Francesco Liistro (Azienda Usl Toscana Sud Est, Arezzo, Italy) presented nine-month outcomes from the IN.PACT BTK randomised study. He revealed that the IN.PACT 014 BTK drug-coated balloon (DCB; Medtronic) demonstrates efficacy through nine months compared to percutaneous transluminal angioplasty (PTA) in a complex population.
The study was a prospective, multicentre, randomised (1:1) feasibility study. Fifty chronic limb-threatening ischaemia (CLTI) patients with infrapopliteal chronic total occlusions (CTOs) were enrolled at nine sites across five European countries and followed through 60 months.
Focusing on key eligibility criteria, Liistro told viewers that the “most challenging” lesions were purposefully included in the study, comprising single or multiple total occlusions with lesion lengths ≥40mm.
Focusing on nine-month angiographic outcomes, Liistro communicated that sub-segmental late lumen loss was 0.59±0.94 in the IN.PACT 014 DCB group, compared to 1.26±0.81 in the PTA group (p=0.017). In terms of classic late lumen loss, he informed viewers that this was 0.89±0.77 in the DCB group and 1.31±0.72 in the PTA group (p=0.07).
In addition, the presenter detailed that functional flow by duplex ultrasound (DUS) at nine months was 84.6% in the DCB group and 60.6% in the PTA group (0.341). Finally, he reported that 91.3% of patients reached the composite safety endpoint.
“This novel, randomised, feasibility study with a 014 BTK balloon utilising the 3.5μg/mm2 drug formulation and enhanced study design provides an opportunity to affect future BTK studies and treatment algorithms,” Liistro concluded.
ACOART II and ACOART BTK Italy studies support safety and efficacy of Litos DCB
Wei Guo (Chinese PLA General Hospital, Beijing, China) presented 24-month results of the multicentre, randomised ACOART II study. Addressing LINC viewers, Guo described ACOART II as the first randomised BTK trial in China, and—following on from ACOART I—further demonstrates the safety and efficacy of the Litos DCB (Acotec) for the treatment of BTK artery disease.
Regarding 24-month patency, Guo detailed that the rate of clinically-driven target lesion revascularisation (CD-TLR) was 10.3% in the DCB group (6/58) compared to 24.6% in the PTA group (14/57; p=0.042), the rate of wound healing was 90% in the DCB group (27/30) vs. 81.3% in the PTA group (26/32; p=0.342), and the rate of major amputation was 3.4% (2/58) vs. 1.8% (1/57) in the two groups, respectively (p=0.565).
Presenting 12-month results of the ACOART BTK Italy study, Liistro noted their similarity to those of the ACOART II study, and concluded that the Litos DCB “shows efficacy and safety in the treatment of complex BTK lesions in CLTI patients”.
“The strongest message for clinicians is the drastic reduction of reocclusion showed by the DCB in baseline occluded vessels,” he informed LINC viewers, adding that future studies should include only occluded vessels at baseline and that the primary endpoint of these studies should be reocclusion by DUS.
Luminor DCB yields positive results out to 12 months
Also to present in the late-breaking session was Tjun Tang (Singapore General Hospital, Singapore), who outlined 12-month outcomes from the MERLION trial of the Luminor DCB (iVascular) in BTK lesions.
The MERLION trial assessed the treatment of long tibial occlusive lesions (TASC C and D) in what Tang described as a “challenging and frail” group of CLTI patients. A total of 50 patients—94% with diabetes, 50% with end-stage renal failure, and 88% with a Rutherford score of either five or six—were included in the study. The cohort had a total of 66 atherosclerotic lesions with a mean lesion length of 13.7±9.5cm.
The presenter reported a 100% technical success rate in conjunction with a low rate of bailout stenting (4.5%). Treatment with the Luminor DCB yielded no deaths within 30 days, and a 12-month amputation-free survival rate of 74%.
In addition, the Luminor DCB proved to be efficacious out to 12 months, with a 69% rate of target lesion primary patency and a 12-month freedom from TLR rate of 82%.
Finally, Tang communicated that full wound closure was achieved in 66% of patients and that 60% had improved by at least one Rutherford category at 12 months.
Use of limus-based devices highlighted in four late-breaking trials
Presenting results of the multicentre, dual-blinded, phase II, randomised controlled TANGO study, Ehrin Armstrong (University of Colorado, Aurora, USA) relayed that temsirolimus adventitial drug delivery has provided “robust outcomes” so far, and that a “sizeable effect” has been seen in more complex lesions with temsirolimus delivery.
Twelve-month results from the prospective, single-centre, physician-initiated PRESTIGE BTK study were also revealed. The objective of this clinical investigation has been to evaluate safety and performance outcomes of the SELUTION SLR novel sirolimus-eluting balloon (MedAlliance), for the treatment of long tibial occlusive lesions (TASC C and D) in patients with CLTI.
Presenter Tze Tec Chong (Singapore General Hospital, Singapore) announced that the primary patency rate was 78% and the rate of wound healing was 81%. In addition, freedom from target lesion revascularisation (TLR) was exhibited by 93% of patients and 84% demonstrated amputation free survival (AFS). All these figures have been sustained from the six-month data.
“We have observed minimal slow-flow phenomena and some cases of fast wound healing with SELUTION SLR. It is also easy to track and deliver. We are looking forward to gaining further clinical experience with this device,” commented Chong.
Marianne Brodmann (University of Graz, Graz, Austria) revealed results of the DEEPER LIMUS study—a pilot study examining the performance and safety of the limus-coated Temporary Spur stent system (Reflow Medical), which is for clinical investigational use only, in infrapopliteal arteries.
Broadmann stressed that the Temporary Spur stent system provides localised drug delivery, and may prevent acute vessel recoil and increase luminal gain. In addition, she relayed that the system reduced dissection risk through controlled penetration of the vessel wall, and leaves nothing behind, preserving the natural function of the vessel and allowing future treatment options.
The presenter summarised that there were now “promising” clinical data on the Temporary Spur stent system, not only from DEEPER LIMUS, but also from the DEEPER OUS and DEEPER studies.
Reporting outcomes from the multicentre, single-arm DEEPER OUS trial of the Temporary Spur stent system in conjunction with a commercially available paclitaxel-coated balloon, Michael Lichtenberg (Karolinen Hospital, Arnsberg, Germany) echoed the findings presented by Brodmann.
New data show potential of Limflow system to improve outcomes for no-option CLTI
“Deep vein arterialisation is safe and technically feasible,” stated Peter Schneider (University of California San Francisco, San Francisco, USA) in a presentation on 12-month data from the PROMISE I early feasibility study of the LimFlow system (LimFlow).
Schneider announced that limb salvage for patients with ‘no-option’ revascularisation was achievable in 77% of patients at 12 months, and concluded that lesion from this initial trial will be “incredibly valuable” moving forward. “We continue to gain insights into technical issues and methods to improve outcomes for these patients,” he stated.