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The COBRA II (COmplex Bifurcation lesions: RAndomized comparison of a fully bioresorbable modified-T stenting strategy versus bifurcation reconstruction with a dedicated self-expanding stent in combination with bioresorbable scaffolds) study: Final 5-year follow-up.
Indian Heart J
December 2023
Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium; Department of Cardiovascular Sciences, Katholieke Universiteit Leuven, Leuven, Belgium.
Background: In order to advocate further research in bioresorbable scaffold (BVS) technology we report the final 5-year outcomes of the COBRA II study, the only randomized controlled trial (RCT) performed to investigate the safety, feasibility, and performance of Absorb BVS (Abbott Vascular) in true coronary bifurcations.
Methods: COBRA II was a prospective single-center RCT. Fifteen patients with true coronary bifurcation lesions were randomized to bifurcation treatment with self-expanding biolimus-eluting Axxess bifurcation device (Biosensors International) combined with additional bioresorbable everolimus-eluting Absorb BVS in the bifurcation branches on (Axxess group) or to 2-stent mod-T stenting technique with Absorb BVS (mod-T group).
Ultrathin, Biodegradable-Polymer Sirolimus-Eluting Stent vs Thin, Durable-Polymer Everolimus-Eluting Stent.
JACC Cardiovasc Interv
July 2022
Department of Preventive Medicine and Public Health, Toho University School of Medicine, Ota-ku, Japan.
Background: Previous trials suggested the superiority of ultrathin- over thin-strut drug-eluting stents (DES) concerning target lesion failure (TLF) at 1 year after index percutaneous coronary intervention.
Objectives: The aim of this randomized comparison study of ultrathin-strut and thin-strut DES (CASTLE [Randomized Comparison All-Comer Study of Ultrathin Strut and Thin Strut Drug-Eluting Stent]; jRCTs032180084) was to examine the impact of differences in strut thickness of DES on clinical outcomes when implanted with angiography and intravascular ultrasound or optical coherence tomographic guidance.
Methods: CASTLE was a multicenter, prospective, noninferiority study conducted at 65 institutions in Japan.
Multivessel Disease Patients' Outcome and Second Generation Stent: Is Syntax Still a Valid Score? A Real-World Study from a Tertiary Center.
Acta Med Acad
December 2020
Department of Cardiovascular and Thoracic Medicine, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
Objective: The SYNTAX trial was designed to evaluate whether multivessel disease patients could benefit from percutaneous or surgical revascularization using a paclitaxel eluting stents, but after the introduction of second generation stents, this score needs to be reevaluated. The aim of our study was to analyze the association between SYNTAX score and the prognosis of multivessel patients submitted to percutaneous coronary intervention (PCI) and second generation everolimus eluting stents (EES) implantation.
Materials And Methods: Data on 289 patients with multivessel coronary artery disease submitted to PCI with EES were stored in a dedicated database and retrospectively analyzed.
Biodegradable- Versus Durable-Polymer Drug-Eluting Stents for STEMI: Final 2-Year Outcomes of the BIOSTEMI Trial.
JACC Cardiovasc Interv
March 2021
Division of Cardiology, Geneva University Hospitals, Geneva, Switzerland. Electronic address:
Objectives: The aim of this study was to investigate the safety and efficacy of biodegradable-polymer sirolimus-eluting stents (BP-SES) compared with durable-polymer everolimus-eluting stents (DP-EES) in patients with ST-segment elevation myocardial infarction (STEMI).
Background: Primary percutaneous coronary intervention (PCI) is an effective treatment for patients with STEMI, and long-term outcomes are determined by the safety and efficacy profile of the newest generation drug-eluting stents.
Methods: BIOSTEMI (A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention) was an investigator-initiated, multicenter, assessor-blind, randomized superiority trial using Bayesian methods.
Bioresorbable vascular scaffold versus metallic drug-eluting stent in patients at high risk of restenosis: the COMPARE-ABSORB randomised clinical trial.
EuroIntervention
October 2020
Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.
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).
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