VIVA

VIVA

Source:

Zeller T, et al. Late-breaking clinical trials. Presented at: VIVA 20; Nov. 6-8, 2020 (virtual meeting).

Disclosures: The study was funded by Medtronic. Zeller reports he has financial ties with Abbott Vascular, B. Braun, Bard Peripheral Vascular, Bayer, BIBA Medical, Biotronik, Boston Scientific, Cardiovascular Systems Inc., Cook Medical, Efemoral, Intact Vascular, MedAlliance, Medtronic, Philips, Pluristem, QT Medical, Shockwave Medical, Spectranetics, Terumo, TriReme, Veryan, Vesper and W.L. Gore and Associates.
November 06, 2020
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DCB remains effective in real-world PAD population at 5 years

Source:

Zeller T, et al. Late-breaking clinical trials. Presented at: VIVA 20; Nov. 6-8, 2020 (virtual meeting).

Disclosures: The study was funded by Medtronic. Zeller reports he has financial ties with Abbott Vascular, B. Braun, Bard Peripheral Vascular, Bayer, BIBA Medical, Biotronik, Boston Scientific, Cardiovascular Systems Inc., Cook Medical, Efemoral, Intact Vascular, MedAlliance, Medtronic, Philips, Pluristem, QT Medical, Shockwave Medical, Spectranetics, Terumo, TriReme, Veryan, Vesper and W.L. Gore and Associates.
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In a real-world population of patients with peripheral artery disease treated with a drug-coated balloon, nearly 70% remained free from clinically driven target lesion revascularization at 5 years, according to data presented at VIVA 20.

Thomas Zeller

Among the IN.PACT Global cohort of 1,416 patients (mean age, 69 years; 68% men) treated with the DCB (IN.PACT Admiral, Medtronic), 69.4% were free from clinically driven TLR at 5 years, Thomas Zeller, MD, PhD, associate professor of angiology at Universitaets-Herzzentrum Freiburg, Bad Krozingen, Germany, said during a presentation at the virtual conference.

Artery Plaque
Source: Adobe Stock.

“Almost 70% of patients, regardless of how complex their lesions, have been free from reintervention within 5 years, so that means there are a lot of cost savings with this particular treatment,” he said.

The primary safety endpoint of freedom from device- and procedure-related death at 30 days, freedom from major target limb amputation at 5 years and freedom from clinically driven TLR at 5 years was met in 67.4% of patients, Zeller said.

He noted the mean time to first clinically driven TLR was 669.2 days (range, 1-1,751; standard deviation, 462.5).

Major adverse events occurred in 45.9% of the cohort at 5 years, including death from any cause in 19.5% of patients, clinically driven target vessel revascularization in 31.9%, major target limb amputation in 1.7% and thrombosis in 5.7%, Zeller said.

The 5-year mortality rate in this cohort was much lower than epidemiological death rates observed in European patients with PAD treated conservatively, he said, noting vital status information was available in 96.4% of patients.

He said predictors of clinically driven TLR included in-stent restenosis (HR = 1.399; 95% CI, 1.083-1.843), Rutherford category 4 or greater (HR = 1.39; 95% CI, 1.014-1.906), CAD (HR = 1.362; 95% CI, 1.095-1.67), moderate-to-severe or severe calcification (HR = 1.311; 95% CI, 1.029-1.671), previous target limb revascularization (HR = 1.285; 95% CI, 1-1.65) and long lesion length (HR = 1.025; 95% CI, 1.014-1.038).

Rutherford category 4 or greater, CAD, previous target limb revascularization and long lesion length were also among the predictors of major adverse events, Zeller said.

“The IN.PACT Global study remains the largest and only reported real-world drug-coated balloon study with clinical events committee adjudications out to 5 years,” Zeller said during the presentation. “The results demonstrate sustained effectiveness of the IN.PACT Admiral DCB. Robust real-world data continue to demonstrate durable real-world results, indication that the IN.PACT Admiral DCB is a viable solution for the treatment of femoropopliteal disease, resolving patients’ needs and I would say also sparing money for the entire health care system.”