Drug-Eluting-Balloon Angioplasty in Tunisian population versus Everolimus-platinum-chrome-stent for de-novo coronary lesion.

RESEARCH PROBLEM: Drug-eluting balloon (DEB) angioplasty is a well-established treatment modality for in-stent restenosis, however its safety and efficacy in de-novo lesion especially in large vessel remains undetermined. Theoretically, DEB sight to eliminate stent thrombosis and reduce restenosis rates by leaving no metal behind. AIM: To compare the results of angioplasty of de novo lesions by DEB (SEQUENT PLEASE) versus DES (Promus Premier and Promus Elite) in a Tunisian population. THE ENDPOINTS will be primarily the Late Lumen Loss at 12 months and secondarily the Major Cardiovascular Event rate (MACE) at 12 months. INVESTIGATIVE PROCESS: This is a randomized controlled non-inferiority trial including 290 patients with chronic coronary disease or non-ST elevation myocardial infarction with de novo lesions. After coronarography, angiographic parameters concerning lesion location and quantitative analysis will be collected. Patients will be treated with DEB or DES according to their allocation group. Before removal of the guide, post-procedural angiographic parameters will be evaluated. Follow-up will be performed for 12 months and an angiographic examination will be performed either as an emergency or at 12 months. The significance level will be 5%. A univariate analysis will be performed to search for predictive factors of MACE. RESEARCH PLAN: Ethical considerations will be undertaken and respected. The study will run for 15 months starting August 25, 2021 Trial registration: NCT05516446.

Design and Rationale of the National Tunisian Registry of Heart Failure (NATURE-HF): Protocol for a Multicenter Registry Study.

BACKGROUND: The frequency of heart failure (HF) in Tunisia is on the rise and has now become a public health concern. This is mainly due to an aging Tunisian population (Tunisia has one of the oldest populations in Africa as well as the highest life expectancy in the continent) and an increase in coronary artery disease and hypertension. However, no extensive data are available on demographic characteristics, prognosis, and quality of care of patients with HF in Tunisia (nor in North Africa). OBJECTIVE: The aim of this study was to analyze, follow, and evaluate patients with HF in a large nation-wide multicenter trial. METHODS: A total of 1700 patients with HF diagnosed by the investigator will be included in the National Tunisian Registry of Heart Failure study (NATURE-HF). Patients must visit the cardiology clinic 1, 3, and 12 months after study inclusion. This follow-up is provided by the investigator. All data are collected via the DACIMA Clinical Suite web interface. RESULTS: At the end of the study, we will note the occurrence of cardiovascular death (sudden death, coronary artery disease, refractory HF, stroke), death from any cause (cardiovascular and noncardiovascular), and the occurrence of a rehospitalization episode for an HF relapse during the follow-up period. Based on these data, we will evaluate the demographic characteristics of the study patients, the characteristics of pathological antecedents, and symptomatic and clinical features of HF. In addition, we will report the paraclinical examination findings such as the laboratory standard parameters and brain natriuretic peptides, electrocardiogram or 24-hour Holter monitoring, echocardiography, and coronarography. We will also provide a description of the therapeutic environment and therapeutic changes that occur during the 1-year follow-up of patients, adverse events following medical treatment and intervention during the 3- and 12-month follow-up, the evaluation of left ventricular ejection fraction during the 3- and 12-month follow-up, the overall rate of rehospitalization over the 1-year follow-up for an HF relapse, and the rate of rehospitalization during the first 3 months after inclusion into the study. CONCLUSIONS: The NATURE-HF study will fill a significant gap in the dynamic landscape of HF care and research. It will provide unique and necessary data on the management and outcomes of patients with HF. This study will yield the largest contemporary longitudinal cohort of patients with HF in Tunisia. TRIAL REGISTRATION: ClinicalTrials.gov NCT03262675; https://clinicaltrials.gov/ct2/show/NCT03262675. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12262.

Is there a latent left ventricular dysfunction in hypertensive patients with preserved ejection fraction?

INTRODUCTION: Early detection of left ventricular (LV) dysfunction may represent a clinical finding that would justify aggressive treatment aimed to reduce cardiovascular morbidity and mortality. AIM: To evaluate longitudinal contractility in patients with essential hypertension and preserved LV ejection fraction (EF), in an attempt to detect latent impairment of LV systolic function. METHODS: Prospective case-control study carried out on 121 (67 male/54 female) hypertensive patients (HTN group) with preserved EF and without any symptoms of heart failure and 39 age- and gender-matched healthy subjects as a control group. Conventional echocardiographic study, as well as 2D Longitudinal strain imaging by 2D-speckle tracking echocardiography (2D-STE), were performed. RESULTS: Mean age of patients was 60,48 ± 10.5 years old. The LV end-diastolic diameter and LVEF were comparable between the two groups. Hypertensive patients had greater septal thickness, left ventricular mass, and maximum left atrium volume (p respectively at 0.02; 0.04; and 0.01). Only 20 patients (16.5%) had left ventricular hypertrophy (LVH). The architecture of LV was normal in 57.8 % (n=70) patients. A statistically significant difference between the two groups was found for all diastolic function parameters except Em /Ea ratio and DTEm. In comparison with normal controls, GLS was significantly attenuated in patients with HTN (-17.69 ± 4.06 % versus -22.70 ± 5.02% in controls (p=0.000) and 67 (55.4%) hypertensive patients had a GLS<-20% (in absolute value). The decrease of GLS was more marked in the hypertensive group with left ventricular hypertrophy. CONCLUSION: The results of our study confirmed that GLS is a sensitive biomarker of subclinical myocardial dysfunction in hypertensive patients, this suggests that identifying patients at higher risk for heart failure and earlier inter¬vention may be beneficial.

Clopidogrel utilization in patients with coronary artery disease and diabetes mellitus: should we determine CYP2C19*2 genotype?

PURPOSE: Clopidogrel non-responsiveness is multifactorial; several genetic and non-genetic factors may contribute to impaired platelet inhibition. The goal of this study is to determine the effect of the cytochrome P450 CYP2C19*2 polymorphism on the platelet response to clopidogrel in patients with and without diabetes mellitus (DM). METHODS: We conducted an observational study in patients with coronary artery disease and consequent exposure to clopidogrel therapy (75 mg/day for at least 7 consecutive days). We have analyzed two groups of patients: group I (DM patients) and group II (non-diabetes mellitus patients). Platelet reactivity was assessed by the VerifyNow P2Y12 assay and high on clopidogrel platelet reactivity (HPR) was defined as P2Y12 reaction units (PRU) ≥ 208. Genotyping for CYP2C19*2 polymorphism was performed by PCR-RFLP. RESULTS: We have included 150 subjects (76 DM and 74 non-diabetes mellitus patients). The carriage of CYP2C19*2 allele, in DM patients, was significantly associated to HPR (odds ratio (OR) 4.437, 95% confidence interval (CI) 1.134 to 17.359; p = 0.032). Furthermore, 8.4% of the variability in percent inhibition by clopidogrel could be attributed to CYP2C19*2 carrier status. However, in non-diabetes mellitus patients, there was no significant difference in platelet response to clopidogrel according to the presence or absence of CYP2C19*2 allele carriage (OR 1.260, 95% CI 0.288 to 5.522; p = 0.759). CONCLUSIONS: Our study suggests that the carriage of CYP2C19*2 polymorphism, in DM patients, might be a potential predictor of persisting HPR in these high-risk individuals. TRIAL REGISTRATION: Clinical Trials.gov NCT03373552 (Registered 13 December 2017).