Clinical Outcome of Patients With and Without Diabetes Mellitus After Percutaneous Coronary Intervention With the Resolute Zotarolimus-Eluting Stent 2-Year Results From the Prospectively Pooled Analysis of the International Global RESOLUTE Program

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F13%3A43907363" target="_blank" >RIV/00216208:11120/13:43907363 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064173:_____/13:#0000305

Výsledek na webu

<a href="http://dx.doi.org/10.1016/j.jcin.2012.11.006" target="_blank" >http://dx.doi.org/10.1016/j.jcin.2012.11.006</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jcin.2012.11.006" target="_blank" >10.1016/j.jcin.2012.11.006</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Clinical Outcome of Patients With and Without Diabetes Mellitus After Percutaneous Coronary Intervention With the Resolute Zotarolimus-Eluting Stent 2-Year Results From the Prospectively Pooled Analysis of the International Global RESOLUTE Program

Popis výsledku v původním jazyce

The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes. Background The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes. Methods We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complexpatients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years. Results The 12-month rate of target vessel failure in the pre-specifie

Název v anglickém jazyce

Clinical Outcome of Patients With and Without Diabetes Mellitus After Percutaneous Coronary Intervention With the Resolute Zotarolimus-Eluting Stent 2-Year Results From the Prospectively Pooled Analysis of the International Global RESOLUTE Program

Popis výsledku anglicky

The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes. Background The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes. Methods We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complexpatients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years. Results The 12-month rate of target vessel failure in the pre-specifie

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FA - Kardiovaskulární nemoci včetně kardiochirurgie

OECD FORD obor

—

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2013

Kód důvěrnosti údajů

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

Název periodika

Journal of American College of Cardiology: Cardiovascular Interventions

ISSN

1936-8798

e-ISSN

—

Svazek periodika

6

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

12

Strana od-do

357-368

Kód UT WoS článku

000317487900009

EID výsledku v databázi Scopus

—