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Absorb bioresorbable scaffold versus Xience metallic stent for prevention of restenosis following percutaneous coronary intervention in patients at high risk of restenosis: Rationale and design of the COMPARE ABSORB trial

Identifikátory výsledku

  • Kód výsledku v IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F19%3AN0000077" target="_blank" >RIV/00064173:_____/19:N0000077 - isvavai.cz</a>

  • Nalezeny alternativní kódy

    RIV/00216208:11120/19:43918338

  • Výsledek na webu

    <a href="https://doi.org/10.1016/j.carrev.2019.04.013" target="_blank" >https://doi.org/10.1016/j.carrev.2019.04.013</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1016/j.carrev.2019.04.013" target="_blank" >10.1016/j.carrev.2019.04.013</a>

Alternativní jazyky

  • Jazyk výsledku

    angličtina

  • Název v původním jazyce

    Absorb bioresorbable scaffold versus Xience metallic stent for prevention of restenosis following percutaneous coronary intervention in patients at high risk of restenosis: Rationale and design of the COMPARE ABSORB trial

  • Popis výsledku v původním jazyce

    BACKGROUND: The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis. DESIGN: COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years. CONCLUSIONS: The prospective COMPARE ABSORB randomized trial (ClinicalTrials.govNCT02486068) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis.

  • Název v anglickém jazyce

    Absorb bioresorbable scaffold versus Xience metallic stent for prevention of restenosis following percutaneous coronary intervention in patients at high risk of restenosis: Rationale and design of the COMPARE ABSORB trial

  • Popis výsledku anglicky

    BACKGROUND: The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis. DESIGN: COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years. CONCLUSIONS: The prospective COMPARE ABSORB randomized trial (ClinicalTrials.govNCT02486068) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis.

Klasifikace

  • Druh

    J<sub>imp</sub> - Článek v periodiku v databázi Web of Science

  • CEP obor

  • OECD FORD obor

    30201 - Cardiac and Cardiovascular systems

Návaznosti výsledku

  • Projekt

  • Návaznosti

    N - Vyzkumna aktivita podporovana z neverejnych zdroju

Ostatní

  • Rok uplatnění

    2019

  • Kód důvěrnosti údajů

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

Údaje specifické pro druh výsledku

  • Název periodika

    Cardiovascular Revascularization Medicine

  • ISSN

    1553-8389

  • e-ISSN

    1878-0938

  • Svazek periodika

    20

  • Číslo periodika v rámci svazku

    7

  • Stát vydavatele periodika

    US - Spojené státy americké

  • Počet stran výsledku

    6

  • Strana od-do

    577-582

  • Kód UT WoS článku

    000476750600011

  • EID výsledku v databázi Scopus

    2-s2.0-85066279694