BACKGROUND: Patients with severe aortic stenosis present frequently (∼50%) with concomitant obstructive coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as the preferred treatment. Transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) represent a valid treatment alternative. We aimed to test the non-inferiority of FFR-guided PCI plus TAVI versus SAVR plus CABG in patients with severe aortic stenosis and complex coronary artery disease. METHODS: This international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial was conducted at 18 tertiary medical centres across Europe. Patients (aged ≥70 years) with severe aortic stenosis and complex coronary artery disease, deemed feasible for percutaneous or surgical treatment according to the on-site Heart Team, were randomly assigned (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG according to a computer-generated sequence with random permuted blocks sizes stratified by site. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularisation, valve reintervention, and life-threatening or disabling bleeding at 1 year post-treatment. The trial was powered for non-inferiority (with a margin of 15%) and if met, for superiority. The primary and safety analyses were done per an intention-to-treat principle. This trial is registered with ClinicalTrials.gov (NCT03424941) and is closed. FINDINGS: Between May 31, 2018, and June 30, 2023, 172 patients were enrolled, of whom 91 were assigned to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age of patients was 76·5 years (SD 3·9). 118 (69%) of 172 patients were male and 54 (31%) patients were female. FFR-guided PCI plus TAVI resulted in favourable outcomes for the primary endpoint (four [4%] of 91 patients) versus SAVR plus CABG (17 [23%] of 77 patients; risk difference -18·5 [90% CI -27·8 to -9·7]), which was below the 15% prespecified non-inferiority margin (pnon-inferiority<0·001). FFR-guided PCI plus TAVI was superior to SAVR plus CABG (hazard ratio 0·17 [95% CI 0·06-0·51]; psuperiority<0·001), which was driven mainly by all-cause mortality (none [0%] of 91 patients vs seven (10%) of 77 patients; p=0·0025) and life-threatening bleeding (two [2%] vs nine [12%]; p=0·010). INTERPRETATION: The TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment. FUNDING: Isala Heart Centre and Medtronic.

• MeSH
• aortální stenóza * chirurgie   komplikace   MeSH
• chirurgická náhrada chlopně metody   MeSH
• frakční průtoková rezerva myokardu * MeSH
• koronární angioplastika * metody   MeSH
• koronární bypass * metody   MeSH
• lidé MeSH
• nemoci koronárních tepen * chirurgie   komplikace   terapie   MeSH
• prospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• transkatetrální implantace aortální chlopně * metody   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• hodnocení ekvivalence MeSH
• multicentrická studie MeSH
• srovnávací studie MeSH

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
• antagonisté purinergních receptorů P2Y aplikace a dávkování   škodlivé účinky   terapeutické užití   MeSH
• dvojitá slepá metoda MeSH
• fosfoprotein stimulovaný vazodilatátorem 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
• 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

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: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD. AIMS: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is noninferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD. METHODS: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve reintervention, and life threatening or disabling bleeding at 1 year. The TCW trial is powered for noninferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a noninferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis. SUMMARY: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI-TAVI) is noninferior to the guidelines recommended approach (CABG-SAVR).

• MeSH
• aortální chlopeň chirurgie   MeSH
• aortální stenóza * komplikace   diagnóza   chirurgie   MeSH
• frakční průtoková rezerva myokardu * MeSH
• koronární angioplastika * škodlivé účinky   MeSH
• koronární bypass MeSH
• lidé MeSH
• nemoci koronárních tepen * komplikace   diagnóza   chirurgie   MeSH
• prospektivní studie MeSH
• transkatetrální implantace aortální chlopně * MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články 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

INTRODUCTION: Observational studies have shown low bleeding rates in patients with atrial fibrillation (AF) treated by left atrial appendage closure (LAAC); however, data from randomized studies are lacking. This study compared bleeding events among patients with AF treated by LAAC and nonvitamin K anticoagulants (NOAC). METHODS: The Prague-17 trial was a prospective, multicenter, randomized trial that compared LAAC to NOAC in high-risk AF patients. The primary endpoint was a composite of a cardioembolic event, cardiovascular death, and major and clinically relevant nonmajor bleeding (CRNMB) defined according to the International Society on Thrombosis and Hemostasis (ISTH). RESULTS: The trial enrolled 402 patients (201 per arm), and the median follow-up was 3.5 (IQR 2.6-4.2) years. Bleeding occurred in 24 patients (29 events) and 32 patients (40 events) in the LAAC and NOAC groups, respectively. Six of the LAAC bleeding events were procedure/device-related. In the primary intention-to-treat analysis, LAAC was associated with similar rates of ISTH major or CRNMB (sHR 0.75, 95% CI 0.44-1.27, p = 0.28), but with a reduction in nonprocedural major or CRNMB (sHR 0.55, 95% CI 0.31-0.97, p = 0.039). This reduction for nonprocedural bleeding with LAAC was mainly driven by a reduced rate of CRNMB (sHR for major bleeding 0.69, 95% CI 0.34-1.39, p = .30; sHR for CRNMB 0.43, 95% CI 0.18-1.03, p = 0.059). History of bleeding was a predictor of bleeding during follow-up. Gastrointestinal bleeding was the most common bleeding site in both groups. CONCLUSION: During the 4-year follow-up, LAAC was associated with less nonprocedural bleeding. The reduction is mainly driven by a decrease in CRNMB.

• MeSH
• antikoagulancia škodlivé účinky   MeSH
• cévní mozková příhoda * diagnóza   etiologie   prevence a kontrola   MeSH
• fibrilace síní * komplikace   diagnóza   farmakoterapie   MeSH
• krvácení chemicky indukované   MeSH
• lidé MeSH
• prospektivní studie MeSH
• síňové ouško * chirurgie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

Kontext: V rámci pandemie nemoci covid-19 byl objeven život ohrožující syndrom postihující dominantně mladé dospělé, který přichází zpravidla do čtyř týdnů po primoinfekci virem SARS-CoV-2. Onemocnění bývá spojeno s postižením více orgánových soustav včetně srdce. Tato nová jednotka byla pojmenována jako multisystémový zánětlivý syndrom dospělých (běžně používaná anglická zkratka MIS-A). Kazuistika: Popisujeme případ mladého dospělého pacienta s MIS-A s predominantním kardiálním postižením, vstupně s horečkou a známkami akutního levostranného srdečního selhání v souvislosti s recentní infekcí virem SARS-CoV-2. Pacient byl léčen imunomudulační terapií methylprednisolonem a intravenózními imunoglobuliny s promptní úpravou stavu a rychlou normalizací ejekční frakce levé komory.

Background: As a part of world-wide spreading COVID-19 disease pandemic, a life-threatening syndrome affecting predominantly young adults was discovered. This entity usually occurs within 4 weeks after the onset of SARS-CoV-2 infection. The disease is often associated with several organ involvements, including the heart. This newly emerging unit is known as multisystem inflammatory syndrome in adults (MIS-A). Case presentation: We describe a case of a 29-year-old patient with MIS-A with predominant cardiac involvement. At admission the patient experienced fever and signs of acute left-sided heart failure, which was thought to be associated with recent SARS-CoV-2 infection as MIS-A. The patient was treated with immunomodulation therapy including methylprednisolone and intravenous immunoglobulins with prompt improvement of patient's condition and rapid normalization of the left ventricular ejection fraction.

• Klíčová slova
• multisystémový zánětlivý syndrom,
• MeSH
• Aspirin aplikace a dávkování   MeSH
• COVID-19 komplikace   MeSH
• dospělí MeSH
• gadolinium terapeutické užití   MeSH
• intravenózní imunoglobuliny aplikace a dávkování   MeSH
• kombinovaná farmakoterapie MeSH
• lidé MeSH
• methylprednisolon aplikace a dávkování   MeSH
• postakutní syndrom COVID-19 * diagnostické zobrazování   farmakoterapie   patologie   MeSH
• srdce diagnostické zobrazování   MeSH
• srdeční selhání etiologie   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• Publikační typ
• kazuistiky MeSH
• přehledy MeSH

BACKGROUND: The PRAGUE-17 (Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) was noninferior to nonwarfarin direct oral anticoagulants (DOACs) for preventing major neurological, cardiovascular, or bleeding events in patients with atrial fibrillation (AF) who were at high risk. OBJECTIVES: This study sought to assess the prespecified long-term (4-year) outcomes in PRAGUE-17. METHODS: PRAGUE-17 was a randomized noninferiority trial comparing percutaneous LAAC (Watchman or Amulet) with DOACs (95% apixaban) in patients with nonvalvular AF and with a history of cardioembolism, clinically-relevant bleeding, or both CHA2DS2-VASc ≥3 and HASBLED ≥2. The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically relevant bleeding, or procedure-/device-related complications (LAAC group only). The primary analysis was modified intention-to-treat. RESULTS: This study randomized 402 patients with AF (201 per group, age 73.3 ± 7.0 years, 65.7% male, CHA2DS2-VASc 4.7 ±1.5, HASBLED 3.1 ± 0.9). After 3.5 years median follow-up (1,354 patient-years), LAAC was noninferior to DOACs for the primary endpoint by modified intention-to-treat (subdistribution HR [sHR]: 0.81; 95% CI: 0.56-1.18; P = 0.27; P for noninferiority = 0.006). For the components of the composite endpoint, the corresponding sHRs were 0.68 (95% CI: 0.39-1.20; P = 0.19) for cardiovascular death, 1.14 (95% CI: 0.56-2.30; P = 0.72) for all-stroke/transient ischemic attack, 0.75 (95% CI: 0.44-1.27; P = 0.28) for clinically relevant bleeding, and 0.55 (95% CI: 0.31-0.97; P = 0.039) for nonprocedural clinically relevant bleeding. The primary endpoint outcomes were similar in the per-protocol (sHR: 0.80; 95% CI: 0.54-1.18; P = 0.25) and on-treatment (sHR: 0.82; 95% CI: 0.56-1.20; P = 0.30) analyses. CONCLUSIONS: In long-term follow-up of PRAGUE-17, LAAC remains noninferior to DOACs for preventing major cardiovascular, neurological, or bleeding events. Furthermore, nonprocedural bleeding was significantly reduced with LAAC. (PRAGUE-17 [Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation]; NCT02426944).

• MeSH
• cévní mozková příhoda epidemiologie   prevence a kontrola   MeSH
• fibrilace síní terapie   MeSH
• inhibitory faktoru Xa terapeutické užití   MeSH
• krvácení epidemiologie   MeSH
• lidé MeSH
• následné studie MeSH
• prospektivní studie MeSH
• senioři MeSH
• síňové ouško chirurgie   MeSH
• tranzitorní ischemická ataka epidemiologie   prevence a kontrola   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• hodnocení ekvivalence MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH

Autoři prezentují vlastní zkušenosti s použitím litotripse kalcifikovaných pánevních tepen k usnadnění perkutánní implantace chlopně do aortální pozice (TAVI) transfemorálním přístupem.

The authors present a case report of lithotripsy-assisted transfemoral aortic valve implantation (TAVI) in patients with calcified and stenotic pelvic arteries.

• MeSH
• laserová litotripse metody   MeSH
• lidé MeSH
• pánev krevní zásobení   MeSH
• senioři MeSH
• transkatetrální implantace aortální chlopně * metody   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• Publikační typ
• kazuistiky MeSH