Several late-breaking clinical trial results were presented at the VIVA (Vascular InterVentional Advances) 2024 symposium, showcasing advancements in the treatment of vascular diseases. The studies highlighted innovative approaches and technologies aimed at improving patient outcomes in challenging conditions such as chronic limb-threatening ischemia (CLTI), peripheral artery disease (PAD), and carotid stenosis.
Esprit BTK Scaffold Shows Durable Benefits in CLTI
Two-year results from the LIFE-BTK randomized controlled trial demonstrated the sustained benefits of the Esprit Below-the-Knee (BTK) Drug-Eluting Resorbable Scaffold (Abbott) in patients with CLTI and infrapopliteal lesions. The Esprit BTK scaffold showed superior long-term outcomes compared to percutaneous transluminal angioplasty (PTA). 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 (hazard ratio of 0.48, P = .0004). The scaffold also significantly reduced binary restenosis, with rates of 35.2% for Esprit BTK compared to 57.8% for PTA (P = .0054).
Shockwave Javelin IVL Catheter Demonstrates Safety and Efficacy in PAD
The Mini S/FORWARD PAD IDE study evaluated the Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) catheter (Shockwave Medical) for modifying calcium in severely narrowed calcified vessels. The pooled analysis included 103 lesions in 90 patients. The primary effectiveness endpoint, defined as residual stenosis ≤ 50% without flow-limiting dissection, was achieved in 99% of cases (P < .0001). The primary safety endpoint, major adverse events at 30 days, was met in 1.1% of cases (P = .0012). Baseline stenosis was reduced to 23% ± 9.1% at final angiography, with no perforations or embolization events through 30 days.
Disrupt PAD BTK II Study Shows Promise for Calcified Below-the-Knee Lesions
The Disrupt PAD BTK II study assessed the Shockwave Peripheral Intravascular Lithotripsy (IVL) System (Shockwave Medical) in 250 patients with calcified infrapopliteal lesions. Procedural success, defined as ≤ 50% residual stenosis without serious angiographic complications, was achieved in 97.9% of cases. After IVL, residual stenosis was reduced to 29%, and to 25.5% after optional postdilatation and/or stent implantation. At 30 days, the MALE rate was 0.8%, and mean improvement in VascuQoL scores was 4 ± 5 (P < .0001).
RESTORE ATK and RESTORE BTK Trials Highlight Novel Laser IVL System
The RESTORE ATK and RESTORE BTK trials evaluated a novel laser and optics-based intravascular lithotripsy (IVL) system (Bolt IVL, Bolt Medical) for calcified lesions in the peripheral vasculature. 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.
TCAR with ENROUTE System Safe and Effective for Carotid Stenosis
The ROADSTER 3 study evaluated transcarotid artery revascularization (TCAR) using the ENROUTE Transcarotid Stent System (TSS) and Neuroprotection System (NPS) (Boston Scientific Corporation) for carotid stenosis in standard-surgical-risk patients. In the intent-to-treat population, the rate of stroke/death/MI at 30 days was 0.9%. The incidence of cranial nerve injury within 30 days was 0.6%, with both cases resolving within 6 months. These results demonstrate that TCAR is safe and effective in patients at standard risk for adverse events from carotid endarterectomy.
Neuroguard IEP Carotid Stent System Shows Long-Term Durability
The PERFORMANCE II study assessed the Neuroguard IEP 3-in-1 Carotid Stent System (Contego Medical) with integrated embolic protection for carotid artery stenosis in patients at elevated risk. The 30-day stroke rate was 1.3%. The rate of in-stent restenosis (ISR) was 3.85% at 2 years, and the rate of clinically driven target lesion revascularization (CD-TLR) at 2 years was 0.36%. These 2-year results demonstrate the procedural safety and long-term durability of the Neuroguard IEP system in high-surgical-risk patients.
CAVT Reduces Healthcare Resource Utilization in Intermediate-Risk PE
A retrospective study evaluated computer-assisted vacuum thrombectomy (CAVT) (Penumbra, Inc.) compared to other treatments for intermediate-risk pulmonary embolism (PE). CAVT patients experienced significantly shorter length of stay (LOS) compared to anticoagulation, catheter-directed thrombolysis (CDL), and mechanical thrombectomy (MT) patients (P < .0001). Postprocedure ICU utilization was lower in the CAVT group compared to the CDL group (P < .0001). CAVT patients had fewer composite complications versus MT patients (P = .0034) and a reduced incidence of acute kidney injury compared to the MT and CDL groups (P < .05).
ClotTriever System Demonstrates Symptom Relief in DVT
Two-year outcomes from the CLOUT registry, evaluating mechanical thrombectomy (MT) with the ClotTriever System (Inari Medical) in proximal lower extremity DVT, showed that 81.5% of treated limbs had no postthrombotic syndrome (PTS) compared to 18.8% at baseline. Significant improvements were observed in revised Venous Clinical Severity Score, Numeric Pain Rating Scale, and EQ-5D scores when compared to baseline. These data support MT treatment for DVT.
