Long lesions (≥ 15 cm), total occlusions, and in-stent restenosis represent a unique treatment challenge in peripheral vascular disease. IN.PACT Global study is a prospective, multicenter, single arm designed to evaluate the safety and efficacy of IN.PACT® ADMIRAL® drug eluting balloon for the treatment of superficial femoral and popliteal arteries in a real-world population.
A subset of patients underwent Doppler ultrasound scans at 12 months to assess the patency, being divided these patients into three groups according to the original injury (stent restenosis, de novo lesions ≥ 15 cm, and a total occlusions ≥ 5 centimeters).
Of the total, 157 patients were followed by Doppler at 12 months and originally presented a de novo lesion ≥ 15 cm. 41% of these patients had a history of diabetes and the average lesion length reached 26.4 ± 8.61 cm. The primary patency defined as the absence of revascularization of the target lesion justified by the clinic, was 91.1%. No major amputations within 12 months were observed. The combined safety end point (no mortality, no amputation, and revascularization) at 12 months was 94%.
Conclusion
The study showed a low rate of re-intervention and high permeability to 12 months in this subgroup of complex patients treated with the paclitaxel eluting balloon.
Dierk Scheinert
2015-05-20
Original title: Drug Coated Balloon Treatment for Patients with Intermittent Claudication: New Insights from the IN.PACT Global Study Long Lesion (≥ 15 cm) Imaging Cohort.
