Year in Review: STORM-PE, CREST-2, and LIFE-BTK Headline Endovascular News

Randomized trial evidence around device treatments for pulmonary embolism (PE), asymptomatic carotid stenosis, and below-the-knee (BTK) chronic limb-threatening ischemia (CLTI), as well as a decision on reimbursement for renal denervation, drove news in the endovascular space this past year.

When reflecting on 2025, the first theme to come to mind for Eric Secemsky, MD (Beth Israel Deaconess Medical Center, Boston, MA), was “real advancement in the PE technology that’s now on the market.”

A story on the results of the STORM-PE trial was one of the most-read on TCTMD this year. That study showed that patients with acute intermediate-high-risk PE who underwent computer-assisted vacuum thrombectomy (CAVT) using the 16-Fr Lightning Flash system (Penumbra) had a greater reduction in the RV/LV ratio at 48 hours than those treated with anticoagulation alone.

The trial illustrates maturation of evidence around devices for the treatment of PE, Secemsky indicated. “We saw the PE devices lead before the data and we saw some really quick uptake and a whole field built, and it’s nice to now be able to step back and remind ourselves that we are doing the right things with randomized trial data supporting an intervention over anticoagulation,” he said.

There are still more data to come—from PEERLESS II, HI-PEITHO, and PE-TRACT, for instance. But STORM-PE “is just one more important piece to say, ‘Listen, if we intervene on these high-risk PE patients in the hospital, they have a safe outcome and they tend to be more functionally intact when they get back home after that discharge,’” Secemsky said. “And I think that was really meaningful just to support where a lot of us felt like our practices had moved to but hadn’t had the data necessarily to follow up on that.”

Treating Carotid Disease

The long-awaited results of the CREST-2 trials pitting carotid stenting and carotid endarterectomy individually against medical therapy alone in patients with asymptomatic carotid stenosis also came out this year. Stenting, but not surgery, demonstrated superiority to medical therapy when it came to a composite of any stroke or death within the first 44 days, or ipsilateral ischemic stroke within 4 years of follow-up.

“The interesting part for carotid intervention right now is that there seems to be a clear divide that’s happened between asymptomatic and symptomatic [patients],” Secemsky said, noting that those with stroke or TIA are primarily going to stroke centers and being managed by neurologists, neurointerventionalists, and neurosurgeons. Asymptomatic patients, on the other hand, tend to be managed by multidisciplinary teams of cardiologists, vascular surgeons, and interventional radiologists.

CREST-2 “is going to shake up this space a little bit” and suggests that for patients with a reasonable life expectancy, “probably early intervention on asymptomatic carotid disease is the right decision,” he said. “We were still questioning that before CREST-2, so that definitely has some legs and I think it will be really interesting to see how it plays out in clinical practice.”

BTK Intervention

Another major development in endovascular therapies was the release of longer-term data from LIFE-BTK. At 3 years, patients with infrapopliteal CLTI who had been treated with the everolimus-eluting Esprit BTK resorbable scaffold (Abbott) continued to have a higher rate of freedom from above-ankle amputation in the index limb, occlusion of the target vessel, binary restenosis of the target lesion, and clinically driven target lesion revascularization compared with those who had been treated with percutaneous transluminal angioplasty (59.5% vs 44.8%; P = 0.025).

That “really continues to support the role of a bioabsorbable scaffold for infrapopliteal arteries,” Secemsky said, adding that reimbursement issues will have to be addressed moving forward as the technology continues to evolve. “It’s still hard to justify the cost of them without the necessary payment schedule.”

An economic analysis from the LIFE-BTK investigators did, however, suggest that use of the Esprit BTK is likely to be cost-effective for US hospital systems.

Results of the MOTIV BTK trial of another bioresorbable scaffold—the sirolimus-eluting Motiv (REVA Medical)—are expected in 2026.

In terms of other BTK interventions, Secemsky highlighted drug-coated balloons and the Spur retrievable scaffold system (Reflow Medical) as technologies to watch.

Renal Denervation and PAD Developments

Reimbursement concerns were at least partly assuaged this year for another technology—renal denervation. In October, the US Centers for Medicare & Medicaid Services (CMS) issued a final national coverage determination (NCD) on radiofrequency- and ultrasound-based renal denervation for the treatment of uncontrolled hypertension. Continued evolution among commercial devices in this space and Boston Scientific’s acquisition of SoniVie—which developed an ultrasound-based renal denervation technology—were also big news in 2025, Secemsky highlighted.

TCTMD wrote a number of stories related to peripheral artery disease, including two covering American Heart Association scientific statements on PAD pain and sex differences in peripheral vascular disease. In addition, a survey study highlighted implicit bias in peripheral vascular disease treatment leading to low-value care for Black patients.

Data from the SWEDEPAD 1 and 2 national registry trials spurred new questions about the safety of paclitaxel devices in PAD, while several studies presented at the 2025 Charing Cross International Symposium in April suggested that sirolimus-based technologies may have a role in the treatment of peripheral vascular disease.

Glucagon-like peptide-1 (GLP-1) receptor agonists may have a place in the treatment of PAD as well, according to data that came out in 2025. In the STRIDE trial, semaglutide (Wegovy; Novo Nordisk) improved mean walking distance, pain-free walking ability, and several measures of quality of life at 1 year in patients with diabetes and symptomatic PAD. A potential vascular benefit of GLP-1 receptor agonism was bolstered by a retrospective study of more than 100,000 patients, in which rates of major adverse limb events, major adverse cardiac events, and hospitalizations all were lower in patients on one of the medications.