Faculty of Medicine

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Depression in Survivors of Acute Myocardial Infarction
(ScopeMed, 2019)
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Comparison of IFN-γ Levels in Children with Tuberculosis Disease (TB) and Latent Tuberculosis Infection (LTBI)
(Scientific Foundation SPIROSKI, 2018-11-25)
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Simonovska, Liljana
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Dilberovska, Mirjana
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Dacevski, Dragan
This study aimed to evaluate the importance of IFN-γ in the diagnosis of pediatric TB and LTBI and to compare the IFN-γ levels.
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Development and validation of a bioanalytical LC-UV method with solid-phase extraction for determination of valproic acid in saliva.
(Macedonian Academy of Sciences and Arts/Walter de Gruyter GmbH, 2012-06)
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Haxhiu, Arlinda
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A bioanalytical HPLC method with UV detection for the determination of the antiepileptic drug valproic acid in human saliva has been developed and validated. Saliva represents an alternative matrix for therapeutic monitoring of antiepileptic drugs due to the increasing interest in free drug concentration. The proposed method involved solid-phase extraction for sample preparation and yielded very good mean recoveries of 99.4 % and 97.9 % for valproic acid and IS, respectively. The calibration function for valproic acid was linear over the concentration range of 1.0-50.0 μg mL⁻¹ (R² = 0.9989). Within-run and between-run precision and accuracy were studied at four concentrations and RSDs were less than 7.3 and 2.2 %, while accuracy values were higher than 96.8 and 97.5 %, respectively. The described method provides sensitivity, linearity, precision, accuracy and is suitable for analyses of valproic acid in saliva samples.
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Dose-dependent teratogenicity of valproate in mono- and polytherapy: an observational study
(Wolters Kluwer, 2015-09)
Tomson T
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Battino D
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Bonizzoni E
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Craig J
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Lindhout D
Abstract Objective: To assess the risk of major congenital malformations (MCMs) in association with maternal use of valproic acid (VPA) in monotherapy or adjunctive therapy, and its relationship with dose. Methods: The analysis was based on prospectively acquired data from EURAP, a registry enrolling women treated with antiepileptic drugs (AEDs) in early pregnancy, in which the primary outcome is presence of MCMs at 1 year after birth. Exposure was defined as type and dose of AEDs at time of conception. A comparison was made among 3 exposure types: (1) VPA monotherapy (n = 1,224); (2) VPA combined with lamotrigine (LTG) (n = 159); and (3) VPA combined with another AED but not LTG (n = 205). Results: The frequency of MCMs at 1 year after birth was 10.0% for VPA monotherapy, 11.3% for exposures to VPA and LTG, and 11.7% for exposures to VPA + another (non-LTG) AED. Regardless of exposure group, the frequency of MCMs increased with dose of VPA, being highest at doses ≥1,500 mg/d (24.0% for monotherapy, 31.0% for VPA + LTG, and 19.2% for VPA + other AEDs), and was similar across treatment groups at the lowest VPA dose level of <700 mg/d (5.9% for monotherapy, 7.0% for VPA + LTG, and 5.4% for VPA + other AEDs). Conclusions: The risk of MCMs associated with VPA exposure increases with increasing VPA dose, both in the presence and in the absence of one concomitant AED, and appears to be related primarily to the dose of VPA.
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Comparative risk of major congenital malformations with eight different antiepileptic drugs: a prospective cohort study of the EURAP registry.
(Elsevier, 2018-06)
Tomson T
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Battino D
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Bonizzoni E
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Craig J
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Lindhout D
Background: Evidence for the comparative teratogenic risk of antiepileptic drugs is insufficient, particularly in relation to the dosage used. Therefore, we aimed to compare the occurrence of major congenital malformations following prenatal exposure to the eight most commonly used antiepileptic drugs in monotherapy. Methods: We did a longitudinal, prospective cohort study based on the EURAP international registry. We included data from pregnancies in women who were exposed to antiepileptic drug monotherapy at conception, prospectively identified from 42 countries contributing to EURAP. Follow-up data were obtained after each trimester, at birth, and 1 year after birth. The primary objective was to compare the risk of major congenital malformations assessed at 1 year after birth in offspring exposed prenatally to one of eight commonly used antiepileptic drugs (carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, and valproate) and, whenever a dose dependency was identified, to compare the risks at different dose ranges. Logistic regression was used to make direct comparisons between treatments after adjustment for potential confounders and prognostic factors. Findings: Between June 20, 1999, and May 20, 2016, 7555 prospective pregnancies met the eligibility criteria. Of those eligible, 7355 pregnancies were exposed to one of the eight antiepileptic drugs for which the prevalence of major congenital malformations was 142 (10·3%) of 1381 pregnancies for valproate, 19 (6·5%) of 294 for phenobarbital, eight (6·4%) of 125 for phenytoin, 107 (5·5%) of 1957 for carbamazepine, six (3·9%) of 152 for topiramate, ten (3·0%) of 333 for oxcarbazepine, 74 (2·9%) of 2514 for lamotrigine, and 17 (2·8%) of 599 for levetiracetam. The prevalence of major congenital malformations increased with the dose at time of conception for carbamazepine (p=0·0140), lamotrigine (p=0·0145), phenobarbital (p=0·0390), and valproate (p<0·0001). After adjustment, multivariable analysis showed that the prevalence of major congenital malformations was significantly higher for all doses of carbamazepine and valproate as well as for phenobarbital at doses of more than 80 mg/day than for lamotrigine at doses of 325 mg/day or less. Valproate at doses of 650 mg/day or less was also associated with increased risk of major congenital malformations compared with levetiracetam at doses of 250-4000 mg/day (odds ratio [OR] 2·43, 95% CI 1·30-4·55; p=0·0069). Carbamazepine at doses of more than 700 mg/day was associated with increased risk of major congenital malformations compared with levetiracetam at doses of 250-4000 mg/day (OR 2·41, 95% CI 1·33-4·38; p=0·0055) and oxcarbazepine at doses of 75-4500 mg/day (2·37, 1·17-4·80; p=0·0169). Interpretation: Different antiepileptic drugs and dosages have different teratogenic risks. Risks of major congenital malformation associated with lamotrigine, levetiracetam, and oxcarbazepine were within the range reported in the literature for offspring unexposed to antiepileptic drugs. These findings facilitate rational selection of these drugs, taking into account comparative risks associated with treatment alternatives. Data for topiramate and phenytoin should be interpreted cautiously because of the small number of exposures in this study.
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Active Smoking is Associated with Lower Dialysis Adequacy in Prevalent Dialysis Patients
(Scientific Foundation Spiroski (publications), 2019-11-15)
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Mladenovska, Daniela
Dialysis adequacy measured by single pool Kt/V (spKt/V) lower than 1.2 or urea reduction rate (URR) lower than 65% is associated with a significant increase in patient mortality rate. Patients' adherence to the medical treatment is crucial to achieve recommended targets for spKt/V. Smoking is a recognized factor of non-adherence.
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Transition Towards Transradial Approach Improves Outcomes of Acute Myocardial Infarction PCI
(Macedonian Academy of Sciences and Arts/Walter de Gruyter GmbH, 2017-09-01)
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Antov, Slobodan
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Kalpak, Gjorgji
Introduction and aim: Transradial (TRA) instead of transfemoral (TFA) approach strategy has been presented in research literature as superior access strategy especially for acute ST elevation myocardial infarction (STEMI) primary percutaneous coronary intervention (PCI). There is a paucity of registry-based data of outcomes from default TRA strategy compared to TFA. Materials and methods: All-comers STEMI PCI institutional Registry identified 1808 consecutive patients in time-frame of 40 months from 2007 to 2010, without making any exclusions. Moreover, we applied Propensity Score Matching (PSM) to replace randomization, address the potential confounding and selection bias. PSM derived 565 congruent pairs of patients from the groups. Results: After 30 days the primary composite endpoint of major adverse cardiovascular events (MACE) was in favor of TRA 6.5% vs. 12.4% in TFA group, simultaneously secondary endpoints of death in TRA with rate of 4.8% and with rate of 10.1% in TFA. Moreover, the rate of major access related bleeding was 1.1% in TRA vs. 8.5% in TFA, in contrast the major non-access related bleeding was 1.8% and 2.4% respectively showed no significant difference. One year Kaplan Meier survival plots were in favor of TRA. Conclusions: Default transradial access strategy is associated with improved STEMI PCI outcomes.
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The no-reflow phenomenon in the young and in the elderly
(Elsevier BV, 2016-11-01)
Cenko, Edina
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Ricci, Beatrice
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Câlmâc, Lucian
Background The objectives of this study were to evaluate the incidence of no-reflow as independent predictor of adverse events and to assess whether baseline pre-procedural treatment options may affect clinical outcomes. Methods Data were derived from the ISACS-TC registry (NCT01218776) from October 2010 to January 2015. No-reflow was defined as post-PCI TIMI flow grades 0–1, in the absence of post-procedural significant (≥25%) residual stenosis, abrupt vessel closure, dissection, perforation, thrombus of the original target lesion, or epicardial spasm. The outcome measure was in-hospital mortality. Results No-reflow was identified in 128 of 5997 patients who have undergone PCI (2.1%). On multivariate analysis, patients with no-reflow were more likely to be older (OR: 1.20, 95% CI: 1.01–1.44), to have a history of hypercholesterolemia (OR: 1.95, 95% CI: 1.31–2.91) and to be admitted with a diagnosis of STEMI (OR: 2.96, 95% CI: 1.85–4.72). Angiographic characteristics associated with no-reflow phenomenon were: stenosis ≥50% of the right coronary artery, presence of multivessel disease and pre-procedural TIMI blood flow grades 0–1. No-reflow was highly predictive of in-hospital mortality (17.2% vs. 4.2%; adjusted OR: 4.60, 95% CI: 2.61–8.09). Administration of pre-procedural unfractioned heparin or 600mg clopidogrel loading dose was associated with less incidence of no-reflow (OR: 0.65, 95% CI: 0.43–0.99 and 0.61, 95% CI: 0.37–1.00, respectively). Aspirin, enoxaparin, and 300mg clopidogrel loading dose, did not significantly impact the occurrence of the no-reflow. Conclusions We found that pre-procedural administration of 600mg loading dose of clopidogrel and/or unfractioned heparin is associated with reduced incidence of no-reflow.
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Development and external validation of a post-discharge bleeding risk score in patients with acute coronary syndrome: The BleeMACS score
(Elsevier BV, 2018-03-01)
Raposeiras-Roubín, Sergio
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Faxén, Jonas
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Íñiguez-Romo, Andrés
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Henriques, Jose Paulo Simao
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D'Ascenzo, Fabrizio
Accurate 1-year bleeding risk estimation after hospital discharge for acute coronary syndrome (ACS) may help clinicians guide the type and duration of antithrombotic therapy. Currently there are no predictive models for this purpose. The aim of this study was to derive and validate a simple clinical tool for bedside risk estimation of 1-year post-discharge serious bleeding in ACS patients.
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Complete or incomplete coronary revascularisation in patients with myocardial infarction and multivessel disease: a propensity score analysis from the “real-life” BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry
(Europa Digital & Publishing, 2017-07)
Quadri, Giorgio
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D’Ascenzo, Fabrizio
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Moretti, Claudio
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D’Amico, Maurizio
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Raposeiras-Roubín, Sergio
Aims: The benefit of complete or incomplete percutaneous coronary intervention (PCI) in patients with myocardial infarction and multivessel disease remains debated. The aim of our study was to compare a complete vs. a “culprit only” revascularisation strategy in patients with myocardial infarction distinguishing the different clinical subsets (STEMI and NSTEMI) and to provide one-year clinical outcome from the “real-life” BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry. Methods and results: We conducted a multicentre study including all patients with myocardial infarction and multivessel coronary disease included in the BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry. They were divided into two groups, complete revascularisation (CR) and incomplete revascularisation (IR). The primary endpoint was the death rate at one-year follow-up. Secondary endpoints were in-hospital repeat myocardial infarction (re-AMI), in-hospital heart failure (HF), major adverse cardiovascular events (MACE) and myocardial infarction at one year. Four thousand five hundred and twenty patients were included in our analysis, with a diagnosis of STEMI in 67.7% and NSTEMI in 32.3%. CR was performed in 27.2% and 42.4%, respectively. At univariate analysis, in-hospital and one-year outcomes were similar between CR and IR in STEMI patients (all p-values >0.05). In NSTEMI patients, CR was associated with a lower one-year death rate (4.5% vs. 8.5%; p=0.002), re-AMI (3.7% vs. 6.6%; p=0.016) and MACE (8.1% vs. 13.9%; p=0.001). After propensity score matching, CR also reduced events in STEMI patients, including one-year mortality (5.3% vs. 13.8%; p<0.001), re-AMI (4.9% vs. 17.4%; p<0.001) and MACE (8.5% vs. 24.6%; p<0.001). Conclusions: This multicentre retrospective registry showed the benefit of CR in terms of reduction of one-year mortality in patients with myocardial reinfarction and multivessel coronary disease. Randomised controlled trials including functional evaluation of the lesions should be performed to confirm our results.

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