There are plenty of clinical studies assessing the use of angioplasty for en la peripheral artery disease with restenosis rates as high as 40% and 60% at 6 and 12 months.
Drug coated balloons have significantly raised primary patency, but they have mostly been tested in short lesions with mild calcification and no total occlusions.
This registry assessed paclitaxel coated balloon Lutonix (Bard Lutonix, New Hope, Minnesota) in a heterogeneous population in the real world.
Also read: “Different Techniques to Improve Outcomes in Intermittent Claudication”.
The study prospectively included 691 patients from 38 centers in 10 countries, treated with Lutonix paclitaxel DCB in femoropopliteal lesions. Primary safety end point was freedom from a composite of target vessel restenosis, major index limb amputation, and device or procedure related death at 30 days. Primary efficacy endpoint was freedom from target lesion restenosis at 12 months.
Freedom at 30 days from the composite safety endpoint was 99.4%. Freedom from target lesion restenosis was 93.4%/89.3% for the overall population, 93.2%/88.2% for long lesions up to 500 mm, and 90.7%/84.6% for instent restenosis at 12/24 months respectively.
Also read: “Promising Evolution of DCB in Long Femoropopliteal Lesions”.
More than 76% of patients showed improvement of at least 1 Rutherford category.
Conclusion
The Global SFA Registry at 24 months confirms the Lutonix DCB is a safe and effective at long term in patients with peripheral artery disease in the real world, including total occlusions, long lesions and instent restenosis.
Editorial Comment
The population in this study presented multiple comorbidities, including coronary artery disease (60.2%), dyslipidemia (70%), hypertension (84.9%) and diabetes (39.5%).
Most patients were in Rutherford class 3 (66%) before treatment and nearly half (47.3%) was able to improve to class 0 at 24 months.
Predilation was performed in most total occlusions (83.6%), but in barely half of stenotic lesions, which did not affect long term outcomes.
Long lesions (up to 500 mm) required stent “bailout” up to 25% and that did not affect long term results.
Título original: The 24-Month Results of the Lutonix Global SFA Registry. Worldwide Experience with Lutonix Drug-Coated Balloon.
Referencia: Marcus Thieme et al. J Am Coll Cardiol Intv 2017. Article in press.
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