5 results on '"Esposito, Giovanni"'
Search Results
2. Prognostic Implications of Declining Hemoglobin Content in Patients Hospitalized With Acute Coronary Syndromes.
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Leonardi S, Gragnano F, Carrara G, Gargiulo G, Frigoli E, Vranckx P, Di Maio D, Spedicato V, Monda E, Fimiani L, Fioretti V, Esposito F, Avvedimento M, Magliulo F, Leone A, Chianese S, Franzese M, Scalise M, Schiavo A, Mazzone P, Esposito G, Andò G, Calabrò P, Windecker S, and Valgimigli M
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- Acute Coronary Syndrome blood, Aged, Aged, 80 and over, Europe epidemiology, Female, Hemorrhage mortality, Humans, Inpatients statistics & numerical data, Male, Middle Aged, Prognosis, Acute Coronary Syndrome mortality, Hemoglobins metabolism, Hemorrhage blood
- Abstract
Background: Contemporary definitions of bleeding endpoints are restricted mostly to clinically overt events. Whether hemoglobin drop per se, with or without overt bleeding, adversely affects the prognosis of patients with acute coronary syndrome (ACS) remains unclear., Objectives: The aim of this study was to examine in the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial the incidence, predictors, and prognostic implications of in-hospital hemoglobin drop in patients with ACS managed invasively stratified by the presence of in-hospital bleeding., Methods: Patients were categorized by the presence and amount of in-hospital hemoglobin drop on the basis of baseline and nadir hemoglobin values and further stratified by the occurrence of adjudicated in-hospital bleeding. Hemoglobin drop was defined as minimal (<3 g/dl), minor (≥3 and <5 g/dl), or major (≥5 g/dl). Using multivariate Cox regression, we modeled the association between hemoglobin drop and mortality in patients with and without overt bleeding., Results: Among 7,781 patients alive 24 h after randomization with available hemoglobin data, 6,504 patients (83.6%) had hemoglobin drop, of whom 5,756 (88.5%) did not have overt bleeding and 748 (11.5%) had overt bleeding. Among patients without overt bleeding, minor (hazard ratio [HR]: 2.37; 95% confidence interval [CI]: 1.32 to 4.24; p = 0.004) and major (HR: 2.58; 95% CI: 0.98 to 6.78; p = 0.054) hemoglobin drop were independently associated with higher 1-year mortality. Among patients with overt bleeding, the association of minor and major hemoglobin drop with 1-year mortality was directionally similar but had wider CIs (minor: HR: 3.53 [95% CI: 1.06 to 11.79]; major: HR: 13.32 [95% CI: 3.01 to 58.98])., Conclusions: Among patients with ACS managed invasively, in-hospital hemoglobin drop ≥3 g/dl, even in the absence of overt bleeding, is common and is independently associated with increased risk for 1-year mortality. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox; NCT01433627)., Competing Interests: Author Disclosures The MATRIX trial was sponsored by Società Italiana di Cardiologia Invasiva (a nonprofit organization), which received grant support from The Medicines Company and Terumo. This substudy did not receive any direct or indirect funding. Dr. Leonardi has received grants and personal fees from AstraZeneca, Bristol Myers Squibb/Pfizer, and Chiesi; and has received personal fees from Bayer outside the submitted work. Dr. Gragnano has received research grant support from the European Society of Cardiology outside the submitted work. Dr. Gargiulo has received consultant fees from Daiichi-Sankyo outside the submitted work. Dr. Vranckx has received personal fees from AstraZeneca, Terumo, CSL Behring, Daiichi-Sankyo, and Bayer Health Care outside the submitted work. Dr. Frigoli is affiliated with CTU Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in the design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern’s conflicts of interest, visit the University of Bern Web site (and see Research, Declaration of Interest). Dr. Windecker has received research and educational grants to the institution from Abbott, Amgen, Bristol Myers Squibb, Bayer, Boston Scientific, Biotronik, Cardinal Health, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Johnson & Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed outside the submitted work. Dr. Valgimigli has received grants and personal fees from Abbott, Terumo, AstraZeneca; has received personal fees from Chiesi, Bayer, Daiichi-Sankyo, Amgen, Alvimedica, Biosensors, and Idorsia; and has received grants from Medicure outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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3. One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry.
- Author
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Stabile E, Gerardi D, Magliulo F, Zhelev D, Chervenkoff V, Taeymans K, Kotasov D, Goverde P, Giugliano G, Trimarco B, and Esposito G
- Subjects
- Aged, Angioplasty, Balloon adverse effects, Angioplasty, Balloon mortality, Cardiovascular Agents adverse effects, Constriction, Pathologic, Critical Illness, Equipment Design, Europe, Female, Humans, Intermittent Claudication diagnostic imaging, Intermittent Claudication mortality, Intermittent Claudication physiopathology, Ischemia diagnostic imaging, Ischemia mortality, Ischemia physiopathology, Male, Middle Aged, Paclitaxel adverse effects, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease mortality, Peripheral Arterial Disease physiopathology, Prospective Studies, Recurrence, Registries, Time Factors, Treatment Outcome, Vascular Patency, Angioplasty, Balloon instrumentation, Cardiovascular Agents administration & dosage, Coated Materials, Biocompatible, Femoral Artery diagnostic imaging, Femoral Artery physiopathology, Intermittent Claudication therapy, Ischemia therapy, Paclitaxel administration & dosage, Peripheral Arterial Disease therapy, Popliteal Artery diagnostic imaging, Popliteal Artery physiopathology, Vascular Access Devices
- Abstract
Purpose: To report the 1-year outcomes of the prospective Legflow drug-coated balloon (DCB) registry, which evaluated the safety and 12-month efficacy of the Legflow balloon in the treatment of femoropopliteal disease., Methods: The Legflow is a new generation of DCB that has a homogenous, stable surface coating incorporating 0.1-µm paclitaxel particles. From January 2014 to June 2016, 139 patients (mean age 67.1±10.8 years; 109 men) were enrolled at 4 European institutions. Seventy-nine (56.8%) patients had claudication, while 60 (43.2%) had critical limb ischemia (CLI). Mean lesion length (MLL) was 90.0±41.2 mm. Eighty (57.6%) patients were treated for de novo lesions (MLL 83.2±41.2 mm), 29 (20.9%) for postangioplasty restenosis (MLL 81.2±30.9 mm), and 30 (21.6%) for in-stent restenosis (MLL 117.0±39.5 mm). The primary outcome measure was freedom from binary restenosis as determined by a peak systolic velocity ratio ≥2.4 on duplex or >50% stenosis on digital subtraction angiography at 12 months. The secondary outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months., Results: Technical success was achieved in all the 139 treated patients. During the hospital stay, 3 CLI patients died of wound-related complications and 3 CLI patients underwent urgent TLR due to early occlusion in 2 and stent thrombosis in 1. At 12 months, 4 additional patients died of cardiac disease unrelated to the procedure. Of the 132 patients available for 1-year follow-up, the primary outcome (freedom from restenosis) was obtained in 107 (81.1%) patients. Freedom from CD-TLR was obtained in 110 (83.3%). Of the 25 late restenoses >50%, only 3 asymptomatic patients did not require TLR. Freedom from CD-TLR was higher in claudicants (87.0%) than in CLI patients (78.2%, p=0.20). In patients treated for in-stent restenosis, freedom from TLR at 1 year was 89.2%., Conclusion: These data suggest that the use of a new generation paclitaxel-coated balloon represents a safe and effective therapeutic strategy for femoropopliteal obstructions in different clinical and anatomical settings. These data will need to be confirmed with longer-term follow-up and in randomized controlled trials.
- Published
- 2019
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4. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study.
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Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Bøtker HE, Wijns W, Christiansen EH, and Holm NR
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- Aged, Angina Pectoris etiology, Angina Pectoris physiopathology, Coronary Stenosis complications, Coronary Stenosis physiopathology, Europe, Feasibility Studies, Female, Follow-Up Studies, Humans, Imaging, Three-Dimensional, Japan, Male, Predictive Value of Tests, Prospective Studies, Reproducibility of Results, Severity of Illness Index, Angina Pectoris diagnosis, Coronary Angiography methods, Coronary Stenosis diagnosis, Coronary Vessels physiopathology, Fractional Flow Reserve, Myocardial physiology
- Abstract
Background: Quantitative flow ratio (QFR) is a novel modality for physiological lesion assessment based on 3-dimensional vessel reconstructions and contrast flow velocity estimates. We evaluated the value of online QFR during routine invasive coronary angiography for procedural feasibility, diagnostic performance, and agreement with pressure-wire-derived fractional flow reserve (FFR) as a gold standard in an international multicenter study., Methods and Results: FAVOR II E-J (Functional Assessment by Various Flow Reconstructions II Europe-Japan) was a prospective, observational, investigator-initiated study. Patients with stable angina pectoris were enrolled in 11 international centers. FFR and online QFR computation were performed in all eligible lesions. An independent core lab performed 2-dimensional quantitative coronary angiography (2D-QCA) analysis of all lesions assessed with QFR and FFR. The primary comparison was sensitivity and specificity of QFR compared with 2D-QCA using FFR as a reference standard. A total of 329 patients were enrolled. Paired assessment of FFR, QFR, and 2D-QCA was available for 317 lesions. Mean FFR, QFR, and percent diameter stenosis were 0.83±0.09, 0.82±10, and 45±10%, respectively. FFR was ≤0.80 in 104 (33%) lesions. Sensitivity and specificity by QFR was significantly higher than by 2D-QCA (sensitivity, 86.5% (78.4-92.4) versus 44.2% (34.5-54.3); P <0.001; specificity, 86.9% (81.6-91.1) versus 76.5% (70.3-82.0); P =0.002). Area under the receiver curve was significantly higher for QFR compared with 2D-QCA (area under the receiver curve, 0.92 [0.89-0.96] versus 0.64 [0.57-0.70]; P <0.001). Median time to QFR was significantly lower than median time to FFR (time to QFR, 5.0 minutes [interquartile range, -6.1] versus time to FFR, 7.0 minutes [interquartile range, 5.0-10.0]; P <0.001)., Conclusions: Online computation of QFR in the catheterization laboratory is clinically feasible and is superior to angiographic assessment for evaluation of intermediary coronary artery stenosis using FFR as a reference standard., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02959814., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)
- Published
- 2018
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5. Impact of Sex on Comparative Outcomes of Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management: Data From the Randomized MATRIX-Access Trial.
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Gargiulo G, Ariotti S, Vranckx P, Leonardi S, Frigoli E, Ciociano N, Tumscitz C, Tomassini F, Calabrò P, Garducci S, Crimi G, Andò G, Ferrario M, Limbruno U, Cortese B, Sganzerla P, Lupi A, Russo F, Garbo R, Ausiello A, Zavalloni D, Sardella G, Esposito G, Santarelli A, Tresoldi S, Nazzaro MS, Zingarelli A, Petronio AS, Windecker S, da Costa BR, and Valgimigli M
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- Acute Coronary Syndrome diagnostic imaging, Acute Coronary Syndrome mortality, Acute Coronary Syndrome physiopathology, Aged, Aged, 80 and over, Catheterization, Peripheral adverse effects, Catheterization, Peripheral mortality, Coronary Angiography, Europe, Female, Health Status Disparities, Humans, Male, Middle Aged, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Postoperative Complications epidemiology, Punctures, Risk Factors, ST Elevation Myocardial Infarction diagnostic imaging, ST Elevation Myocardial Infarction mortality, ST Elevation Myocardial Infarction physiopathology, Sex Factors, Time Factors, Treatment Outcome, Acute Coronary Syndrome surgery, Catheterization, Peripheral methods, Femoral Artery, Percutaneous Coronary Intervention methods, Radial Artery, ST Elevation Myocardial Infarction surgery
- Abstract
Objectives: This study sought to assess whether transradial access (TRA) compared with transfemoral access (TFA) is associated with consistent outcomes in male and female patients with acute coronary syndrome undergoing invasive management., Background: There are limited and contrasting data about sex disparities for the safety and efficacy of TRA versus TFA for coronary intervention., Methods: In the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) program, 8,404 patients were randomized to TRA or TFA. The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACCE or major bleeding., Results: Among 8,404 patients, 2,232 (26.6%) were women and 6,172 (73.4%) were men. MACCE and NACE were not significantly different between men and women after adjustment, but women had higher risk of access site bleeding (male vs. female rate ratio [RR]: 0.64; p = 0.0016), severe bleeding (RR: 0.17; p = 0.0012), and transfusion (RR: 0.56; p = 0.0089). When comparing radial versus femoral, there was no significant interaction for MACCE and NACE stratified by sex (p
int = 0.15 and 0.18, respectively), although for both coprimary endpoints the benefit with TRA was relatively greater in women (RR: 0.73; p = 0.019; and RR: 0.73; p = 0.012, respectively). Similarly, there was no significant interaction between male and female patients for the individual endpoints of all-cause death (pint = 0.79), myocardial infarction (pint = 0.25), stroke (pint = 0.18), and Bleeding Academic Research Consortium type 3 or 5 (pint = 0.45)., Conclusions: Women showed a higher risk of severe bleeding and access site complications, and radial access was an effective method to reduce these complications as well as composite ischemic and ischemic or bleeding endpoints., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2018
- Full Text
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