Top Endovascular News of 2024

After years of being consumed by the paclitaxel mortality debate, the endovascular field saw new advances in drug and device therapies in 2024, as well as the first treatment for below-the-knee (BTK) disease to be approved by regulatory authorities in the United States.

Large-bore mechanical thrombectomy scored a win over catheter-directed thrombolysis in patients with acute intermediate-risk pulmonary embolism. In the PEERLESS trial (PEERLESS; 32 Down), the difference was driven by less clinical deterioration and/or bailout as well as less use of intensive care for those treated with the FlowTriever system (Inari Medical). Thrombectomy also was associated with greater improvement in several measures of early recovery at 24 hours, shorter length of stay, and a lower 30-day readmission rate.

An endovascular technique called percutaneous transmural arterial bypass, which mimics surgical bypass without the need for open surgical cutdown in complex superficial femoropopliteal lesions, delivered good patency through 3 years with no late venous issues or deep vein thrombosis complications, final data from the DETOUR 2 trial (DETOUR; 14 Down) showed. In a session at VIVA 2024, one expert noted that the technique can be a useful option for patients who have previously failed standard endovascular interventions.

At the 2024 Charing Cross International Symposium, investigators presented topline results from the BASIL-3 trial (BASIL; 15 Down), which showed no improvement in amputation-free survival when patients with chronic limb-threatening ischemia (CLTI) were treated with DES and drug-coated balloon (DCB) technologies versus plain balloon angioplasty. The trial was part of series of studies that have attempted to fill evidence gaps since the National Institute for Health and Care Excellence noted in 2012 that there was insufficient data to support the use of DES and DCB in the treatment of PAD. Discussants at the CX Symposium questioned the trial’s endpoint and suggested that it was insufficiently powered, with COVID-related deaths potentially diluting the mortality endpoint.

While BASIL-3 and many other trials in PAD and CLTI have focused primarily on paclitaxel-based therapies, interest in limus-based treatments has increased in recent years.

In the SIRONA trial (SIRONA; 19 Down), investigators put several paclitaxel DCBs and a sirolimus DCB (MagicTouch, Concept Medical) head-to-head 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 follow patients to 5 years and is expected to fill some knowledge gaps including how sirolimus can best be utilized in BTK lesions and long-term safety differences in comparison with paclitaxel.

Other Headlines

This year also saw an update to the existing guidelines for the treatment of PAD, which emphasized the need for rigorous medical therapy as well as collaborative vascular care to address well-documented health disparities. The chair of the writing committee told TCTMD that another important aspect of the document is that it stresses the importance of foot care across the whole spectrum of PAD and the role of foot care professionals in helping manage patients with CLTI.

The SAFE-IVC study, done in collaboration with the US Food and Drug Administration, offered some eye-opening statistics on indwelling inferior vena cava filters, namely that only about 15% of Medicare patients with one implanted have them removed in a timely manner, which an editorialist called “inexplicably and unacceptably” low.

As the year closed out, the American Heart Association published a scientific statement on radial access in peripheral vascular interventions that highlights potential benefits for patients as well as hurdles that remain before it can become a preferred access route.

In the year since Medicare’s National Coverage Determination expanded access in the United States to carotid artery stenting (CAS), researchers are continuing to add needed data on CAS and transcarotid artery revascularization techniques. In a debate at VIVA, experts clashed over unresolved issues, including protections to safeguard patients from operators who don’t have the necessary skills or experience to embark on CAS cases.

“It’s clear that there's a lot of unmet need clinically and we now have therapies that are more accessible,” Sahil Parikh, MD (NewYork-Presbyterian/Columbia University Irving Medical Center), told TCTMD.  ”The challenge is that this has been a relatively dormant area for a decade or more. We've got a whole cadre of young, early-career operators who are not facile with carotid stenting, so they're either going to have to be brought up to speed slowly or they're going to have to decide if they're interested in doing carotid interventions. The professional societies are rallying to meet these educational gaps, and I think that'll be an ongoing goal for the foreseeable future.”

Parikh identified some other big news this year, including the FDA approval of a bioresorbable scaffold for below-the-knee infrapopliteal disease. The approval was based on data from the LIFE-BTK study, which showed that the everolimus-eluting Esprit BTK scaffold (Abbott Vascular) was safe and effective at 1 year compared with conventional angioplasty alone. The 2-year data, presented this year at VIVA, show fewer reinterventions in patients who receive the scaffold, with researchers saying that the drug and scaffold seem to be an effective combination in preventing biologic restenosis.

“So far the utilization of the scaffold in clinical practice has been modest,” Parikh said. “There is a postmarket trial that is just getting underway, and it will be interesting to see what those data show in terms of how it performs in the real-world, especially in longer lesions or more complex lesions than were included in the trial.”

After years of not much new happening in the BTK treatment space, he said there is even more reason for optimism as a result of new devices to help in difficult treatment scenarios. One of those introduced this year is a peripheral intravascular lithotripsy (IVL) catheter (Shockwave E8, Shockwave Medical) that is longer and more deliverable for challenging BTK lesions, particularly nonhealing wounds affecting the feet and toes.

Another is the Bare Temporary Spur system (Reflow Medical), which received CE Mark approval in early 2024 for use with a DCB to treat de novo or restenotic lesions in the infrapopliteal arteries. The system mimics stenting of BTK lesions without the long-term risk of a stent implant.

“We also saw new data this year on the Javelin device [Shockwave Medical], which is a forward-facing peripheral IVL catheter for crossing lesions that are otherwise uncrossable,” Parikh noted. Pooled data from a feasibility study and an investigational device exemption study found the device allowed for full lesion crossing in 93% of patients with heavily calcified, stenotic peripheral arteries.