High-Grade, Non-Flow-Limiting Dissections Do Not Negatively Impact Long-term Outcome After Paclitaxel-Coated Balloon Angioplasty: An Additional Analysis From the THUNDER Study

• Published in: Journal of endovascular therapy Vol. 20; no. 6; pp. 792 - 800
• Main Authors: Tepe, Gunnar, Zeller, Thomas, Schnorr, Beatrix, Claussen, Claus D., Beschorner, Ulrich, Brechtel, Klaus, Scheller, Bruno, Speck, Ulrich
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.12.2013; Allen Press Inc
• Subjects: Aged; Aneurysm, Dissecting - diagnosis; Aneurysm, Dissecting - etiology; Aneurysm, Dissecting - physiopathology; Aneurysm, Dissecting - therapy; Angioplasty; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Cardiovascular Agents - administration & dosage; Coated Materials, Biocompatible; Constriction, Pathologic; Dissection; Double-Blind Method; Drug dosages; Equipment Design; Female; Femoral Artery - diagnostic imaging; Femoral Artery - physiopathology; Germany; Humans; Intervention; Male; Middle Aged; Paclitaxel - administration & dosage; Peripheral Arterial Disease - diagnosis; Peripheral Arterial Disease - therapy; Popliteal Artery - diagnostic imaging; Popliteal Artery - physiopathology; Prospective Studies; Radiography; Recurrence; Regional Blood Flow; Retreatment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Veins & arteries; stent; paclitaxel; target lesion revascularization; drug-eluting balloon; superficial femoral artery; late lumen loss; femoropopliteal segment; outcome analysis; balloon angioplasty; drug-coated balloon; popliteal artery; dissection
• ISSN: 1526-6028; 1545-1550; 1545-1550
• DOI: 10.1583/13-4392R.1

Purpose: To investigate the impact of using paclitaxel-coated balloons (PCB) on outcome after post-angioplasty dissection in femoropopliteal arteries. Methods: The angiograms obtained in the THUNDER study (ClinicalTrials.gov identifier NCT00156624) were analyzed to compare degrees of dissection and angiographic parameters between the control (uncoated balloons, n=43) and treatment (PCBs, n=43) groups before and after the intervention and at 6-month follow-up. Furthermore, target lesion revascularizations (TLR) were documented up to 2 years. Results: In each group, 24 (56%) patients had a dissection after the intervention. At the 6-month follow-up, patients with dissection of any grade after treatment with PCBs had significantly less late lumen loss (0.4 mm) than patients with dissection after treatment with uncoated balloons (1.9 mm, p=0.001) and a lower degree of stenosis (20% vs. 51%, respectively; p=0.003). Patients with severe dissection (grades C, D, or E) especially seemed to benefit from the PCBs, with late lumen loss of 0.4 mm vs. 2.4 mm for controls (p=0.05). The binary restenosis rate was also markedly lower in the PCB group (20%) than in the uncoated group (55%, p=0.02). In the 2-year follow-up, TLR was performed in 56% of patients in the control group compared to 10% of patients in the PCB group (p=0.002). Conclusion: The results of this subgroup analysis suggest that patients with dissection following treatment with a paclitaxel-coated balloon have a very acceptable outcome and stent implantation is not necessary as long as the dissection does not result in acute flow limitation.