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Drug technology
PACLITAXEL DCB PERFORMS WELL IN ‘CHALLENGING ANATOMY’ OF FEMOROPOPLITEAL IN-STENT RESTENOSIS, VQI REGISTRY DATA SHOW
By Jocelyn Hudson
THE IN.PACT ADMIRAL DRUG-
coated balloon (DCB) shows promising results in treating femoropopliteal in-stent restenosis (ISR) in a Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry-based, postmarket surveillance study. This is according to Daniel Bertges, MD, a vascular surgeon from the University of Vermont Medical Center in Burlington, Vermont, who presented interim, 24-month data from the prospective, non-randomized study in a late-breaking clinical trials session at Vascular Interventional Advances (VIVA) 2022 in Las Vegas (Oct. 31–Nov. 3).
Bertges revealed a freedom from target lesion revascularization (TLR) rate of 89.8% at one year and 72% at two years in the “challenging anatomy” of in-stent restenosis within the femoropopliteal artery segment as the headline findings.
The presenter informed VIVA 2022 that he and colleagues conducted a multicenter study involving 300 patients at 43 US sites within the SVS VQI. The primary endpoint was TLR within 12 months post-index procedure, and secondary endpoints—assessed at 12, 24, and 36 months—included allcause mortality, TLR, target vessel revascularization, major target limb amputation, and technical success, which was defined as successful deployment of the balloon without resulting in occlusion and having residual stenosis ≤30% and resting systolic pressure gradient of <10mmHg, if measured.
Bertges noted that patients were included in the study if they were ≥18 years of age, had undergone single-limb and single-treatment during index procedure and received primary treatment of the ISR lesion with an IN.PACT Admiral DCB, and had de novo or recurrent ISR in the superficial femoral and/or popliteal artery and documented ischemia with Rutherford classification 2, 3, or 4. Those patients who had undergone bilateral femoropopliteal artery repair or had a history of tissue loss in the target limb were excluded. Failure to successfully cross the target lesion was another exclusion criterion.
Giving details of the patients included in the IN.PACT SVS ISR registry, Bertges explained that 20% of patients (60/300) had chronic limb-threatening ischemia (CLTI), 56% (168/300) had diabetes, and 53.7% (161/300) had TASC C–D lesions, among other characteristics.
In his conclusion, the presenter remarked that these results “demonstrate the ability of the VQI to conduct postmarket evaluation of peripheral devices in partnership with industry and federal regulators.”
Speaking to Vascular Specialist following his VIVA 2022 presentation, Bertges commented that one of the main benefits of registry data is that it is “obtained from everyday practice,” and therefore “includes data from a variety of practitioners working to care for a variety of patient populations, as opposed to the sometimes restrictive inclusion and exclusion criteria of clinical trials.”
With reference to a particular benefit of the VQI registry, he stressed that there is “power in numbers,” noting that the VQI includes “several hundred thousand procedures recorded over the past decade or more” and that it continues to accrue tens of thousands of patients annually. “That’s a rich repository of information.”
Furthermore, Bertges referenced the multispecialty nature of the VQI registry— which includes vascular surgeons, cardiologists, radiologists—as another of its strong points, as well as its “continued efforts towards gathering the best longitudinal data on our procedures for our patients.”
Looking ahead to what is next for the study, Bertges informed Vascular Specialist that the researchers are looking to track their results out to three years. “We expect those findings to be reported back to the investigators, to the sponsor, and to our FDA [Food and Drug Administration] regulators in the early part of the summer of 2023, and so we look forward to bringing those results to the vascular community following that.”
Daniel Bertges at VIVA 2022
DANIEL BERTGES
LIMB SALVAGE
End-stage CLTI: Deep-vein arterialization procedure demonstrates amputation-free survival rate of 66% at six months
Six-month results from the PROMISE II trial of the LimFlow deep-vein arterialization system showed an overall amputation-free survival of 66%—“well above” the primary endpoint target of 54%, chief investigator Daniel Clair, MD, told the 2022 Vascular Interventional Advances (VIVA) meeting (Oct. 31–Nov. 3) in Las Vegas.
The PROMISE II research team further demonstrated a limb salvage rate of 76% and overall survival rate of 87% in a group of patients that Clair, professor and chair in the Department of Vascular Surgery at Vanderbilt University in Nashville, Tennessee, described as “the sickest group of patients ever enrolled in a lower-extremity pivotal trial.”
PROMISE II was conducted at 20 sites in the U.S. with more than 100 enrollees, all of whom were classed as having Rutherford 5 and 6 levels of peripheral arterial disease (PAD)—commonly referred to as a “no-option” group of end-stage chronic limb-threatening ischemia (CLTI) patients.
Clair reported a technical success rate of 99% across “a wide range of investigators from all different specialties” using the LimFlow transcatheter arterialization system among a patient population he described as predominately older, male, diabetic and who bore the “typical group of comorbidities,” with around 20% on dialysis.
There was a large difference in outcomes for dialysis vs. non-dialysis patients—driven primarily by an increased mortality in the dialysis group, Clair noted. “The primary reason this group did not meet [the target] is really overall survival,” he told VIVA 2022. “This is obviously a very sick group of patients.
If you have end-stage renal disease, and in addition, reach the point where your limb is not salvageable, there is probably major changes that we need to do in order to improve their overall survival.” Six-month results also showed a wound healing rate of 75% , Clair said, rising to almost 80% at the 12-month mark, according to independent core lab evaluation. Pain scores for this patient population, “These results are very much too, continue to decline over time alongside “a significant improvement in their quality of life,” he added. in line with what we saw in the Additionally, Clair reported an improvement in the patient group’s Rutherford classification at the six-month point, PROMISE I outcomes, and from telling VIVA that almost 20% were categorized as either my viewpoint, now we have to Rutherford 0 or 1. Out to a year, he continued, “at least pre liminarily,” nearly 60% were recorded as Rutherford 0. find a new name for this group Concluding, Clair said: “The PROMISE II study met its of patients” endpoint with a very reliable amputation-free survival. Transcatheter arterialization is safe and effective. These results DANIEL CLAIR are very much in line with what we saw in the PROMISE I outcomes, and from my viewpoint, now we have to find a new name for this group of patients.”—Bryan Kay
