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result(s) for
"Tebaldi, Matteo"
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Angio-Based Index of Microcirculatory Resistance for the Assessment of the Coronary Resistance: A Proof of Concept Study
by
Di Girolamo, Domenico
,
Tumscitz, Carlo
,
Tebaldi, Matteo
in
Aged
,
Capillary Resistance
,
Coronary Angiography - methods
2020
Background. The study of coronary microcirculation has gained increasing consideration and importance in cath lab. Despite the increase of evidence, its use still remains very limited. QFR is a novel angio-based approach for the evaluation of coronary stenosis. The aim of our study was to use the QFR assessment in stable patients to recreate the IMR formula and to correlate the result of the two techniques. Methods. From June 1, 2019, to February 29, 2019, 200 patients with CCS and indication of coronary artery angiography and referred to the cath lab of the University Hospital of Ferrara (Italy) were enrolled. After baseline coronary angiogram, quantitative flow ratio, fractional flow reserve, and index of microcirculatory resistance evaluation were performed. Results. Pearson correlation (r) between angio-based index of microcirculatory resistance (A-IMR) and IMR 0.32 with R2 = 0.098, P=0.03: McNemar test showed a difference between the two tests of 6.82% with 95% CI from –12.05% to 22.89%, which is not significant (P=0.60). Bland and Altman plot showed a mean difference of 23.3 (from −26.5 to 73.1). Sensitivity, specificity, NPV, and PPV were 70%, 83.3%, 75%, and 70% for A-IMR value >44.2. The area under the ROC curve for A-IMR was 0.76 (95% CI 0.61–0.88, P=0.0003). Conclusion. We have validated for the first time the formula of the A-IMR, a tool for the calculation of microvascular resistance which does not require the use of pressure guides and the induction of hyperemia.
Journal Article
Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial
by
den Heijer, Pieter
,
Vazquez, Nicolás
,
Serra, Antonio
in
Biological and medical sciences
,
Cardiology. Vascular system
,
Chromium Alloys
2012
Everolimus-eluting stent (EES) reduces the risk of restenosis in elective percutaneous coronary intervention. However, the use of drug-eluting stent in patients with ST-segment elevation myocardial infarction (STEMI) is still controversial. Data regarding the performance of second-generation EES in this setting are scarce. We report the 1-year result of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) trial, comparing EES with bare-metal stents (BMS) in patients with STEMI.
This multicentre, prospective, randomised, all-comer controlled trial was done in 12 medical centres in three countries. Between Dec 31, 2008, and May 15, 2010, we recruited patients with STEMI up to 48 h after the onset of symptoms requiring emergent percutaneous coronary intervention. Patients were randomly assigned (ratio 1:1) to receive EES or BMS. Randomisation was in blocks of four or six patients, stratified by centre and centralised by telephone. Patients were masked to treatment. The primary endpoint was the patient-oriented combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularisation at 1 year and was analysed by intention to treat. The secondary endpoints of the study included the device-oriented combined endpoint of cardiac death, target vessel myocardial infarction or target lesion revascularisation, and rates of all cause or cardiac death, recurrent myocardial infarction, target lesion or target vessel revascularisation, stent thrombosis, device and procedure success, and major and minor bleeding. This trial is registered with ClinicalTrials.gov, number NCT00828087.
Of the 1504 patients randomised, 1498 patients were randomly assigned to receive EES (n=751) or BMS (n=747). The primary endpoint was similar in both groups (89 [11·9%] of 751 patients in the EES group vs 106 [14·2%] of 747 patients in the BMS group; difference −2·34 [95% CI −5·75 to 1·07]; p=0·19). Device-oriented endpoint (44 [5·9%] in the EES group vs 63 [8·4%] in the BMS group; difference −2·57 [95% CI −5·18 to 0·03]; p=0·05) did not differ between groups, although rates of target lesion and vessel revascularisation were significantly lower in the EES group (16 [2·1%] vs 37 [5·0%], p=0·003, and 28 [3·7%] vs 51 [6·8%], p=0·0077, respectively). Rates of all cause (26 [3·5%] for EES vs 26 [3·5%] for BMS, p=1·00) or cardiac death (24 [3·2%] for EES vs 21 [2·8%] for BMS, p=0·76) or myocardial infarction (10 [1·3%] vs 15 [2·0%], p=0·32) did not differ between groups. Stent thrombosis rates were significantly lower in the EES group (4 [0·5%] patients with definite stent thrombosis in the EES group vs 14 [1·9%] in the BMS group and seven [0·9%] patients with definite or probable stent thrombosis in the EES group vs 19 [2·5%] in the BMS group, both p=0·019). Although device success rate was similar between groups, procedure success rate was significantly higher in the EES group (731 [97·5%] vs 705 [94·6%]; p=0·0050). Finally, Bleeding rates at 1 year were comparable between groups (29 [3·9%] patients in the EES group vs 39 [5·2%] in the BMS group; p=0·19).
The use of EES compared with BMS in the setting of STEMI did not lower the patient-oriented endpoint. However, at the stent level both rates of target lesion revascularisation and stent thrombosis were reduced in recipients of EES.
Spanish Heart Foundation.
Journal Article
Coronary Microvascular Dysfunction: PET, CMR and CT Assessment
by
Pompei, Graziella
,
Cossu, Alberto
,
Tebaldi, Matteo
in
Acute coronary syndromes
,
Cardiomyopathy
,
Clinical medicine
2021
Microvascular dysfunction is responsible for chest pain in various kinds of patients, including those with obstructive coronary artery disease and persistent symptoms despite revascularization, or those with myocardial disease without coronary stenosis. Its diagnosis can be performed with an advanced imaging technique such as positron emission tomography, which represents the gold standard for diagnosing microvascular abnormalities. In recent years, cardiovascular magnetic resonance and cardiac computed tomography have demonstrated to be emerging modalities for microcirculation assessment. The identification of microvascular disease represents a fundamental step in the characterization of patients with chest pain and no epicardial coronary disease: its identification is important to manage medical strategies and improve prognosis. The present overview summarizes the main techniques and current evidence of these advanced imaging strategies in assessing microvascular dysfunction and, if present, their relationship with invasive evaluation.
Journal Article
Diabetes does not attenuate the benefit of physiology-guided complete revascularization in older patients with myocardial infarction
by
Cerrato, Enrico
,
Scarsini, Roberto
,
Vadalà, Giuseppe
in
Acute coronary syndromes
,
Angiology
,
Angioplasty
2026
Background
In patients with myocardial infarction (MI) and multivessel disease, diabetes mellitus is associated with more diffuse coronary atherosclerosis and worse clinical outcomes, often influencing revascularization decisions. The Functional Assessment in Elderly MI Patients with Multivessel Disease (FIRE) trial demonstrated the superiority of physiology-guided complete revascularization in older patients with MI. Whether this benefit is preserved in patients with diabetes remains uncertain.
Methods
In FIRE, 1445 patients aged ≥ 75 years with MI and multivessel disease were randomized to culprit-only or physiology-guided complete revascularization. In this prespecified analysis, outcomes were assessed according to diabetes status. The primary endpoint was a composite of death, MI, stroke, or revascularization at 3 years. The key secondary endpoint was cardiovascular death or MI. The safety endpoint included contrast-associated acute kidney injury, stroke, or Bleeding Academic Research Consortium type 3–5 bleeding.
Results
Among 1445 patients, 463 (32%) had diabetes. After adjustment for baseline characteristics, diabetes was independently associated with a higher risk of the primary endpoint (hazard ratio [HR] 1.26, 95% confidence interval [CI] 1.02–1.56) and heart failure (HR 1.35, 95% CI 1.01–1.83) at 3 years. Physiology-guided complete revascularization reduced the primary outcome in both patients with diabetes (HR 0.70, 95% CI 0.50–0.97) and without diabetes (HR 0.75, 95% CI 0.58–0.97), with no evidence of effect modification by diabetes status (p for interaction = 0.712). Similar consistency was observed for the key secondary and safety endpoints.
Conclusions
In older patients with MI and multivessel disease, physiology-guided complete revascularization reduces ischemic events irrespective of diabetes status, supporting its use in elderly diabetic patients.
Trial registration
ClinicalTrials.gov Identifier NCT03772743.
Journal Article
Unsolved Questions in the Revascularization of Older Myocardial Infarction Patients with Multivessel Disease
by
Tebaldi, Matteo
,
Sanguettoli, Federico
,
Zanarelli, Luca
in
Acute coronary syndromes
,
Angioplasty
,
Cardiovascular disease
2022
Background: In cardiology, the global phenomenon of population ageing poses new major challenges, ranging from more comorbid and frail patients to the presence of complex, calcified and multiple coronary lesions. Considering that elderly patients are under-represented in randomized clinical trials (RCT), the aim of this systematic review is to summarize the current knowledge on the revascularization of the elderly patient with myocardial infarction and multivessel coronary artery disease. Methods: A systematic review following PRISMA guidelines has been performed. The search was conducted on Pubmed (Medline), Cochrane library, Google Scholar and Biomed Central databases between January and February 2022. We selected the articles focusing on patients hospitalized for myocardial infarction (MI) with multivessel disease and aged 75 years or older. A total of 36 studies have been included. Results: Multivessel coronary artery disease is present in around 50–60% of older patients with MI. The in-hospital mortality rate of patients older than 75 years is double compared to their younger counterpart, and the most prevalent complications after revascularization are bleeding and renal failure. In the treatment of patients with ST elevation MI (STEMI), primary percutaneous coronary intervention should be the first choice over fibrinolysis. However, it is not clear whether this population would benefit from complete revascularization or not. In patients with non-ST elevation MI (NSTEMI), an invasive approach with either percutaneous coronary intervention or coronary artery bypass graft may be chosen, but a conservative strategy is also accepted. There are no data from large trials about the comparison of possible revascularization strategies in NSTEMI patients. Conclusions: This systematic review shows that this field of research lacks randomized clinical trials to guide revascularization strategy in older STEMI or NSTEMI patients with MI. New results are expected from ongoing trials.
Journal Article
A counseling program on nuisance bleeding improves quality of life in patients on dual antiplatelet therapy: A randomized controlled trial
by
Spitaleri, Giosafat
,
Vieceli Dalla Sega, Francesco
,
Del Franco, Annamaria
in
Acute coronary syndromes
,
Antiplatelet therapy
,
Anxiety
2017
Nuisance bleeding is a major determinant of quality of life and drug discontinuation in patients on dual antiplatelet therapy (DAPT). However, no randomized trial has been focused on the impact of nuisance bleeding on quality of life.
BATMAN is an investigator-driven, randomized, controlled, single-center, open trial (NCT02554006). Four hundred and forty-eight consecutive patients with indication to at least 6 months of DAPT were randomized to: i) multimodal counseling program focused on nuisance bleedings (interventional arm); ii) usual discharge process (control arm). The primary endpoint was the one-month health-related quality of life assessed by the EuroQol-5 Dimension (EQ-5D) visual analog scale (VAS) score. Secondary endpoints were EQ-5D at 1 and 6 months, EQ-5D VAS at 6 months, DAPT withdrawal, need of information regarding DAPT and/or nuisance bleedings, 6-month ischemic and bleeding adverse events.
The EQ5D-VAS was significantly higher in the interventional arm compared to the control arm at 1 and 6 months (81[74-88] vs. 73[64-80], p < 0.001 at 1 month; 82[76-88] vs. 74[65-81], p < 0.001 at 6 months). Patients in the interventional arm had also significantly lower pain/discomfort and anxiety/depression at the EQ-5D both at 1 and 6 months. Patients in the control arm withdrew DAPT significantly more (7 (3%) vs. 1 (0.4%), p = 0.03) and looked for information regarding DAPT and/or about nuisance bleeding more frequently than those in the interventional arm (178 (79%) vs.19 (8%), p < 0.001).
The systematic utilization of a multimodal counseling program improved quality of life and reduced the DAPT withdrawal rate in patients on DAPT.
Journal Article
A Prospective Real-World Study Evaluating the Feasibility and Diagnostic Yield of Patient-Recorded Smartwatch EKGs During Palpitations: The WATCHinTIME Study
2026
Introduction: Palpitations are one of the most common cardiovascular complaints, affecting approximately 6% to 11% of the general population. Since palpitations often occur sporadically and resolve before medical evaluation, diagnosing the underlying rhythm disturbance requires documentation via an electrocardiogram (ECG) recorded during the symptomatic episode. The standard tool for this purpose has long been the 24-h Holter monitor, which has significant limitations, with diagnostic yields as low as 10% to 15%. Objective: This study aims to evaluate the feasibility and diagnostic yield of single-lead ECG recordings from smartwatches in patients presenting with palpitations. Methods: From 1 May 2023 to 1 May 2025, we conducted a prospective, real-world cohort study among consecutive adults referred to the University Hospital of Ferrara-based arrhythmia outpatient clinics for evaluation of palpitations. Eligibility required patients to be ≥21 years of age, report palpitations for which ambulatory documentation was clinically indicated, and already own a compatible smartwatch capable of single-lead ECG. Participants were trained to record a 30-s single-lead ECG at the onset of symptoms. Tracings were transmitted securely and independently reviewed by two blinded electrophysiologists. Results: Fifty-nine patients were enrolled (mean age 52 years, 64% male). Thirty-one patients (52%) transmitted at least one smartwatch-derived electrocardiographic tracing. Seventy-seven smartwatch tracings were received. Of these, 73 (95%) were interpretable; 57 (78%) showed an arrhythmia, whereas 16 (22%) demonstrated normal sinus rhythm. Four recordings (5%) were non-interpretable. From the 57 arrhythmic tracings, 44 distinct arrhythmic diagnoses were identified. Paroxysmal atrial fibrillation (AF) accounted for 16 episodes. Other diagnosed arrhythmias included atrial flutter (n = 6), paroxysmal supraventricular tachycardia (PSVT) (n = 4), premature atrial complexes (PAC) (n = 6), premature ventricular complexes (PVC) (n = 9), inappropriate sinus tachycardia (n = 12), and second-degree atrioventricular (AV) block type I (n = 4). Conclusions: Smartwatch-based ECG monitoring in symptomatic patients is feasible and provides a high diagnostic yield for a broad spectrum of arrhythmias. Unlike large-scale population screening approaches, which generate vast datasets with limited clinical benefit, a symptom-driven strategy applied to carefully selected, educated, and motivated patients proves both clinically valuable and organizationally sustainable. Indeed, the mean number of tracings transmitted per patient was low (1.3), confirming the clinical and operational sustainability of this patient-triggered, real-world approach.
Journal Article
Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study
by
Verdoliva, Sebastiano
,
Marrone, Andrea
,
D’Aniello, Emanuele
in
Acute coronary syndromes
,
Adenosine
,
coronary revascularization
2023
Background: Recently, questions around the efficacy and effectiveness of Fractional Flow Reserve (FFR) have arisen in various clinical settings. Methods: The Clinical Outcome of FFR-guided Revascularization Strategy of Coronary Lesions (HALE-BOPP) study is an investigator-initiated, multicentre, international prospective study enrolling patients who underwent FFR measurement on at least one vessel. In accordance with the decision-making workflow and treatment, the vessels were classified in three subgroups: (i) angio-revascularized, (ii) FFR-revascularized, (iii) FFR-deferred. The primary endpoint was the occurrence of target vessel failure (TVF, cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization). The analysis was carried out at vessel- and patient-level. Results: 1305 patients with 2422 diseased vessels fulfilled the criteria for the present analysis. Wire-related pitfalls and transient adenosine-related side effects occurred in 0.8% (95% CI: 0.4%–1.4%) and 3.3% (95% CI: 2.5%–4.3%) of cases, respectively. In FFR-deferred vessels, the overall incidence rate of TVF was 0.024 (95% CI: 0.019–0.031) lesion/year. After a median follow-up of 3.6 years, the occurrence of TVF was 6%, 7% and 11.7% in FFR-deferred, FFR-revascularized and angio-revascularized vessels, respectively. Compared to angio-revascularized vessels, FFR-guided vessels (both FFR-revascularized and FFR-deferred vessels) showed a lower TVF incidence rate lesion/year (0.029, 95% CI: 0.024–0.034 vs. 0.049, 95% CI: 0.040–0.061 respectively, p = 0.0001). The result was consistent after correction for confounding factors and across subgroups of clinical interest. The patient-level analysis confirmed the lower occurrence of TVF in negative-FFR vs. positive-FFR subgroups. Conclusions: In a large prospective observational study, an FFR-based strategy for the deferral of coronary lesions is a reliable and safe tool, associated with good outcomes. Clinical Trial Registration: NCT03079739.
Journal Article
Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial
by
Cerrato, Enrico
,
Cortese, Giancarlo
,
Vaudano, Paolo
in
Acute coronary syndromes
,
Adolescent
,
Adult
2020
BackgroundThe role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.Methods and analysisPULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.Trial registration numberNCT04144881
Journal Article
Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction
by
Cerrato, Enrico
,
Penzo, Carlo
,
Jurado-Roman, Alfonso
in
Acute Kidney Injury - etiology
,
Age groups
,
Aged
2023
The benefit of complete revascularization in older patients (≥75 years of age) with myocardial infarction and multivessel disease remains unclear.
In this multicenter, randomized trial, we assigned older patients with myocardial infarction and multivessel disease who were undergoing percutaneous coronary intervention (PCI) of the culprit lesion to receive either physiology-guided complete revascularization of nonculprit lesions or to receive no further revascularization. Functionally significant nonculprit lesions were identified either by pressure wire or angiography. The primary outcome was a composite of death, myocardial infarction, stroke, or any revascularization at 1 year. The key secondary outcome was a composite of cardiovascular death or myocardial infarction. Safety was assessed as a composite of contrast-associated acute kidney injury, stroke, or bleeding.
A total of 1445 patients underwent randomization (720 to receive complete revascularization and 725 to receive culprit-only revascularization). The median age of the patients was 80 years (interquartile range, 77 to 84); 528 patients (36.5%) were women, and 509 (35.2%) were admitted for ST-segment elevation myocardial infarction. A primary-outcome event occurred in 113 patients (15.7%) in the complete-revascularization group and in 152 patients (21.0%) in the culprit-only group (hazard ratio, 0.73; 95% confidence interval [CI], 0.57 to 0.93; P = 0.01). Cardiovascular death or myocardial infarction occurred in 64 patients (8.9%) in the complete-revascularization group and in 98 patients (13.5%) in the culprit-only group (hazard ratio, 0.64; 95% CI, 0.47 to 0.88). The safety outcome did not appear to differ between the groups (22.5% vs. 20.4%; P = 0.37).
Among patients who were 75 years of age or older with myocardial infarction and multivessel disease, those who underwent physiology-guided complete revascularization had a lower risk of a composite of death, myocardial infarction, stroke, or ischemia-driven revascularization at 1 year than those who received culprit-lesion-only PCI. (Funded by Consorzio Futuro in Ricerca and others; FIRE ClinicalTrials.gov number, NCT03772743.).
Journal Article