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Paclitaxel-coated balloon effective in peripheral CTOs at 1 year
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A paclitaxel-coated balloon treated peripheral chronic total occlusions safely and effectively at 1 year, according to new data from the IN.PACT Global study.
The researchers analyzed 126 patients (mean age, 68 years; 69% men) from the IN.PACT Global CTO imaging cohort in a prospective, real-world study. All patients had CTOs of at least 5 cm (mean, 22.83 cm), were treated with the paclitaxel-coated balloon (IN.PACT Admiral, Medtronic) and underwent duplex ultrasonography evaluated by an independent core lab.
The primary safety endpoint was freedom from device- or procedure-related death at 30 days and freedom from major target limb amputation and target vessel revascularization at 1 year.
The primary efficacy endpoint was primary patency, defined as freedom from restenosis and clinically driven target lesion revascularization, at 1 year.
At 1 year, the Kaplan-Meier estimate of primary patency was 85.3% and 46.8% of lesions required provisional stenting, Gunnar Tepe, MD, from the department of diagnostic and interventional radiology, RoMed Klinikum, Rosenheim, Germany, and colleagues wrote.
The primary safety endpoint was achieved by 88.7% of patients, according to the researchers, who noted that there were no cases of device- or procedure-related death at 30 days or major target limb amputation at 1 year.
“Twelve-month outcomes from this study are better than what has been reported on metal stents or stent grafts for femoropopliteal CTO in the majority of the literature,” Tepe and colleagues wrote.
In a related editorial, Hans Krankenberg, MD, from the Vascular Medicine Center, department of angiology, Asklepios Klinikum Harburg, Hamburg, Germany, wrote that the study “supports the assumption of feasibility and effectiveness of DCB angioplasty with provisional stenting in CTOs. However, despite post hoc comparisons of subgroups regarding lesion crossing, provisional stenting and post-dilation, this study raises a series of relevant issues concerning the treatment strategy.”
These issues include the high rate of provisional stenting and no information about how exercise training might have contributed to clinical improvement, he wrote. – by Erik Swain
Disclosures: The study was funded by Medtronic. Tepe reports he received research grants from and is a compensated advisory board member for Medtronic. Please see the study for all other authors’ relevant financial disclosures. Krankenberg reports no relevant financial disclosures.
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