Endovascular Advancements: New Devices and Strategies Emerge for PAD and CLTI
Key Insights
Large-bore mechanical thrombectomy demonstrates superiority over catheter-directed thrombolysis in acute intermediate-risk pulmonary embolism (search), reducing clinical deterioration and ICU stays.
Percutaneous transmural arterial bypass shows sustained patency at 3 years for complex superficial femoropopliteal lesions (search), offering a bypass alternative without open surgery.
The FDA approved a bioresorbable scaffold for below-the-knee infrapopliteal disease, showing safety and efficacy at 1 year compared to angioplasty alone.
The endovascular field has seen significant progress in 2024 with new drug and device therapies, including the first FDA-approved treatment for below-the-knee (BTK) disease. These advancements address critical unmet needs in peripheral artery disease (search) (PAD (search)) and chronic limb-threatening ischemia (search) (CLTI (search)).
Thrombectomy vs. Thrombolysis in Pulmonary Embolism
In the PEERLESS trial, large-bore mechanical thrombectomy using the FlowTriever (search) system (Inari Medical) outperformed catheter-directed thrombolysis in patients with acute intermediate-risk pulmonary embolism (search). The study demonstrated less clinical deterioration and/or bailout, reduced intensive care unit utilization, greater improvement in early recovery measures at 24 hours, shorter hospital stays, and a lower 30-day readmission rate. These results highlight the potential of mechanical thrombectomy to improve outcomes in pulmonary embolism patients.
DETOUR 2 Trial: Percutaneous Arterial Bypass
Final data from the DETOUR 2 trial revealed that percutaneous transmural arterial bypass, an endovascular technique mimicking surgical bypass for complex superficial femoropopliteal lesions (search), achieved good patency through 3 years. The technique avoids the need for open surgical cutdown and showed no late venous issues or deep vein thrombosis complications. Experts at VIVA 2024 noted its utility for patients who have not responded to standard endovascular interventions.
BASIL-3 Trial and Drug-Coated Devices
The BASIL-3 trial, presented at the 2024 Charing Cross International Symposium, investigated the use of drug-eluting stents (DES) and drug-coated balloons (DCB) versus plain balloon angioplasty in patients with CLTI (search). The trial found no improvement in amputation-free survival with DES and DCB technologies. Discussants questioned the trial's endpoint and statistical power, suggesting that COVID-related deaths may have diluted the mortality endpoint. This trial contributes to the ongoing evaluation of drug-coated devices in PAD (search) and CLTI.
SIRONA Trial: Sirolimus vs. Paclitaxel DCBs
The SIRONA trial compared paclitaxel DCBs with a sirolimus DCB (MagicTouch (search), Concept Medical (search)) and found little difference in primary patency and no differences in the composite of clinically driven target vessel revascularization, major target limb amputation, and device- or procedure-related death at 1 year. The trial will continue to follow patients for 5 years to assess the long-term safety and efficacy of sirolimus in BTK lesions.
FDA Approval of Bioresorbable Scaffold for BTK Lesions
The FDA approved the everolimus-eluting Esprit BTK scaffold (search) (Abbott Vascular), a bioresorbable scaffold for below-the-knee infrapopliteal disease. This approval was based on the LIFE-BTK study, which demonstrated the scaffold's safety and efficacy at 1 year compared with conventional angioplasty alone. Two-year data presented at VIVA showed fewer reinterventions in patients receiving the scaffold, suggesting that the drug and scaffold combination effectively prevents biologic restenosis (search). A postmarket trial is underway to assess its real-world performance, particularly in longer or more complex lesions.
Other Advancements
Other notable developments include the introduction of a peripheral intravascular lithotripsy (IVL) catheter (Shockwave E8 (search), Shockwave Medical (search)) for challenging BTK lesions and the Bare Temporary Spur system (search) (Reflow Medical (search)), which received CE Mark approval for use with a DCB to treat de novo or restenotic lesions in the infrapopliteal arteries. Additionally, new data on the Javelin device (search) (Shockwave Medical), a forward-facing peripheral IVL catheter, showed it allowed for full lesion crossing in 93% of patients with heavily calcified, stenotic peripheral arteries.