Cláudio David

The incidence of thrombotic events with idarucizumab and andexanet alfa: A systematic review and meta-analysis

Thrombosis Research, 2020

Direct thrombin inhibitor, dabigatran and factor Xa inhibitors, apixaban, edoxaban, and rivaroxab... more Direct thrombin inhibitor, dabigatran and factor Xa inhibitors, apixaban, edoxaban, and rivaroxaban (DOACs/NOACs), are currently the first-choice drugs in some indications. Life-threatening bleeding occurring during DOACs treatment may benefit from the use of reversal agents, however there are some concerns regarding potential rebound thrombotic events. In this systematic review we aimed to estimate the incidence of thrombotic events in patients treated with idarucizumab or andexanet alfa. Methods: This systematic review included all prospective and retrospective studies, enrolling patients that received specific antidotes (idarucizumab, andexanet alfa and cirapantag) for anticoagulation reversal, published until October 2019 in CENTRAL, MEDLINE and PsycINFO. Studies in healthy individuals and those with less than 10 patients were excluded. The primary outcome was the incidence of thrombotic events and the secondary outcome was all-cause mortality. Studies screening and data extraction was performed in duplicate by reviewers. A random-effects meta-analysis was performed using the Freeman-Tukey transformation of the data. The results are expressed in percentages, with 95%-confidence intervals (CI), limited between 0 and 100% due to the data transformation. Results: Overall 16 studies with 1774 patients were included (13 studies enrolling 1384 patients that received idarucizumab; 3 studies enrolling 390 patients that received andexanet alfa; cirapantag studies were not found). The pooled incidence rate of thrombotic events in the patients treated with specific antidote was 5.5% (95% CI 2.0-10.1%) until 30-90 days. The incidence of all-cause mortality was 13.3% (95% CI 9.6-17.5%). Conclusions: In patients requiring idarucizumab or andexanet alfa to reach haemostasis, our data shows that there were 5.5% thrombotic events. The causality of harm associated to antidotes remains to be established due to the design of studies without a control group.

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Copeptin for Discriminating Two-Year Mortality in Heart Failure Patients with Moderate to Severe Systolic Dysfunction

Journal of Clinical & Experimental Cardiology, 2012

Background: Patients with heart failure and impaired systolic function may have a highly variable... more Background: Patients with heart failure and impaired systolic function may have a highly variable clinical course that renders it difficult to assess the individual prognosis. We hypothesized that ejection fraction would incompletely characterize prognosis in systolic heart failure and that biomarkers would add significant information. This study addresses the specific question whether co-peptin may add value in the evaluation of two-year prognosis in heart failure patients with known systolic dysfunction. Methods: Prospective observational cohort study in 37 patients with symptomatic chronic heart failure (classes II to IV of the NYHA classification) and moderate to severe left ventricular systolic dysfunction. We evaluated clinical, echo-cardiographic and laboratory predictors of 24-month mortality specifically assessing the role of co-peptin. Results: Six patients (16%) died during the follow-up. Patients who died had significant higher prevalence of NYHA class IV heart failure, higher blood osmolality and higher levels of NT-proBNP and co-peptin. In unvariable analysis NYHA functional class (p=0.013), serum creatinine (p=0.034), osmolality (p=0.009), NT-proBNP (p=0.013) and copeptin (p=0.003) were predictors of mortality at 24 months. Only copeptin (p=0.004) remained an independent predictor of death in Cox regression analysis. Our results suggest that, in patients with heart failure and impaired left ventricular systolic function, copeptin level determination may be useful for predicting mortality at two years.

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Young Investigator Award session – Clinical Science442Left bundle branch block and coronary artery disease in coronary ct angiography443Focal myocardial fibrosis and abnormal left ventricular strain in patients with sarcoidosis without clinical evidence of cardiac disease444Arhgap24, a first gene...

European Heart Journal – Cardiovascular Imaging, 2015

Purpose: Left bundle branch block (LBBB) is considered an unfavourable prognostic marker in heart... more Purpose: Left bundle branch block (LBBB) is considered an unfavourable prognostic marker in heart disease. Testing for coronary artery disease (CAD) is often prompted by incidental LBBB finding, but published studies disagree about an association between LBBB and CAD. Thus, we assessed the association of LBBB with CAD in patients undergoing coronary CT angiography (CCTA). Methods: We enrolled 818 patients (106 LBBB patients and 712 controls) without known CAD, cardiomyopathy, valvular or congenital heart disease who underwent CCTA. Image quality was assessed on a 4-point scale for each coronary segment. After exclusion of nondiagnostic studies, comparison of CAD prevalence (≥50% coronary stenosis) was performed using triple case-matching for pre-test probability (based on age, gender and typicality of symptoms) in 101 LBBB patients and 303 matched controls. Results: Mean age was 57.2 + 11.1 years. CAD prevalence did not differ between LBBB patients and matched controls: 15% vs. 16% (p=0.88). Similarly, no significant differences were found in cardiovascular risk factors (CVRF), stenosis severity, CAD extent, nonobstructive disease and vessel-based analysis. In multivariate analysis, age, gender, typical angina and CVRF, but not LBBB (p=0.94), emerged as significant and independent predictors of obstructive CAD. Image quality was very high in LBBB and controls (3.8 versus 3.9). LBBB did not affect image quality in multivariate analysis including technical factors (p=0.70). Conclusion: CAD prevalence is similar in LBBB patients at low-to-moderate pre-test probability compared to controls matched for age, gender, symptom typicality and CVRF. LBBB does not affect image quality in CCTA, which is therefore a useful imaging modality in LBBB patients.

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Prevalence of hypercholesterolemia in Portugal and Europe: the same reality?

Revista Portuguesa de Cardiologia

Safety and tolerability of sacubitril-valsartan: a systematic review and meta-analysis

Expert Opinion on Drug Safety, 2021

Introduction: Sacubitril-valsartan is a recently approved drug. However, there are few data regar... more Introduction: Sacubitril-valsartan is a recently approved drug. However, there are few data regarding safety issues. We aimed to summarize the available evidence regarding sacubitril-valsartan’s safety and tolerability. Methods: We conducted a systematic review with meta-analysis of randomized controlled trials (RCTs) enrolling patients receiving sacubitril-valsartan for any condition, compared with standard therapy or placebo. Database search was performed in October 2019. Outcomes were adverse events (AEs), serious AEs (SAEs), discontinuation due to AEs, and five AEs of special interest. Data were reported using risk ratio (RR) and 95% confidence interval (95%CI). Results: We included 20 RCTs (22510 participants). When compared with active controls, there were no differences in SAEs (RR=0.93, 95%CI 0.86–1.01) and AEs (RR=1.00, 95%CI 0.97–1.03). However, sacubitril-valsartan resulted in an 8% risk reduction in discontinuation due to AEs (95%CI 0.85–0.99) and an increased risk of hy...

meta-analysis of randomised controlled trials diabetic and non-diabetic patients : Efficacy of lipid lowering drug treatment for

Objective To evaluate the clinical benefit of lipid lowering drug treatment in patients with and ... more Objective To evaluate the clinical benefit of lipid lowering drug treatment in patients with and without diabetes mellitus, for primary and secondary prevention. Design Systematic review and meta-analysis. Data sources Cochrane, Medline, Embase, and reference lists up to April 2004. Study selection Randomised, placebo controlled, double blind trials with a follow-up of at least three years that evaluated lipid lowering drug treatment in patients with and without diabetes mellitus. Data extraction Two independent reviewers extracted data. The primary outcome was major coronary events defined as coronary heart disease death, non-fatal myocardial infarction, or myocardial revascularisation procedures. Results Twelve studies were included. Lipid lowering drug treatment was found to be at least as effective in diabetic patients as in non-diabetic patients. In primary prevention, the risk reduction for major coronary events was 21% (95% confidence interval 11% to 30%; P < 0.0001) in di...

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Abstract 698: Late Enhancement in Isolated Noncompaction Left Ventricle is Related to Repetitive Ventricular Arrhythmias

Circulation, 2008

Custos da doença atribuíveis à hipercolesterolémia em Portugal

Revista Portuguesa De Pneumologia, 2004

Cardiovascular diseases are the main cause of death in Portugal, in developed countries and, inde... more Cardiovascular diseases are the main cause of death in Portugal, in developed countries and, indeed, worldwide. Hypercholesterolemia is a major risk factor for these diseases, including ischemic heart disease, cerebrovascular disease, and peripheral vascular disease. This paper reports the results of a study of the cost of illness associated with hypercholesterolemia and the costs directly attributable to hypercholesterolemia in Portugal, estimated from data for the year 2000. The results indicate that the cost of the health care provided to deal with illnesses associated with hypercholesterolemia was Euros 735.9 million (direct costs) and the costs of lost production due to disability of patients of working age was Euros 74.82 million (indirect costs). The costs attributable to hypercholesterolemia, those that would be avoided if hypercholesterolemia were completely eliminated, amount to Euros 358.84 million in direct costs and Euros 28.31 million in indirect costs. These results c...

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Myocardial perfusion and angioplasty. Comparison of myocardial contrast echocardiography and scintigraphy

Revista portuguesa de cardiologia : orgao oficial da Sociedade Portuguesa de Cardiologia = Portuguese journal of cardiology : an official journal of the Portuguese Society of Cardiology, 2002

OBJECTIVES To estimate the efficacy of myocardial contrast echocardiography (MCE) by harmonic pow... more OBJECTIVES To estimate the efficacy of myocardial contrast echocardiography (MCE) by harmonic power imaging (HPI), in evaluation of perfusion in one-vessel coronary disease treated by angioplasty, using myocardial scintigraphy as gold standard. STUDY DESIGN Prospective comparative study. SETTING Ambulatory. POPULATION We included 33 patients (pts), aged 53.5 +/- 9 years, 27 male. INCLUSION CRITERIA pts with one-vessel coronary disease (> or = 70% stenosis), with indication for angioplasty; sinus rhythm; good echocardiographic window with harmonic imaging. Exclusion criterion: previous myocardial infarction. METHODS All patients underwent myocardial scintigraphy and HPI together with stress echocardiography, both followed by angioplasty (stenting in ten). HPI and myocardial scintigraphy were repeated, in all patients, at three months after intervention. Ten patients were re-assessed by coronary angiography for ischemia on the scintigraphic study. For the HPI exam, Levovist was sel...

The Risk of Mortality Associated With Opioid Use in Patients With Acute Heart Failure: Systematic Review and Meta-analysis

Journal of Cardiovascular Pharmacology

AIMS The impact of opioids in acute heart failure (AHF) is unclear. This systematic review with m... more AIMS The impact of opioids in acute heart failure (AHF) is unclear. This systematic review with meta-analysis aimed to evaluate the mortality risk associated with opioid use in AHF. METHODS AND RESULTS An electronic search was performed in MEDLINE, CENTRAL, Web of Science Core Collection and SCIELO (December 2019) for randomized controlled trials and observational studies evaluating the impact of opioids in in-hospital and 30-day mortality in patients with AHF. Data were screened, extracted and appraised by two independent reviewers. A random-effects meta-analysis to estimate the pooled odds ratios (OR) with 95% confidence intervals (CI) was performed and heterogeneity was evaluated using the I statistics. Six observational retrospective studies with 151735 participants were included. Pooled results showed a statistical significant association between morphine and in-hospital mortality (OR 1.78; 95% CI 1.01-3.13; I=92%; 6 studies) and 30-day mortality (OR 1.56; 95% CI 1.14-2.15; I=0; 2 studies). Both outcomes were rated as having a serious risk of bias and had a very low Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) evidence. CONCLUSION Opioids appear to be associated with an increased risk of short-term mortality in AHF patients, however the confidence in the estimated effect is very low, which highlights the need of further research to evaluate this question.

Antithrombotic Therapy Recommendations in the European Society of Cardiology Guidelines: How Robust Are the Randomized Controlled Trials Underpinning Them?

TH Open

Introduction Criticisms have been raised against the sole use of p-value in interpreting results ... more Introduction Criticisms have been raised against the sole use of p-value in interpreting results from randomized controlled trials (RCTs). Additional tools have been suggested, like the fragility index (FI), a measure of a trial's robustness/fragility, and derivative measures. The FI is the minimum number of patients who would have to be converted from nonevents to events, in the group with the least events, for a result to lose statistical significance. Objective This study aimed to evaluate RCT supporting European Society of Cardiology (ESC) guidelines regarding antithrombotics, using the FI and FI-related measures. Methods FI, fragility quotient (FQ), and FI minus LTF lost to follow-up (FI − LTF) were calculated for the RCT underpinning recommendations regarding antithrombotic therapy from the updated ESC guidelines. LTF was compared with FI. Results were calculated for the total group of studies, as per guideline and as per recommendation type. Results Overall, 61 studies we...

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P3723Left atrial abnormal mechanics by speckle tracking as an early subclinical manifestation in patients with systemic sclerosis

European Heart Journal

Strain echocardiography / Chronic heart failure-pathophysiology and mechanisms 783 strain (GLS) a... more Strain echocardiography / Chronic heart failure-pathophysiology and mechanisms 783 strain (GLS) and mean peak strain rate (PSR) were improved significantly in PRP-H group (GLS=-18.4%±3.2, PSR=-1.0/s±0.12) in comparison to either saline (GLS=-12.6%±4.4, PSR=-0.6/s±0.15) (p=0.03), and MI-only groups (GLS=-9.7%±4.1, PSR=-0.5/s±0.23) (p<0.01). Mean global circumferential (GCS) and radial strains (GRS) showed marginal improvement in PRP-H group (GCS=-23.4%±3.9, GRS= 26%±5.7) when compared to sham controls (GCS=-27%±4.8, GRS= 31%±6.2) (p=0.05), saline (GCS=-21.3%±4.7, GRS= 24%±3.9) (p=0.062, NS), and MI-only groups (GCS=-18%±5.8, GRS= 21.4%±6.8) (p=0.05). GLS improvement correlated with the EF%, FAC, dP/dt-max changes (r 2 = 0.81, 0.67, and 0.74 respectively) within all groups, but not with the PRSW. Conclusions: 2D STE-derived ventricular strain is a reliable method to evaluate the effects of intra-myocardial injection of the PRP-enhanced hydrogel which proved to have the potential to improve injured myocardium both structurally and functionally. GLS and GRS can indicate and correlate with subtle changes in other gold-standard indexes. P3723 Left atrial abnormal mechanics by speckle tracking as an early subclinical manifestation in patients with systemic sclerosis

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The association of influenza infection and vaccine with myocardial infarction: systematic review and meta-analysis of self-controlled case series

Expert Review of Vaccines

ABSTRACT Introduction: Influenza vaccination may be beneficial in coronary disease patients; howe... more ABSTRACT Introduction: Influenza vaccination may be beneficial in coronary disease patients; however the infection and vaccination are associated with acute inflammation, a trigger of cardiovascular events. We aimed to review the risk of myocardial infarction (MI) associated with Influenza infection and the safety of vaccination in self-controlled case series (SCCS). Methods: We performed a systematic review with meta-analysis of SCCS studies to evaluate the risk of MI associated with Influenza infection/vaccination. Database search was performed in August/2018. The data were reported using the incident rate ratio (IRR) and 95% confidence interval (95%CI). Results: three studies for Influenza infection and two studies for Influenza vaccination were eligible. The risk of MI following an Influenza infection was significantly increased in the first 3 days (IRR 5.79; 95%CI: 3.59–9.38) and between 4-7 days (IRR 4.52; 95%CI: 2.80–7.32). In the first 4 weeks following the Influenza vaccination, there was a significant decrease of MI risk (IRR 0.84, 95%CI: 0.78–0.91). Conclusions: Short-term MI risk in Influenza infection is significantly increased, with a low-to-moderate confidence in the pooled evidence. The Influenza vaccine was safe regarding the short-term risk for MI, and the risk reduction is possibly related to a healthy period bias.

625 Perfusion assessment by myocardial contrast echocardiography and parametric imaging after primary angioplasty predicts late remodelling of left …

European …, 2006

meta-analysis of randomised controlled trials diabetic and non-diabetic patients: Efficacy of lipid lowering drug treatment for Rapid responses Topic collections Efficacy of lipid lowering drug treatment for diabetic and non-diabetic patients: meta-analys

Objective To evaluate the clinical benefit of lipid lowering drug treatment in patients with and ... more Objective To evaluate the clinical benefit of lipid lowering drug treatment in patients with and without diabetes mellitus, for primary and secondary prevention. Design Systematic review and meta-analysis. Data sources Cochrane, Medline, Embase, and reference lists up to April 2004. Study selection Randomised, placebo controlled, double blind trials with a follow-up of at least three years that evaluated lipid lowering drug treatment in patients with and without diabetes mellitus. Data extraction Two independent reviewers extracted data. The primary outcome was major coronary events defined as coronary heart disease death, non-fatal myocardial infarction, or myocardial revascularisation procedures. Results Twelve studies were included. Lipid lowering drug treatment was found to be at least as effective in diabetic patients as in non-diabetic patients. In primary prevention, the risk reduction for major coronary events was 21% (95% confidence interval 11% to 30%; P < 0.0001) in di...

Aspirin in the primary prevention of cardiovascular disease on diabetic patients: Systematic review and meta-analysis

Primary Care Diabetes

Influenza vaccination in patients with heart failure: a systematic review and meta-analysis of observational studies

Heart

ObjectiveDespite the progression of treatments over decades, heart failure (HF) is a disease with... more ObjectiveDespite the progression of treatments over decades, heart failure (HF) is a disease with high morbidity, mortality and economic burden. Influenza infection is an important trigger for cardiovascular (CV) events, including HF. Influenza vaccination has been seen to reduce the risk of CV mortality in patients with coronary disease, but the effect in patients with HF is still unclear. Therefore, we conducted a systematic review to evaluate the effect of influenza vaccination in the morbimortality of patients with HF.MethodsMEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Health Technology Assessment and PsycINFO databases (December 2018) were searched for longitudinal studies evaluating influenza vaccination compared with a non-vaccination control group in patients with HF. The risk of bias was assessed according to the ROBINS-I tool. We performed a random-effects meta-analysis to estimate the pooled HRs with 95% CIs, and hetero...

Cardiotoxicity in Hematological Diseases: Are the Tyrosine Kinase Inhibitors Imatinib and Nilotinib Safe?

Cardiovascular toxicology, Jan 3, 2018

Chemotherapy-induced cardiotoxicity is a growing concern. The cardiotoxic impact of new drugs suc... more Chemotherapy-induced cardiotoxicity is a growing concern. The cardiotoxic impact of new drugs such as tyrosine kinase inhibitors is unknown, especially the ones used for chronic myeloid leukemia. We aim to evaluate nilotinib- and imatinib-induced cardiotoxicity. Single-center prospective study of consecutive patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors was conducted during 2015. Patients underwent an initial clinical, laboratorial and echocardiographic evaluation, repeated after 1 year. Eleven patients were included [60.0 (11) years, 63.6% of males; seven patients treated with imatinib and four with nilotinib]. After 1 year of follow-up, all patients remained in functional NYHA class I, with a similar Minnesota quality of life score. Also there was no difference in the biomarkers evaluated (cystatin-C and NT-proBNP). Likewise, no modification in systolic or diastolic function evaluated by echocardiography was observed. All patients presented normal ...

Cardiotoxicity in Hematological Diseases: Are the Tyrosine Kinase Inhibitors Imatinib and Nilotinib Safe?

Cardiovascular toxicology, Jan 3, 2018

Chemotherapy-induced cardiotoxicity is a growing concern. The cardiotoxic impact of new drugs suc... more Chemotherapy-induced cardiotoxicity is a growing concern. The cardiotoxic impact of new drugs such as tyrosine kinase inhibitors is unknown, especially the ones used for chronic myeloid leukemia. We aim to evaluate nilotinib- and imatinib-induced cardiotoxicity. Single-center prospective study of consecutive patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors was conducted during 2015. Patients underwent an initial clinical, laboratorial and echocardiographic evaluation, repeated after 1 year. Eleven patients were included [60.0 (11) years, 63.6% of males; seven patients treated with imatinib and four with nilotinib]. After 1 year of follow-up, all patients remained in functional NYHA class I, with a similar Minnesota quality of life score. Also there was no difference in the biomarkers evaluated (cystatin-C and NT-proBNP). Likewise, no modification in systolic or diastolic function evaluated by echocardiography was observed. All patients presented normal ...

Non-vitamin K antagonist oral anticoagulants in cardiovascular disease management: Evidence and unanswered questions

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