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)

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F25%3AE0111740" target="_blank" >RIV/00843989:_____/25:E0111740 - isvavai.cz</a>

Alternative codes found

RIV/61988987:17110/25:A2603DJQ RIV/00216208:11110/25:10499902 RIV/61989592:15110/25:73634508 RIV/00064165:_____/25:10499902

Result on the web

<a href="https://doi.org/10.1161/CIRCINTERVENTIONS.124.014677" target="_blank" >https://doi.org/10.1161/CIRCINTERVENTIONS.124.014677</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1161/CIRCINTERVENTIONS.124.014677" target="_blank" >10.1161/CIRCINTERVENTIONS.124.014677</a>

Result language

angličtina

Original language name

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)

Original language description

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 (?late 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.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2025

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Circulation: Cardiovascular Interventions

ISSN

1941-7640

e-ISSN

1941-7632

Volume of the periodical

18

Issue of the periodical within the volume

5

Country of publishing house

US - UNITED STATES

Number of pages

8

Pages from-to

1-8

UT code for WoS article

001502756700006

EID of the result in the Scopus database

2-s2.0-105001811406