VIVA

VIVA

Source:

Tepe G, et al. Late-Breaking Clinical Trials. Presented at: VIVA 21; Oct. 4-7, 2021; Las Vegas (hybrid meeting).

Disclosures: The study was funded by Medtronic. Tepe reports financial ties with 480 Biomedical, Abbott Vascular, Bard Peripheral Vascular, B. Braun, Biotronik, Boston Scientific, Covidien, Medtronic, Philips, Terumo/Bolton, Veryan/BioMimics and W.L. Gore and Associates.
October 08, 2021
2 min read
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DCB 5-year results in complex patients with PAD similar to overall cohort

Source:

Tepe G, et al. Late-Breaking Clinical Trials. Presented at: VIVA 21; Oct. 4-7, 2021; Las Vegas (hybrid meeting).

Disclosures: The study was funded by Medtronic. Tepe reports financial ties with 480 Biomedical, Abbott Vascular, Bard Peripheral Vascular, B. Braun, Biotronik, Boston Scientific, Covidien, Medtronic, Philips, Terumo/Bolton, Veryan/BioMimics and W.L. Gore and Associates.
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In patients with complex peripheral artery disease, a drug-coated balloon performed similarly to how it did in the general PAD population, according to new data from the IN.PACT Global registry.

Gunnar Tepe, MD, from the department of diagnostic and interventional radiology, RoMed Klinikum, Rosenheim, Germany, presented 5-year results of the IN.PACT Global registry in patients with complex PAD treated with the DCB (IN.PACT Admiral, Medtronic) at VIVA 21.

Stent with balloon
Source: Adobe Stock

The analysis included 417 patients, of whom 132 had in-stent restenosis (mean age, 68 years; 69% men), 158 had long lesions (at least 15 cm; mean age, 70 years; 67% men) and 127 had chronic total occlusion of a lesion at least 5 cm (mean age, 67 years; 69% men).

“This is the first presentation of prospectively collected 5-year data from prespecified in-stent restenosis, long lesion and chronic total occlusion cohorts from a large global DCB study,” Tepe said during a presentation, noting that such patients are usually excluded from randomized controlled trials.

Device success and clinical success occurred in at least 99% of all three groups, whereas clinical success occurred in 98.5% of the in-stent restenosis group, 99.4% of the long lesion group and 98.4% of the CTO group, Tepe said.

At 5 years, the rate of freedom from clinically driven target lesion revascularization was 58% in the in-stent restenosis group, 67.3% in the long lesion group and 69.8% the CTO group, Tepe said, noting the rate for the overall cohort was 69.4%.

The safety composite of freedom from 30-day device- or procedure-related death, 5-year major target limp amputation or 5-year clinically driven target vessel revascularization was achieved in 56% of the in-stent restenosis group, 65.7% of the long lesion group and 69.8% of the CTO group, he said.

Major adverse events, including death, clinically driven TVR, major target limb and thrombosis, occurred in 53.1% of the in-stent restenosis group, 48.9% of the long lesion group and 43% of the CTO group at 5 years, according to the researchers.

Tepe said 96.4% had vital status follow-up at 5 years, and of those, the survival rates were 81.4% in the in-stent restenosis group, 75.2% in the long lesion group and 78.2% in the CTO group.

“Real-world data from the IN.PACT Global study continue to confirm long-term clinical safety and effectiveness of the IN.PACT Admiral DCB when used to treat complex lesions, as in this study,” Tepe said during the presentation. “These data support incorporating the use of the IN.PACT Admiral DCB into clinical algorithms for complex femoropopliteal disease: in-stent restenosis, long lesions and CTO.”