Comparing the Efficacy of Sirolimus and Paclitaxel-Eluting Balloon Catheters in the Treatment of Coronary In-Stent Restenosis: A Prospective Randomized Study (TIS 2 Study)
Language English Country United States Media print-electronic
Document type Comparative Study, Equivalence Trial, Journal Article, Multicenter Study
- Keywords
- angioplasty, balloon, coronary, coronary restenosis, paclitaxel, sirolimus,
- MeSH
- Angioplasty, Balloon, Coronary * adverse effects instrumentation MeSH
- Coated Materials, Biocompatible * administration & dosage MeSH
- Time Factors MeSH
- Cardiovascular Agents administration & dosage adverse effects MeSH
- Percutaneous Coronary Intervention * adverse effects instrumentation MeSH
- Coronary Restenosis * diagnostic imaging therapy mortality etiology MeSH
- Middle Aged MeSH
- Humans MeSH
- Coronary Artery Disease * diagnostic imaging therapy mortality MeSH
- Paclitaxel * administration & dosage adverse effects MeSH
- Prospective Studies MeSH
- Prosthesis Design MeSH
- Risk Factors MeSH
- Aged MeSH
- Sirolimus * administration & dosage adverse effects MeSH
- Cardiac Catheters MeSH
- Drug-Eluting Stents adverse effects MeSH
- Stents adverse effects MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Equivalence Trial MeSH
- Multicenter Study MeSH
- Comparative Study MeSH
- Names of Substances
- Coated Materials, Biocompatible * MeSH
- Cardiovascular Agents MeSH
- Paclitaxel * MeSH
- Sirolimus * MeSH
BACKGROUND: Current therapy for in-stent restenosis (ISR) is based on drug-eluting stents (DES) or drug-eluting balloon catheters. This prospective randomized study compared the efficacy of a novel sirolimus-eluting balloon (SEB) catheter to that of a paclitaxel-eluting balloon (PEB) catheter for the treatment of bare-metal stent (BMS-ISR) or DES-ISR. METHODS: A total of 145 patients with 158 BMS or DES-ISR lesions were randomly assigned to the treatment with either SEB or PEB. The in-segment late lumen loss at 12 months, the 12-month incidence of binary ISR, and major adverse cardiac events (cardiac death, nonfatal acute myocardial infarction, or target lesion revascularization) were compared between groups. RESULTS: The noninferiority of SEB compared with PEB in the treatment of BMS/DES-ISR with respect to late lumen loss was not demonstrated (Δlate lumen loss, -0.024 mm [95% CI, -0.277 to 0.229]; for a noninferiority margin of 0.20 mm), except in the post hoc subanalysis for the BMS-ISR group (-0.203 mm [95% CI, -0.584 to 0.178]). No significant differences in the incidence of repeated binary ISR (31.6% versus 30.4%, P=0.906) or 12-month major adverse cardiac events (31% for both; P>0.999) between the SEB and PEB groups were observed. CONCLUSIONS: The noninferiority of SEB relative to PEB in the treatment of BMS/DES-ISR with respect to late lumen loss was not confirmed. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03667313.
Department of Internal Medicine and Cardiology University Hospital Ostrava Czech Republic
Department of Medical Biophysics Palacky University Olomouc Czech Republic
References provided by Crossref.org
ClinicalTrials.gov
NCT03667313
