Randomised comparison of a biodegradable polymer ultra-thin sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients with de novo native coronary artery lesions: the meriT-V trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00159816%3A_____%2F18%3A00069329" target="_blank" >RIV/00159816:_____/18:00069329 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.4244/EIJ-D-18-00762" target="_blank" >http://dx.doi.org/10.4244/EIJ-D-18-00762</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.4244/EIJ-D-18-00762" target="_blank" >10.4244/EIJ-D-18-00762</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Randomised comparison of a biodegradable polymer ultra-thin sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients with de novo native coronary artery lesions: the meriT-V trial

Popis výsledku v původním jazyce

Aims: The aim of this study was to evaluate the safety and efficacy of the BioMime sirolimus-eluting coronary stem (SES) compared to the XIENCE family of everolimus-eluting coronary stents (EES) in the treatment of patients with de novo native coronary artery lesions. Methods and results: The meriT-V is a prospective, multicentre, randomised, open-label, active-controlled, non-inferiority trial. A total of 256 patients with up to two de novo native coronary artery lesions were enrolled and randomly assigned (2:1) to BioMime SES or XIENCE EES. BioMime SES was non-inferior to XIENCE EES for the primary endpoint of in-stent late lumen loss (0.15 +/- 0.27 mm vs. 0.15 +/- 0.29 mm; difference: -0.006 mm; 95% confidence interval: -0.085 to 0.072; p=0.87; p for non-inferiority &lt;0.0001) at nine-month follow-up. The major adverse cardiac events rate was numerically lower in the BioMime SES group (2.98% vs. 7.14%; p=0.13), driven by a statistically significant lower risk of any myocardial infarction (0.60% vs. 4.76%; p=0.03), when compared with the XIENCE EES group. There was no difference in target vessel myocardial infarction (p=0.62) between the groups. There was no definite or probable stent thrombosis in either group. Conclusions: In the treatment of de novo native coronary artery lesions, the biodegradable polymer ultrathin SES (BioMime) was non-inferior to a durable polymer EES (XIENCE) at nine-month follow-up. Further studies powered for clinical endpoints are needed.

Název v anglickém jazyce

Randomised comparison of a biodegradable polymer ultra-thin sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients with de novo native coronary artery lesions: the meriT-V trial

Popis výsledku anglicky

Aims: The aim of this study was to evaluate the safety and efficacy of the BioMime sirolimus-eluting coronary stem (SES) compared to the XIENCE family of everolimus-eluting coronary stents (EES) in the treatment of patients with de novo native coronary artery lesions. Methods and results: The meriT-V is a prospective, multicentre, randomised, open-label, active-controlled, non-inferiority trial. A total of 256 patients with up to two de novo native coronary artery lesions were enrolled and randomly assigned (2:1) to BioMime SES or XIENCE EES. BioMime SES was non-inferior to XIENCE EES for the primary endpoint of in-stent late lumen loss (0.15 +/- 0.27 mm vs. 0.15 +/- 0.29 mm; difference: -0.006 mm; 95% confidence interval: -0.085 to 0.072; p=0.87; p for non-inferiority &lt;0.0001) at nine-month follow-up. The major adverse cardiac events rate was numerically lower in the BioMime SES group (2.98% vs. 7.14%; p=0.13), driven by a statistically significant lower risk of any myocardial infarction (0.60% vs. 4.76%; p=0.03), when compared with the XIENCE EES group. There was no difference in target vessel myocardial infarction (p=0.62) between the groups. There was no definite or probable stent thrombosis in either group. Conclusions: In the treatment of de novo native coronary artery lesions, the biodegradable polymer ultrathin SES (BioMime) was non-inferior to a durable polymer EES (XIENCE) at nine-month follow-up. Further studies powered for clinical endpoints are needed.

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

2018

Kód důvěrnosti údajů

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

Název periodika

Eurointervention

ISSN

1774-024X

e-ISSN

—

Svazek periodika

14

Číslo periodika v rámci svazku

11

Stát vydavatele periodika

FR - Francouzská republika

Počet stran výsledku

8

Strana od-do

1207-1214

Kód UT WoS článku

000452498600012

EID výsledku v databázi Scopus

2-s2.0-85058636243