Retrievable scaffold therapy (RST) with the Spur® peripheral retrievable scaffold system (Reflow Medical; Figure 1) represents a novel approach to BTK CLTI treatment. The Spur system consists of a retrievable nitinol scaffold with radial spikes integrated onto a balloon delivery platform. The radial spikes are designed to penetrate the lesion and vessel wall in a controlled manner, reduce recoil, change vessel compliance, and create channels that enhance drug uptake to the adventitia (Figure 2).15 Following Spur RST, commercially available DCBs are applied to provide long-term patency.16–18 This combined strategy is intended to deliver stent-like results while leaving nothing behind.

The academic, all-comers SirPAD trial enrolled 1,252 patients with femoropopliteal or below-the-knee PAD who were randomized to receive either the sirolimus-coated balloon MagicTouch PTA or any uncoated balloon angioplasty. The primary outcome of major adverse limb events (MALE), encompassing major unplanned amputations affecting the target limb or target-lesion revascularization for critical ischemia, occurred in 8.8% of patients enrolled in the sirolimus-coated balloon group vs. 15% in the uncoated balloon group at one year, corresponding to a median unbiased estimate of the risk difference of -4.9%. This difference was both noninferior and superior in favour of MagicTouch PTA (Concept Medical Inc.) vs. uncoated balloon. Furthermore, the authors showed a statistically significant reduction in the composite key secondary endpoint of any unplanned target-limb amputation or any target limb revascularization.

12 Month Outcomes of the SUCCESS PTA Study show consistent safety and effectiveness in claudicant and CLTI patients when using the SELUTION SLR™ drug eluting balloon.

RNA-seq identified downregulation of the Hedgehog signaling pathway in CARMN-KO models and revealed that CARMN regulates this pathway through its downstream miRNA, miR-143-3p, which targets Hedgehog-interacting protein (HHIP), an antagonist of Hedgehog signaling. Delivery of HHIP-specific siRNA or miR-143-3p mimics rescued EC angiogenic defects and improved blood flow recovery in both CARMN-KO and WT mice. These findings underscore the critical role of CARMN in modulating angiogenesis through the miR-143-3p-HHIP-Hedgehog signaling axis, providing insights into SMC-EC interactions and potential therapeutic strategies for CLTI.

Until this recent Health Canada approval for the Esprit BTK system, Abbott notes that the standard of care has been balloon angioplasty. However, the company notes that treatment with balloon angioplasty alone can have poor short- and long-term results, and—in many instances—the vessels do not remain patent, requiring additional treatment.

Sahil Parikh (Columbia University Irving Medical Center, New York, USA) reported that, at three years, Esprit BTK demonstrated a 33% relative improvement in the composite primary efficacy endpoint of primary patency and limb salvage compared to percutaneous transluminal angioplasty (PTA; 59.5% vs. 44.8%; p=0.0025 log rank test). Parikh added that the Esprit BTK was also associated with significantly lower rates of binary restenosis (38% vs. 49%; p=0.018 log rank test), and lower clinically driven target lesion revascularisation (CD-TLR) rates, though the latter did not reach statistical significance (10.2% vs. 18.4%; p=0.052 log rank test). Furthermore, the presenter shared that safety outcomes, the composite of freedom from major adverse limb events at three years, and perioperative death at 30 days were similar between the two arms (90.8% vs. 94.2%; p=0.23 log rank test).  

Drug-coated balloons and stents don’t reduce the risk of amputation or improve quality of life for people with peripheral artery disease in the legs. That’s the takeaway from two major clinical trials led by researchers at the University of Gothenburg.

“Endovascular thrombectomy has transformed acute ischaemic stroke care, with onset-to-puncture [OTP] time widely recognised as a critical determinant of outcome,” the authors write, outlining the backdrop to their study. “However, emerging evidence suggests that in-hospital procedure time—from arterial puncture to final recanalisation—may have an equally or more significant impact.”

For patients with compromised limb viability, such as acute and chronic limb-threatening ischaemia, or severe functional impairment that does not improve with exercise training, lower extremity revascularization is recommended. Given the complexity of PAD management, a multidisciplinary vascular team is required to achieve the best individualized treatment. Further research efforts should focus on reducing ischaemic events and health disparities and on optimizing the implementation of GDMT and exercise therapy, as well as improving the quality of life in patients with PAD.

A press release details that AMBITION BTK is a prospective, multicentre, randomised controlled trial (RCT) designed to investigate the clinical safety and effectiveness of the Auryon atherectomy system combined with standard balloon angioplasty, compared to balloon angioplasty alone, in treating infrapopliteal lesions in patients with CLTI. The primary endpoint will be evaluated using a win-ratio approach, comparing the two treatment groups based on the following components in a hierarchical manner at 12 months: freedom from major amputation, freedom from clinically driven target lesion revascularisation (CD-TLR), and primary patency.

According to Reflow Medical, the Spur stent system is the first and only retrievable stent system that features a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system. It is designed for controlled lesion penetration and treatment through a series of radially expandable spikes. Known as retrievable scaffold therapy (RST), the spikes on the Spur stent penetrate the lesion to increase the acute luminal diameter and modify the lesion morphology to change vessel compliance and reduce vessel recoil effect.

A new statement from leading heart and blood vessel experts in Europe is providing clinical guidance for treatments to prevent blood clots in patients with a serious condition called chronic limb-threatening ischemia (CLTI), after they have had procedures to restore blood flow in their lower limbs. The statement, and the systematic review it is based on, comes from the European Society of Cardiology (ESC) Working Group on Aorta and Peripheral Vascular Diseases and Working Group on Cardiovascular Pharmacotherapy.

StentIt’s RFS device is a bioresorbable stent built from microfibers, providing structural support to instantly open, and facilitate the reconstruction of the artery. Due to the porous design of the implant, patient’s own cells infiltrate into the mesh, triggering the formation of new vascular tissue. While the artery is being reconstructed from the inside-out, the synthetic implant gradually resorbs and ultimately disappears over time. 

In Wednesday’s peripheral arterial programme, which hosted several podium-first presentations, lower limb drug-eluting technologies took centre stage—signalling a potential shift in the treatment paradigm for chronic limb-threatening ischaemia (CLTI). Investigators shared compelling new data from studies ranging from first-in-human trials to large-scale registries, which vie to redefine durability and safety, as well as cost-effectiveness, in the peripheral arterial treatment landscape.

Critical Limb Ischemia (CLI) is a condition manifested by pain at rest, a non-healing wound, or gangrene. It occurs due to severe blockages in the arteries of a person’s lower extremities/limbs (legs), which markedly reduces blood flow. This condition is a serious form of Peripheral Arterial Disease or PAD that is caused by the buildup of fats, cholesterol or some other substances in and around your artery walls.

Presented today, late-breaking data from the second year of the LIFE-BTK clinical trial demonstrate the long-term effectiveness of the US Food and Drug Administration (FDA)-approved Esprit BTK everolimus-eluting resorbable scaffold system (Abbott Vascular) in patients with the most severe form of below-the-knee (BTK) peripheral arterial disease (PAD). The data show that the Esprit BTK offers sustained benefits over balloon angioplasty with fewer repeat procedures at two years.

Using the most conservative delta between the two groups in terms of the primary efficacy endpoint at 365 days, not inclusive of the treatment window, the Esprit BTK scaffold costs an additional US$7,086 per primary efficacy endpoint avoided. This led Parikh to report that the Esprit BTK scaffold achieves a 64% probability of cost-effectiveness at a US$10,000 willingness-to-pay threshold compared to angioplasty. As a result of this, he averred: “The use of Esprit BTK at one year alone is likely to be cost effective.”

Using peptides replicating the membrane-distal portion of CD31, which is prominently exposed on the inner side of healthy vessels, can simulate the surface of a healthy endothelium. This approach effectively prevents the deposition and activation of blood platelets and leukocytes, which are abnormally prolonged by the presence of a foreign body at sites of endovascular stent implantation, and promotes the acquisition of physiological phenotype by the ECs covering the surface.

Peripheral artery disease (PAD) is the lower limb manifestation of systemic atherosclerotic disease. PAD may initially present with symptoms of intermittent claudication, whilst chronic limb-threatening ischaemia (CLTI), the end stage of PAD, presents with rest pain and/or tissue loss. PAD is an age-related condition present in over 10% of those aged ≥65 in high-income countries. Guidelines regarding definition, diagnosis and staging of PAD and CLTI have been updated to reflect the changing patterns and presentations of disease given the increasing prevalence of diabetes.

Despite medical and technical progress, therapy of lower extremity arterial disease (LEAD) remains limited by subsequent disease progression and ultimate limb ischaemia. Even today, interventional and surgical revascularisation does not enable long-term success in all patients, and/or may not be technically feasible in end-stage LEAD anymore. Subsequent intractable claudication, impaired quality-of-life and work capacity, limb loss, and associated morbidity and mortality have thus generated impetus for alternative therapies.