Second Round of Late-Breaking Clinical Trial Results Announced at VIVA24

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 second of four 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 this afternoon's 4 late-breaking clinical trial presentations.

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).

About the VIVA Foundation

The VIVA Foundation, 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 the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide.