Bioresorbable vascular scaffold versus metallic drug-eluting stent in patients at high risk of restenosis: the COMPARE- ABSORB randomised clinical trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F20%3A43920763" target="_blank" >RIV/00216208:11120/20:43920763 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064173:_____/20:N0000078

Výsledek na webu

<a href="https://doi.org/10.4244/EIJ-D-19-01079" target="_blank" >https://doi.org/10.4244/EIJ-D-19-01079</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.4244/EIJ-D-19-01079" target="_blank" >10.4244/EIJ-D-19-01079</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Bioresorbable vascular scaffold versus metallic drug-eluting stent in patients at high risk of restenosis: the COMPARE- ABSORB randomised clinical trial

Popis výsledku v původním jazyce

Aims: The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS). Methods and results: The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS aim. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: -1.2%-3.0%, p non-inferiority &lt;0.001). Definite or probable device thrombosis (2.0% vs 0.6%, hazard ratio [BR] 3.32, 95% CI: 1.22-8.99, p=0.012) and TVMI (4.0% vs 2.1%, HR 1.96, 95% CI: 1.10-3.51, p=0.02) were significantly higher in the BVS group than in the EES group. Conclusions: In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at one year. BVS carried a higher risk of device thrombosis and TVMI than EES.

Název v anglickém jazyce

Bioresorbable vascular scaffold versus metallic drug-eluting stent in patients at high risk of restenosis: the COMPARE- ABSORB randomised clinical trial

Popis výsledku anglicky

Aims: The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS). Methods and results: The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS aim. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: -1.2%-3.0%, p non-inferiority &lt;0.001). Definite or probable device thrombosis (2.0% vs 0.6%, hazard ratio [BR] 3.32, 95% CI: 1.22-8.99, p=0.012) and TVMI (4.0% vs 2.1%, HR 1.96, 95% CI: 1.10-3.51, p=0.02) were significantly higher in the BVS group than in the EES group. Conclusions: In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at one year. BVS carried a higher risk of device thrombosis and TVMI than EES.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2020

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

16

Číslo periodika v rámci svazku

8

Stát vydavatele periodika

FR - Francouzská republika

Počet stran výsledku

9

Strana od-do

645-653

Kód UT WoS článku

000582258100003

EID výsledku v databázi Scopus

2-s2.0-85094684391