Management of Hyperlipidemia in Very High and Extreme Risk Patients in Croatia: an observational study of treatment patterns and lipid control.

Our observational study evaluated current management of elevated low-density lipoprotein cholesterol (LDL-C) in adult secondary prevention patients (all very high risk (VHR) by European guidelines) attending specialist clinics across Croatia. Data were collected retrospectively from patient records for the preceding 12 months. The subset judged to be at extreme risk (ER; American Association of Clinical Endocrinologists (AACE) criteria; n=48) were compared with the remaining patients (VHR group; n=41). All patients were receiving statins (75.6% VHR/81.3% ER at high-intensity), with only a minority receiving concomitant lipid-lowering treatment (7.3% VHR/16.7% ER). Median (Q1, Q3) LDL-C levels at the last visit were 1.9 (1.6, 2.4) mmol/L for VHR and 2.1 (1.5, 3.1) mmol/L for ER, with only 41.5% (95% CI 26.3-57.9) of VHR patients and 27.1% (15.3-41.9) of ER patients attaining their LDL-C targets (<1.8 mmol/L and <1.42 mmol/L, respectively). Thus, we found that a substantial proportion of VHR and ER secondary prevention patients being treated across Croatia had LDL-C levels exceeding the targets recommended in the European and newer AACE guidelines, but not all were receiving high-intensity statins. Identification of ER patients and their lipid patterns may help optimize usage of high-intensity statin treatment, alone or along with newer treatments, for better control of elevated LDL-C.

Comparison of clinical assessment and multifrequency bioimpedance analysis as methods of estimating volume status in peritoneal dialysis patients - A single-center experience
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INTRODUCTION: Clinical assessment (CA) is frequently used for the evaluation of volume status in peritoneal dialysis (PD) patients despite its subjectivity. Multiple-frequency bioelectrical impedance analysis (MF-BIA) is objective, accurate, and quick, proving to be a promising technique for measuring volume status. The aim of this study was to assess volume status in PD patients using CA and MF-BIA and to compare results. MATERIALS AND METHODS: Incident PD patients were prospectively analyzed between January 1, 2014, and January 1, 2016, at the Clinical Hospital Center of -Rijeka, Croatia. Volume status measurements were performed once a month for 6 consecutive months. The presence of symptoms and signs associated with hyper- or hypovolemia were detected by CA. Euvolemia was defined as a symptom-free state or up to 2 symptoms maximum. Patients lacking up to 1.2 L of volume or with up to 1.2 L in excess were considered euvolemic, as measured by MF-BIA. RESULTS: A total of 45 PD patients were analyzed; 51% were men, 27% were diabetic, the mean age was 52 ± 26 years, and PD duration was 11.5 ± 6.5 months. In comparison to MF-BIA, CA showed a significant difference in detected hypervolemia between baseline and follow-up (p = 0.708 vs. p = 0.01, respectively) and among all measurements (p < 0.01). Contrary to CA, volume status measured by MF-BIA correlated significantly with systolic and diastolic blood pressure (R = 0.29; p ≤ 0.01 and R = 0.26; p ≤ 0.01, respectively). CA showed low sensitivity (0.24) and high specificity (0.92) in detecting hypervolemia. CONCLUSION: MF-BIA is an effective, objective, and safe method for assessing volume status in PD patients. Longitudinal monitoring of body composition changes - including hydration state - leading to adequate therapeutic intervention is a promising and potential application of MF-BIA along with CA.

Cardiac manifestations in alcoholic liver disease.

Alcoholic liver disease is the most prevalent cause of progressive liver disease in Europe. Alcoholic cirrhosis occurs in 8%-20% of cases of alcoholic liver disease. It has significant influence on cardiovascular system and haemodynamics through increased heart rate, cardiac output, decreased systemic vascular resistance, arterial pressure and plasma volume expansion. Cirrhotic cardiomyopathy is characterised by systolic and diastolic dysfunction and electrophysiological abnormalities, if no other underlying cardiac disease is present. It is often unmasked only during pharmacological or physiological stress, when compensatory mechanisms of the heart become insufficient to maintain adequate cardiac output. Low-to-moderate intake of alcohol can be cardioprotective. However, heavy drinking is associated with an increased risk of cardiovascular diseases, such as alcoholic cardiomyopathy, arterial hypertension, atrial arrhythmias as well as haemorrhagic and ischaemic stroke. Alcoholic cardiomyopathy is characterised by dilated left ventricle (LV), increased LV mass, normal or reduced LV wall thickness and systolic dysfunction.

Nonalcoholic fatty liver disease (NAFLD) and cardiovascular risk in renal transplant recipients.

BACKGROUND/AIMS: Renal transplant recipients (RTRs) are at high risk for cardiovascular (CVD) mortality. Recently, nonalcoholic fatty liver disease (NAFLD) has been recognized as a new risk factor for adverse CVD events in the general population. We examined whether transient elastography (TE) defined NAFLD was associated with atherosclerosis in RTRs, as measured by ultrasound in the carotid arteries. METHODS: Carotid atherosclerosis was assesses in 71 RTRs with a TE proven NAFLD. With the help of TE liver stiffness was used to assess liver fibrosis and Controlled Attenuation Parameter (CAP) was used to detect and quantify liver steatosis. NAFLD was defined by the presence of steatosis with CAP values ≥238 dB.m(-1). RESULTS: RTRs with NAFLD showed more carotid atherosclerosis than RTRs without NAFLD. RTRs-NAFLD patients had the mean intima-media measurements (ITM) of 1.1±0.1 mm and that was statistically significant higher than the mean ITM founded in RTRs without NAFLD (1.1±0.1 vs. 0.9±0.1 mm; p<0.0001). Furthermore, RTRs-NAFLD patients had statistically significant higher prevalence of plaques in comparison with RTRs without NAFLD (p=0.021). CONCLUSION: We showed for the first time that carotid atherosclerosis is advanced in RTRs with NAFLD. Detection of NAFLD by TE should alert to the existence of an increased cardiovascular risk in RTRs.

Non-alcoholic fatty liver disease proven by transient elastography in hemodialysis patients: is it a new risk factor for adverse cardiovascular events?

BACKGROUND/AIMS: Cardiovascular diseases (CVD) are the leading cause of mortality in hemodialysis (HD) patients. Recently, non-alcoholic fatty liver disease (NAFLD) has been recognized as a new risk factor for adverse CVD events in the general population. Our aim was to analyze the incidence of NAFLD in HD patients by using transient elastography and to analyze whether the presence of NAFLD is associated with a higher CVD risk in HD patients. METHODS: The subjects were 72 HD patients and 50 sex- and age-matched controls. RESULTS: NAFLD was found in 52.8% of HD patients. HD patients with NAFLD showed more carotid atherosclerosis and more adverse CVD events than HD patients without NAFLD and control subjects. CONCLUSION: We showed for the first time that HD patients have a high prevalence of NAFLD. HD patients with NAFLD show an advanced carotid atherosclerosis. Detection of NAFLD by transient elastography should alert to the existence of an increased cardiovascular risk in HD patients.

Detection of myocardial ischemia in diabetic patients: the limitations of myocardial perfusion imaging.

In the study of 286 patients with suspected coronary artery disease and recent exercise single photon emission computed tomography (SPECT) test, we performed coronary angiography with coronary fractional flow reserve (FFR) measurement and tested the differences between diabetic (103) and non-diabetic (183) patients in ischemia detection by this two methods. The diabetic patients had a higher prevalence of hypertension, higher BMI and cholesterol levels, as well as longer duration of hospitalization than non-diabetic patients. There was no difference found between groups according to the exercise SPECT test, but, there were significantly more negative results in the non-diabetic group than in the diabetic group according to the FFR test, also, the percentage of stenosis was higher in diabetic patients. The concordance between the two methods was found, it was fair in diabetic patients (kappa = 0.25, 95% C.I. 0.06-0.45) and moderate in non-diabetic patients (kappa = 0.49, 95% C.I. 0.36-0.62).

The prevalence of overweight and obesity among Croatian hospitalized coronary heart disease patients.

The aim of this article was to investigate the prevalence of overweight and obesity using selected anthropometric variables in a sample of hospitalized coronary heart disease (CHD) patients in Croatia (N = 1,298). Prevalence of overweight and obesity in surveyed patient population was high: 48.2% of participants were overweight and 28.6% were obese according to their body mass index; measured through waist-to-hip ratio 54.5% of participants were centrally obese. These data on prevalences of overweight, obesity and central obesity show that although there are some reassuring trends, there is still considerable amount of work to be done if the prevalence of this cardiovascular risk factor is to be reduced further among Croatian CHD patients. While the prevalence of obesity seems to be on the decline, the prevalence of overweight is rising, which may be just an early warning sign of an incoming wave of obesity epidemic in future years.

[Volume assessment in the acute heart and renal failure]. / Odredivanje volumnog statusa u akutnom zatajivanju srca i bubrega.

Acute kidney injury (AKI) is an important clinical issue, especially in the setting of critical care. It has been shown in multiple studies to be a key independent risk factor for mortality, even after adjustment for demographics and severity of illness. There is wide agreement that a generally applicable classification system is required for AKI which helps to standardize estimation of severity of renal disfunction and to predict outcome associated with this condition. That's how RIFLE (Risk-Injury-Failure-Loss-End-stage renal disease), and AKIN (Acute Kidney Injury Network) classifications for AKI were found in 2004 and 2007, respectively. In the clinical setting of heart failure, a positive fluid balance (often expressed in the literature as weight gain) is used by disease management programs as a marker of heart failure decompensation. Oliguria is defined as urine output less than 0,3 ml/kg/h for at least 24 h. Since any delay in treatment can lead to a dangerous progression of the AKI, early recognition of oliguria appears to be crucial. Critically ill patients with oliguric AKI are at increased risk for fluid imbalance due to widespread systemic inflammation, reduced plasma oncotic pressure and increased capillary leak. These patients are particulary at risk of fluid overload and therefore restrictive strategy of fluid administration should be used. Objective, rapid and accurate volume assessment is important in undiagnosed patients presenting with critical illness, as errors may result in interventions with fatal outcomes. The historical tools such as physical exam, and chest radiography suffer from significant limitations. As gold standard, radioisolopic measurement of volume is impractical in the acute care enviroment. Newer technologies offer the promise of both rapid and accurate bedside estimation of volume status with the potential to improve clinical outcomes. Blood assessment with bioimpendance vector analysis, and bedside ultrasound seem to be promising technologies for this need.

Bone mineral densitometry in patients on hemodialysis: difference between genders and what to measure.

INTRODUCTION: Chronic kidney disease (CKD) and osteoporosis are important health problems. There is an interrelationship between osteoporosis and CKD. Bone densitometry is the "gold" standard in the diagnosis of osteoporosis. Unfortunately, there are some problems with the interpretation of bone densitometry in CKD patients. The goal of this study was to determine bone mineral density (BMD) in CKD patients, to assess the difference between genders and different sites of bone densitometry correlation between BMD and laboratory parameters, and to assess the most optimal measuring site. METHODS: We studied 134 hemodialysis (HD) patients (62 females, 72 males). The mean age was 56.4+/-12.4 years and the mean duration of HD was 54.4+/-60 months. BMD of the lumbar spine (posterior-anterior projection and lateral projection), hip (femoral neck, trochanter, intertrochanter, total femur, the Ward's Triangle), and forearm (ultradistal (UD), middistal (MID), distal third portion, and total forearm) was measured using dual X-ray absorptiometry (DXA) (Hologic Delphi apparatus). Values were expressed as BMD, T-score, and Z-score. RESULTS: Females had lower values of BMD in all measurement points. There were no significant differences in T- and Z-scores of forearm between males and females. Age was in a positive correlation with lumbar spine BMD in males and females. There was a negative correlation with neck and forearm BMD in both groups. Serum parathyroid hormone (PTH) was also in negative correlation with hip and forearm BMD in both groups. The best correlation of BMD in different sites was between forearm and neck. CONCLUSION: BMD data in CKD patients should be interpreted with caution and appendicular skeletal sites should be included in the evaluation.

Acute renal failure due to pericardial tamponade in a 60-year-old male patient.

Acute renal failure (ARF) is still a considerable factor in hospital morbidity and mortality. This clinical condition occurs in up to 25% of critically ill patients. Mortality in these patients varies widely depending on the cause. ARF in the context of a large pericardial effusion and pericardial tamponade has not often been reported. This paper presents a case of life-threatening pericardial tamponade and a consecutive rapid onset of ARF. Successful treatment with pericardiocentesis was performed, which was followed by restitution of renal function.

[Recommendations of Croatian societies on treatment of macrovascular and microvascular complications in patients with metabolic syndrome and diabetes type 2--treatment of residual risk]. / Preporuke Hrvatskih strucnih drustava o lijecenju makrovaskularnih i mikrovaskularnih komplikacija u bolesnika s metabolickim sindromom i secernom bolesti tipa 2--lijecenje preostalog kardiovaskularno [corrected] rizika.

Quite a number of studies have shown that despite achieving targets for total and LDL cholesterol, blood pressure and glycemia according to the guidelines, many patients remain at high residual risk for cardiovascular diseases (CVD), both macrovascular and microvascular. This is particularly true for patients with established CVD, type 2 diabetes, obesity and/or metabolic syndrome who have very often atherogenic dyslipidemia characterized by decreased plasma concentrations of HDL cholesterol and increased triglycerides. To address this issue a working group of experts has been established to produce this document in order to recommend therapeutic interventions for reducing this residual risk. This document has been endorsed by relevant Croatian scientific and professional societies (Croatian atherosclerosis socitey, Croatian hypertension society, Croatian cardiac society, Croatian diabetes society, Croatian endocrinology society, Croatian obesity society, Croatian internal medicine society and Croatian society for clinical pharmacology).

A simple prognostic model for assessing in-hospital mortality risk in patients with acutely decompensated heart failure.

Background An assessing of the in-hospital mortality risk for an emergency hospitalized patient with acutely decompensated heart failure (ADHF) is challenging task. Simple formula can help. Methods On the base of six indicators identified in derivation group, simple formula for assessing the risk for in-hospital mortality of ADHF patients was derived and later tested in validation group. Results The retrospective analysis of a derivation group (533 survivors, 121 deceased) identified six risk indicators: age, heart rate (HR), systolic blood pressure (SBP) and serum concentrations of urea, sodium (Na) and uric acid (UA). The final formula was created ([age/10]2 × HR/SBP)+(Urea-Na/10)+UA/100 and formula result of 53 was established as cut-off result. In the derivation group, at the cut-off point of 53, area under the ROC curve (AUC) was 0.741 (95% CI 0.701-0.776); with sensitivity 54% and specificity 83%. The discriminative capacity of the formula was significantly higher than each of its components. In the validation group of 591 patients (527 survived, 64 died) AUC was also 0.741 (95% CI 0.706-0.774), sensitivity was 66% and specificity 76%. Positive predictive value (PPV) of the developed formula was modest (34%), but negative predictive value (NPV) was 95%. N-terminal pro-B type natriuretic peptide and troponin I were determined, but not included into formula. Conclusions The developed formula enables simple, rapid and inexpensive risk assessment, but its disadvantage is a low PPV. However, a high NPV permits the identification of patients with a low risk of in-hospital mortality, which could lead to a more rational patient treatment.

The prevalence of supraventricular arrhythmias with regard to the type and degree of left ventricular hypertrophy in patients with hypertensive heart disease.

OBJECTIVES: We investigated the correlation between the type and degree of left ventricular hypertrophy and the prevalence of supraventricular arrhythmias in patients with hypertensive heart disease. METHODS: The study included 179 patients (79 men, 100 women, aged 43-80 years, median 68 years) with left ventricular hypertrophy. Patients were classified into three groups (concentric, eccentric and asymmetric types of hypertrophy) and into three subgroups (mild, moderate and severe hypertrophy). After discontinuation of all medication for 48 h, blood pressure was measured, electrocardiography and echocardiography performed and the prevalence of supraventricular arrhythmias assessed using Holter monitoring and bicycle ergometry. Antihypertensive drugs and duration of previous treatment were taken into consideration. RESULTS: Atrial fibrillation or paroxysmal supraventricular tachycardia were found in 43% of patients. The analysis showed no significant correlation between the prevalence of atrial fibrillation and/or paroxysmal supraventricular tachycardia and the degree (P = 0.607) and type of left ventricular hypertrophy (P = 0.455). However, the frequency of supraventricular premature beats was higher in the concentric and eccentric types than in the asymmetric type (P = 0.048) and increased with the degree of hypertrophy (significantly in men with the concentric type, P = 0.015). CONCLUSION: Concentric and eccentric types of left ventricular hypertrophy have a greater impact on the frequency of atrial arrhythmias. In the concentric type the prevalence of supraventricular premature beats correlates with the degree of left ventricular hypertrophy. Patients with moderate and severe concentric and eccentric left ventricular hypertrophy should be always tested using Holter monitoring and bicycle ergometry and treated with the maximum tolerable doses of antihypertensives, particularly with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers.

Influence of the type and degree of left ventricular hypertrophy on the prevalence of ventricular arrhythmias in patients with hypertensive heart disease.

PURPOSE: To investigate the correlation between the prevalence of ventricular arrhythmias (VA) and the type and degree of left ventricular hypertrophy (LVH) in hypertensive patients using exercise testing and Holter monitoring. PATIENTS AND METHODS: A total of 192 patients (87 men and 105 women) without coronary disease were divided into three groups according to type of LVH (concentric, eccentric, and asymmetric) and three subgroups in relation to the degree of hypertrophy (mild, moderate, and severe). In all subjects blood pressure was measured, electrocardiographic and echocardiographic data obtained and the prevalence of VA determined by Holter monitoring and bicycle ergometry. RESULTS: The most frequent LVH type was the concentric (63%), followed by eccentric (28%) and asymmetric (9%). Severe LVH was found in 10% of patients. Complex VA during Holter monitoring were identified in > 40% of patients. During the stress test this percentage increased by additional 7.4%. There was no statistically significant difference between groups in frequency of simple (p = 0.757) and complex (p = 0.657, p = 0.819, p = 0.617, for polytopic, pairs and ventricular tachycardia, respectively) VA. Increased prevalence of VA was found for the moderate and severe degree in all types. In the concentric type the difference was statistically significant for simple VA (p = 0.042). CONCLUSION: : There was no correlation between type of LVH and prevalence of VA. The severity of hypertrophy contributes more to a greater prevalence of VA than the LVH pattern. The combination of severe degree and concentric type carries the greatest cardiovascular risk.

Efficacy of healthy weight loss program in obesity treatment: Croatian experience.

We evaluated the efficiency of a six-month outpatient weight loss treatment program combining healthy diet, fat reduction, psychological counseling, exercise, and orlistat treatment, by measuring body weight and levels of cardiovascular risk factors in 476 subjects with BMI over 30 or 28 with increased blood pressure, cholesterol, and sugar at the baseline and at the end of program. After four weeks of adjustment to a mild low-calorie diet (1600 kcal/day) and counseling, subjects started receiving orlistat (120 mg TID). The mean weight loss after 6 months was 10.9%. Systolic pressure dropped by 6.7%, diastolic by 4.2%, fasting blood glucose by 10.1%, and total cholesterol by 9.8%. Only 9 subjects (7.8%) poorly tolerated the treatment. More men than women were able to maintain the achieved weight loss six months after the program (70.6% vs. 58.3%, respectively). The healthy weight loss program was an efficient approach to obesity treatment.

[Guidelines for diagnostics and treatment of arterial hypertension. Practical recommendations of the Croatian Working Group for Hypertension. Consideration on the ESH-ESC 2007 guidelines]. / Smjernice za dijagnosticiranje i lijecenje arterijske hipertenzije. Prakticne preporuke hrvatske radne skupine i osvrt na smjernice ESH/ESC 2007.

ESH/ECS guidelines for diagnostics and treatment of arterial hypertension 2007 is a basic paper for all physicians who treat hypertensive patients. Since publishing, this article has been the most cited medical paper. According to ESH/ECS guidelines some local peculiarities in each country should be considered when diagnosing and treating hypertensive patients. Practical recommendations of the Croatian working group for the diagnostics and treatment of hypertension are in agreement with ESH/ECS guidelines. However, few additional issues are added and further discussed in this paper (hypertensive crisis, treatment of hypertension in patients undergoing dialysis and in renal transplanted patients, role of family physicians, role of nurse). We believe that this paper will contribute better control of hypertension in Croatia. All medical societies and institutions that took part in writing this document, have to consider this paper as an official statement.

Prognostic factors for in-hospital mortality of patients hospitalized for acutely decompensated heart failure.

Objectives Despite improved treatment during last 20 years, prognosis for patients hospitalized for acutely decompensated heart failure (ADHF) is poor and mortality rates reported for these patients are high. Laboratory results can assist clinicians in evaluation and triaging of patients on hospital admission, and are important for the medical decision-making and prognosis assessments. Recently, new guidelines for the diagnosis and treatment of acute and chronic HF patients were published introducing a new group of patients with mid-range left ventricular ejection fraction (LVEF). Methods In order to explore the prognostic value for the in-hospital mortality of ADHF patients we analyzed laboratory test results for 165 emergency hospitalized patients regarding the survival and LVEF. Results In-hospital mortality was 16%. Patients who died were older than survivals (p = 0.003). There were no differences in LVEF between survivals and non-survivals. Patients who survived had significantly lower N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity cardiac troponin T (hs-cTnT), uric acid, urea, creatinine, and red blood cell distribution width (RDW) than patients who died (p < 0.001). All these tests had a good discrimination power between survivals and non-survivals (p < 0.001), but their incremental addition to NT-proBNP didn't improve its overall prognostic value. There was only a very weak correlation between NT-proBNP concentrations and LVEF. Groups with different LVEF status showed significant difference in number of erythrocytes, RDW and hemoglobin concentrations. Conclusions NT-proBNP had the best discriminatory power between survivals and non-survivals. Some routine laboratory test results, like RDW, uric acid, urea, and creatinine, have potentially significant value.

Comparison of survival between diabetic and non-diabetic patients on maintenance hemodialysis: a single-centre experience.

We analyzed survival rates of 144 prevalent patients on maintenance hemodialysis from 1998 to 2003 at the Department of Nephrology and Dialysis, Rijeka University Hospital, Rijeka, Croatia, and evaluated risk factors predicting their survival. Included were only end-stage renal disease (ESRD) patients on maintenance hemodialysis treatment dialysed more than 6 months before entering the study and who were clinically stable. The patients were randomised in two groups according to the presence or absence of diabetic nephropathy as the cause of ESRD and followed-up. The patient's death as outcome measure was recorded. The survival rates were estimated by the Kaplan-Meier method. The major causes of death were cardiovascular disease in 40 (60.6%) patients. An acute myocardial infarction in 15 (22.7%) patients was the major single cause of death. We found a significantly lower survival of diabetic patients than non-diabetic patients (P=0.0013). The most important predictors of death among diabetic patients on maintenance hemodialysis were hyperglycaemia (P<0.001), ischemic heart disease (P=0.004), hypercholesterolemia (P=0.013), and low delivered dialysis dose (P=0.013). The survival of diabetic patients undergoing hemodialysis was much worse than survival of non-diabetic patients. The cardiovascular disease remained the major cause of death in both groups. Early detection of pre-existing cardiovascular risk factors and diseases, and treatment of infections leading to sepsis, are of great importance, as they may influence the survival rates. Intensive management of diabetic patients is essential.

Predictive parameters of gestational diabetes mellitus.

Gestational diabetes mellitus is a carbohydrate intolerance recognized in pregnancy. The objective of this study was to determine the prevalence of gestational diabetes mellitus (GDM) of all deliveries at the University Hospital Rijeka, Croatia (34 997 deliveries over 10-year period) using 2-hour 75 g oral glucose tolerant test and to evaluate the impact of GDM on neonatal outcomes and mother's health. Gestational diabetes was diagnosed in 55 of 128 pregnant women with suspected glucose intolerance. Logistic regression analysis was used to examine the relationship between fasting plasma glucose, age, family history, body mass index, maternal weight gain, neonatal weight, neonatal head diameter and Apgar score in the gestational diabetes group and in the non-diabetes group. The results indicate that fasting plasma glucose greater than 7.0 mmol/L and maternal overweight are strong predictors for GDM and macrosomia. There was no difference in the mode of delivery, and vitality and metabolic complications among the infants of all analyzed mothers. We concluded that to prevent GDM as well as to reduce the rate of macrosomic infants good glycemic control should be initiated as soon as possible. The 2-hour 75 g OGTT is worth enough to evaluate GDM. Women should be counseled and encouraged to lose weight before or at the beginning of the conception period.

Drug-Coated Balloon Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention: A Feasibility Study.

BACKGROUND: Drug-eluting stents (DES) represent a significant evolution in the treatment of patients with acute myocardial infarction with ST elevation. However, stent-related adverse events have led to an introduction of drug-coated balloons (DCB) applied particularly to bifurcation lesions, in-stent restenosis and small vessel disease. The aim of this study was to determine whether a DCB-only strategy has a similar safety profile and equal angiographic and clinical outcomes to DES implantation in primary percutaneous coronary intervention (pPCI). MATERIALS AND METHODS: Seventy-five patients with acute myocardial infarction with ST elevation were randomized into DES and DCB groups of 37 and 38 patients, respectively. The study end-points were major adverse cardiac events and late lumen loss during the 6 months following the pPCI. RESULTS: Reinfarction occurred in 5.4% of patients in the DES and 5.3% of patients in the DCB group after 1 month (risk ratio = 1.03, 95% CI [0.15-6.91], P = 0.98). After 6 months, major adverse cardiac events were reported in 5.4% of patients in the DES group and none in the DCB group (risk ratio = 5.13, 95% CI [0.25-103.42], P = 0.29). Late lumen loss in the DES group was 0.10 ± 0.19mm and -0.09 ± 0.09mm in the DCB group (P < 0.05). CONCLUSIONS: A DCB-only strategy is safe and feasible in the pPCI setting and showed good clinical and angiographic outcomes in a 6-month follow-up period.