Outcomes of patients with myocardial infarction and cardiogenic shock treated with culprit vessel-only versus multivessel primary PCI.

INTRODUCTION AND OBJECTIVES: Multivessel primary percutaneous coronary intervention (pPCI) is still often used in patients with ST-elevation myocardial infarction (STEMI) and cardiogenic shock (CS). The study aimed to compare the characteristics and prognosis of patients with CS-STEMI and multivessel coronary disease (MVD) treated with culprit vessel-only pPCI or multivessel-pPCI during the initial procedure. MATERIAL AND METHODS: From 2016 to 2020, 23,703 primary PCI patients with STEMI were included in a national all-comers registry of cardiovascular interventions. Of them, 1,213 (5.1%) patients had CS and MVD at admission to the hospital. Initially, 921 (75.9%) patients were treated with culprit vessel (CV)-pPCI and 292 (24.1%) with multivessel (MV)-pPCI. RESULTS: Patients with 3-vessel disease and left main disease had a higher probability of being treated with MV-pPCI than patients with 2-vessel disease and patients without left main disease (28.5% vs. 18.6%; p < 0.001 and 37.7% vs. 20.6%; p < 0.001). Intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), and other mechanical circulatory support systems were more often used in patients with MV-pPCI. Thirty (30)-day and 1-year all-cause mortality rates were similar in the CV-pPCI and MV-pPCI groups (odds ratio, 1.01; 95% confidence interval [CI] 0.77 to 1.32; p = 0.937 and 1.1; 95% CI 0.84 to 1.44; p = 0.477). The presence of 3-vessel disease and the use of ECMO were the strongest adjusted predictors of 30-day and 1-year mortality. CONCLUSIONS: Our data from an extensive all-comers registry suggests that selective use of MV-pPCI does not increase the all-cause mortality rate in patients with CS-STEMI and MVD compared to CV-pPCI.

Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial.

BACKGROUND: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly being used for circulatory support in patients with cardiogenic shock, although the evidence supporting its use in this context remains insufficient. The ECMO-CS trial (Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock) aimed to compare immediate implementation of VA-ECMO versus an initially conservative therapy (allowing downstream use of VA-ECMO) in patients with rapidly deteriorating or severe cardiogenic shock. METHODS: This multicenter, randomized, investigator-initiated, academic clinical trial included patients with either rapidly deteriorating or severe cardiogenic shock. Patients were randomly assigned to immediate VA-ECMO or no immediate VA-ECMO. Other diagnostic and therapeutic procedures were performed as per current standards of care. In the early conservative group, VA-ECMO could be used downstream in case of worsening hemodynamic status. The primary end point was the composite of death from any cause, resuscitated circulatory arrest, and implementation of another mechanical circulatory support device at 30 days. RESULTS: A total of 122 patients were randomized; after excluding 5 patients because of the absence of informed consent, 117 subjects were included in the analysis, of whom 58 were randomized to immediate VA-ECMO and 59 to no immediate VA-ECMO. The composite primary end point occurred in 37 (63.8%) and 42 (71.2%) patients in the immediate VA-ECMO and the no early VA-ECMO groups, respectively (hazard ratio, 0.72 [95% CI, 0.46-1.12]; P=0.21). VA-ECMO was used in 23 (39%) of no early VA-ECMO patients. The 30-day incidence of resuscitated cardiac arrest (10.3.% versus 13.6%; risk difference, -3.2 [95% CI, -15.0 to 8.5]), all-cause mortality (50.0% versus 47.5%; risk difference, 2.5 [95% CI, -15.6 to 20.7]), serious adverse events (60.3% versus 61.0%; risk difference, -0.7 [95% CI, -18.4 to 17.0]), sepsis, pneumonia, stroke, leg ischemia, and bleeding was not statistically different between the immediate VA-ECMO and the no immediate VA-ECMO groups. CONCLUSIONS: Immediate implementation of VA-ECMO in patients with rapidly deteriorating or severe cardiogenic shock did not improve clinical outcomes compared with an early conservative strategy that permitted downstream use of VA-ECMO in case of worsening hemodynamic status. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02301819.

Trends in outcomes of women with myocardial infarction undergoing primary angioplasty-Analysis of randomized trials.

Background: Sex- and gender-associated differences determine the disease response to treatment. Aim: The study aimed to explore the hypothesis that progress in the management of STE-myocardial infarction (STEMI) overcomes the worse outcome in women. Methods and results: We performed an analysis of three randomized trials enrolling patients treated with primary PCI more than 10 years apart. PRAGUE-1,-2 validated the preference of transport for primary PCI over on-site fibrinolysis. PRAGUE-18 enrollment was ongoing at the time of the functional network of 24/7PCI centers, and the intervention was supported by intensive antiplatelets. The proportion of patients with an initial Killip ≥ 3 was substantially higher in the more recent study (0.6 vs. 6.7%, p = 0.004). Median time from symptom onset to the door of the PCI center shortened from 3.8 to 3.0 h, p < 0.001. The proportion of women having total ischemic time ≤3 h was higher in the PRAGUE-18 (OR [95% C.I.] 2.65 [2.03-3.47]). However, the percentage of patients with time-to-reperfusion >6 h was still significant (22.3 vs. 27.2% in PRAGUE-18). There was an increase in probability for an initial TIMI flow >0 in the later study (1.49 [1.0-2.23]), and also for an optimal procedural result (4.24 [2.12-8.49], p < 0.001). The risk of 30-day mortality decreased by 61% (0.39 [0.17-0.91], p = 0.029). Conclusion: The prognosis of women with MI treated with primary PCI improved substantially with 24/7 regional availability of mechanical reperfusion, performance-enhancing technical progress, and intensive adjuvant antithrombotic therapy. A major modifiable hindrance to achieving this benefit in a broad population of women is the timely diagnosis by health professional services.

The relationship between symptom onset-to-needle time and ischemic outcomes in patients with acute myocardial infarction treated with primary PCI: Observations from Prague-18 Study.

OBJECTIVES: Based on previous studies with clopidogrel, the time between acute myocardial infarction (AMI) symptoms onset and primary percutaneous coronary intervention (PCI) was proven as important prognostic factor. Our aim was to assess the relationship between symptoms onset to needle time (SNT) and procedural results and the occurrence of ischemic endpoints in primary angioplasty patients treated with potent P2Y12 inhibitors. METHODS: A total of 1,131 out of 1,230 patients randomized to the Prague-18 study (prasugrel vs. ticagrelor in primary PCI) were divided into a high and a low-risk group. The effect of defined SNT on patients' ischemic endpoints and prognosis by their risk status at admission was tested. RESULTS: The median SNT was 3.2 hours. Longer SNTs resulted in a more frequent incidence of TIMI flow <3 post PCI (p=0.015). There were significant differences in the occurrence of the combined ischemic endpoint among the compared SNT groups at 30 days (p=0.032), and 1 year (p=0.011), with the highest incidence in the ≤1 h SNT group of patients. "Latecomers" (SNT>4 hs) in the high-risk group experienced more reinfarction within 1 year [OR (95% CI) 3.23 (1.09-9.62) p=0.035]; no difference was found in the low-risk group. CONCLUSIONS: In the era of intense antithrombotic medication, stratification of MI patients undergoing primary angioplasty, based on initial ischemic risk assessment affected prognosis more than symptom onset to needle time. Longer time delay was significantly related to increased incidence of ischemic events and all-cause mortality only in patients with high ischemic risk.

Stent Selection for Primary Angioplasty and Outcomes in the Era of Potent Antiplatelets. Data from the Multicenter Randomized Prague-18 Trial.

Drug-eluting stents (DES) are the recommended stents for primary percutaneous coronary intervention (PCI). This study aimed to determine why interventional cardiologists used non-DES and how it influenced patient prognoses. The efficacy and safety outcomes of the different stents were also compared in patients treated with either prasugrel or ticagrelor. Of the PRAGUE-18 study patients, 749 (67.4%) were treated with DES, 296 (26.6%) with bare-metal stents (BMS), and 66 (5.9%) with bioabsorbable vascular scaffold/stents (BVS) between 2013 and 2016. Cardiogenic shock at presentation, left main coronary artery disease, especially as the culprit lesion, and right coronary artery stenosis were the reasons for selecting a BMS. The incidence of the primary composite net-clinical endpoint (EP) (death, nonfatal myocardial infarction, stroke, serious bleeding, or revascularization) at seven days was 2.5% vs. 6.3% and 3.0% in the DES, vs. with BMS and BVS, respectively (HR 2.7; 95% CI 1.419-5.15, p = 0.002 for BMS vs. DES and 1.25 (0.29-5.39) p = 0.76 for BVS vs. DES). Patients with BMS were at higher risk of death at 30 days (HR 2.20; 95% CI 1.01-4.76; for BMS vs. DES, p = 0.045) and at one year (HR 2.1; 95% CI 1.19-3.69; p = 0.01); they also had a higher composite of cardiac death, reinfarction, and stroke (HR 1.66; 95% CI 1.0-2.74; p = 0.047) at one year. BMS were associated with a significantly higher rate of primary EP whether treated with prasugrel or ticagrelor. In conclusion, patients with the highest initial risk profile were preferably treated with BMS over BVS. BMS were associated with a significantly higher rate of cardiovascular events whether treated with prasugrel or ticagrelor.

Myocardial Involvement Detected Using Cardiac Magnetic Resonance Imaging in Patients with Systemic Sclerosis: A Prospective Observational Study.

INTRODUCTION AND OBJECTIVES: Cardiac involvement in systemic sclerosis (SSc) patients affects mortality. Cardiac magnetic resonance (CMR) is capable of detecting structural changes, including diffuse myocardial fibrosis that may develop over time. Our aim was to evaluate myocardial structure and function changes using CMR in patients with SSc without known cardiac disease during a 5-year follow-up and find possible correlations with selected biomarkers. METHODS: A total of 25 patients underwent baseline and follow-up CMR examinations according to a pre-specified protocol. Standard biochemistry, five biomarkers (hsTnI, NT-proBNP, galectin-3, sST2, and GDF-15), and disease-specific functional parameters enabling the classification of disease severity were also measured. RESULTS: After five years, no patient suffered from manifest heart disease. Mean extracellular volume (ECV) and T1 mapping values did not change significantly (p ≥ 0.073). However, individual increases in native T1 time and ECV correlated with increased galectin-3 serum levels (r = 0.56; p = 0.0050, and r = 0.71; p = 0.0001, respectively). The progression of skin involvement assessed using the Rodnan skin score and a decrease in the diffusing capacity of the lungs were associated with increased GDF-15 values (r = 0.63; p = 0.0009, and r = -0.51; p = 0.011, respectively). CONCLUSIONS: During the 5-year follow-up, there was no new onset of heart disease observed in patients with SSc. However, in some patients, CMR detected progression of sub-clinical myocardial fibrosis that significantly correlated with elevated galectin-3 levels. GDF-15 values were found to be associated with disease severity progression.

MiR-126-3p and MiR-223-3p as Biomarkers for Prediction of Thrombotic Risk in Patients with Acute Myocardial Infarction and Primary Angioplasty.

Aim. This study was designed to evaluate the relationship between microRNAs (miRNAs), miR-126-3p and miR-223-3p, as new biomarkers of platelet activation, and predicting recurrent thrombotic events after acute myocardial infarction (AMI). Methods and Results. The analysis included 598 patients randomized in the PRAGUE-18 study (ticagrelor vs. prasugrel in AMI). The measurements of miRNAs were performed by using a novel miRNA immunoassay method. The association of miRNAs with the occurrence of the ischemic endpoint (EP) (cardiovascular death, nonfatal MI, or stroke) and bleeding were analyzed. The miR-223-3p level was significantly related to an increased risk of occurrence of the ischemic EP within 30 days (odds ratio (OR) = 15.74, 95% confidence interval (CI): 2.07-119.93, p = 0.008) and one year (OR = 3.18, 95% CI: 1.40-7.19, p = 0.006), respectively. The miR-126-3p to miR-223-3p ratio was related to a decreased risk of occurrence of EP within 30 days (OR = 0.14, 95% CI: 0.03-0.61, p = 0.009) and one year (OR = 0.37, 95% CI: 0.17-0.82, p = 0.014), respectively. MiRNAs were identified as independent predictors of EP even after adjustment for confounding clinical predictors. Adding miR-223-3p and miR-126-3p to miR-223-3p ratios as predictors into the model calculating the ischemic risk significantly increased the predictive accuracy for combined ischemic EP within one year more than using only clinical ischemic risk parameters. No associations between miRNAs and bleeding complications were identified. Conclusion. The miR-223-3p and the miR-126-3p are promising independent predictors of thrombotic events and can be used for ischemic risk stratification after AMI.

Uricemia in the acute phase of myocardial infarction and its relation to long-term mortality risk.

Aim: Although uric acid has antioxidant effects, hyperuricemia has been established as an indicator of increased cardiovascular mortality in various patient populations. Treatment of asymptomatic hyperuricemia in patients with acute myocardial infarction (MI) is not routinely recommended, and the efficacy of such treatment in terms of cardiovascular risk reduction remains doubtful. Materials & methods: In a prospective cohort study, we followed 5196 patients admitted for a MI between 2006 and 2018. We assessed the relationship between baseline uricemia and the incidence of all-cause death and cardiovascular mortality and the effect of long-term allopurinol treatment. Hyperuricemia was defined as serum uric acid >450 µmol/l in men and >360 µmol/l in women. Results: In the entire cohort, the 1-year all-cause and cardiovascular mortality rates were 8 and 7.4%, and the 5-year rates were 18.3 and 15.3%, respectively. Using a fully adjusted model, hyperuricemia was associated with a 70% increased risk of both all-cause death and cardiovascular mortality at 1 year, and the negative prognostic value of hyperuricemia persisted over the 5-year follow-up (for all-cause death, hazard risk ratio = 1.45 [95% CI: 1.23-1.70] and for cardiovascular mortality, hazard risk ratio = 1.52 [95% CI: 1.28-1.80], respectively). Treatment of asymptomatic hyperuricemia with allopurinol did not affect mortality rates. Conclusion: Hyperuricemia detected in patients during the acute phase of an MI appears to be independently associated with an increased risk of subsequent fatal cardiovascular events. However, hyperuricemia treatment with low-dose allopurinol did not prove beneficial for these patients.

The prognostic impact of renal function decline during hospitalization for myocardial infarction.

Aim: We analyzed the mortality risk of myocardial infarction (MI) patients according to renal function, observed during hospitalization. Materials & methods: Patients hospitalized for MI between 2006 and 2018 were followed (n = 5659). We divided the sample into four groups by estimated glomerular filtration (eGFR) [ml/min]: normal functions (lowest eGFR during hospitalization >60); transiently moderate insufficiency (lowest eGFR >30 and ≤60, highest >60); permanently moderate insufficiency (highest eGFR >30 and ≤60); severe insufficiency (highest and lowest eGFR ≤30). Results: Permanently moderate renal insufficiency indicates increased 5-years all-cause mortality (hazard risk ratio: 2.27 [95% CIs: 1.87-2.75], p < 0.0001), but a similar risk was found in patients with the only transient decline of renal functions (hazard risk ratio: 2.08 [95% CIs: 1.70-2.55], p < 0.0001). Both moderate insufficiency subgroups (transient/permanent) did not statistically differ regarding mortality risk. Conclusion: Even just fluctuation of eGFR toward moderate insufficiency during hospitalization represents an important prognostic indicator in MI patients.

The Effect of Diabetes on Prognosis Following Myocardial Infarction Treated with Primary Angioplasty and Potent Antiplatelet Therapy.

PURPOSE: To investigate the prognostic significance of diabetes mellitus (DM) in patients with high risk acute myocardial infarction (AMI) treated with primary percutaneous coronary intervention (pPCI) in the era of potent antithrombotics. METHODS: Data from 1230 ST-segment elevation myocardial infarction (STEMI) patients enrolled in the PRAGUE-18 (prasugrel vs. ticagrelor in pPCI) study were analyzed. Ischemic and bleeding event rates were calculated for patients with and without diabetes. The independent impact of diabetes on outcomes was evaluated after adjustment for outcome predictors. RESULTS: The prevalence of DM was 20% (N = 250). Diabetics were older and more often female. They were more likely to have hypertension, hyperlipoproteinemia, multivessel coronary disease and left main disease, and be obese. The primary net-clinical endpoint (EP) containing death, spontaneous nonfatal MI, stroke, severe bleeding, and revascularization at day 7 occurred in 6.1% of patients with, and in 3.5% of patients without DM (HR 1.8; 95% CI 0.978-3.315; P = 0.055). At one year, the key secondary endpoint defined as cardiovascular death, spontaneous MI, or stroke occurred in 8.8% with, and 5.5% without DM (HR 1.621; 95% CI 0.987-2.661; P = 0.054). In those with DM the risk of total one-year mortality (6.8% vs. 3.9% (HR 1.773; 95% CI 1.001-3.141; P = 0.047)) and the risk of nonfatal reinfarction (4.8% vs. 2.2% (HR 2.177; 95% CI 1.077-4.398; P = 0.026)) were significantly higher compared to in those without DM. There was no risk of major bleeding associated with DM (HR 0.861; 95% CI 0.554-1.339; P = 0.506). In the multivariate analysis, diabetes was independently associated with the one-year risk of reinfarction (HR 2.176; 95% Confidence Interval, 1.055-4.489; p = 0.035). CONCLUSION: Despite best practices STEMI treatment, diabetes is still associated with significantly worse prognoses, which highlights the importance of further improvements in the management of this high-risk population.

The prognostic significance of periprocedural infarction in the era of potent antithrombotic therapy. The PRAGUE-18 substudy.

BACKGROUND: The prognostic significance of periprocedural myocardial infarction (MI) remains controversial. METHODS AND RESULTS: The study aims to investigate the incidence of periprocedural MI in the era of high sensitivity diagnostic markers and intense antithrombotics, and its impact on early outcomes of patients with acute MI treated with primary angioplasty (pPCI). Data from the PRAGUE-18 (prasugrel versus ticagrelor in pPCI) study were analyzed. The primary net-clinical endpoint (EP) included death, spontaneous MI, stroke, severe bleeding, and revascularization at day 7. The key secondary efficacy EP included cardiovascular death, spontaneous MI, and stroke within 30 days. The incidence of peri-pPCI MI was 2.3% (N = 28) in 1230 study patients. The net-clinical EP occurred in 10.7% of patients with, and in 3.6% of patients without, peri-pPCI MI (HR 2.92; 95% CI 0.91-9.38; P = 0.059). The key efficacy EP was 10.7% and 3.2%, respectively (HR 3.44; 95% CI 1.06-11.13; P = 0.028). Patients with periprocedural MI were at a higher risk of spontaneous MI (HR 6.19; 95% CI 1.41-27.24; P = 0.006) and stent thrombosis (HR 10.77; 95% CI 2.29-50.70; P = 0.003) within 30 days. Age, hyperlipidemia, multi-vessel disease, post-procedural TIMI <3, pPCI on circumflex coronary artery, and periprocedural GP IIb/IIIa inhibitor were independent predictors of peri-pPCI MI. CONCLUSIONS: In the era of intense antithrombotic therapy, the occurrence of peri-pPCI MI is despite highly sensitive diagnostic markers a rare complication, and is associated with an increased risk of early reinfarction and stent thrombosis.

Blood pressure measurement in patients with cardiogenic shock: the effect of norepinephrine.

BACKGROUND: Before arterial cannulation for invasive blood pressure monitoring, clinical decision-making depends on non-invasive blood pressure in critically ill patients. Whether non-invasive blood pressure is comparable to invasive measurement is not clearly elucidated. We address this issue as it relates to the use of norepinephrine in patients with cardiogenic shock. METHODS: We analysed invasive and non-invasive blood pressure in 85 patients admitted to the Coronary-Care Unit for cardiogenic shock. We compared initial blood pressure measurement (just after radial artery cannulation) and blood pressure taken during the first 72 hours after admission. Invasive blood pressure was used as the reference method. RESULTS: Initial invasive mean and systolic arterial pressures were in a good agreement with oscillometric blood pressure; mean differences were -0.4 ± 8.8 and +6.1 ± 14.4 mmHg with correlation coefficients of 0.76 and 0.74. Doses of norepinephrine were significant negative determinants of invasive/oscillometric blood pressure differences. The invasive/oscillometric mean arterial pressures and SBP differences were +0.1 ± 3.4 and 7.6 ± 1.6 mmHg in patients treated with nothing or a maximum norepinephrine dose of 0.6 µg/kg/min. However, treatment with very high doses of norepinephrine was associated with a steep rise in mean arterial pressures and SBP invasive/oscillometric differences (-9.5 ± 3.3 and -8.5 ± 5.2 mmHg). In a total of 967 sets of blood pressure measurements, invasive/oscillometric differences were relatively stable across blood pressure categories, with the exception of measurements assessed after very high norepinephrine doses. CONCLUSIONS: Non-invasive BP is a sufficient substitute for invasive measurement in cardiogenic shock patients, with the exception of those receiving very high doses of norepinephrine.

Factors influencing the accuracy of non-invasive blood pressure measurements in patients admitted for cardiogenic shock.

BACKGROUND: Although invasively measured blood pressure (invBP) is regarded as a "gold standard" in critically ill cardiac patients, the non-invasive BP is still widely used, at least at the initiation of medical care. The erroneous interpretation of BP can lead to clinical errors. We therefore investigated the agreement of both methods with respect to some common clinical situation. METHODS: We included 85 patients hospitalized for cardiogenic shock. We measured BP every 6 h for the first 72 h of hospitalization, in all patients. Each set of BP measurements included two invasive (invBP), two auscultatory (auscBP), and two oscillometric (oscBP) BP measurements. InvBP was considered as a gold standard. Mean non-invasive arterial pressure (MAP) was calculated as (diastolic pressure + (pulse pressure ÷ 3)). We used Bland-Altman analysis and we calculated concordance correlation coefficients to assess agreement between different BP methods. RESULTS: We obtained 967 sets of BP measurements. AuscMAP and oscMAP were on average only 0.4 ± 8.2 and 1.8 ± 8.5 mmHg higher than invMAP, respectively. On the other hand, auscSBP and oscSBP were on average - 6.1 ± 11.4 and - 4.1 ± 9.8 mmHg lower than invSBP, respectively. However, the mean differences and variability for systolic and diastolic BP variability were large; the 2 standard deviation differences were ± 24 and 18 mmHg. In hypotension, non-invasive BP tended to be higher than invBP while the opposite was true for high BP values. Clinical conditions associated with hypotension generally worsened the accuracy of non-invasive MAP. CONCLUSIONS: Mean arterial pressure measured non-invasively appears to be in good agreement with invasive MAP in patients admitted for cardiogenic shock. Several clinical associated with hypotension can affect accuracy of non-invasive measurement. Auscultatory and oscillometric measurements had similar accuracy even in patients with arrhythmia.

1-Year Outcomes of Patients Undergoing Primary Angioplasty for Myocardial Infarction Treated With Prasugrel Versus Ticagrelor.

BACKGROUND: Early outcomes of patients in the PRAGUE-18 (Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction) study did not find any significant differences between 2 potent P2Y12 inhibitors. OBJECTIVES: The 1-year follow-up of the PRAGUE-18 study focused on: 1) a comparison of efficacy and safety between prasugrel and ticagrelor; and 2) the risk of major ischemic events related to an economically motivated post-discharge switch to clopidogrel. METHODS: A total of 1,230 patients with acute myocardial infarction (MI) treated with primary percutaneous coronary intervention were randomized to prasugrel or ticagrelor with an intended treatment duration of 12 months. The combined endpoint was cardiovascular death, MI, or stroke at 1 year. Because patients had to cover the costs of study medication after hospital discharge, some patients decided to switch to clopidogrel. RESULTS: The endpoint occurred in 6.6% of prasugrel patients and in 5.7% of ticagrelor patients (hazard ratio: 1.167; 95% confidence interval: 0.742 to 1.835; p = 0.503). No significant differences were found in: cardiovascular death (3.3% vs. 3.0%; p = 0.769), MI (3.0% vs. 2.5%; p = 0.611), stroke (1.1% vs. 0.7%; p = 0.423), all-cause death (4.7% vs. 4.2%; p = 0.654), definite stent thrombosis (1.1% vs. 1.5%; p = 0.535), all bleeding (10.9% vs. 11.1%; p = 0.999), and TIMI (Thrombolysis In Myocardial Infarction) major bleeding (0.9% vs. 0.7%; p = 0.754). The percentage of patients who switched to clopidogrel for economic reasons was 34.1% (n = 216) for prasugrel and 44.4% (n = 265) for ticagrelor (p = 0.003). Patients who were economically motivated to switch to clopidogrel had (compared with patients who continued the study medications) a lower risk of major cardiovascular events; however, they also had lower ischemic risk. CONCLUSIONS: Prasugrel and ticagrelor are similarly effective during the first year after MI. Economically motivated early post-discharge switches to clopidogrel were not associated with an increased risk of ischemic events. (Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction [PRAGUE-18]; NCT02808767).

High-sensitivity Troponins after a Standardized 2-hour Treadmill Run.

BACKGROUND: The aim of this study was to examine high-sensitivity troponin T and I (hsTnT and hsTnI) after a treadmill run under laboratory conditions and to find a possible connection with echocardiographic, laboratory and other assessed parameters. METHODS: Nineteen trained men underwent a standardized 2-hour-long treadmill run. Concentrations of hsTnT and hsTnI were assessed before the run, 60, 120 and 180 minutes after the start and 24 hours after the run. Changes in troponins were tested using non-parametric analysis of variance (ANOVA). The multiple linear regression model was used to find the explanatory variables for hsTnT and hsTnI changes. Values of troponins were evaluated using the 0h/1h algorithm. RESULTS: Changes in hsTnT and hsTnI levels were statistically significant (p<0.0001 and p<0.0001, respectively). In a multiple regression model (adjusted R2: 0.60, p=0.005 for hsTnT and adjusted R2: 0.60, p=0.005 for hsTnI), changes in both troponins can be explained by relative left wall thickness (LV), training volume, body temperature after the run and creatinine changes. According to the 0h/1h algorithm, none of the runners was evaluated as negative. CONCLUSIONS: Relative LV wall thickness, creatinine changes, training volume and body temperature after the run can predict changes in hsTnT and hsTnI levels. When medical attention is needed after physical exercise, hsTn levels should be tested only when clinical suspicion and the patient's history indicate a high probability of myocardial damage.

Myocardial fibrosis detected by magnetic resonance in systemic sclerosis patients - Relationship with biochemical and echocardiography parameters.

OBJECTIVES: Systemic scleroderma (SSc) is a rare connective tissue disease presenting with fibrosis affecting skin and internal organs. Cardiovascular magnetic resonance (CMR) with quantification of extracellular volume (ECV) and T1 mapping might help to detect heart involvement. We aimed to evaluate whether myocardial involvement correlates with functional and laboratory parameters. METHODS: Thirty-three asymptomatic SSc patients (29 women, aged 56.6±12.2years) and 20 controls (10 women, 53.7±13.1years) were examined using CMR, echocardiography, functional pulmonary test and laboratory assessment. RESULTS: SSc patients had higher ECV (27.5±2.8 vs. 22.8±1.9%, P<0.0001) and native T1 values (1258.9±51.2 vs. 1192.2±32.6, P<0.0001) compared to controls. Plasma level of growth differentiation factor 15 (GDF-15) and galectin-3 correlated with ECV (r=0.35; P=0.0076 and r=0.38; P=0.0081) and native T1 (r=0.31; P=0.023 and r=0.35; P=0.012). GDF-15 was also negatively correlated with diffusing capacity of the lung for carbon monoxide (r=-0.58; P=0.0004) and positively correlated with modified Rodnan skin score (r=0.59; P=0.0003). Conventional echocardiography parameters were similar in SSc patients and controls. However, the global longitudinal peak systolic strain (GLPS) was lower in SSc patients compared to controls (18.6±1.6 vs. 21.1±1.2%; P<0.0001). GLPS also negatively correlated with native T1 (r=-0.35; P=0.0097), ECV (r=-0.33; P=0.014), GDF 15 (r=-0.31; P=0.022), and galectin-3 (r=-0.37; P=0.0076). CONCLUSIONS: Asymptomatic heart involvement is common in SSc patients and includes focal and diffuse myocardial fibrosis. GDF-15 and galectin-3 were positively correlated with myocardial fibrosis parameters. Future outcome studies must show whether measurement of GDF-15 and galectin-3 in SSC patients might be may be useful in clinical practice.

Extra corporeal membrane oxygenation in the therapy of cardiogenic shock (ECMO-CS): rationale and design of the multicenter randomized trial.

AIMS: Extracorporeal membrane oxygenation (ECMO) in veno-arterial configuration represents an increasingly used method for circulatory support. ECMO in cardiogenic shock offers rapid improvement of circulatory status and significant increase in tissue perfusion. Current evidence on the use of ECMO in cardiogenic shock remains insufficient. The aim of the ECMO-CS trial is to compare two recognized therapeutic approaches in the management of severe cardiogenic shock: early conservative therapy and early implantation of veno-arterial ECMO on the background of standard care. METHODS: Eligible patients have either rapidly deteriorating or severe cardiogenic shock, defined using echocardiography, hemodynamic and metabolic criteria. Patients are randomized to the one of two arms: immediate veno-arterial ECMO therapy or early conservative therapy. All other diagnostic and therapeutic procedures are performed as per current standard of care, including other cardiovascular interventions (i.e. percutaneous coronary intervention or cardiac surgery). Follow-up includes visits at 30 days, 6 months and 12 months. Primary endpoint is a composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device at 30 days. The sample size of 120 individuals (60 in each arm) provides 80% power to detect 50% reduction of primary endpoint, at alpha = 0.05. Patient recruitment started in October 2014. CONCLUSION: The results of the ECMO-CS trial may significantly influence current practice in the management of patients with severe and rapidly deteriorating cardiogenic shock. ECMO-CS trial registration number is NCT02301819.

Relationship between hsTnI and coronary stenosis in asymptomatic women with rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) is a condition associated with accelerated progression of atherosclerosis in affected individuals. Myocardial assessment using exercise testing in such patients, however, is often difficult to perform. Our objective was to determine the factors associated with severe coronary stenosis using computed tomography (CT) angiography of the coronary arteries in asymptomatic patients with RA. METHODS: Forty-four women with RA were examined using CT angiography to detect atherosclerotic involvement and significant coronary stenosis (>50 %). CT findings were correlated with the cardiovascular risk score, and with classical and most recent parameters of atherosclerosis. RESULTS: CT angiography of the coronary arteries revealed severe stenosis (>70 %) in 9 % of patients. High-sensitivity troponin I level was associated with severe coronary stenosis (odds ratio 6.37; 95 % confidence interval 1.53 - 26.48; P = 0.011). Adjustment for confounders did not alter this result (P = 0.039). In contrast, classical and modified Systemic Coronary Risk Evaluation scores had no value in predicting severe stenosis (P ≥ 0.49). CONCLUSION: The present study showed the possible benefits of a coronary CT angiography in women with RA and asymptomatic ischemic coronary heart disease. Increased levels of high-sensitivity troponin I may be a potential indication for this type of examination. However, further studies are needed to confirm these results.