Restricted accessResearch articleFirst published online 2013-12
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
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.
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