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)

Kód výsledku v 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>

Nalezeny alternativní kódy

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

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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)

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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)

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

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

Název periodika

Circulation: Cardiovascular Interventions

ISSN

1941-7640

e-ISSN

1941-7632

Svazek periodika

18

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

8

Strana od-do

1-8

Kód UT WoS článku

001502756700006

EID výsledku v databázi Scopus

2-s2.0-105001811406