NICE guidance - SeQuent Please balloon catheter for in- stent coronary restenosis

Last reviewed 01/2018

Current treatment options for patients with in-stent restenosis include balloon angioplasty, repeat stenting (usually using a drug-eluting stent), cutting balloon angioplasty, directional coronary atherectomy, rotational coronary atherectomy and brachytherapy

• after implantation of a drug-eluting stent, antiplatelet therapy with clopidogrel and aspirin is usually continued for 12 months
• various paclitaxel and other drug-eluting balloon catheters are available.

SeQuent Please is a balloon catheter for percutaneous transluminal coronary angioplasty. The balloon is coated with the antimitotic drug paclitaxel, with the aim of reducing restenosis

• the balloon section of the catheter is coated with paclitaxel at a dose of 3 microgram/mm2. When the balloon is expanded, paclitaxel is released into the vessel wall
  • using paclitaxel reduces smooth muscle cell proliferation that can give rise to restenosis and recurrence of symptoms. The aim of targeted delivery is to achieve a high local concentration of drug in the vessel wall with minimal systemic release
  • the balloon catheter is also coated in iopromide, an X-ray contrast medium which aims to improve the solubility and transfer of paclitaxel to the vessel wall
• after treatment, antiplatelet therapy with clopidogrel is recommended for 3 months in addition to aspirin to reduce the risk of thrombosis

NICE have issued guidance stating that (1):

• the SeQuent Please balloon catheter should be considered for use in patients with in-stent restenosis in bare metal coronary artery stents
  
  
• SeQuent Please balloon catheter can also be considered as an option for patients with in-stent restenosis in any type of coronary artery stent if:
  • there are clinical reasons to minimise the duration of clopidogrel treatment (for example, there is concern about an increased risk of bleeding or there is the need for surgical intervention) or
  • placement of further stents is not technically possible

Reference:

• 1) NICE (December 2010).SeQuent Please balloon catheter for in-stent coronary restenosis