The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the results for the first two rounds of Late-Breaking Clinical Trials presented at the VIVA24 conference, at Wynn Las Vegas.
VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present a variety of lectures and live case presentations from clinical centers around the world. The audience is comprised of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists. Below are highlights of today’s 9 late-breaking clinical trial presentations.
Two-Year Outcomes of the LIFE-BTK Randomized Controlled Trial Evaluating the Esprit™ BTK Drug-Eluting Resorbable Scaffold for Treatment of Infrapopliteal Lesions
Presented by: Brian DeRubertis, MD
The 2-year results from the LIFE-BTK randomized controlled trial highlight the sustained benefits of the Esprit Below-the-Knee (BTK) Drug-Eluting Resorbable Scaffold (Abbott) in treating patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal lesions. Esprit BTK demonstrated superior long-term outcomes compared to percutaneous transluminal angioplasty (PTA), particularly in terms of vessel patency and limb salvage.
At 2 years, 61.5% of patients treated with Esprit BTK achieved the combined endpoint of limb salvage and primary patency, compared to 32.8% in the PTA group. This marked an absolute risk difference (ARD) of 28.66% and a hazard ratio of 0.48 (P = .0004), confirming the scaffold’s superior efficacy in maintaining open arteries and preventing disease progression. The scaffold’s biological efficacy was evident in its ability to significantly reduce binary restenosis, with rates of 35.2% for Esprit BTK compared to 57.8% for PTA (ARD, -22.57%; P = .0054), ensuring continued vessel patency over time.
The composite of freedom from major adverse limb events at 2 years and perioperative death at 30 days was comparable between the two arms, with Esprit BTK achieving a 90.4% safety rate versus a 95.9% safety rate with PTA (P = .16), demonstrating that the scaffold offers a safe alternative for infrapopliteal interventions.
The 2-year outcomes of the LIFE-BTK trial suggest durable performance and long-term benefits with Esprit BTK. Its ability to maintain vessel patency and reduce restenosis presents a promising treatment option for CLTI patients, with efficacy and safety outcomes that compare favorably to PTA.
First Clinical Use of an Innovative Forward-Shifted Peripheral Intravascular Lithotripsy System: Late-Breaking Primary Outcomes of the Mini S/FORWARD PAD IDE Study
Presented by: JD Corl, MD
Successful endovascular treatment of peripheral artery disease is dependent on the modification of challenging lesion morphologies. The Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) catheter (Shockwave Medical) has a forward-shifted IVL emitter designed to modify calcium in subtotal occlusions or extremely narrowed calcified vessels.
The premarket, prospective, single-arm Mini S feasibility and FORWARD PAD IDE studies were pooled, and this analysis includes 103 lesions in 90 patients treated at 19 sites in Australia, New Zealand, and the United States. The primary effectiveness endpoint was defined as residual stenosis ≤ 50% without flow-limiting dissection at final angiography, and the primary safety endpoint was major adverse events at 30 days. Endpoints were adjudicated by an angiographic core laboratory and a clinical events committee.
Lesion characteristics included preprocedural stenosis of 82.9% ± 16.7%, severe calcification present in 82.5%, and 38% chronic total occlusions. The Javelin catheter was able to fully cross the target lesion in 93% of cases. The primary effectiveness (99%; P < .0001) and primary safety endpoints (1.1%; P = .0012) both met prespecified performance goals. Baseline stenosis was reduced to 23% ± 9.1% at final angiography, and there were no perforations or embolization events through 30 days.
In this 30-day analysis, the Shockwave Javelin Peripheral IVL catheter met prespecified efficacy and safety performance goals, with marked target lesion stenosis reduction without perforations or distal embolization. Further follow-up will assess longer-term outcomes with the Javelin Peripheral IVL catheter.
Thirty-Day Outcomes From the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee PAD
Presented by: Venita Chandra, MD
Below-the-knee (BTK) lesions may be particularly challenging to treat owing to length, diffuse disease, and extent of calcification. The Disrupt PAD BTK II study is a core lab–adjudicated, prospective, multicenter, single-arm study of patients with moderately to severely calcified BTK lesions treated with the Shockwave Peripheral Intravascular Lithotripsy (IVL) System (Shockwave Medical).
Disrupt PAD BTK II enrolled 250 patients with calcified infrapopliteal lesions and Rutherford category 3 to 5 presentation from 38 sites in the United States and Europe. The primary safety endpoint was major adverse limb events (MALE) or postoperative death at 30 days. The primary effectiveness endpoint was procedural success, defined as ≤ 50% residual stenosis for all treated target lesions without serious core lab–adjudicated serious angiographic complications. Follow-up is planned through 2 years.
A total of 305 lesions in 250 patients were treated with a procedural success of 97.9%. Mean target lesion length was 76.3 ± 65.2 mm, diameter stenosis was 77.7% ± 17.9%, and 84.8% had moderate or severe calcification as assessed by an independent angiographic core lab. After IVL, residual stenosis was reduced to 29% and to 25.5% after optional postdilatation and/or stent implantation. At 30 days, there were no deaths, the MALE rate was 0.8%, and mean improvement in VascuQoL scores was 4 ± 5 (P < .0001). Of the patients with baseline wounds, 15.8% healed and 53.4% were improved at 30 days.
IVL treatment of patients with moderately to severely calcified BTK lesions resulted in high procedural success, significant reduction in residual stenosis, and improvements in patient quality of life and wound healing, with minimal adverse events at 30-day follow-up. These outcomes support the safety and effectiveness of IVL in the treatment of patients with complex calcified BTK lesions.
Laser and Optics-Based Peripheral Intravascular Lithotripsy System for the Treatment of Above-the-Knee and Below-the-Knee Calcified Lesions: Results of the RESTORE ATK and RESTORE BTK Trials
Presented by: Thomas Zeller, MD
Arterial calcification portends poor procedural success for peripheral vascular interventions and suboptimal long-term outcomes. These studies aimed to evaluate the initial safety and efficacy of a novel laser and optics-based intravascular lithotripsy (IVL) system for calcified lesions in the peripheral vasculature (Bolt IVL, Bolt Medical).
The RESTORE ATK and RESTORE BTK trials were prospective, nonrandomized, multicenter studies conducted in Europe. Patients were treated with IVL and followed to 6 months (above the knee [ATK]) and 30 days (below the knee [BTK]). The primary safety endpoints were freedom from major adverse events (MAEs) (composite of death, clinically driven target limb revascularization [CD-TLR], and unplanned major amputation) within 30 days following the index procedure. Efficacy endpoints included procedural success (residual diameter stenosis < 50%) evaluated by an independent core laboratory.
Ninety-five (ATK) and 20 (BTK) patients were enrolled. The mean age for ATK and BTK was 70 ± 8 years and 73 ± 10 years, with 33% and 30% females, respectively. The superficial femoral and anterior tibial arteries were the most treated in each trial, with a mean vessel diameter of 5.5 ± 0.7 mm and 2.9 ± 0.4 mm, respectively, and percent diameter stenosis of 93.7% ± 7.2% and 91.4% ± 8.8%, respectively. The efficacy endpoint was achieved in 100% of patients in both studies. Residual diameter stenosis postprocedure was 21.2% ± 8.4% (ATK) and 22.8% ± 11.5% (BTK) with no MAEs occurring within 30 days. No cases of perforation, abrupt closure, no reflow, distal embolization, or dissections meeting serious AE criteria were observed. No stents were placed in BTK, and only three were placed in ATK despite the lesion complexity, length, and chronic total occlusions. Ninety-two ATK patients completed 6-month follow-up, and 18 BTK patients completed 30-day follow-up, with 2.2% and 0% CD-TLR, respectively, and no deaths or limb amputations.
These studies demonstrate the safety and effectiveness of a novel laser and optics-based IVL catheter for treatment of severely calcified ATK and BTK peripheral lesions.
Total REALITY: Comparison of Directional Atherectomy vs Balloon Predilatation Prior to Drug-Coated Balloon Treatment of Long, Calcified Femoropopliteal Lesions
Presented by: Venita Chandra, MD
Drug-coated devices provide good long-term outcomes for femoropopliteal revascularization, but calcification can limit drug uptake. Vessel preparation with atherectomy may provide better periprocedural results than standard predilatation, reducing the need for permanent scaffolds and preserving future treatment options. However, there are limited randomized trial data supporting its use.
The single-arm, prospective, multicenter VIVA REALITY study evaluated directional atherectomy (DA) prior to use of drug-coated balloons (DCBs) in highly calcified lesions. In an updated analysis, investigators used pooled data from the REALITY study and data from prospective, multicenter studies evaluating DCB with standard predilatation to determine whether DA prior to DCB would result in less provisional stent use and comparable safety and effectiveness versus percutaneous transluminal angioplasty (PTA) followed by DCB.
In the Total REALITY analysis, patients in the REALITY study treated with DA plus DCB (n = 84) were matched by propensity scores to eligible patients treated with PTA plus DCB from the Total IN.PACT data set (n = 143). All studies included angiographic and duplex ultrasound (DUS) core laboratories and event adjudication by independent clinical event committees.
Significant differences in severe calcification (PACSS 4) persisted after matching (71.4% for DA + DCB vs 5.9% for PTA + DCB; P < .001). As expected, 12-month primary patency (freedom from both clinically driven target lesion revascularization and DUS-derived restenosis) did not differ between groups. In the DA plus DCB arm, there was a trend toward higher stent-free patency through 12 months using Kaplan-Meier estimates (79.1% vs 68.1%; P = .09) and a significantly lower provisional stent rate (9.5% vs 21.1%; P = .014). Major adverse limb events did not differ between groups.
The Total REALITY analysis underscores the complexity of lesions included in the REALITY study, particularly the high prevalence of severe calcification. Nevertheless, DA plus DCB achieved a significantly lower provisional stent rate and trended toward higher stent-free patency. DA plus DCB is a viable, safe, and effective alternative to PTA plus DCB in treating long and highly calcified lesions while reducing the need for permanent implants.
Prospective, Multicenter Evaluation of Transcarotid Artery Revascularization in Standard-Risk Patients: 30-Day Outcomes of the ROADSTER 3 Study
Presented by: Meghan Dermody, MD
The ROADSTER 3 study is the first-ever prospective, multicenter trial evaluating the safety and effectiveness of transcarotid artery revascularization (TCAR) using the ENROUTE Transcarotid Stent System (TSS) in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) (both Boston Scientific Corporation) for the treatment of carotid stenosis in standard-surgical-risk patients. The primary endpoint for this single-arm, postapproval study is a composite of major adverse events (stroke, death, or myocardial infarction [MI]) through 30 days postprocedure, plus ipsilateral stroke from day 31 to 365 postprocedure. The incidence of cranial nerve injury (CNI) within 30 days postprocedure is a key secondary endpoint. All patients underwent independent neurologic assessments before the procedure, as well as within 24 hours, at 30 days, and at 1 year after TCAR. Events were adjudicated by an independent clinical events committee.
Of the 344 patients enrolled (320 treated per-protocol [PP]) at 53 United States sites, 75.3% were aged < 75 years, 42.7% were female, and 16.3% were symptomatic. Among symptomatic patients, 25% experienced a neurologic event within 2 weeks preceding TCAR. The mean lesion length was 23.3 mm, 47.4% had a type II or type III aortic arch, and 17.2% of lesions had severe calcification.
In the intent-to-treat population, the rate of stroke/death/MI at 30 days was 0.9% (0.6% PP) with a 30-day stroke rate of 0.9% (0.6% PP). There were no deaths or MIs through 30-day follow-up. The incidence of CNI within 30 days was 0.6% (0.6% PP); both resolved within 6 months.
These 30-day results of the ROADSTER 3 study demonstrate that TCAR, using the ENROUTE TSS in conjunction with the ENROUTE NPS, is safe and effective in patients at standard risk for adverse events from carotid endarterectomy.
Two-Year Outcomes of the PERFORMANCE II Trial: A Prospective, Multicenter, Single-Arm Investigation of a 3-in-1 Carotid Stent System With Integrated Embolic Protection
Presented by: William A. Gray, MD
The PERFORMANCE II study is a prospective, multicenter, single-arm, open-label study evaluating the safety and effectiveness of the Neuroguard IEP 3-in-1 Carotid Stent System (Contego Medical) with integrated embolic protection (IEP) for the treatment of carotid artery stenosis in patients at elevated risk for adverse events following carotid endarterectomy.
305 patients were enrolled at 32 sites in the United States and Europe. The primary endpoint was the 30-day rate of major adverse events (MAEs), defined as death, all stroke, and myocardial infarction (MI) within 30 days of the index procedure, plus ipsilateral stroke through 12 months of the procedure. Events were adjudicated by an independent clinical events committee. Imaging was analyzed by an independent core lab.
Twenty percent of patients were symptomatic, and 43.5% were diabetic. 230 (75%) patients presented with physiologic high-risk criteria, 75 (25%) patients had anatomic high-risk criteria, and 85 (28%) had both. The mean target lesion stenosis was 85%, and 34% were severely calcified.
In a per-protocol analysis, the 30-day stroke rate was 1% (3 patients). In an intention-to-treat analysis, the 30-day stroke rate was 1.3% (4 patients), the death/stroke rate was 1.6% (5 patients), and the death/stroke/MI rate was 2.3% (7 patients). The rate of 30-day all-stroke plus ipsilateral stroke through 1 year was 1.8% (5 patients), all of which were minor. There were no major strokes, stent thrombosis, or neurologic deaths through 2 years.
The rate of in-stent restenosis (ISR) was 3.65% at 1 year and 3.85% at 2 years. There was no clinically driven target lesion revascularization (CD-TLR) at 1 year and one CD-TLR (0.36%) at 2 years.
These 2-year results of the PERFORMANCE II study demonstrate the remarkable procedural safety and long-term durability of the Neuroguard IEP 3-in-1 Carotid Stent System in high-surgical-risk patients. Despite a 43.5% rate of diabetes and 34% rate of severe calcification, the 3.85% rate of ISR and 0.36% rate of CD-TLR at 2 years were very low.
Healthcare Resource Utilization and Outcomes Among Patients With Intermediate-Risk PE Treated With Computer-Assisted Vacuum Thrombectomy vs Other Treatment Modalities
Presented by: Parag J. Patel, MD, MS
This nationwide retrospective study evaluates health care resource utilization and outcomes among patients with intermediate-risk pulmonary embolism (PE) treated with computer-assisted vacuum thrombectomy (CAVT) (Penumbra, Inc.) compared to anticoagulation (AC), catheter-directed thrombolysis (CDL), or other mechanical thrombectomy (MT) in the United States.
Using data from the Vizient clinical database, adult inpatients with intermediate-risk PE discharged between July 1, 2020, and September 30, 2023, were identified. ICD-10 procedure codes were used to identify treatment modalities. A total of 2,060 patients were propensity matched 1:1 to equate 515 CAVT patients to AC, CDL, and MT patients using demographics, Elixhauser Comorbidity Index, payer, and hospital type.
Key results showed that CAVT patients experienced significantly shorter length of stay (LOS) (4.6 ± 3.2 days) compared to AC (6.2 ± 3.7 days), CDL (7.1 ± 4.4 days), and MT (7 ± 4.6 days) patients (P < .0001). Additionally, postprocedure LOS was shorter for CAVT patients (3.8 ± 3.2 days) than CDL (6.1 ± 4.3 days; P < .0001) or MT (6.2 ± 4.5 days; P < .0001) patients. Postprocedure intensive care unit (ICU) utilization was lower in the CAVT group compared to the CDL group (44.3% vs 82.7%; P < .0001), with a shorter mean ICU stay (0.7 ± 1.3 days vs 1.6 ± 1.5 days; P < .0001). CAVT patients had fewer composite complications versus MT patients (1.2% vs 4.1%; P = .0034) and had a reduced incidence of acute kidney injury developing during the hospitalization compared to the MT (1.9% vs 4.9%; P = .0099) and CDL groups (1.9% vs 4.5%; P = .0214). No differences were observed between CAVT and the other groups for in-hospital mortality, 30-day all-cause mortality, and PE-related readmissions.
CAVT for the treatment of intermediate-risk PE led to significant reduction of hospital LOS and fewer complications without increasing mortality or readmissions compared to AC, CDL, and other MT.
Complete Two-Year Outcomes in Patients Receiving Mechanical Thrombectomy for DVT in the CLOUT Registry
Presented by: David J. Dexter, MD
Prospective data detailing long-term outcomes following endovascular treatment for deep vein thrombosis (DVT) are limited due to the field’s relatively recent development. The CLOUT registry is a prospective, multicenter study evaluating patient outcomes following mechanical thrombectomy (MT) with the ClotTriever System (Inari Medical) in proximal lower extremity DVT.
This presentation represents the largest available data set detailing MT outcomes for DVT and the first reporting of final results through 2 years from all available patients enrolled in the completed CLOUT registry. Study inclusion was all-comer: patients were aged ≥ 18 years and enrolled regardless of bilateral disease, duration of symptoms, prior treatment for the current DVT, or contraindications to thrombolytic therapy. In total, 285 patients completed the 2-year follow-up visit.
At 2 years post-MT, 81.5% of treated limbs had no postthrombotic syndrome (PTS; Villalta score < 5) compared to 18.8% at baseline. Furthermore, the prevalence of moderate or severe PTS (Villalta score ≥ 10) was 6.4% at 2 years compared to 46.9% at baseline. Flow was demonstrated in 93.9% of treated vessels and compressibility in 96.2% via duplex ultrasound assessment. Further significant improvements were observed in revised Venous Clinical Severity Score, Numeric Pain Rating Scale, and EQ-5D scores when compared to baseline.
These real-world data detailing MT for DVT outcomes with the ClotTriever System demonstrate significant symptom relief and quality-of-life improvement for patients in addition to recovery of vessel function and a low rate of subsequent PTS. Such favorable long-term outcomes coupled with previously reported acute safety and effectiveness profiles support MT treatment for DVT. Definitive evidence comparing MT plus anticoagulation to anticoagulation alone will come from the currently enrolling DEFIANCE randomized controlled trial (NCT05701917).
