Late-breaking clinical trial results presented at the VIVA24 conference in Las Vegas highlight advancements in treating vascular diseases. The studies covered a range of interventions, including drug-eluting scaffolds, intravascular lithotripsy, and thrombectomy techniques, offering new hope for patients with challenging vascular conditions.
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) for treating chronic limb-threatening ischemia (CLTI) and infrapopliteal lesions. Brian DeRubertis, MD, presented data showing that Esprit BTK significantly outperformed percutaneous transluminal angioplasty (PTA) in vessel patency and limb salvage.
At two 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 versus 57.8% for PTA (P = .0054).
Shockwave IVL Catheters Demonstrate Safety and Efficacy
Two studies focused on the Shockwave Intravascular Lithotripsy (IVL) system (Shockwave Medical) for treating calcified peripheral artery disease (PAD). The Mini S/FORWARD PAD IDE study, presented by JD Corl, MD, evaluated the Shockwave Javelin Peripheral IVL catheter, which has a forward-shifted IVL emitter designed to modify calcium in subtotal occlusions or extremely narrowed calcified vessels. The pooled analysis of 103 lesions in 90 patients showed that the Javelin catheter was able to fully cross the target lesion in 93% of cases. The primary effectiveness endpoint (residual stenosis ≤ 50% without flow-limiting dissection) was met in 99% of cases (P < .0001), and the primary safety endpoint (major adverse events at 30 days) was met in 1.1% of cases (P = .0012).
Venita Chandra, MD, presented 30-day outcomes from the Disrupt PAD BTK II study, which enrolled 250 patients with calcified infrapopliteal lesions. Procedural success, defined as ≤ 50% residual stenosis without serious angiographic complications, was achieved in 97.9% of cases. At 30 days, the major adverse limb event (MALE) rate was 0.8%, and mean improvement in VascuQoL scores was 4 ± 5 (P < .0001).
Thomas Zeller, MD, presented results from the RESTORE ATK and RESTORE BTK trials, which evaluated a novel laser and optics-based IVL system (Bolt IVL, Bolt Medical) for calcified lesions. 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.
Directional Atherectomy Plus DCB Reduces Stenting in Calcified Lesions
In the Total REALITY analysis, also presented by Venita Chandra, MD, directional atherectomy (DA) prior to drug-coated balloon (DCB) treatment was compared to balloon predilatation followed by DCB in long, calcified femoropopliteal lesions. The analysis showed that DA plus DCB resulted in a significantly lower provisional stent rate (9.5% vs 21.1%; P = .014) and trended toward higher stent-free patency at 12 months (79.1% vs 68.1%; P = .09).
TCAR Demonstrates Safety and Efficacy in Standard-Risk Patients
The ROADSTER 3 study, presented by Meghan Dermody, MD, evaluated transcarotid artery revascularization (TCAR) using the ENROUTE Transcarotid Stent System and Neuroprotection System (Boston Scientific) for carotid stenosis in standard-surgical-risk patients. The rate of stroke/death/MI at 30 days was 0.9% (0.6% per-protocol), with a 30-day stroke rate of 0.9% (0.6% per-protocol).
William A. Gray, MD, presented two-year outcomes of the PERFORMANCE II study, evaluating the Neuroguard IEP 3-in-1 Carotid Stent System (Contego Medical) with integrated embolic protection for carotid artery stenosis in high-surgical-risk patients. The rate of in-stent restenosis (ISR) was 3.65% at 1 year and 3.85% at 2 years, with a very low clinically driven target lesion revascularization (CD-TLR) rate of 0.36% at 2 years.
CAVT Shows Benefits in Intermediate-Risk PE
A retrospective study presented by Parag J. Patel, MD, MS, 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 (4.6 days) compared to anticoagulation (6.2 days), catheter-directed thrombolysis (7.1 days), and other mechanical thrombectomy (7 days) (P < .0001). Postprocedure ICU utilization was also lower in the CAVT group compared to the CDL group (44.3% vs 82.7%; P < .0001).
Mechanical Thrombectomy Improves Outcomes in DVT
David J. Dexter, MD, presented two-year outcomes from the CLOUT registry, evaluating mechanical thrombectomy (MT) with the ClotTriever System (Inari Medical) for deep vein thrombosis (DVT). At two years post-MT, 81.5% of treated limbs had no postthrombotic syndrome (PTS), compared to 18.8% at baseline. The prevalence of moderate or severe PTS was 6.4% at 2 years compared to 46.9% at baseline.
