Five-Year Outcomes of Post-Drug-Coated Balloon Angioplasty Dissection in Complex Femoropopliteal Artery Disease

Hao Ren, Jie Liu, Jiwei Zhang, Baixi Zhuang, Weiguo Fu, Danming Wu, Feng Wang, Yu Zhao, Pingfan Guo, Wei Bi, Shenming Wang, Wei Guo, Hao Ren, Jie Liu, Jiwei Zhang, Baixi Zhuang, Weiguo Fu, Danming Wu, Feng Wang, Yu Zhao, Pingfan Guo, Wei Bi, Shenming Wang, Wei Guo

Abstract

Objective: To evaluate the long-term outcomes after drug-coated balloon (DCB) angioplasty dissection in patients with complex femoropopliteal artery disease.

Methods: Two hundred patients with femoropopliteal peripheral artery disease were enrolled in the AcoArt I trial and randomly assigned to either the DCB or percutaneous transluminal angioplasty (PTA) group. A total of 86 patients with post-balloon angioplasty dissection were reanalyzed. The primary endpoint was clinically driven target lesion revascularization (CD-TLR) over five years. Kaplan-Meier curve estimates were used to evaluate the association between the treatment and CD-TLR. Interaction and stratified analyses were also performed.

Results: Over five years, patients treated with DCB angioplasty demonstrated an acceptable effect with a numerically higher but not statistically significant rate of freedom from CD-TLR compared with those treated by PTA (Kaplan-Meier estimate of 77.6% vs 64.4%; log-rank P = 0.08). Among the patients who underwent TLR, the mean time from intervention to TLR in the DCB group was significantly prolonged compared to the PTA group (P < 0.001). The stratified analysis showed that the Rutherford classification played an interactive role in the association between the DCB angioplasty and low CD-TLR rate at five years. No significant difference in the all-cause mortality was found in the patients with post-balloon angioplasty dissection between the two treatment groups.

Conclusion: The five-year follow-up outcomes of the post-balloon angioplasty dissection in the AcoArt I trial demonstrated that DCB angioplasty is more trustworthy than PTA, with a higher rate of freedom than CD-TLR and sustained improvement in clinical symptoms. However, the all-cause mortality rate in patients with femoropopliteal lesions is similar after both DCB angioplasty and PTA.

Clinical trial registration: http://www.clinicaltrials.gov.

Unique identifier: NCT01850056.

Keywords: balloon angioplasty; dissection; drug-coated balloon; femoropopliteal artery disease; long-term outcomes; percutaneous transluminal angioplasty.

Conflict of interest statement

The authors report no conflicts of interest in this work.

© 2021 Ren et al.

Figures

Figure 1
Figure 1
Flow diagram of patients with dissection in the AcoArt I trial throughout the five-year follow-up. *One death occurred before the six-month follow-up. # Two patients were treated for in-stent restenosis. ##Four patients were treated for in-stent restenosis. &Two patients were excluded due to use of a non-assigned uncoated balloon. §One death occurred shortly after the six-month follow-up.
Figure 2
Figure 2
(A) Kaplan–Meier curve estimate of freedom from CD-TLR at five years. (B) Kaplan–Meier curve estimate of freedom from all-cause death at five years.
Figure 3
Figure 3
(A) Post hoc analysis of freedom from CD-TLR at five years. (B) Post hoc analysis of freedom from CD-TLR at two years.

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Source: PubMed

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