Biomaterial Database

Superficial Femoral Artery in-Stent Restenosis Treated with Paclitaxel-Coated Balloon Angioplasty - Results of Three-Year Follow-Up. 2023

Julio Cesar Peclat de Oliveira, and Rossano Kepler Alvim Fiorelli, and Ana Paula Rolim Maia Peclat, and Lucas Maia Peclat de Oliveira, and Rafael Oliveira, and Sergio Quilici Belczac, and Renato Santos Almeida, and Marcelo Bellini Dalio, and Edwaldo Edner Joviliano, and Bianca Gutfilen

Federal University of Rio de Janeiro, Brazil.

BACKGROUND In-stent restenosis remains a common and important complication after endovascular treatment of superficial femoral artery peripheral artery disease. It occurs in 14 to 35% of cases in 1 year and there is still no efficient treatment for this condition. Paclitaxel-coated balloons have shown promising results. OBJECTIVE Investigate the 3 year results of superficial femoral artery in-stent restenosis treated with paclitaxel-coated balloon angioplasty, using the Lutonix™ 035 device. METHODS We conducted a retrospective observational study with patients with symptomatic (Rutherford 2 to 5) superficial femoral artery in-stent restenosis, that were treated with paclitaxel-coated balloon angioplasty using the Lutonix™ 035 device, in a single center from January 2016 to December 2020. Duplex scan was used to follow the patients. Primary patency was obtained through Kaplan-Meier analysis. Mortality, and amputation rates were also evaluated. RESULTS 105 patients were included. Two patients had technical failure and required an additional stent, and were thus excluded. 103 patients were analyzed. Primary patency was 91.26, 80.47, and 67.71%, respectively, in the first, second, and third year after the procedure. There were no deaths 30 days after the procedure. There were no major amputations during the 3 year follow-up. CONCLUSIONS Paclitaxel-coated balloon angioplasty with the Lutonix™ 035 device was a safe and effective treatment to superficial femoral artery in-stent restenoses. The results were maintained along the 3 year follow-up.

UI	MeSH Term	Description	Entries
D011150	Popliteal Artery	The continuation of the femoral artery coursing through the popliteal fossa; it divides into the anterior and posterior tibial arteries.	Arteria Poplitea,Artery, Popliteal,Popliteal Arteries
D003251	Constriction, Pathologic	The condition of an anatomical structure's being constricted beyond normal dimensions.	Stenosis,Stricture,Constriction, Pathological,Pathologic Constriction,Constrictions, Pathologic,Pathologic Constrictions,Pathological Constriction,Stenoses,Strictures
D005263	Femoral Artery	The main artery of the thigh, a continuation of the external iliac artery.	Common Femoral Artery,Arteries, Common Femoral,Arteries, Femoral,Artery, Common Femoral,Artery, Femoral,Common Femoral Arteries,Femoral Arteries,Femoral Arteries, Common,Femoral Artery, Common
D005500	Follow-Up Studies	Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease.	Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000800	Angioplasty, Balloon	Use of a balloon catheter for dilation of an occluded artery. It is used in treatment of arterial occlusive diseases, including renal artery stenosis and arterial occlusions in the leg. For the specific technique of BALLOON DILATION in coronary arteries, ANGIOPLASTY, BALLOON, CORONARY is available.	Balloon Angioplasty,Dilation, Transluminal Arterial,Arterial Dilation, Transluminal,Arterial Dilations, Transluminal,Dilations, Transluminal Arterial,Transluminal Arterial Dilation,Transluminal Arterial Dilations
D014654	Vascular Patency	The degree to which BLOOD VESSELS are not blocked or obstructed.	Patency, Vascular,Patencies, Vascular,Vascular Patencies
D016896	Treatment Outcome	Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.	Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D017239	Paclitaxel	A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.	7-epi-Taxol,Anzatax,Bris Taxol,NSC-125973,Onxol,Paclitaxel, (4 alpha)-Isomer,Paxene,Praxel,Taxol,Taxol A,7 epi Taxol,NSC 125973,NSC125973,Taxol, Bris
D058729	Peripheral Arterial Disease	Lack of perfusion in the EXTREMITIES resulting from atherosclerosis. It is characterized by INTERMITTENT CLAUDICATION, and an ANKLE BRACHIAL INDEX of 0.9 or less.	Peripheral Arterial Diseases,Peripheral Artery Disease,Arterial Disease, Peripheral,Arterial Diseases, Peripheral,Artery Disease, Peripheral,Artery Diseases, Peripheral,Disease, Peripheral Arterial,Disease, Peripheral Artery,Diseases, Peripheral Arterial,Diseases, Peripheral Artery,Peripheral Artery Diseases