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THUNDER: Benefit of paclitaxel-coated balloon maintained at 5 years
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Use of a paclitaxel-coated balloon was associated with reduced late lumen loss, binary stenosis and target lesion revascularization at 5-year follow-up.
Researchers for the THUNDER trial reported 5-year follow-up data on patients with femoropopliteal arteries that were treated with paclitaxel-coated balloons (PCB), angioplasty with paclitaxel in contrast medium or no paclitaxel. The primary outcome of the trial was late lumen loss at 6 months. Freedom from TLR, binary restenosis rate and amputation served as secondary endpoints.
The present study evaluated outcomes in patients treated with PCB vs. control, and analyzed late lumen loss at 6 months and TLR up to 5 years based on sex and lesion length.
According to the results, the cumulative incidence of TLR was significantly lower in the PCB group compared with the control group during the 5-year follow-up (21% vs. 56%; P=.0005).
The researchers also examined patients with angiographic and duplex sonographic follow-up at 5 years (n=31). In those patients, the binary restenosis rate was lower for the PCB group compared with the control group (17% vs. 54%; P=.04).
Eight of 54 evaluable patients (15%) died between 24 months and 5 years (12.5% of control group, 16.7% of PCB group).
Two patients (baseline Rutherford class 5) required major amputations below the knee at 0.6 months and 2.4 months after receiving a PCB. Another patient (baseline Rutherford class 3) required a major amputation below the knee at 11 months after receiving a PCB. From 24-month to 5-year follow-up, one major below-the-knee amputation was reported in the PCB group (45 months post-intervention) and one in the control group (28 months post-intervention).
Late lumen loss at 6 months was significantly lower in the PCB group (0.4 ± 1.2 mm vs. 1.7 ± 1.8 mm; P<.001). At 12 months, mean late lumen loss was determined in 69% of the PCB group and 67% of the control group. TLR was performed before 12-month re-angiography in two patients in the PCB group and 14 in the control group. The researchers reported a significant difference in favor of the PCB group (0.7 ± 1.5 mm vs. 1.9 ± 1.9 mm; P=.01).
Analysis by sex revealed a similar rate of late lumen loss at 6-month follow-up between men and women in the control group (1.76 mm vs. 1.61 mm) and PCB group (0.42 mm vs. 0.37 mm). However, at 5 years, the cumulative rate of TLR was lower after treatment with a PCB in men compared with women (17% vs. 38%). The cumulative 5-year TLR rate in the control group was higher for men (71% vs. 52%).
“Women account for a growing percentage of the elderly population presenting with peripheral arterial disease. The analysis presented here suggests that the response to treatment with PCB may be different in men and women, confirming a tendency observed in the PACIFIER study,” the researchers wrote. “Although late lumen loss at 6 months was similar in the PCB group in women and men, the long-term benefit of coated-balloon treatment appears to be greater in men than women, although absolute numbers of patients are small.”
Analysis by lesion length indicated a positive benefit of PCB treatment regarding late lumen loss and TLR independent of lesion length.
The researchers observed no signs of aneurysm formation or constrictive fibrosis during follow-up.
Disclosure: The research was supported by Medrad Inc. Several researchers report financial relationships with Boston Scientific, Medrad and Medtronic.
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