BACKGROUND: Inflammation is associated with adverse cardiovascular events. Data from recent trials suggest that colchicine reduces the risk of cardiovascular events. METHODS: In this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients who had myocardial infarction to receive either colchicine or placebo and either spironolactone or placebo. The results of the colchicine trial are reported here. The primary efficacy outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization, evaluated in a time-to-event analysis. C-reactive protein was measured at 3 months in a subgroup of patients, and safety was also assessed. RESULTS: A total of 7062 patients at 104 centers in 14 countries underwent randomization; at the time of analysis, the vital status was unknown for 45 patients (0.6%), and this information was most likely missing at random. A primary-outcome event occurred in 322 of 3528 patients (9.1%) in the colchicine group and 327 of 3534 patients (9.3%) in the placebo group over a median follow-up period of 3 years (hazard ratio, 0.99; 95% confidence interval [CI], 0.85 to 1.16; P = 0.93). The incidence of individual components of the primary outcome appeared to be similar in the two groups. The least-squares mean difference in C-reactive protein levels between the colchicine group and the placebo group at 3 months, adjusted according to the baseline values, was -1.28 mg per liter (95% CI, -1.81 to -0.75). Diarrhea occurred in a higher percentage of patients with colchicine than with placebo (10.2% vs. 6.6%; P<0.001), but the incidence of serious infections did not differ between groups. CONCLUSIONS: Among patients who had myocardial infarction, treatment with colchicine, when started soon after myocardial infarction and continued for a median of 3 years, did not reduce the incidence of the composite primary outcome (death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization). (Funded by the Canadian Institutes of Health Research and others; CLEAR ClinicalTrials.gov number, NCT03048825.).
- MeSH
- C-Reactive Protein * analysis MeSH
- Stroke prevention & control MeSH
- Double-Blind Method MeSH
- Myocardial Infarction * prevention & control mortality MeSH
- Kaplan-Meier Estimate MeSH
- Colchicine * therapeutic use adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Recurrence MeSH
- Secondary Prevention MeSH
- Aged MeSH
- Spironolactone therapeutic use adverse effects MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: Mineralocorticoid receptor antagonists have been shown to reduce mortality in patients after myocardial infarction with congestive heart failure. Whether routine use of spironolactone is beneficial after myocardial infarction is uncertain. METHODS: In this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients with myocardial infarction who had undergone percutaneous coronary intervention to receive either spironolactone or placebo and either colchicine or placebo. The results of the spironolactone trial are reported here. The two primary outcomes were a composite of death from cardiovascular causes or new or worsening heart failure, evaluated as the total number of events; and a composite of the first occurrence of myocardial infarction, stroke, new or worsening heart failure, or death from cardiovascular causes. Safety was also assessed. RESULTS: We enrolled 7062 patients at 104 centers in 14 countries; 3537 patients were assigned to receive spironolactone and 3525 to receive placebo. At the time of our analyses, the vital status was unknown for 45 patients (0.6%). For the first primary outcome, there were 183 events (1.7 per 100 patient-years) in the spironolactone group as compared with 220 events (2.1 per 100 patient-years) in the placebo group over a median follow-up period of 3 years (hazard ratio adjusted for competing risk of death from noncardiovascular causes, 0.91; 95% confidence interval [CI], 0.69 to 1.21; P = 0.51). With respect to the second primary outcome, an event occurred in 280 of 3537 patients (7.9%) in the spironolactone group and 294 of 3525 patients (8.3%) in the placebo group (hazard ratio adjusted for competing risk, 0.96; 95% CI, 0.81 to 1.13; P = 0.60). Serious adverse events were reported in 255 patients (7.2%) in the spironolactone group and 241 (6.8%) in the placebo group. CONCLUSIONS: Among patients with myocardial infarction, spironolactone did not reduce the incidence of death from cardiovascular causes or new or worsening heart failure or the incidence of a composite of death from cardiovascular causes, myocardial infarction, stroke, or new or worsening heart failure. (Funded by the Canadian Institutes of Health Research and others; CLEAR ClinicalTrials.gov number, NCT03048825.).
- MeSH
- Mineralocorticoid Receptor Antagonists * therapeutic use adverse effects MeSH
- Stroke mortality MeSH
- Double-Blind Method MeSH
- Myocardial Infarction * mortality drug therapy MeSH
- Kaplan-Meier Estimate MeSH
- Cardiovascular Diseases mortality prevention & control MeSH
- Percutaneous Coronary Intervention MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Spironolactone * therapeutic use adverse effects MeSH
- Heart Failure * drug therapy mortality MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
BACKGROUND AND AIM: Diabetes has been shown in last decades to be associated with a significantly higher mortality among patients with ST-segment elevation myocardial infarction (STEMI) treated with primary PCI (PPCI). Therefore, the aim of current study was to evaluate the impact of diabetes on times delays, reperfusion and mortality in a contemporary STEMI population undergoing PPCI, including treatment during the COVID pandemic. METHODS AND RESULTS: The ISACS-STEMI COVID-19 is a large-scale retrospective multicenter registry involving PPCI centers from Europe, Latin America, South-East Asia and North-Africa, including patients treated from 1st of March until June 30, 2019 and 2020. Primary study endpoint of this analysis was in-hospital mortality. Secondary endpoints were postprocedural TIMI 0-2 flow and 30-day mortality. Our population is represented by 16083 STEMI patients. A total of 3812 (23,7 %) patients suffered from diabetes. They were older, more often males as compared to non-diabetes. Diabetic patients were less often active smokers and had less often a positive family history of CAD, but they were more often affected by hypertension and hypercholesterolemia, with higher prevalence of previous STEMI and previous CABG. Diabetic patients had longer ischemia time, had more often anterior MI, cardiogenic shock, rescue PCI and multivessel disease. They had less often out-of-hospital cardiac arrest and in-stent thrombosis, received more often a mechanical support, received less often a coronary stent and DES. Diabetes was associated with a significantly impaired postprocedural TIMI flow (TIMI 0-2: 9.8 % vs 7.2 %, adjusted OR [95 % CI] = 1.17 [1.02-1.38], p = 0.024) and higher mortality (in-hospital: 9.1 % vs 4.8 %, Adjusted OR [95 % CI] = 1.70 [1.43-2.02], p < 0.001; 30-day mortality: 10.8 % vs 6 %, Adjusted HR [95 % CI] = 1.46 [1.26-1.68], p < 0.001) as compared to non-diabetes, particularly during the pandemic. CONCLUSIONS: Our study showed that in a contemporary STEMI population undergoing PPCI, diabetes is significantly associated with impaired epicardial reperfusion that translates into higher in-hospital and 30-day mortality, particularly during the pandemic.
- MeSH
- Time-to-Treatment MeSH
- Time Factors MeSH
- COVID-19 * mortality epidemiology MeSH
- Diabetes Mellitus * mortality diagnosis epidemiology MeSH
- Risk Assessment MeSH
- ST Elevation Myocardial Infarction * mortality therapy diagnosis MeSH
- Percutaneous Coronary Intervention * mortality adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Hospital Mortality MeSH
- Registries MeSH
- Retrospective Studies MeSH
- Risk Factors MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
BACKGROUND: Hypertension is the most prevalent cardiovascular risk factor, with several detrimental effects on the cardiovascular system. Contrasting results have been reported so far on its prognostic role in patients admitted for ST-segment elevation myocardial infarction (STEMI). Therefore, we investigated the impact of hypertension on short-term mortality in a large multicenter contemporary registry of STEMI patients, including patients treated during COVID-19 pandemic. METHODS: The ISACS-STEMI COVID-19 was a retrospective registry that included STEMI patients treated with primary percutaneous coronary intervention (PCI) between March and June of 2019 and 2020 in 109 high-volume primary PCI centers from 4 continents. We collected data on baseline, clinical and procedural characteristics, in-hospital outcome and 30-day mortality. For this analysis patients were grouped according to history of hypertension at admission. RESULTS: A total of 16083 patients were assessed, including 8813 (54.8%) with history of hypertension. These patients were more often elderly, with a worse cardiovascular risk profile, but were less frequently active smoker. Some procedural differences were observed between the two groups, including lower rate of thrombectomy and use of glycoprotein IIb/IIIa inhibitors or cangrelor but more extensive coronary disease in patients with hypertension. Between patients with and without hypertension, there was no significant difference in SARS-CoV-2 positivity. Hypertensive patients had a significantly higher in-hospital and 30-day mortality, similarly observed in both pre-COVID-19 and COVID-19 era, and confirmed after adjustment for main baseline differences and propensity score (in-hospital mortality: adjusted odds ratio (OR) [95% confidence interval (CI)] =1.673 [1.389-2.014], P < 0.001; 30-day mortality: adjusted hazard ratio (HR) [95% CI] = 1.418 [1.230-1.636], P < 0.001). CONCLUSION: This is one of the largest and contemporary study assessing the impact of hypertension in STEMI patients undergoing primary angioplasty, including also the COVID-19 pandemic period. Hypertension was independently associated with significantly higher rates of in-hospital and 30-day mortality.
- MeSH
- COVID-19 * complications mortality MeSH
- Hypertension * complications mortality MeSH
- ST Elevation Myocardial Infarction * mortality complications therapy MeSH
- Percutaneous Coronary Intervention * MeSH
- Middle Aged MeSH
- Humans MeSH
- Hospital Mortality MeSH
- Registries * MeSH
- Retrospective Studies MeSH
- Risk Factors MeSH
- SARS-CoV-2 MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
AIMS: Among patients with cardiogenic shock, immediate initiation of extracorporeal membrane oxygenation (ECMO) did not demonstrate any benefit at 30 days. The present study evaluated 1-year clinical outcomes of the Extracorporeal Membrane Oxygenation in the therapy of Cardiogenic Shock (ECMO-CS) trial. METHODS AND RESULTS: The ECMO-CS trial randomized 117 patients with severe or rapidly progressing cardiogenic shock to immediate initiation of ECMO or early conservative strategy. The primary endpoint for this analysis was 1-year all-cause mortality. Secondary endpoints included a composite of death, resuscitated cardiac arrest or implantation of another mechanical circulatory support device, duration of mechanical ventilation, and the length of intensive care unit (ICU) and hospital stays. In addition, an unplanned post-hoc subgroup analysis was performed. At 1 year, all-cause death occurred in 40 of 58 (69.0%) patients in the ECMO arm and in 40 of 59 (67.8%) in the early conservative arm (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.66-1.58; p = 0.93). The composite endpoint occurred in 43 (74.1%) patients in the ECMO group and in 47 (79.7%) patients in the early conservative group (HR 0.83, 95% CI 0.55-1.25; p = 0.29). The durations of mechanical ventilation, ICU stay and hospital stay were comparable between groups. Significant interaction with treatment strategy and 1-year mortality was observed in subgroups according to baseline mean arterial pressure (MAP) indicating lower mortality in the subgroup with low baseline MAP (<63 mmHg: HR 0.58, 95% CI 0.29-1.16; pinteraction = 0.017). CONCLUSIONS: Among patients with severe or rapidly progressing cardiogenic shock, immediate initiation of ECMO did not improve clinical outcomes at 1 year compared to the early conservative strategy. However, immediate ECMO initiation might be beneficial in patients with advanced haemodynamic compromise.
- MeSH
- Time Factors MeSH
- Intensive Care Units MeSH
- Shock, Cardiogenic * therapy mortality MeSH
- Middle Aged MeSH
- Humans MeSH
- Extracorporeal Membrane Oxygenation * methods MeSH
- Survival Rate trends MeSH
- Aged MeSH
- Respiration, Artificial methods MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
The prevalence of left-sided valvular heart disease (VHD) increases with age, but data on the impact of pre-existing VHD in patients with acute myocardial infarction (AMI) are limited. We aimed to define the clinical characteristics and outcomes of AMI patients with pre-existing left VHD. The analysis is based on data from three merged national registries. The dataset included 47,436 patients admitted with AMI over a 5year period at all Cath Labs nationwide. Pre-existing VHD was diagnosed in 1,445 patients (3.0%), moderate-to-severe mitral regurgitation (MR) in 510 patients (35.3%), and moderate-to-severe aortic stenosis (AS) in 869 patients (60.1%). Patients with VHD had worse baseline characteristics, pre-existing coronary artery disease, more complicated in-hospital course with higher Killip class, lower left ventricular ejection fraction, and more comorbidities. Angiographically more frequent left main stenosis, TIMI flow 3 before PCI, less frequent stent implantation. Patients with pre-existing VHD had significantly higher 7-day (10.1% vs. 4.5%, p < 0.001), 30-day (16.0% vs. 7.0%, p < 0.001) and 1-year mortality (28.7 vs. 12.7%, p < 0.001) compared to patients without. Conclusions. Patients with pre-existing VHD and AMI are characterized by complicated in-hospital course with higher Killip class, lower ejection fraction, angiographically less severe stenosis, TIMI flow 3 prior to PCI, and less frequent stent implantation. This is a high-risk group with higher short - and long-term mortality and earlier intervention should be considered.
- MeSH
- Aortic Valve Stenosis * complications epidemiology MeSH
- Myocardial Infarction * complications mortality MeSH
- Middle Aged MeSH
- Humans MeSH
- Mitral Valve Insufficiency * complications epidemiology MeSH
- Registries MeSH
- Risk Factors MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
Dlouhodobé podávání betablokátorů pacientům po infarktu myokardu (IM) se zachovalou ejekční frakcí levé komory (EFLK) zůstává kontroverzní. Zatímco benefit betablokátorů je prokázán u pacientů se sníženou EFLK, pro nemocné s EFLK > 40 % chybí jednoznačná data z randomizovaných klinických studií. Dvě nedávno publikované studie (REDUCE-AMI a ABYSS) přinesly rozdílné výsledky ohledně bezpečnosti vysazení betablokátorů. REDUCE-AMI neprokázala přínos dlouhodobého podávání betablokátorů na mortalitu nebo nový IM, zatímco ABYSS ukázala vyšší riziko KV hospitalizací po vysazení, zejména u hypertoniků. Výsledky metaanalýz zůstávají rozporuplné. Fixní kombinace betablokátorů s jinými léky může zlepšit adherenci a kardiovaskulární prognózu, zejména u hypertenzních pacientů. Odpověď na otázku trvalé indikace betablokátorů by měly přinést tři probíhající studie (BETAMI, DANBLOCK, REBOOT).
The long-term use of beta-blockers in patients after myocardial infarction (MI) with preserved left ventricular ejection fraction (LVEF) remains controversial. While benefits of beta-blockers are well established in patients with reduced LVEF, there is a lack of randomized clinical trial data for patients with LVEF > 40 %. Two recent studies (REDUCE-AMI and ABYSS) yielded conflicting results regarding the safety of beta-blocker discontinuation. REDUCE-AMI showed no mortality or reinfarction benefit from long-term beta-blocker therapy, while ABYSS indicated increased cardiovascular hospitalizations, especially in hypertensive patients. Results of meta-analyses remain inconclusive. Fixed-dose combinations of beta-blockers with other cardiovascular medications may improve adherence and long-term outcomes, particularly in hypertensive patients. Ongoing randomized trials (BETAMI, DANBLOCK, REBOOT) may provide definitive answers.
- Keywords
- kardiovaskulární riziko,
- MeSH
- Adrenergic beta-Antagonists * pharmacology therapeutic use MeSH
- Heart Failure, Diastolic * drug therapy MeSH
- Myocardial Infarction drug therapy MeSH
- Cardiovascular Diseases etiology MeSH
- Clinical Studies as Topic MeSH
- Humans MeSH
- Treatment Interruption MeSH
- Check Tag
- Humans MeSH
Monotherapy with a potent P2Y12 receptor antagonist after 1 month of dual antiplatelet therapy (DAPT) may reduce bleeding in the absence of increased ischaemic events compared to 12-month DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). PCI guidance with optical coherence tomography (OCT) may enhance stent expansion. COMPARE STEMI ONE is an international, multicentre, open-label, randomised controlled trial. In 1,656 ST-segment elevation myocardial infarction (STEMI) patients, prasugrel monotherapy after 1 month of DAPT, as compared to standard 12-month prasugrel-based DAPT, will be tested for non-inferiority for the primary composite endpoint of net adverse clinical events - defined as all-cause death, myocardial infarction, stroke, or Bleeding Academic Research Consortium Type 3 or 5 bleeding events - at 11 months after randomisation. Furthermore, an ancillary substudy will test the superiority of OCT-guided versus angiography-guided staged complete revascularisation in achieving a larger minimal stent area (MSA) in non-culprit lesions during staged procedures. COMPARE STEMI ONE is the first randomised controlled trial assessing an abbreviated 1-month DAPT regimen followed by prasugrel monotherapy in the context of STEMI. The trial will also study the value of OCT-guided PCI in terms of the MSA of non-culprit lesions and may elucidate potential synergies between intravascular imaging-guided PCI and abbreviated DAPT regimens. (ClinicalTrials.gov: NCT05491200).
- MeSH
- Purinergic P2Y Receptor Antagonists * therapeutic use MeSH
- ST Elevation Myocardial Infarction * therapy drug therapy diagnostic imaging surgery MeSH
- Platelet Aggregation Inhibitors * therapeutic use MeSH
- Coronary Angiography methods MeSH
- Percutaneous Coronary Intervention * methods MeSH
- Humans MeSH
- Tomography, Optical Coherence * methods MeSH
- Prasugrel Hydrochloride * therapeutic use MeSH
- Randomized Controlled Trials as Topic MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Clinical Trial Protocol MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
Autorka v príspevku uvádza kazuistiku pacienta s pokročilou granulomatózou s polyangitídou, ktorý bol privezený po úspešnej kardiopulmonálnej resuscitácii v rámci infarktu myokardu v ťažkom kardiogénnom šoku a vyžadoval umelú pľúcnu ventiláciu. Autorka sa snaží poukázať na závažnosť základného ochorenia, s ktorým sa v súčasnej dobe stretávame čoraz častejšie. Zároveň vyzdvihuje dôležitosť primárnej zdravotnej starostlivosti, ktorá prispieva k správnej diagnostike a liečbe ochorenia.
The author presents a case study of a patient with advanced granulomatosis with polyangiitis, who was admitted after successful cardiopulmonary resuscitation due to myocardial infarction in severe cardiogenic shock and required mechanical ventilation. The author aims to high light the severity of the underlying disease, which is being encountered increasingly often in contemporary practice. At the same time, the author emphasizes the importance of primary healthcare in contributing to the accurate diagnosis and treatment of the disease
- MeSH
- Granulomatosis with Polyangiitis diagnostic imaging etiology classification physiopathology therapy MeSH
- Myocardial Infarction nursing therapy MeSH
- Shock, Cardiogenic MeSH
- Critical Care Nursing MeSH
- Critical Care MeSH
- Pulmonary Ventilation MeSH
- Treatment Outcome MeSH
- Publication type
- Case Reports MeSH
OBJECTIVES: The aim of the study was to analyse the role of conservative treatment and regional differences in 30-day hospital mortality for acute myocardial infarction (AMI) patients in the Czech Republic. METHODS: Using administrative data from Czech health insurance companies for 2018-2020, we employed a probit model to examine factors influencing mortality across 13 complex cardiovascular centres, calculating average marginal effects to ensure interpretable results. RESULTS: Conservative treatment was associated with a 4.7 percentage point increase in 30-day mortality compared to percutaneous coronary intervention (PCI) treatment (95% CI: 3.6-5.7). This effect varied significantly across different types of AMI and healthcare providers, with regional variations in mortality ranging from 0 to 4.3 percentage points relative to the best-performing centre. CONCLUSIONS: Higher proportions of conservative treatment significantly contribute to increased 30-day mortality in complex cardiovascular centres. The persistent regional variations after controlling for patient characteristics suggest the need for standardized treatment protocols and improved data collection systems to reduce disparities in outcomes.
- MeSH
- Myocardial Infarction * mortality therapy MeSH
- Conservative Treatment * statistics & numerical data mortality MeSH
- Percutaneous Coronary Intervention statistics & numerical data mortality MeSH
- Middle Aged MeSH
- Humans MeSH
- Hospital Mortality * trends MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Czech Republic MeSH