Incidence and its characteristics of repetition of reintervention after drug-eluting stent implantation for femoropopliteal lesion

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• 作者：Osamu Iida ; MD^a ; ^{iida.osa@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Mitsuyoshi Takahara ; MD ; PhD^b ; ^c ; Yoshimitsu Soga ; MD ; PhD^d ; Keisuke Hirano ; MD ; PhD^e ; Yasutaka Yamauchi ; MD ; PhD^f ; Kan Zen ; MD ; PhD^g ; Hiroyoshi Yokoi ; MD^h ; Masaaki Uematsu ; MD ; PhD^a ; on behalf of the ZEPHYR investigators^&lowast ; ; Nobuyoshi Azuma ; Makoto Nakahama ; Junichi Tazaki ; Tsuyoshi Miyazawa ; Masashi Fukunaga ; Takahide Suzuki ; Nobuhiro Suematsu ; Yoshinori Tsubakimoto ; Taketsugu Tsuchiya ; Osamu Iida ; Atsushi Tosaka ; Yasutaka Yamauchi ; Kyozo Inoue ; Yoshimitsu Soga ; Terutoshi Yamaoka ; Daizo Kawasaki ; Kan Zen ; Masatsugu Nakano ; Keisuke Hirano ; Michiaki Higashitani ; Daisuke Ogasawara ; Kenji Suzuki ; Yoshiaki Shintani ; Yusuke Miyashita ; Norihiko Shinozaki ; Makoto Utsunomiya ; Hiroki Takahashi
• 刊名：Journal of Vascular Surgery
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：64
• 期：6
• 页码：1691-1695.e1
• 全文大小：347 K

文摘

Although clinical trials demonstrated the superiority of the Zilver (Cook Medical, Bloomington, Ind) paclitaxel-eluting stent (PTX), a recently developed drug-eluting stent (DES), to conventional therapy for femoropopliteal (FP) lesions, the incidence and risk factors of the repetition of reintervention after DES implantation in clinical practice remained unrevealed.

Methods

This was a subanalysis of the ZEPHYR (ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy) study, enrolling FP lesions undergoing endovascular therapy (EVT) with DES implantation. The current study analyzed the 2-year database including 583 FP lesions in 495 patients undergoing preoperative intravascular ultrasound imaging before DES implantation. The primary outcome measure was re-re-EVT, defined as undergoing additional EVT more than once during the 2-year follow-up after DES implantation. The secondary outcome measure was re-EVT, defined as undergoing at least one additional EVT during the follow-up.

Results

Critical limb ischemia (CLI) was present in 28% of the study population, 23% had a history of EVT, and 43% had chronic total occlusion. Mean lesion length was 16 ± 10 cm, and intravascular ultrasound imaging-evaluated external elastic membrane area was 28 ± 10 mm². The cumulative incidence rate of re-re-EVT at 2 years was estimated to be 14%, whereas that of re-EVT was 31%. After multivariate analysis, CLI and smaller external elastic membrane area were independently associated with the outcome.

Conclusions

The incidence and risk factors of the repetition of reintervention after DES implantation for FP lesions were revealed. The current findings suggest that DES implantation might be a careful indication in CLI cases especially with a small vessel.