Randomized controlled trial of remote ischaemic conditioning in ST-elevation myocardial infarction as adjuvant to primary angioplasty (RIC-STEMI).

To test whether remote ischaemic conditioning (RIC) as adjuvant to standard of care (SOC) would prevent progression towards heart failure (HF) after ST-elevation myocardial infarction (STEMI). Single-centre parallel 1:1 randomized trial (computerized block-randomization, concealed allocation) to assess superiority of RIC (3 cycles of intermittent 5 min lower limb ischaemia) over SOC in consecutive STEMI patients (NCT02313961, clinical trials.gov). From 258 patients randomized to RIC or SOC, 9 and 4% were excluded because of unconfirmed diagnosis and previously unrecognized exclusion criteria, respectively. Combined primary outcome of cardiac mortality and hospitalization for HF was reduced in RIC compared with SOC (n = 231 and 217, respectively; HR = 0.35, 95% CI 0.15-0.78) as well as each outcome in isolation. No difference was found in serum troponin I levels between groups. Median and maximum follow-up time were 2.1 and 3.7 years, respectively. In-hospital HF (RR = 0.68, 95% CI 0.47-0.98), need for diuretics (RR = 0.68, 95% CI 0.48-0.97) and inotropes and/or intra-aortic balloon pump (RR = 0.17, 95% CI 0.04-0.76) were decreased in RIC. On planned 12 months follow-up echocardiography (n = 193 and 173 in RIC and SOC, respectively) ejection fraction (EF) recovery was enhanced in patients presenting with impaired left ventricular (LV) function (10% absolute difference in median EF compared with SOC; P < 0.001). In addition to previously reported improved myocardial salvage index and reduced infarct size RIC was shown beneficial in a combined hard clinical endpoint of cardiac mortality and hospitalization for HF. Improved EF recovery was also documented in patients with impaired LV function.

Proton pump inhibitors in patients treated with aspirin and clopidogrel after acute coronary syndrome.

INTRODUCTION: Clopidogrel is an antiplatelet agent converted to its active metabolite by cytochrome P-450 isoenzymes. Numerous drugs are known to inhibit P-450 isoenzymes, including proton pump inhibitors (PPIs), which are often associated with aspirin and clopidogrel to prevent adverse gastrointestinal effects. In vitro studies first showed that PPIs reduced the antiplatelet effect of clopidogrel, while recent clinical studies have raised concerns that the addition of a PPI to clopidogrel in acute coronary syndrome (ACS) patients could actually increase the risk of recurrent cardiovascular events. OBJECTIVE: The aim of this study was to evaluate whether the prescription of a PPI conferred a worse prognosis in patients discharged with aspirin and clopidogrel treatment after ACS. METHODS: A total of 876 patients admitted with ACS and discharged with aspirin and clopidogrel, with a planned duration of at least six months, from January 2004 to March 2008, were reviewed. Patients were classified in two groups according to whether or not a PPI was prescribed at discharge. The PPIs considered were those mainly metabolized by cytochrome P-450 2C19. We excluded patients with insufficient information available on either prescription or clinical records that could allow clearly confirm or exclude exposure to a PPI. Primary end points were six-month all-cause mortality and the composite of death, myocardial infarction and unstable angina at six months. RESULTS: Of the 802 patients considered for further analysis, 274 (34.2%) individuals were medicated with a PPI in addition to dual antiplatelet therapy. Patients taking PPIs were older, more often had renal insufficiency and less often had a history of coronary revascularization and smoking. They more often presented with Killip class >I and lower hemoglobin concentration on admission. There were no significant differences between the two groups in terms of medical treatment (during hospital stay and at discharge) or invasive procedures. By multivariate analysis, independent and positive predictors of PPI prescription were older age and lower hemoglobin concentration on admission. Patients taking PPIs had a slightly higher prevalence of six-month mortality (6.5% vs. 3.9%) and of the composite end point (12.9% vs. 9.2%), although without statistical significance. By multivariate analysis including potential confounding variables, the prescription of a PPI on top of aspirin and clopidogrel was still n ot associated with a worse prognosis. CONCLUSIONS: In the present study, PPI precription in addition to aspirin and clopidogrel after ACS was not associated with a worse six-month prognosis.

Predictors of pre-hospital delay in patients with ST-segment elevation myocardial infarction.

BACKGROUND: Early reperfusion therapy in ST-elevation myocardial infarction (STEMI) correlates with its success. The aim of our study was to characterize patients admitted with a diagnosis of STEMI with longer prehospital delay and to analyze its impact on the choice of treatment and on in-hospital prognosis. METHODS: We performed a retrospective cohort study of 797 patients consecutively admitted with a diagnosis of STEMI from January 2002 to December 2007. The cutoff for longer pre-hospital delay was defined as three hours. We analyzed demographic, clinical and echocardiographic data and determined the predictors of pre-hospital delay of > or = 3 h. RESULTS: Of the 797 patients, 77% were male and mean age was 62 +/- 13.64 years. Patients with longer pre-hospital delay were older (p < 0.001), with a higher proportion of female (p = 0.001), hypertensive (p = 0.002), diabetic (p < 0.001), and surgically revascularized patients (p = 0.007), and those with symptom onset between 10 pm and 8 am (p = 0.001). The group with shorter pre-hospital delay included more men (p = 0.001), patients with prior myocardial infarction (p = 0.025) and smokers (p = 0.009). Independent predictors of pre-hospital delay of 3 h included female gender (odds ratio [OR] 1.5, 95% confidence interval [CI] 1.03-2.16), diabetes (OR 1.78, 95% CI 1.23-2.56), systemic arterial hypertension (OR 1.41, 95% CI 1.04-1.93), and symptom onset between 10 pm and 8 am (OR 1.76, 95% CI 1.31-2.38). Independent predictors of pre-hospital delay of > or = 3 h included male gender (OR 0.67, 95% CI 0.46-0.97) and prior myocardial infarction (OR 0.48, 95% CI 0.27-0.84). Reperfusion therapy was performed in 72%, 52% and 12% of patients with pre-hospital delay of <3 h, 3-12 h and >12 h, respectively (p for trend <0.001). Patients with longer delay more often had severely reduced left ventricular ejection fraction (LVEF) (p = 0.004). A non-significant trend was observed towards increased in-hospital mortality with longer delay (8.3% vs. 6.6%, p for trend = 0.342). CONCLUSIONS: A significant proportion of patients continue to have long pre-hospital delay. Female patients and those with diabetes, systemic arterial hypertension and symptom onset between 10 pm and 8 am made up the majority of this group. Longer pre-hospital delay was associated with a lower probability of being treated with reperfusion therapy, a higher frequency of severely depressed LVEF and a non-significant increase in in-hospital mortality. It is essential to develop mechanisms to reduce pre-hospital delay.

Association between red blood cell distribution width and outcomes at six months in patients with acute coronary syndromes.

BACKGROUND: Higher values of red ceildistribution width (RDW) may be associated with adverse outcomes in patients with heart failure and in those with stable coronary artery disease. We assessed the hypothesis that higher RDW values are associated with adverse cardiovascular outcomes in patients with acute coronary syndromes (ACS). METHODS: We studied 1796 patients with ACS admitted to a coronary care unit. We analyzed clinical and laboratory characteristics, management, and outcomes of patients according to tertiles of baseline RDW. The primary outcome was death or myocardial infarction (MI) during six-month follow-up. RESULTS: Patients with higher RDW values tended to be older, were more likely to be female and have a history of MI, and more often had renal dysfunction, anemia, and Killip class >I on admission (p < 0.05). Higher RDW values were associated with increased 6-month mortality (tertile 1: 8.2%; tertile 2: 10.9%; tertile 3: 15.5%; p = 0.001 for trend) and increased 6-month death/MI rates (tertile 1, 13.0%; tertile 2, 17.2%; tertile 3, 22.9%; p < 0.0001 for trend). An association between higher RDW and increased 6-month death/MI rates was found in patients with non-ST-elevation ACS (10.5% vs. 15.3% vs. 22.7%; p < 0.001 for trend), with a tendency in patients admitted with ST-elevation MI (15.1% vs. 19.1% vs. 23.1%; p = 0.053 for trend). After adjustment for baseline characteristics and treatment, higher RDW values remained independently associated with the study's primary composite outcome but not with all-cause death. Using the first tertile of RDW as reference, the adjusted odds ratio (OR) for 6-month death/MI among patients in the highest RDW tertile was 1.43 (95% confidence interval [CI], 1.00-2.05; p = 0.049). Using RDW as a continuous variable, the adjusted OR for 6-month death/MI was 1.16 (95% CI, 1.03-1.30; p = 0.017) per 1% increase in RDW. CONCLUSIONS: RDW is an easily determined predictor of outcome after ACS. We found a graded independent association between higher RDW values and adverse outcomes in patients with ACS.

Prognostic impact of hemoglobin drop during hospital stay in patients with acute coronary syndromes.

INTRODUCTION: Bleeding is currently the most common non-cardiac complication of therapy in patients with acute coronary syndromes (ACS), and may itself be associated with adverse outcomes. The aim of this study was to determine the effect of hemoglobin drop during hospital stay on outcome among patients with ACS. METHODS: Using Cox proportional-hazards modeling, we examined the association between hemoglobin drop and death or myocardial infarction (MI) at 6 months in 1172 patients admitted with ACS to an intensive cardiac care unit. Patients were stratified according to quartiles of hemoglobin drop: Q1, < or = 0.8 g/dL; Q2, 0.9-1.5 g/dL; Q3, 1.6-2.3 g/dL; Q4, > or = 2.4 g/dL. We also identified independent predictors of increased hemoglobin drop (> or =2.4 g/dL) using multivariate logistic regression analysis. RESULTS: Median nadir hemoglobin concentration was 1.5 g/dL lower (IQR 0.8-2.3) compared with baseline hemoglobin (p < 0.0001). Independent predictors of increased hemoglobin drop included older Sage, renal dysfunction, lower weight, and use of thrombolytic therapy, glycoprotein IIb/IIIa inhibitors, nitrates, and percutaneous coronary intervention. Higher levels of hemoglobin drop were associated with increased rates of 6-month mortality (8.0% vs. 9.4% vs. 9.6% vs. 15.7%; p for trend = 0.014) and 6-month death/ MI (12.4% vs. 17.0% vs. 17.2% vs. 22.1%; p for trend = 0.021). Using Q1 as reference group, the adjusted hazard ratio (HR) for 6-month mortality and 6-month death/MI among patients in the highest quartile of hemoglobin drop was 1.83 (95% confidence interval [CI] 1.08-3.11; p = 0.026) and 1.60 (95% CI 1.04-2.44; p = 0.031) respectively. Considered as a continuous variable, the adjusted HR for 6-month mortality was 1.16 (95% CI 1.01-1.32; p = 0.030) per 1 g/dL increase in hemoglobin drop. CONCLUSIONS: A decrease in hemoglobin frequently occurs during hospitalization for ACS and is independently associated with adverse outcomes.

Smoking in acute coronary syndromes--the "smoker's paradox" revisited.

INTRODUCTION: Although a well-known risk factor for coronary disease, smoking has long been associated with lower short-term mortality in acute coronary syndromes (ACS). There are few recent works on Portuguese populations examining all aspects of smoking in ACS, particularly the interaction between smoking and other risk factors, and the management and prognosis of patients according to smoking status. OBJECTIVE: We sought to examine clinical characteristics, presentation, in-hospital treatment, angiographic features and prognosis of patients with and without smoking history admitted with ACS. METHODS: A total of 1228 patients consecutively admitted with ACS from January 2004 to March 2007 were analyzed. Patients were classified into two groups, those with present or past smoking habits (n=450) making up Group I and those without smoking habits (n=778), Group II. The main outcome analyzed was overall mortality during hospital stay and at 6 months. RESULTS: Smokers and former smokers were younger and more frequently male (odds ratio [OR] = 22.46; 95% confidence interval [CI]: 12.94-38.96), and less often had diabetes (OR = 0.41; 95% CI: 0.30-0.54), hypertension (OR = 0.31; 95% CI: 0.24-0.39) and renal insufficiency (OR = 0.26; 95% CI: 0.18-0.36). Patients with smoking habits more frequently presented with ST elevation (OR = 1.32; 95% CI: 1.04-1.67), more often received evidence-based medical therapy, namely beta blockers (during hospital stay, OR = 2.42; 95% CI: 1.63-3.56 and at discharge, OR = 1.45; 95% CI: 1.03-2.1) and statins (at discharge, OR = 2.48; 95% CI: 1.2-6.1), and more frequently underwent coronary angiography (OR = 2.15; 95% CI: 1.63-2.84). Although smokers and former smokers had lower in-hospital mortality on univariate analysis (OR = 0.54; 95% CI: 0.31-0.96), this association was not confirmed on multivariate analysis, with adjustment for known short-term mortality predictors (OR = 1.25; 95% CI: 0.61-2.54). Similarly, multivariate analysis failed to confirm lower 6-month mortality for smokers and former smokers (OR = 2.0; 95% CI: 1.17-3.41). CONCLUSIONS: Clinical characteristics and management options differed between ACS patients with and without smoking habits. These differences explained the lower shortterm mortality initially observed between the two groups. In our population of patients admitted with ACS, we did not find a real "smoker's paradox".

Non-ST elevation acute coronary syndrome: QRS duration and long-term prognosis.

BACKGROUND: Recent studies have demonstrated that QRS duration (QRSd) is associated with poor prognosis in heart failure and ST-elevation myocardial infarction. Less is known about the prognostic importance of QRSd in patients with non-ST elevation acute coronary syndrome (non-ST ACS). AIM: To determine if admission QRSd is associated with 1-year mortality in non-ST ACS. METHODS: We studied 539 patients (aged 65.52 +/- 12.47 years, 69.9% male) admitted to the coronary unit with non-ST ACS. QRSd was measured on the admission electrocardiogram. RESULTS: Mean QRSd was 94.29 +/- 18.3 ms. One-year mortality was 13.4%. QRSd showed a good correlation with 1-year mortality and its best cut-off was 92 ms. Patients with QRSd > or = 92 ms were older, more frequently male and with prior history of coronary heart disease. On admission they presented more often in Killip class > 1, and had a higher incidence of heart failure and left ventricular systolic dysfunction. They less often underwent coronary angiography. One-year mortality was higher in patients with QRSd > or = 92 ms. After adjusting for baseline characteristics and treatment, QRSd > or = 92 ms remained an independent predictor of 1-year mortality (adjusted OR=3.87; 95% CI 1.74-8.44). CONCLUSION: In this non-ST ACS population, QRSd was an independent predictor of 1-year mortality after the event.

Impact of atrial fibrillation in acute coronary syndromes.

INTRODUCTION: Atrial fibrillation (AF) is a relatively common arrhythmia in the context of acute coronary syndromes (ACS). However, the impact of AF on these patients' survival is not well established. The present study aimed to estimate the prevalence of AF in ACS patients and to evaluate its impact on in-hospital and six-month post-event mortality, from any cause. METHODS: This was a retrospective cohort study that included 1183 patients admitted consecutively to a Coronary Care Unit with ACS. Demographic and clinical data and information from various complementary exams were collected and occurrence of AF during the first 48 hours of hospitalization was analyzed. Six-month follow-up was achieved in 95.9% of the patients. Logistic regression statistical analysis was used to identify independent predictors of in-hospital and six-month post-event mortality. RESULTS: AF was diagnosed in 140 patients (11.8%); these patients were older (73.89 +/- 8.69 vs. 63.20 +/- 12.73 years; p<0.0001) and less likely to be male (60.0% vs. 74.1%; p=0.001), and had a lower prevalence of dyslipidemia (32.9% vs. 44.1%; p=0.001) and smoking (10.0% vs. 25.9%; p<0.0001). Fewer patients with AF underwent reperfusion therapy (19.3% vs. 29.7%; p=0.006), beta-blocker therapy (72.1% vs. 85.7%; p<0.0001), and cardiac catheterization (48.2% vs. 62.9%; p=0.001) or percutaneous coronary intervention (14.3% vs. 23.4%; p=0.01). These patients more frequently developed heart failure (54.3% vs. 28.5%; p<0.0001) and more often presented left ventricular dysfunction (69.3% vs. 57.2%; p=0.002). In patients presenting AF, there were significant increases in in-hospital (12.1% vs. 4.2%; p<0.0001) and six-month mortality (27.2% vs. 8.2%. p<0.0001). In multivariate analysis, AF remained an independent marker of in-hospital (OR 1.95; 95% CI 1.03-3.69; p=0.03) and six-month mortality (OR 2.89; 95% CI 1.67-5.00; p=0.0001), as was age >75 years, severe left ventricular dysfunction and heart failure. The performance of coronary angiography correlated with improved prognosis. CONCLUSIONS: AF in the context of ACS is an independent predictor of increased in-hospital and six-month mortality. These findings should be taken into consideration in the management and treatment of such patients.

Prognostic impact of moderate renal dysfunction in acute coronary syndromes.

INTRODUCTION: End-stage renal disease is associated with high cardiovascular mortality. The prognostic importance of milder degrees of renal impairment in patients who have had an acute coronary syndrome (ACS) is less well defined. The purpose of this study was to evaluate the impact of baseline renal dysfunction assessed by estimated glomerular filtration rate (GFR) on mortality in patients admitted with an ACS. METHODS: We studied all patients with an ACS consecutively admitted to an Intensive Cardiac Care Unit over 18 months. The GFR was estimated by means of the four-component Modification of Diet in Renal Disease study equation. Patients were grouped according to their estimated GFR (less than 45.0; 45.0 to 59.9; 60.0 to 74.9; and at least 75.0 ml/min/1.73 m2). Primary outcome was death from any cause. RESULTS: The mean age of the 589 study patients was 64.1 years, 73.7% were male, and 49.2% had an ACS with ST-segment elevation. Arterial hypertension, diabetes mellitus, prior myocardial infarction, and Killip class > I were incrementally more common across increasing renal dysfunction strata (p < 0.01). The use of reperfusion therapy, beta-blockers, and coronary angioplasty was lower in groups with reduced estimated GFR (p < 0.001). Overall six-month mortality was 13.6%. Using the group with an estimated GFR of at least 75.0 ml/min/1.73 m2 as the reference group yielded odds ratios for six-month mortality that increased with the degree of renal impairment. After adjusting for baseline characteristics, impaired renal funtion remained associated with increased mortality. The multivariable-adjusted odds ratio for six-month mortality in patients with mild renal impairment (GFR 60.0 to 74.9 ml/min/1.73 m2) was 2.71 (95% confidence interval [CI] 1.09 to 6.69), compared with 7.53 (95% CI, 3.21 to 17.71) and 8.10 (95% CI, 3.18 to 20.60) in patients with moderate and more severe renal dysfunction, respectively. CONCLUSIONS: Baseline renal dysfunction, as assessed by estimated GFR, is a potent and easily identifiable determinant of outcome after an ACS. Even mild levels of renal impairment are independently associated with increased mortality after an ACS.

Heart failure after acute coronary syndrome: identify to treat better!

INTRODUCTION: The development of heart failure (HF) following acute coronary syndromes (ACS) significantly worsens short- and long-term prognosis. The present study aimed to identify clinical characteristics, detectable at admission for ACS, that could predict HF development during hospitalization, and to evaluate its impact on in-hospital mortality. METHODS: This was a retrospective cohort study that included 601 patients consecutively admitted with ACS. Demographic, clinical and laboratory data at admission were collected and HF was defined as maximum Killip class II or III. Logistic regression analysis was performed to identify independent predictors of HF and, additionally, in-hospital death. RESULTS: 29.3% of the population developed HF, mostly older patients (69.52+/-11.9 years vs. 61.81+/-12.4 years, p<0.0001), women, hypertensive, diabetic and non-smokers. On admission, this subgroup of patients presented with higher heart rate and glycemia, and lower glomerular filtration rate (eGFR) and hemoglobin. The percentage of patients with left ventricular systolic dysfunction (LVSD) was significantly higher in the group of patients with HF (74.4% versus 48.7%, p<0.0001); however, no significant differences were found in the type of ACS or its location. In the present study, we found that patients with HF were stratified less invasively (less likely to undergo cardiac catheterization or percutaneous coronary intervention). The development of HF was associated with longer hospitalization and higher in-hospital mortality (7.4% versus 2.1%, p=0.004) on univariate analysis, but not on multivariate analysis. On multivariate analysis, only age (OR=1.04; 95% CI 1.02-1.06), diabetes mellitus (OR=1.77; 95% CI 1.05-2.96), glycemia (OR=1.05; 95% CI 1.01-1.08), eGFR <60 ml/min/1.73m2 (OR=2.90, 95% CI 1.73- 4.84), heart rate (OR=1.03, 95% CI 1.02-1.04) and LVSD (OR=2.48, 95% CI 1.59-3.85) were independent predictors of HF. CONCLUSIONS: HF is a frequent complication in ACS and is associated with higher in-hospital mortality. Identifying risk of HF development on admission, through easily acquired clinical characteristics (older age, diabetes and/or elevated glycemia, renal failure and higher heart rate), will certainly influence immediate therapeutic choices and permit an individualized approach to each patient.

Admission glycemia: a predictor of death after acute coronary syndrome in non-diabetic patients?

BACKGROUND: Previous studies have demonstrated that acute phase hyperglycemia is associated with increased in-hospital mortality in diabetic patients admitted with acute coronary syndrome (ACS), but this has not been clearly demonstrated in non-diabetic patients. The present study was designed to determine whether admission hyperglycemia (AG) is an independent predictor of in-hospital and six-month mortality after ACS in non-diabetic patients. METHODS: This was a retrospective cohort study of 426 non-diabetic patients consecutively admitted with ACS. The patients were stratified into quartile groups according to AG, which was also analyzed as a continuous variable. Vital status was obtained at six-month follow-up in 96.8% of the patients surviving hospitalization. Logistic regression analysis was used to identify independent predictors of in-hospital and six-month death. RESULTS: Of the 426 patients included in the study (age 62.6 years+/-13.1, 77% male), 22 (5.4%) patients died during hospitalization and 20 (5.2% of the patients surviving hospitalization) within six months of ACS. Mean AG was 134.89 mg/dl+/-51.95. The higher the AG, the more probable was presentation with ST-segment elevation ACS (STEMI), anterior STEMI, higher heart rate, Killip class higher than one (KK >1), higher serum creatinine and greater risk of in-hospital and six-month death. In multivariate analysis, only age (OR=1.10; 95% CI 1.04-1.17), STEMI (OR=3.02; 95% CI 1.07-8.50), AG (OR=1.073; 95% CI 1.004-1.146), serum creatinine (OR=1.10; 95% CI 1.009-1.204) and KK >1 on admission (OR=4.65; 95% CI 1.59-13.52) were independently associated with in-hospital death. Age (OR=1.07; 95% CI 1.03-1.12), serum creatinine (OR=1.09; 95% CI 1.01-1.18) and in-hospital development of heart failure (OR=2.34; 95% CI 1.07-5.10) were independently associated with higher risk of death within six months of ACS. CONCLUSIONS: AG is an independent predictive factor of in-hospital death after ACS in non-diabetic patients. Although it did not show an independent association with higher risk of six-month death, AG appears to contribute to it, since the risk is greater the higher the AG. Its predictive value may have been blunted by the insufficient power of the sample and/or by the time interval between acquisition of AG and the evaluated endpoint.

Remote ischemic conditioning in ST-elevation myocardial infarction as adjuvant to primary angioplasty (RIC-STEMI): study protocol for a randomized controlled trial.

BACKGROUND: ST-elevation myocardial infarction (STEMI) accounts for nearly one third of acute coronary syndromes. Despite improved STEMI patient care, mortality remains high, contributing significantly to the ischemic heart disease burden. This may partly be related to ischemia-reperfusion injury (IRI). Remote ischemic conditioning (RIC), through short cycles of ischemia-reperfusion applied to a limb, has been shown to reduce IRI in various clinical settings. Our primary hypothesis is that RIC will reduce adverse events related to STEMI when applied as adjunctive therapy to primary percutaneous coronary intervention (PCI). METHODS/DESIGN: "Remote ischemic conditioning in ST-elevation myocardial infarction as adjuvant to primary angioplasty" (RIC-STEMI) is an ongoing prospective, single-center, open-label, randomized controlled trial to assess whether RIC as an adjunctive therapy during primary PCI in patients presenting with STEMI can improve clinical outcomes. After enrollment, participants are randomized according to a computer-generated randomization schedule, in a ratio of 1:1 to RIC or no intervention, in blocks of four individuals. RIC is begun at least 10 min before the estimated time of the first balloon inflation and its duration is 30 min. Ischemia is induced by three cycles of inflation of a blood pressure cuff placed on the left lower limb to 200 mmHg and then deflation to 0 mmHg for another 5 min. Primary endpoint is a combined endpoint of death from cardiac cause or hospitalization for heart failure (HF) on follow-up (including device implantation: implantable cardioverter defibrillator, cardiac resynchronization and left ventricular assist device). Secondary endpoints are myocardial infarction (MI) size (estimated by the 48 h area under the curve of serum troponin I levels), development of Q-wave MI, left ventricular function (assessed by echocardiography within the first 3 days after admission), contrast-induced nephropathy, in-hospital mortality, all-cause mortality and, finally, major adverse cardiovascular events. Patients will have a minimum follow-up period of 12 months. From 11 March 2013 to 31 December 2014, 324 patients have been enrolled and randomized. We expect to complete enrollment of the 494 patients deemed necessary within 3 years. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02313961; registered on 8 December 2014.