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

Abstract

Hao Ren,1,2,* Jie Liu,1,3,* Jiwei Zhang,4 Baixi Zhuang,5 Weiguo Fu,6 Danming Wu,7 Feng Wang,8 Yu Zhao,9 Pingfan Guo,10 Wei Bi,11 Shenming Wang,12 Wei Guo1,3 1Medical School of Chinese PLA, Beijing, 100853, People’s Republic of China; 2Department of Vascular Surgery, Dalian Municipal Central Hospital, Dalian, 116033, People’s Republic of China; 3Department of Vascular and Endovascular Surgery, Chinese PLA General Hospital, Beijing, 100853, People’s Republic of China; 4Department of Vascular Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200120, People’s Republic of China; 5Department of Vascular Surgery, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100080, People’s Republic of China; 6Department of Vascular Surgery, Zhongshan Hospital Fudan University, Shanghai, 200032, People’s Republic of China; 7Department of Vascular Surgery, The People’s Hospital of Liaoning Province, Shenyang, 110016, People’s Republic of China; 8Department of Interventional Therapy, The First Affiliated Hospital of Dalian Medical University, Dalian, 116011, People’s Republic of China; 9Department of Vascular Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400042, People’s Republic of China; 10Department of Vascular Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, People’s Republic of China; 11Department of Vascular Surgery, The Second Hospital of Hebei Medical University, Shijiazhuang, 050073, People’s Republic of China; 12Department of Vascular Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510055, People’s Republic of China*These authors contributed equally to this workCorrespondence: Wei GuoDepartment of Vascular and Endovascular Surgery, Chinese PLA General Hospital, Beijing, 100853, People’s Republic of ChinaTel [phone]Fax [phone]Email [email protected]: 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, femoropopliteal artery disease, long-term outcomes, drug-coated balloon, percutaneous transluminal angioplasty

Keywords

• balloon angioplasty
• dissection
• femoropopliteal artery disease
• long-term outcomes
• drug-coated balloon
• percutaneous transluminal angioplasty