A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent restenosis and drug-eluting stent restenosis

Selected in American Heart Journal by R. El Mahmoud



Seiji Habara, MD, Masashi Iwabuchi, MD, Naoto Inoue, MD, Shigeru Nakamura, MD, Ryuta Asano, MD, Shinsuke Nanto, MD, Yasuhiko Hayashi, MD, Nobuo Shiode, MD, Shigeru Saito, MD, Yuji Ikari, MD, Takeshi Kimura, MD, Joji Hosokawa, MD, Masato Nakamura, MD, Jun-ichi Kotani, MD, Ken Kozuma, MD, and Kazuaki Mitsudo, MDa Kurashiki, Kitakyushu, Sendai, Kyoto, Tokyo, Osaka, Hiroshima, Kamakura, Isehara, and Suita, Japan


American Heart Journal - Volume 166, Number 3


September 2013


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My Comment


The study aims to investigate the efficacy and safety of paclitaxel-coated balloon (PCB) for the treatment of bare-metal stent restenosis (BMS-ISR) and drug-eluting stent restenosis (DES-ISR)

Major findings

  • Randomised, study in 13 hospitals in Japan
  • Inclusion criteria were ISR in BMS or DES: sirolimus-eluting (69%), zotarolimus-eluting (27%), or everolimus-eluting stent (4%), with a reference vessel diameter of 2.0 to 4.0 mm, a lesion length of ≤ 22 mm
  • Treatment was either paclitaxel-coated balloon: SeQuent Please, B. Braun (PCB group) or conventional balloon (BA group)
  • Primary end point was target vessel failure (TVF) at 6-month
  • Secondary angiographic end points were restenosis rate and late lumen loss
  • Secondary clinical end points include TLR, TVR, stent thrombosis, myocardial infarction, death
  • MACE event rate at 6 months in the PCB and BA groups was 6.6% and 31.0% (P <0.001), respectively, all caused by repeated revascularization procedures (TVF)
  • Recurrent restenosis occurred in 4.3% of the PCB group and 31.9% of the BA group (P <0.001).
  • Late lumen loss was lower in the PCB group than in the BA group (0.11 ± 0.33 mm vs 0.49 ± 0.50mm, P <0.001)
  • In the PCB group, recurrent restenosis occurred in 1.1% of BMS-ISR lesions and 9.1% of DES-ISR lesions (P =0.04)
  • Late lumen loss was lower in BMS-ISR lesions than in DES-ISR lesions (0.05 ± 0.28 mm vs 0.18 ± 0.38mm, P =0.03).
  • There was no death, myocardial infarction, or stent thrombosis in either group

My comments

  • The study suggests that PCB provides better outcomes than conventional BA in patients with BMS-ISR and DES-ISR
  • However DES restenosis is associated with poorer outcomes compared with BMS restenosis after treatment with PCB with a higher rate of TVF
  • The effect of PCB on DES-ISR is relatively less than that on BMS-ISR which unmake this option a satisfactory treatment of DES-ISR as we know that optimal treatment strategy for DES restenosis is not adequately defined yet
  •  Today, the best treatment of BMS-ISR is still the drug-eluting stent, but PCB seems to be a good option for treatment of BMS-ISR when a DES can’t be implanted because of difficulties for a longer dual anti-platelet therapy for example

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