Abstract
TCT-431 Comparison of the Efficacy of Sirolimus and Paclitaxel-Eluting Balloon Catheters in the Treatment of Coronary In-Stent Restenosis: The TIS-2 Study
Journal of the American College of Cardiology, Vol.82(17 Supplement), pp.B173-B174
10/2023
DOI: 10.1016/j.jacc.2023.09.440
Abstract
Background
Current therapy for in-stent restenosis (ISR) is based on the drug-eluting stents or drug-eluting balloon catheters (DEB). In clinical practice, paclitaxel is used as an effective antiproliferative agent loaded into DEB. In contrast to paclitaxel, sirolimus is difficult to deliver on the balloon surface due to insufficient tissue uptake and shorter tissue retention of limus drugs. The aim of this prospective randomized noninferiority study was to compare the efficacy of novel sirolimus-eluting balloon catheter (SEB) to the paclitaxel ones (PEB) in the therapy of bare-metal (BMS) or drug-eluting stent restenosis (DES-ISR).
Methods
The study included a total of 128 patients with 141 BMS or DES-ISR lesions who were randomized 1:1 to the treatment with SEB (MagicTouch, Concept Medical) containing phospholipid encapsulated nanoparticles of sirolimus or iopromide-coated PEB (Sequent Please Neo, B.Braun). The primary endpoint was in-segment late lumen loss (LLL) at 12 months. The secondary endpoints were the incidence of binary ISR and 12-month major adverse cardiac events (MACE; CV death, acute myocardial infarction, or target vessel revascularization).
Results
The upper bound of the 2-sided 95% CI of LLL difference between treatments (−0.277 to 0.229) was greater than noninferiority margin (0.20); thus the noninferiority of SEB was not demonstrated. Despite this fact there were no significant differences in the incidence of repeated binary ISR (31.6% vs 30.4%, P = 0.906) and 12-month MACE (31% for both; P > 0.999) between the treatment groups. Similar results not proving the noninferiority of SEB in LLL, without significant differences in the incidence of repeated binary ISR (P = 0.794 and >0.999) and 12-month MACE (P > 0.999 and 0.975) were also achieved in separate subgroups of patients with BMS or DES-ISR.
Conclusion
We did not confirm the noninferiority of SEB in the treatment of BMS/DES-ISR compared with PEB regarding to LLL. However, these results did not negatively translate into the incidence of repeated binary ISR and 12-month MACE in the SEB group. )
Details
- Title: Subtitle
- TCT-431 Comparison of the Efficacy of Sirolimus and Paclitaxel-Eluting Balloon Catheters in the Treatment of Coronary In-Stent Restenosis: The TIS-2 Study
- Creators
- Pavel Kukla - University Hospital OstravaTomas Kovarnik - Charles UniversityJana Zapletalova - Palacký University OlomoucLeos Pleva - University Hospital Ostrava
- Resource Type
- Abstract
- Publication Details
- Journal of the American College of Cardiology, Vol.82(17 Supplement), pp.B173-B174
- DOI
- 10.1016/j.jacc.2023.09.440
- ISSN
- 0735-1097
- eISSN
- 1558-3597
- Language
- English
- Date published
- 10/2023
- Academic Unit
- Electrical and Computer Engineering
- Record Identifier
- 9984638356602771
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