Cardiogenic shock (CS) is a devastating and fatal complication of acute myocardial infarction (AMI). CS can affect the pharmacokinetics and pharmacodynamics of medications. The unique properties of cangrelor make it the optimal P2Y12 inhibitor for CS-AMI, in terms of both efficacy and safety. The DAPT-SHOCK-AMI trial (ClinicalTrials.gov: NCT03551964; EudraCT: 2018-002161-19) will assess the benefits of cangrelor in patients with an initial CS-AMI undergoing primary angioplasty. This randomised, multicentre, placebo-controlled trial of approximately 550 patients (with an allowed 10% increase) in 5 countries using a double-blind design will compare initial P2Y12 inhibitor treatment strategies in patients with CS-AMI of (A) intravenous cangrelor and (B) ticagrelor administered as crushed tablets at a loading dose of 180 mg. The primary clinical endpoint is a composite of all-cause death, myocardial infarction (MI), or stroke within 30 days. The main secondary endpoints are (1) the net clinical endpoint, defined as death, MI, urgent revascularisation of the infarct-related artery, stroke, or major bleeding as defined by the Bleeding Academic Research Consortium criteria; (2) cardiovascular-related death, MI, urgent revascularisation, or heart failure; (3) heart failure; and (4) cardiovascular-related death, all (1-4) within 1 year after study enrolment. A platelet reactivity study that tests the laboratory antiplatelet benefits of cangrelor, when given in addition to standard antiplatelet therapy, will be conducted using vasodilator-stimulated phosphoprotein phosphorylation. The primary laboratory endpoints are the periprocedural rate of onset and the proportion of patients who achieve effective P2Y12 inhibition. The DAPT-SHOCK-AMI study is the first randomised trial to evaluate the benefits of cangrelor in patients with CS-AMI.
- MeSH
- adenosinmonofosfát * analogy a deriváty terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- dvojitá slepá metoda MeSH
- fosfoproteiny MeSH
- infarkt myokardu * komplikace MeSH
- inhibitory agregace trombocytů * škodlivé účinky terapeutické užití aplikace a dávkování MeSH
- kardiogenní šok * mortalita MeSH
- koronární angioplastika škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- purinergní receptory P2Y - antagonisté aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- randomizované kontrolované studie jako téma MeSH
- senioři MeSH
- ticagrelor * terapeutické užití aplikace a dávkování škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
Závěrečná zpráva o řešení grantu Agentury pro zdravotnický výzkum MZ ČR
nestr.
A short-term mortality of patients with acute myocardial infarction (AMI) without cardiogenic shock (CS) and treated with PCI is 5%, mortality of those with CS is 10 times higher. Rapid and effective antiplatelet therapy (acetylsalicylic acid and P2Y12 inhibitor) is of essential importance for an early coronary flow renewal and perfusion of microcirculation, and is as such highly important for patient’s prognosis. Patients with CS are the population with the highest thrombotic risk. CS is an exclusion criterion for participation in randomized studies. Relevant evidence resulting from comparison of antiplatelets in these patients is entirely missing. The project is a randomized study, comparing efficacy of cangrelor and ticagrelor. It is based on an assumption that cangrelor, parenteral and direct-acting P2Y12 inhibitor, has a potential to be an optimal drug for patients with AMI complicated with CS. With regards to hypoperfusion of the splanchnic area, the preferred drug application is the parenteral route while in case of drugs, those not requiring metabolisation, are being preferred.
Krátkodobá mortalita pacientů s akutním infarktem myokardu (AIM), kteří jsou léčeni perkutánní koronární intervencí bez kardiogenního šoku (KŠ) je 5%, mortalita těch s komplikujícím KŠ je desetinásobně vyšší. Rychlá a efektivní kombinovaná protidestičková léčba (kyselina acetylsalicylová a inhibitor P2Y12) má zásadní význam pro časné obnovení průtoku v koronární tepně a perfuzi mikrocirkulace, a tím pro prognózu nemocných. Pacienti s KŠ jsou populací s nejvyšším trombotickým rizikem. Přesto je KŠ vyřazovacím kritériem pro účast v randomizovaných studiích. Relevantní evidence o srovnání efektivity protidestičkových léků u této subpopulace pacientů zcela chybí. Projekt je randomizovanou multicentrickou dvojitě zaslepenou studií srovnávající efektivitu cangreloru a ticagreloru. Vychází z předpokladu, že cangrelor, parenterální a přímý inhibitor P2Y12, má potenciál být optimálním lékem pro pacienty s AIM komplikovaným iniciálně KŠ, kteří podstupují PCI. Vzhledem k hypoperfuzy splanchnika je totiž preferovanou aplikací intravenózní a z léků mají přednost ty, jež nevyžadují metabolizaci.
- Klíčová slova
- prognóza, mortalita, mortality, Outcome, akutní infarkt myokardu, kardiogenní šok, protidestičková léčba, velké kardiovaskulární příhody, cardiogenic shock, antiplatelet therapy, major cardiovascular events, acute myocardial infartion,
- NLK Publikační typ
- závěrečné zprávy o řešení grantu AZV MZ ČR
- MeSH
- infarkt myokardu * epidemiologie terapie MeSH
- lidé MeSH
- nemocnice MeSH
- poskytování zdravotní péče MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
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.
- MeSH
- hemodynamika MeSH
- kardiogenní šok diagnóza terapie MeSH
- lidé MeSH
- mimotělní membránová oxygenace * metody MeSH
- mortalita v nemocnicích MeSH
- retrospektivní studie MeSH
- srdeční zástava * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
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.
- MeSH
- infarkt myokardu s elevacemi ST úseků * komplikace chirurgie MeSH
- infarkt myokardu * komplikace terapie MeSH
- kardiogenní šok etiologie terapie MeSH
- koronární angioplastika * metody MeSH
- lidé MeSH
- nemoci koronárních tepen * komplikace chirurgie MeSH
- rizikové faktory MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Publikační typ
- abstrakt z konference MeSH
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.
- MeSH
- infarkt myokardu * MeSH
- inhibitory agregace trombocytů terapeutické užití MeSH
- klopidogrel MeSH
- koronární angioplastika * škodlivé účinky MeSH
- lidé MeSH
- prasugrel hydrochlorid MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
Pacienti s plicní embolií vedoucí k zástavě oběhu mají obvykle špatnou prognózu. Adekvátně zvolená léčba je klíčová. Vedle antikoagulační a trombolytické terapie máme k dispozici oběhovou a ventilační podporu, mechanickou podporu oběhu ve formě venoarteriální extrakorporální membránové oxygenace (V-A ECMO) a chirurgickou či katétrovou embolektomii. Využití těchto léčebných modalit může být spojeno se specifickými komplikacemi. Prezentujeme případ 17letého mladého muže s mimonemocniční zástavou oběhu, kde konvenční resuscitační postupy nevedly k obnově účinného oběhu, a proto byl za pokračující kardiopulmonální resuscitace (KPR) transportován do regionálního ECMO centra. Nález při bed-side echokardiografickém vyšetření byl velmi suspektní z plicní embolie. Byl podán nefrakcionovaný heparin a pacient byl napojen na V-A ECMO. Vyšetřením výpočetní tomografií (CT) byla potvrzena rozsáhlá oboustranná plicní embolie s dilatací pravé komory srdeční (PKS). Pro progredující oběhovou nestabilitu byla podána trombolytická léčba. Nastalé závažné komplikace si vyžádaly opakované chirurgické intervence. Tato kazuistika je zároveň příkladem nezbytnosti multidisciplinární spolupráce.
Patients with pulmonary embolism leading to cardiac arrest usually have poor prognosis. Adequate treatment is essential. Besides anticoagulant and thrombolytic therapy we can employ circulatory and ventilatory support, mechanical circulatory support like venoarterial extracorporeal membrane oxygenation (V-A ECMo) and surgical or catheter embolectomy. The use of these therapeutic modalities could be connected with specific complications. We present a 17-year-old young man with out-of-hospital cardiac arrest where conventional resuscitation methods were not successful so patient was transported during ongoing cardiopulmonary resuscitation (CPr) to a regional ECMo centre. Bed-side echocardiography was very suspicious of pulmonary embolism. unfractioned heparin was applied and the ECMo support was initiated. Computed tomography verified extensive bilateral pulmonary embolism with right ventricle dilatation. Patient’s hemodynamic status was getting worse so thrombolysis was administered. Severe complications have occurred and led to repeated surgical interventions. This case also demonstrates the necessity of multidisciplinary cooperation.
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.
- Publikační typ
- časopisecké články MeSH