Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis.

Abstract

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 ± 0.45 mm vs. 0.72 ± 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.

• Authors: Seiji Habara, Kazuaki Mitsudo, Kazushige Kadota, Tsuyoshi Goto, Satoki Fujii, Hiroyuki Yamamoto, Harumi Katoh, Naoki Oka, Yasushi Fuku, Shingo Hosogi, Akitoshi Hirono, Takeshi Maruo, Hiroyuki Tanaka, Yoshikazu Shigemoto, Daiji Hasegawa, Hiroshi Tasaka, Mana Kusunose, Suguru Otsuru, Yoji Okamoto, Naoki Saito, Yuki Tsujimoto, Haruki Eguchi, Koshi Miyake, Mitsuru Yoshino
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 4 Issue 2 Pg. 149-54 (Feb 2011) ISSN: 1876-7605 [Electronic] United States
• PMID: 21349452 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Cardiovascular Agents
• Paclitaxel
• Sirolimus

Topics

• Aged
• Aged, 80 and over
• Angioplasty, Balloon, Coronary (adverse effects, instrumentation)
• Cardiovascular Agents (administration & dosage)
• Chi-Square Distribution
• Coronary Angiography
• Coronary Restenosis (diagnostic imaging, therapy)
• Disease-Free Survival
• Drug-Eluting Stents
• Female
• Humans
• Japan
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Paclitaxel (administration & dosage)
• Prospective Studies
• Risk Assessment
• Risk Factors
• Single-Blind Method
• Sirolimus (administration & dosage)
• Time Factors
• Treatment Outcome