Published in:
01-01-2022 | Arterial Diseases | Original Article
Mortality risk after use of a paclitaxel-coated stent in femoropopliteal peripheral artery disease
Authors:
Michinao Tan, Kazushi Urasawa, Takuya Haraguchi, Hiroshi Ando, Yoshinori Tsubakimoto, Daisuke Kamoi, Maoto Habara, Tatsuya Nakama, Hiroshi Sakamoto, Masayoshi Kimura, Tatsuki Doijiri, Makoto Sugihara, Yuki Imoto, Tomoyasu Sato, Taichi Hayashi, Yusuke Sato
Published in:
Cardiovascular Intervention and Therapeutics
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Issue 1/2022
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Abstract
Although paclitaxel-based devices which demonstrated improved outcomes in the treatment of lower-extremity peripheral artery disease (PAD) have been used worldwide, Katsanos et al. reported a systematic review and summary-level meta-analysis of RCTs in which application of paclitaxel-based devices in the femoropopliteal artery was associated with an increased mortality risk. The purpose of this study was to describe the safety of endovascular therapy (EVT) using paclitaxel-coated stents for femoropopliteal disease by evaluating the mortality risk compared with patients treated with paclitaxel-free devices. A retrospective, multicenter, non-randomized study examined 481 de-novo symptomatic PAD patients treated in 13 Japanese medical centers from January 2011 to December 2015. The risk of all-cause mortality was analyzed between the 65 patients treated with a paclitaxel-coated stent (PTX-coated group) and 416 patients treated with an uncoated balloon or bare nitinol stent (PTX-free group). Overall survival of the PTX-coated group and the PTX-free group were compared after propensity score matching. The 2-year overall survival estimates were 87.7% in the PTX-coated group vs 88.7% in the PTX-free group. There were no significant differences in the mortality risk between the groups through a full follow-up of 2 years (p = 0.80). The multivariate cox proportional hazards model identified three significant predictors of mortality; age (HR, 1.08; 95% CI, 1.03–1.13; p = 0.002), hemodialysis (HR, 3.16; 95% CI, 1.34–7.42; p = 0.008), and albumin (g/dl) (HR, 0.46; 95% CI, 0.25–0.85; p = 0.01).