Abstract 9628: Efficacy and Safety of Sequent Please Paclitaxel-Coated Balloon Compared to DIOR Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis
Background: In randomized clinical trials, efficacy and safety of paclitaxel-coated balloon (PCB) angioplasty for the treatment of bare-metal stent (BMS) and drug-eluting stent (DES) restenosis was demonstrated. However there is few data if different PCBs perform equally. This study aims to evaluate the long-term efficacy of two second-generation PCBs in treating coronary in-stent restenosis (ISR).
Methods: Between October 2010 and February 2012, all consecutive patients with ISR lesions treated with the SeQuent Please PCB (B. Braun, Melsungen, Germany) or with the DIOR PCB (Eurocor GmbH, Bonn, Germany) at our institution were prospectively included. Patients were followed up for 24 months by clinical observation. The primary endpoint was the clinically driven target lesion revascularization (TLR) rate at 24 months. The secondary endpoint was the rate of major adverse cardiac events (MACEs), defined as a composite of cardiac death, myocardial infarction, and TLR at 24 months.
Results: 65 patients with 74 ISR lesions were included. 43 ISR lesions (21 BMS, 22 DES) were treated with the SeQuent Please PCB and 31 (11 BMS, 20 DES) with the DIOR PCB. Baseline clinical, lesion characteristics and procedural data did not significantly differ between two groups. The TLR rate was significantly lower in patients with the SeQuent Please PCB compared with the DIOR PCB (4.7 % vs. 22. 6 %, p = 0.03) at 24 months. The number of patients who suffered a MACE was not statistically different across study groups, but a strong trend towards better clinical outcome was discovered in the SeQuent Please PCB group (9.3 % vs. 25.8%, p=0.058).
Conclusions: This real-world practice registry suggests that there are significant differences in terms of TLR between two clinically available PCBs. The SeQuent Please PCB demonstrated lower TLR rate compared to the DIOR PCB at 24 months follow-up.
Author Disclosures: J. Benezet: None. A. Gutierrez-Barrios: None. S. Camacho-Freire: None. A. Agarrado: None. J. Oneto: None.
- © 2014 by American Heart Association, Inc.