Abstract
Background: The efficacy of paclitaxel-eluting balloon catheters (PEB) is affected by the method of binding paclitaxel to the balloon catheter surface. The aim of this study was to compare the long-term efficacy of seal-wing and iopromide-coated PEB for bare-metal stent restenosis (BMS-ISR) treatment. Methods:We analyzed 3-year clinical follow-up data of 132 patients with BMS-ISR. 64 of them were treated with seal-wing PEB, the control group comprised 68 patients from the iopromide-coated PEB arm of the previous TIS clinical study. Primary end-points included the occurrence of major adverse cardiac events (MACE; cardiovascular [CV] death, myocardial infarction [MI], or target vessel revascularization [TVR]) Results:At 3 year clinical follow-up, the incidence of MACE was significantly higher in the seal-wing PEB than in the iopromide-coated PEB group (40.6 % vs. 19.1%; p=0.008); the same can be said about TVR (26.9% vs. 8.8%; p=0.011). Similarly, the event-free survival was significantly longer in the iopromide-coated PEB than in the seal-wing PEB group (p=0.021). No significant differences were found between the groups where CV mortality (4.7% vs. 5.9%; p=1.000), MI (6.3% vs. 4.4%; p=0.712), definite stent thrombosis (0% vs. 2.9%; p=0.497) or the second MACE (4.7% vs. 1.5%; p=0.354) are concerned.Conclusions: Compared to iopromide-coated PEB, the use of seal-wing PEB for BMS-ISR treatment led to a significantly higher 3-year occurrence of MACE and TVR. Trial registartion: ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825 (Registered 7 Nov 2012).
INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO): study protocol for a randomized controlled trial
