Effectiveness of Paclitaxel-Eluting Balloon Catheter in Patients With Sirolimus-Eluting Stent Restenosis

详细信息    查看全文

• 作者：Seiji Habara ; MD ; ^{sh10461@kchnet.or.jp} ; Kazuaki Mitsudo ; MD ; Kazushige Kadota ; MD ; Tsuyoshi Goto ; MD ; Satoki Fujii ; MD ; Hiroyuki Yamamoto ; MD ; Harumi Katoh ; MD ; Naoki Oka ; MD ; Yasushi Fuku ; MD ; Shingo Hosogi ; MD ; Akitoshi Hirono ; MD ; Takeshi Maruo ; MD ; Hiroyuki Tanaka ; MD ; Yoshikazu Shigemoto ; MD ; Daiji Hasegawa ; MD ; Hiroshi Tasaka ; MD ; Mana Kusunose ; MD ; Suguru Otsuru ; MD ; Yoji Okamoto ; MD ; Naoki Saito ; MD ; Yuki Tsujimoto ; MD ; Haruki Eguchi ; MD ; Koshi Miyake ; MD ; Mitsuru Yoshino ; MD
• 关键词：drug-eluting balloon ; in-stent restenosis (ISR) ; sirolimus-eluting stent (SES) restenosis
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2011
• 出版时间：February 2011
• 年：2011
• 卷：4
• 期：2
• 页码：149-154
• 全文大小：929 K

文摘

| Figures/TablesFigures/Tables | ReferencesReferences

Objectives

The aim of this study was to investigate the efficacy of a paclitaxel-eluting balloon (PEB) for the treatment of sirolimus-eluting stent (SES) restenosis.

Background

Because drug-eluting stents (DES) are being used in increasingly complicated settings, DES restenosis is no longer an uncommon phenomenon, and its optimal treatment is unknown.

Methods

This study was a prospective single-blind randomized trial conducted in 50 patients with SES restenosis. Patients were randomly assigned to a PEB group (n = 25) or a conventional balloon angioplasty (BA) group (n = 25). The primary end point was late lumen loss at 6-month follow-up. Secondary end points included the rate of binary restenosis (in-segment analysis) and major adverse cardiac events (MACE) at 6-month follow-up.

Results

At 6-month angiographic follow-up (follow-up rate: 94 % ), in-segment late lumen loss was lower in the PEB group than in the BA group (0.18 ¡À 0.45 mm vs. 0.72 ¡À 0.55 mm; p = 0.001). The incidence of recurrent restenosis (8.7 % vs. 62.5 % ; p = 0.0001) and target lesion revascularization (4.3 % vs. 41.7 % ; p = 0.003) was also lower in the PEB group than in the BA group. The cumulative MACE-free survival was significantly better in the PEB group than in the BA group (96 % vs. 60 % ; p = 0.005).

Conclusions

In patients with SES restenosis, PEB provided much better clinical, angiographic outcomes than conventional BA.