Comparison of the Efficacy of Paclitaxel-Eluting Balloon Catheters and Everolimus-Eluting Stents in the Treatment of Coronary In-Stent Restenosis: The Treatment of In-Stent Restenosis Study
Language English Country United States Media print
Document type Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
27069104
DOI
10.1161/circinterventions.115.003316
PII: CIRCINTERVENTIONS.115.003316
Knihovny.cz E-resources
- Keywords
- coronary restenosis, diabetes mellitus, drug-eluting stents, paclitaxel, stents,
- MeSH
- Coated Materials, Biocompatible * MeSH
- Time Factors MeSH
- Vascular Access Devices * MeSH
- Everolimus administration & dosage MeSH
- Kaplan-Meier Estimate MeSH
- Cardiovascular Agents administration & dosage MeSH
- Percutaneous Coronary Intervention adverse effects instrumentation MeSH
- Coronary Restenosis diagnostic imaging etiology therapy MeSH
- Middle Aged MeSH
- Humans MeSH
- Logistic Models MeSH
- Coronary Artery Disease diagnostic imaging therapy MeSH
- Odds Ratio MeSH
- Paclitaxel administration & dosage MeSH
- Disease-Free Survival MeSH
- Prospective Studies MeSH
- Prosthesis Design MeSH
- Risk Factors MeSH
- Chi-Square Distribution MeSH
- Aged MeSH
- Drug-Eluting Stents * MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Geographicals
- Czech Republic MeSH
- Names of Substances
- Coated Materials, Biocompatible * MeSH
- Everolimus MeSH
- Cardiovascular Agents MeSH
- Paclitaxel MeSH
BACKGROUND: The aim of this prospective randomized noninferiority study was to compare the efficacy of paclitaxel-eluting balloon (PEB) catheters and everolimus-eluting stents (EES) in the treatment of bare metal stent restenosis. METHODS AND RESULTS: A total of 136 patients were enrolled in the study. Each treatment group included 68 patients with 74 in-stent restenotic lesions. The primary end point was in-segment late lumen loss (LLL) at 12 months. Secondary end points were the incidence of binary in-stent restenosis and 12-month major adverse cardiac events. The 2-sided 95% confidence interval of LLL difference between treatments (0.149-0.558) was greater than noninferiority margin (0.12), which demonstrates both noninferiority and superiority of PEB treatment. Furthermore, the PEB group had significantly less 12-month LLL than the EES group (0.02 versus 0.19 mm; P=0.0004). The difference in the incidence of repeated binary restenosis (8.7% versus 19.12%; P=0.078) and 12-month major adverse cardiac events (10.29% versus 19.12%; P=0.213) was not significant. The 12-month LLL was significantly less in the PEB group and also in subgroups with in-stent restenosis >10 mm (0.05 versus 0.26 mm; P=0.0002) and artery diameter <3 mm (0.05 versus 0.16 mm; P=0.003) compared with the EES groups, but not in the subgroup of patients with diabetes mellitus (P=0.254). In the EES group, repetitive binary restenosis had a significantly greater chance of occurring (odds ratio=3.132; 95% confidence interval, 1.058-9.269; P=0.039), even when adjusting for other risk factors. CONCLUSIONS: Treatment of bare metal stent restenosis using PEB led to significantly less 12-month LLL than the implantation of second-generation EES. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01735825.
References provided by Crossref.org
Treatment of coronary in-stent restenosis: a systematic review
ClinicalTrials.gov
NCT01735825
