feasibility of the LimFlow system (LimFlow SA) for use in the treatment of CLTI.
Thirty-two no-option CLTI patients (mean age, 71 ± 14 years; 66% male) were enrolled in a nonrandomized manner at seven centers across the United States. All enrolled patients had Rutherford class 5 or 6 disease and were deemed by an independent review 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.
The LimFlow procedure technical success rate was 97%, with only one technical failure. The primary safety endpoint of AFS at 30 days was 91%. The secondary endpoint of AFS at 6 months was achieved in 74%.
Initial 12-Month Outcomes From the TANGO Trial (Adventitial Temsirolimus in BTK Lesions)
Presenter: Ehrin Armstrong, MD
The TANGO trial is a phase 2, dose escalation, double-blinded trial comparing the delivery of temsirolimus to saline control in patients with severe claudication or critical limb ischemia. This is the first United States trial to investigate a sirolimus analog to improve the durability of peripheral revascularization procedures. The purpose of the trial is to limit neointimal hyperplastic tissue growth into the artery after endovascular below-the-knee (BTK) revascularization procedures, where paclitaxel-coated balloons have had limited success.
Results are now available comparing Bullfrog micro-infusion device (Mercator MedSystems) delivery of either low-dose temsirolimus treatment (0.1 mg/mL; n = 20) or saline control (n = 20) into the perivascular tissue around lesions subsequent to revascularization. Patients (Rutherford category 3–5) with up to 30-cm–long BTK lesions were enrolled in the study.
The primary safety endpoint was 30-day freedom from major adverse limb event or postoperative death, and no events were observed. The primary efficacy endpoint was improvement in 6-month transverse view vessel area loss (TVAL), an angiographic measure that uses the opacified area of the lesion to approximate the neointimal volume.
At 6 months, excluding subjects with unstented severe dissections in their target lesion, TVAL improved to 19% in treatment subjects compared to 38% in controls. With respect to secondary endpoints, 6-month freedom from target lesion failure was reported in 58% (11/19) of treatment subjects compared to 42% (8/19) of controls, favoring treatment by a relative 38%. In patients with total occlusions at baseline, 78% (7/9) of treatment subjects and 25% (2/8) of control subjects were free from reocclusion at 6 months. In treatment subjects with wounds upon enrollment or who developed wounds on their target limb during the study, 71% (5/7) of treatment subjects had full healing of wounds by 12 months without the need for clinically driven target lesion revascularization, whereas 44% (4/9) of control subjects had wound healing without prior clinically driven target lesion revascularization.
The ULYSSE Registry
Presenter: Costantino Del Giudice, MD
The Ulysse registry is a retrospective, nonrandomized, single-center study evaluating the safety and the efficacy of ultrasoundplasty before angioplasty to treat below-the-knee lesions (BTK) in 22 critical limb ischemia (CLI) patients (35 BTK lesions). All patients were Rutherford category 4 to 6 and had moderate-severe calcification. Ultrasoundplasty was performed using the Kapani catheter (Apani Corporation), which delivers a local, low-frequency, high-intensity ultrasound energy to the lesion.
The objective of the study was to demonstrate that locally delivered ultrasound energy may modify plaque structure using microcavitational effects and change plaque compliance without risk of vessel dissection and rupture. Modifications of plaque structure may potentially improve the outcome of a simple balloon angioplasty.
The primary safety outcomes were the major adverse events at 30 days, recurrence of CLI, and surgical or endovascular revascularization at 6 months. The primary efficacy endpoint was angiographic restenosis and target lesion revascularization at 6 months.
Immediate outcomes showed good results, with 100% technical success and no major adverse events. At 6-month angiographic control, primary patency was 97.1%, with 100% ulcer healing and no target lesion revascularization and no CLI recurrence. At 24 months, freedom from restenosis was 91.4% as evaluated by Doppler ultrasound control, with no target lesion revascularization and no CLI recurrence. No major adverse events were reported.
Ultrasoundplasty before angioplasty for BTK lesions may improve clinical outcomes without the need for a drug-eluting device. A larger randomized study is needed to confirm these results.
IN.PACT AV Access 6-Month Lesion Outcomes
Presenter: Robert Lookstein, MD, MHCDL
The IN.PACT AV Access randomized trial is an independently adjudicated, prospective, global, multicenter, single-blinded study evaluating the safety and effectiveness of the IN.PACT AV Access drug-coated balloon (DCB; Medtronic) compared to percutaneous transluminal angioplasty (PTA) for the treatment of 330 patients with obstructive lesions (de novo or restenotic) of the native arteriovenous dialysis fistulae (AVF) in the upper extremity.
The primary effectiveness endpoint was the target lesion primary patency rate, defined as freedom from clinically driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months (210 days) postprocedure. The primary safety endpoint was defined as the serious adverse event rate involving the AV access circuit through 30 days postprocedure.
As reported at CIRSE 2019, both endpoints were met. Target lesion primary patency was 81.4% in the DCB group compared to 59% in the PTA group (P < .001); there was a 56% reduction in the total number of reinterventions required to maintain patency. Twelve-month all-cause mortality was 90.6% in the DCB group compared to 90.4% in the PTA group.
Distribution of lesion location, AVF type, and lesion type among patients in the DCB and PTA groups was similar (P = .310, P = .918, and P = .905, respectively). Six-month primary patency of restenotic lesions was 78.9% in the DCB group compared to 52.4% in the PTA group (difference, 26.5%). Primary patency of radiocephalic fistulas was 81.7% in the DCB group compared to 60% in the PTA group (difference, 21.7%). Primary patency of brachiocephalic fistulas was 80.8% in the DCB group compared to 57.4% in the PTA group (difference, 23.4%). Primary patency of anastomotic lesions was 84.6% in the DCB group compared to 50.0% in the PTA group (difference, 34.6%). Primary patency of cephalic arch lesions was 84.0% in the DCB group compared to 50.0% in the PTA group (difference, 34.0%).
Lateral Subdermic Plexus Insufficiency: A New Paradigm Shift With Restless Leg Syndrome
Presenter: Swar Shah, MD
Restless leg syndrome (RLS) and nighttime leg cramping/Charley horses are common symptoms, but their etiologies have always been poorly understood. Over the years, we have noticed that many patients with chronic superficial venous insufficiency/varicose veins have had presenting symptoms of RLS and nighttime leg cramping/Charley horses. It was also noted that many of these patients presented with abnormal reflux of the lateral subdermic venous plexus (LSP) and superficial veins on the lateral thigh and calf typically not evaluated in most settings. It was hypothesized that there is an association between these leg symptoms and this poorly understood LSP.
A total of 510 patients were evaluated for a correlation between RLS/nighttime leg cramping with reflux in the LSP. In patients with either symptom, 83% and 89%, respectively, had an abnormal LSP on ultrasound. Of patients with both symptoms, 91% had an abnormal LSP on ultrasound. A total of 242 symptomatic patients underwent ultrasound-guided foam sclerotherapy of the LSP and up to 92% were symptom-free at 1 year.
The LSP appears to play a key role in RLS and nighttime cramping and should be added to the comprehensive venous ultrasound, especially for patients presenting with these symptoms. Furthermore, treatment for this is simple, cheap, and effective and can be life-changing for many of these patients.
Early Outcomes From the ClotTriever (CLOUT) Registry
Presenter: David Dexter, MD
The ClotTriever Outcomes (CLOUT) Registry is evaluating real-world patient outcomes following treatment of acute and non-acute lower extremity proximal deep vein thrombosis (DVT) with the ClotTriever system (Inari Medical), a mechanical thrombectomy system 510(k) cleared for the nonsurgical removal of soft thrombi and emboli from peripheral blood vessels.
The CLOUT Registry is enrolling 500 patients with lower extremity DVT involving the femoral vein, iliac vein, and/or inferior vena cava at up to 50 sites. Thrombus age is not capped, including acute, subacute, and chronic clot. Patients with vena cava filters and venous stents are excluded. Baseline demographics, comorbidities, eligibility for thrombolytic treatment, and DVT-specific baseline characteristics are collected prior to the ClotTriever procedure. Patient outcomes are collected at hospital discharge following thrombectomy and at 30 days, 6 months, 1 year, and 2 years postprocedure.
Procedural and acute data from 50 patients across 12 sites and 30-day follow-up data of 37 patients were assessed. 98% of patients were treated in a single session with a median thrombectomy time of 38.0 minutes. Thrombus removal of ≥ 75% via core lab–assessed Marder scores was achieved in 76.5% of treated limbs, including those with chronic disease. There was one (2%) major adverse event, neither procedure nor DVT related: a death 23 days postprocedure due to sepsis and renal failure in a metastatic lung cancer patient. No bleeding complications and one (2%) access site hematoma was reported. At 30-day follow-up, the number of patients with postthrombotic syndrome (PTS) as well as moderate or severe PTS had significantly decreased (P < .01). Additionally, quality of life scores, including Villalta, revised Venous Clinical Severity Score, EQ-5D, and Numeric Pain Rating Scale, showed statistically significant improvement at 30 days. Further registry enrollment and analysis will provide insight for future definitive studies for the treatment of DVT.
Indigo Aspiration System for Acute Pulmonary Embolism
Presenter: Akhilesh K. Sista, MD
EXTRACT-PE is a prospective, single-arm, multicenter trial designed to evaluate the safety and efficacy of mechanical aspiration thrombectomy using the Indigo aspiration system (Penumbra, Inc.) in patients with acute pulmonary embolism (PE).
The trial enrolled 119 patients at 22 U.S. sites. Inclusion criteria were symptomatic acute PE ≤ 14 days, systolic blood pressure ≥ 90 mm Hg, right ventricular (RV)/left ventricular (LV) diameter ratio > 0.9, and age ≥ 18 years. A key exclusion criterion was tissue plasminogen activator administration within 14 days of baseline CTA.
The primary efficacy endpoint was the reduction in RV/LV ratio from baseline to 48 hours as assessed by CTA. The primary safety endpoint was the rate of major adverse events, a composite of device-related death, major bleeding, and device-related serious adverse events (including clinical deterioration, pulmonary vascular injury, and cardiac injury) within 48 hours.
Mechanical aspiration thrombectomy was performed using an 8-F aspiration catheter (CAT8, Penumbra, Inc.) and a Penumbra pump. Median procedure time was 66 minutes, and median time from study device insertion to removal was 37 minutes.
Mean pretreatment RV/LV ratio was 1.47 and was 1.04 at 48 hours postprocedure. Mean reduction in RV/LV ratio was 0.43 (95% confidence interval, 0.38–0.47; P < .0001), corresponding to a 27.3% reduction. Two (1.7%) patients experienced three major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 hours were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively. Rates of any-cause mortality, device-related serious adverse events, and symptomatic PE recurrence within 30 days were 2.5%, 1.7%, and 0%, respectively. Thrombolytic drugs were not used in 98.3% of patients.
Based on the study findings, mechanical aspiration thrombectomy with the Indigo aspiration system is associated with a significant reduction in the RV/LV ratio and a low rate of major adverse events. The Indigo aspiration system met its prespecified safety and efficacy endpoints in the treatment of acute PE.
1-Year Results of the DISAPEAR Registry
Presenter: Steven Kum, MD
The Absorb bioresorbable vascular scaffold (BVS; Abbott Vascular) has demonstrated favorable short- and medium-term results in below-the-knee vessels in patients with chronic limb-threatening ischemia (CLTI) or claudication. The DISAPEAR registry aimed to evaluate the safety and effectiveness of the Absorb BVS in an Asian cohort exclusively with CLTI.
A retrospective analysis was performed in patients with Rutherford class 4 to 6 CLTI with de novo infrapopliteal lesions with angiographic stenosis > 50% who were treated with Absorb BVS between August 2012 and June 2017 at Changi General Hospital, Singapore. Assessments included technical success, primary patency (duplex ultrasound peak systolic velocity ratio < 2.0), freedom from clinically driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, and wound healing at 6 and 12 months after the index intervention.
Forty-one patients (41 limbs) with 53 lesions were treated with 69 scaffolds during the study period. About 90% of the patients had diabetes, 59% had ischemic heart disease, 12% had dialysis-dependent renal failure, and 93% had Rutherford category 5/6 ischemia with tissue loss.
Technical success was achieved in all patients. The mean lesion length was 22.7 ± 17.2 mm. Twenty-four percent of lesions were classified as severely calcified according to the PARC classification. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%. Freedom from major amputation was 98% at both time points and amputation-free survival was 93% and 85% at 6 months and 1 year after the index procedure. Complete wound healing occurred in 79.5% of patients with Rutherford 5 and 6 ischemia by the end of 12 months after the index procedure. There were no deaths within 30 days of the index intervention.
The Absorb BVS demonstrated good patency and clinical outcomes in patients with CLTI and complex infrapopliteal disease and comorbidities such as diabetes and renal failure. Future prospective controlled studies can further help corroborate the significance of these findings.