A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX
Autor: | Gerrit Anne van Es, Taku Asano, Chun-Chin Chang, Rodrigo Modolo, Norihiro Kogame, Robbert J. de Winter, Yuki Katagiri, Patrick W. Serruys, Upendra Kaul, Yoshinobu Onuma, Osama Ibrahim Ibrahim Soliman, Marie-Angèle Morel, Ply Chichareon, Azfar Zaman, Kuniaki Takahashi, Ernest Spitzer |
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Přispěvatelé: | Cardiology, ACS - Atherosclerosis & ischemic syndromes, ACS - Microcirculation, Graduate School, ACS - Heart failure & arrhythmias |
Jazyk: | angličtina |
Rok vydání: | 2019 |
Předmět: |
medicine.medical_specialty
medicine.medical_treatment Population Coronary Artery Disease 030204 cardiovascular system & hematology Coronary artery disease 03 medical and health sciences 0302 clinical medicine Percutaneous Coronary Intervention Coronary stent Absorbable Implants medicine Clinical endpoint Humans Single-Blind Method 030212 general & internal medicine Myocardial infarction Everolimus Prospective Studies education Sirolimus education.field_of_study business.industry Stent Percutaneous coronary intervention Drug-Eluting Stents medicine.disease Surgery Europe Treatment Outcome Stents Cardiology and Cardiovascular Medicine business medicine.drug |
Zdroj: | EuroIntervention, 15(4), E362-E369. EuroPCR EuroIntervention, 15(4), e362-e369. EuroPCR |
ISSN: | 1774-024X |
Popis: | Aims: The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a noninferiority trial in a “real-world” patient population. Methods and results: This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an “allcomers” patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification). Conclusions: The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population. |
Databáze: | OpenAIRE |
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