Key result
Paclitaxel-coated balloon for in-stent restenosis yields a ~9% 6-month MACE rate in real-world use.
Why the study?
Coronary in-stent restenosis remains a significant clinical problem despite drug-eluting stent use, and the efficacy of drug-eluting balloon treatment in real-world patients with ISR was explored.
Supports paclitaxel-coated DEB for ISR in real-world use; hypothesis-generating pending randomized confirmation.
stent Restenosis with Drug-eluting Balloon Catheter: Real-world Outcome and Literature Review Dear Editor, Currently, coronary stent implantation is employed in approximately 90% of percutaneous coronary intervention (PCI) cases.Despite the use of drug-eluting stents (DES), coronary in-stent restenosis (ISR) remains an Achilles' heel of PCI and can occur in about 10% of patients in the real-world population.1,2 We explored the effi cacy of a novel approach using drug-eluting balloon (DEB) in the treatment of our patients with ISR. Materials and MethodsA total of 53 patients who presented to the National University Heart Centre, Singapore, with coronary ISR between March 2008 and March 2010, and underwent repeat PCI, were studied.All patients presented with symptoms and evidence of coronary ischaemia.In-stent restenosis was defi ned as a diameter stenosis of >50% within the stented segment based on quantitative coronary angiography.All patients received adequate antiplatelet therapy prior to the procedure, which included a loading dose of 300 mg clopidogrel on the day before the index procedure or a 600 mg dose immediately before the PCI and aspirin 100 mg a day.The PCI procedure entailed initial lesion dilation with conventional balloon catheter or cutting balloon.This was followed by the use of a DEB; second generation DIOR™ DEB (Eurocor GmbH, Germany) or SeQuent™ Please DEB (B Braun Melsungen, Germany).The DIOR™ balloon contained 3 μg of paclitaxel/mm 2 within a nanoporous balloon surface with paclitaxel microcrystals embedded in a shellac coating.The Sequent Please™ DEB was coated with the same concentration of paclitaxel using iopromide as a hydrophilic spacer.The size of the DEB was selected so as to achieve a balloon-to-vessel ratio of 1:1 and a longer length than the lesion to cover any area that had been treated by the initial balloon dilatation in order to avoid geographical miss.Prolonged infl ation of the DEB for the duration of 40 to 60 seconds was carried out to ensure adequate drug delivery.Patients received dual antiplatelet therapy of aspirin 100 mg and clopidogrel 75 mg for 1 month after the procedure.No patients received additional stent implantation after DEB dilatation.
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Xia et al. (2013) conducted a letter in Coronary in-stent restenosis (n=53). Drug-eluting balloon (paclitaxel-coated) was evaluated on Major adverse cardiac events (MACE) including death, myocardial infarction, repeat target vessel revascularisation, and stent thrombosis at 6 months. Treatment of coronary in-stent restenosis with a paclitaxel-coated drug-eluting balloon demonstrated a low 6-month major adverse cardiac event rate of 9.4% in a real-world cohort.
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