Comparison of the safety and efficacy of two types of drug-eluting balloons (RESTORE DEB and SeQuent® Please) in the treatment of coronary in-stent restenosis: study protocol for a randomized controlled trial (RESTORE ISR China).

Abstract

In-stent restenosis (ISR), characterized by neointimal proliferation and/or neoatherosclerosis in the vessel of the stent, can cause a reduction in lumen diameter after stent implantation, which can directly induce the recurrence of angina symptoms or an acute coronary syndrome in patients and is usually life-threatening.[1]–[3] ISR has also been considered as formidable clinical problem for the interventional cardiologists. In recent years, many remarkable improvements in medical technology of percutaneous coronary intervention (PCI), such as first-generation bare metal stents (BMS) and newer-generation drug-eluting stents (DES) have been achieved, which significantly reduce ISR occurrence in patients with PCI.[4],[5] For example, growing evidence has suggested that the safety and efficacy of revascularization procedures of newer-generation DES was greatly superior to those of first generation DES and BMS.[6]–[10] However, ISR rate remains as high as 5% to 10% for patients treated with newer-generation DES at two years.[11] More recently, a newly developed drug-eluting balloon (DEB) coated with paclitaxel, an antiproliferative drug that could inhibit neointimal hyperplasia, had emerged as an alternative therapeutic tool for ISR disease.[12],[13] DEB plays the anti-restenosis efficacy through a high-concentration, rapid local delivery of paclitaxel without the use of polymers on a stent. To date, there are numerous randomized trials performed to compare the safety and efficacy among plain old balloon angioplasty (POBA), DES and DEB for the treatment of ISR.[14] One recent meta-analysis enrolled eight randomized controlled trials and indicated that DEB was a better option for treatment of ISR when compared to POBA.[15] Another meta-analysis showed that DEB and DES have similar efficacy and safety for the treatment of ISR.[16] SeQuent® Please DEB is the only approved product utilized for ISR treatment in China.[17] Currently, a novel paclitaxel-coated balloon (RESTORE DEB) has been invented for the treatment of ISR. However, clinical information on the two different types of DEB in treatment of ISR is limited. This trial aims to compare the safety and efficacy of the RESTOREDEB versus SeQuent® Please DEB for the treatment of coronary ISR in Chinese patients.