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
The result's identifiers
Result code in 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>
Alternative codes found
RIV/00216208:11120/19:43918338
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
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
Original language description
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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30201 - Cardiac and Cardiovascular systems
Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2019
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Cardiovascular Revascularization Medicine
ISSN
1553-8389
e-ISSN
1878-0938
Volume of the periodical
20
Issue of the periodical within the volume
7
Country of publishing house
US - UNITED STATES
Number of pages
6
Pages from-to
577-582
UT code for WoS article
000476750600011
EID of the result in the Scopus database
2-s2.0-85066279694