NICE medical technologies guidance addresses specific technologies notified to NICE by manufacturers. The 'case for adoption' is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This case is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.
1.1 The case for adopting SeQuent Please balloon catheter in the NHS, when used as described in 1.2 and 1.3, is supported by the evidence. The need for subsequent re-intervention for coronary stenosis is reduced as is the duration of clopidogrel therapy, compared with paclitaxel-eluting stent. SeQuent Please balloon catheter is associated with a cost saving of £467 per patient compared with paclitaxel-eluting stent.
1.2 SeQuent Please balloon catheter should be considered for use in patients with in-stent restenosis in bare metal coronary artery stents.
1.3 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.
1.4 Further research is recommended in a UK setting to compare the outcomes of patients treated with SeQuent Please balloon catheter with the outcomes of patients treated with other types of drug-eluting balloon catheter and stent. This research should report long-term outcomes (for example, after 3 years), including clinical outcomes and details of further revascularisation required for subsequent restenosis. Research should investigate the use of SeQuent Please balloon catheter for restenosis in drug-eluting coronary artery stents and in de novo coronary stenosis where stenting is either technically difficult or is associated with an increased risk of complications. If research shows that SeQuent Please balloon catheter reduces the rate of restenosis in patients with drug-eluting stents or in native coronary arteries, compared with other technologies, then the number of patients for whom it might be suitable would increase significantly.