Publications by authors named "Ferdinande B"

Article Synopsis
  • The BIOMAG-I study evaluated the first-in-human resorbable magnesium scaffold (DREAMS 3G) and showed positive outcomes for clinical results and late lumen loss after 12 months.
  • The current substudy looked into vascular healing parameters using optical coherence tomography (OCT) and intravascular ultrasound (IVUS), focusing on aspects like strut visibility and neointimal growth.
  • Results from 56 patients indicated that almost all scaffold struts became invisible by 12 months, with a favorable vascular healing response, including a significant decrease in protruding neointimal tissue.
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  • * Colchicine is currently the only anti-inflammatory medication showing promise for CAD, but more research is needed to fully understand its effectiveness and safety as a primary treatment option.
  • * The COL BE PCI trial aims to evaluate the efficacy of colchicine versus placebo in 2,770 patients post-percutaneous coronary intervention (PCI), focusing on major cardiovascular events as the primary outcome of the study.
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  • * In a trial with 858 patients, results showed no significant difference in major complications between those who continued anticoagulation (16.5% experienced primary outcomes) and those who interrupted it (14.8%).
  • * Continuation of anticoagulation led to higher incidences of major bleeding (31.1% vs. 21.3%), suggesting that interrupting anticoagulation is safer in this patient population undergoing TAVI.
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  • The optimal management of patients with atrial fibrillation (AF) requiring oral anticoagulation (OAC) during percutaneous coronary intervention (PCI) is debated, with current guidelines suggesting a temporary triple therapy regimen that includes aspirin, which raises bleeding risks.
  • A new study, the WOEST-3 trial, seeks to compare a 30-day dual antiplatelet therapy (DAPT) strategy that temporarily omits OAC against guideline-directed therapy post-PCI for AF patients, aiming to reduce bleeding without sacrificing efficacy.
  • With a sample of 2,000 patients, the trial will evaluate the rates of major bleeding and adverse ischemic events, making it the first randomized controlled trial to explore the omission of OAC
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Background: Evidence-based recommendations for antithrombotic treatment in patients who have an indication for oral anticoagulation (OAC) after transcatheter edge-to-edge mitral valve repair (TEER) are lacking.

Aims: To compare bleeding and thrombotic risk for different antithrombotic regimens post-TEER with MitraClip in an unselected population with the need for OACs.

Methods: Bleeding and thrombotic complications (stroke and myocardial infarction) up to 3 months after TEER with mitraclip were evaluated in 322 consecutive pts with an indication for OACs.

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  • The study aimed to evaluate how the initial composition of plaque affects late loss in the lumen after DREAMS 3G implantation and to compare plaque changes over 6 and 12 months.
  • 116 patients from the BIOMAG-I trial underwent imaging using optical coherence tomography (OCT) before and after the procedure, revealing that those with more fibrous tissue in their plaque initially had greater differences in lumen area after a year.
  • Results showed a significant reduction in lipid areas and an increase in fibrous tissue at follow-up, indicating favorable healing of coronary walls post-implantation.
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  • The study compared the safety and effectiveness of two types of stents—biodegradable-polymer sirolimus-eluting stents and durable-polymer zotarolimus-eluting stents—in patients at high bleeding risk receiving abbreviated dual antiplatelet therapy after coronary interventions.
  • Conducted as a randomized trial across 52 hospitals in 18 countries, it involved 1,948 patients who were randomized to receive one of the two stent types after successful lesion preparation, followed by 1 month of dual antiplatelet therapy.
  • Results showed that at 1 year, the rates of adverse outcomes (death, heart attack, or stent thrombosis) were similar between the two stent types, with
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About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events.

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  • The DREAMS 3G is a new coronary magnesium scaffold designed to match the performance of traditional drug-eluting stents (DES).
  • The BIOMAG-I study is a first-in-human trial that evaluates the safety and effectiveness of this scaffold with a follow-up period of up to 5 years.
  • Results showed that after 12 months, the scaffold demonstrated low rates of complications, confirming its safety and efficacy as a potential alternative to DES.
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  • The BIOFLOW-DAPT trial investigates the safety of the Orsiro Mission stent versus the Resolute Onyx stent in high bleeding risk patients undergoing PCI, focusing on a 1-month dual antiplatelet therapy (DAPT) regimen.
  • The study will assess the occurrence of cardiac death, myocardial infarction, and stent thrombosis over a year, with a total of 1948 participants to ensure reliable results.
  • This is the first randomized trial to evaluate a reduced DAPT duration specifically for HBR patients receiving the Orsiro Mission stent, aiming to balance safety and bleeding risk.
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Background: A third-generation coronary drug-eluting resorbable magnesium scaffold (DREAMS 3G) was developed to enhance the performance of previous scaffold generations and achieve angiographic outcomes comparable to those of contemporary drug-eluting stents.

Methods: This prospective, multicenter, non-randomized, first-in-human study was conducted at 14 centers in Europe. Eligible patients had stable or unstable angina, documented silent ischemia, or non-ST-elevation myocardial infarction, and a maximum of two single de novo lesions in two separate coronary arteries with a reference vessel diameter between 2.

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BACKGROUND During transradial coronary angiography, when conventional J-tip wires fail to deliver catheters to the aortic root due to anatomical obstacles, additional hydrophilic wires, such as Radifocus (Terumo) or Silverway (Asahi), are used. We recently showed that the Silverway guidewire was effective at delivering the catheter to the aortic root. In this study, we aimed to compare the efficacy and safety of Radifocus and Silverway guidewires in 100 patients after failed use of the J-tip guidewire.

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Background: This study aimed to assess the stability of pressure derived fractional flow reserve (FFR) measurement and the handling performance of the OptoWire Deux with an optical pressure sensor relative to the PressureWire X with piezo resistive pressure sensors.

Methods: This multicenter centre observational study included 50 patients between June 2017 and November 2018 undergoing a diagnostic coronary angiography with FFR measurement of moderate to severe lesions. The reliability of FFR measurement measured with the OptoWire Deux relative to the PressureWire X in each lesion was assessed by the presence of drift.

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The present study aims to assess the clinical and hemodynamic impact of percutaneous edge-to-edge mitral valve repair with MitraClip in patients with atrial functional mitral regurgitation (A-FMR) compared with ventricular functional mitral regurgitation (V-FMR). Mitral regurgitation (MR) grade, functional status (New York Heart Association class), and major adverse cardiac events (MACE; all-cause mortality or hospitalization for heart failure) were evaluated in 52 patients with A-FMR and in 307 patients with V-FMR. In 56 patients, hemodynamic assessment during exercise echocardiography was performed before and 6 months after intervention.

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Purpose: Fluid boluses (FB) are often used in post-cardiac arrest (CA) patients with haemodynamic instability. Although FB may improve cardiac output (CO) and mean arterial pressure (MAP), FB may also increase central venous pressure (CVP), reduce arterial PaO, dilute haemoglobin and cause interstitial oedema. The aim of the present study was to investigate the net effect of FB administration on cerebral tissue oxygenation saturation (SctO) in post-CA patients.

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Background: This study aimed to assess the reliability of pressure derived fractional flow reserve (FFR) measurement and the handling performance of the OptoWire Deux with an optical pressure sensor relative to both the PressureWire X and the Verrata Pressure wire with piezoresistive pressure sensors.

Methods: This single centre study included 80 patients between October 2016 and May 2017 undergoing a diagnostic coronary angiography. The reliability of FFR measurement measured with the OptoWire Deux relative to the PressureWire X and Verrata Pressure wire was assessed by the presence of drift.

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Background: Contemporary data on left ventricular function (LVF) recovery in patients with left ventricular dysfunction after ST-elevation myocardial infarction (STEMI) are scarce and to date, no comparison has been made with patients with a baseline normal LVF. This study examined predictors of LVF recovery and its relation to outcomes in STEMI.

Methods: Patients presenting with STEMI between January 2010 and December 2016 were categorized in three groups after 3 months according to left ventricular ejection fraction (EF): (i) baseline normal LVF (EF ≥ 50% at baseline); (ii) recovered LVF (EF < 50% at baseline and ≥ 50% after 3 months); and (iii) reduced LVF (EF < 50% at baseline and after 3 months).

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Objective: To test the prognostic value of brain MRI in addition to clinical and electrophysiologic variables in patients post-cardiac arrest (CA), we explored data from the randomized Neuroprotect Post-CA trial (NCT02541591).

Methods: In this trial, brain MRIs were prospectively obtained. We calculated receiver operating characteristic (ROC) curves for the average apparent diffusion coefficient (ADC) value and percentage of brain voxels with an ADC value <650 × 10 mm/s and <450 × 10 mm/s.

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Background: The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied.

Methods: In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months.

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Background: In patients with shock after acute myocardial infarction (AMI), the optimal level of pharmacologic support is unknown. Whereas higher doses may increase myocardial oxygen consumption and induce arrhythmias, diastolic hypotension may reduce coronary perfusion and increase infarct size.

Objectives: This study aimed to determine the optimal mean arterial pressure (MAP) in patients with AMI and shock after cardiac arrest.

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Background: The roles of anticoagulation alone or with an antiplatelet agent after transcatheter aortic-valve implantation (TAVI) have not been well studied.

Methods: We performed a randomized trial of clopidogrel in patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications. Patients were assigned before TAVI in a 1:1 ratio not to receive clopidogrel or to receive clopidogrel for 3 months.

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Aims: During the first 6-12 h of intensive care unit (ICU) stay, post-cardiac arrest (CA) patients treated with a mean arterial pressure (MAP) 65 mmHg target experience a drop of the cerebral oxygenation that may cause additional cerebral damage. Therefore, we investigated whether an early goal directed haemodynamic optimization strategy (EGDHO) (MAP 85-100 mmHg, SVO2 65-75%) is safe and could improve cerebral oxygenation, reduce anoxic brain damage, and improve outcome when compared with a MAP 65 mmHg strategy.

Methods And Results: A total of 112 out-of-hospital CA patients were randomly assigned to EGDHO or MAP 65 mmHg strategies during the first 36 h of ICU stay.

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Aims: The effect of MitraClip implantation on left ventricular (LV) remodelling has been shown to be highly variable. The present study wants to assess patterns of LV remodelling and its relationship with outcome.

Methods And Results: Serial echocardiography before, 1 and 6 months after MitraClip implantation was performed in 79 pts with severe mitral regurgitation (MR) (age 74 ± 10 years, New York Heart Association III/IV 80%, LV ejection fraction 38 ± 13%, logistic EuroSCORE 21 ± 15, and functional MR 81%).

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Aim: To study the association between global hemodynamics, blood gases, epileptiform EEG activity and survival after out-of-hospital CA (0HCA).

Methods: We retrospectively analyzed 195 comatose post-CA patients. At least one EEG recording per patient was evaluated to diagnose epileptiform EEG activity.

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Background: Post-cardiac arrest (CA) patients admitted to the intensive care unit (ICU) have a poor prognosis, with estimated survival rates of around 30%-50%. On admission, these patients have a large cerebral penumbra at risk for additional damage in case of suboptimal brain oxygenation during their stay in the ICU. The aim of the Neuroprotect post-CA trial is to investigate whether forcing mean arterial blood pressure (MAP) and mixed venous oxygen saturation (SVO) in a specific range (MAP 85-100 mm Hg, SVO 65%-75%) with additional pharmacological support (goal-directed hemodynamic optimization) may better salvage the penumbra, reduce cerebral ischemia, and improve functional outcome when compared with current standard of care (MAP 65 mm Hg).

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