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
Úvod: Velké intrakoronární tromby u pacientů s infarktem myokardu s elevacemi úseku ST (STEMI) mohou způsobit distální embolizaci, fenomén „no-reflow“ a trombózu stentu. Přibližně u 10 % pacientů podstupujících primární perkutánní koronární intervenci (PCI) dochází k distální embolizaci trombu, což způsobuje mikrovaskulární obstrukci koronárních tepen a snížení perfuze myokardiální tkáně. To může mít za následek přetrvávající ischemii, větší velikost infarktu a významné zvýšení 30denní mortality, a to bez ohledu na úspěšnou PCI s normálním průtokem epikardiálními cévami. Kazuistika: Jedenapadesátiletý muž asijského původu byl přijat s diagnózou STEMI. Koronarografie prokázala velký trombus obturující proximální část levé koronární tepny (ACS). Poté, co opakované pokusy o manuální aspirační trombektomii (MAT) a balonkovou angioplastiku nevedly k obnovení průtoku krve koronárními tepnami, byla provedena katetrizační intrakoronární trombolýza s aplikací streptokinázy. Po úspěšném zavedení stentu zůstal v ACS difuzní reziduální trombus. Angiografické zhodnocení ACS provedené o čtyři dny později prokázalo úplné rozpuštění trombu s průtokem infarktovou tepnou TIMI 3. Diskuze: I když v oblasti léčby intrakoronárního trombu neexistuje zlatý standard, je možné využít kombinace farmakologické a mechanické léčby. MAT by v případě STEMI neměla být používána rutinně, nicméně ve vybraných případech může být užitečná. Katetrizační intrakoronární trombolýza může být bezpečnou a účinnou alternativou reperfuzní strategie, pokud MAT samotnou nedosáhneme dostatečného průtoku krve infarktovou tepnou (IRA). Závěr: Řešení intrakoronárního trombu během PCI je i nadále terapeutickou výzvou, přičemž lepších výsledků lze dosáhnout pomocí agresivního, individuálního přístupu šitého na míru.
Introduction: Large intracoronary thrombus in patients presenting with ST elevation myocardial infarction (STEMI) can cause distal embolization, the no-reflow phenomenon, and stent thrombosis. Approximately 10% of patients undergoing primary percutaneous coronary intervention (PCI) have distal embolization of thrombus, causing coronary microvascular obstruction and reduced myocardial tissue perfusion. This can lead to ongoing ischemia, a larger infarct size, and a significant increase in 30-day mortality, regardless of successful PCI with normal epicardial vessel flow. Case Presentation: A 51-year-old Asian male presented with STEMI. Coronary angiography revealed a large thrombus totally occluding the proximal portion of the right coronary artery (RCA). Catheter-directed intracoronary thrombolysis with streptokinase was performed after multiple attempts at manual aspiration thrombectomy (MAT) and balloon angioplasty had failed to achieve coronary blood flow recovery. After successful stenting, a diffuse residual thrombus remained in the RCA. Evaluation angiography of the RCA performed four days later showed complete thrombus dissolution with thrombolysis in myocardial infarction (TIMI) grade 3 flow. Discussion: While there is no gold-standard therapy to deal with intracoronary thrombus, there are combinations of both pharmacological and mechanical therapies that can be utilized. MAT should not be used routinely in STEMI, but may be helpful in selected cases. Catheter-directed intracoronary thrombolysis can be a safe and effective alternative reperfusion strategy when MAT alone fails to achieve sufficient coronary blood flow in the thrombotic infarct-related artery (IRA). Conclusion: The management of intracoronary thrombus during PCI remains a therapeutic challenge, and an aggressive, case-by-case, tailored approach can lead to improved outcomes.
- MeSH
- antikoagulancia terapeutické užití MeSH
- Asijci MeSH
- fibrinolytika terapeutické užití MeSH
- infarkt myokardu s elevacemi ST úseků chirurgie MeSH
- inhibitory agregace trombocytů terapeutické užití MeSH
- koronární angiografie MeSH
- koronární trombóza * chirurgie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mechanická trombolýza * metody MeSH
- nemoci koronárních tepen chirurgie MeSH
- streptokinasa terapeutické užití MeSH
- trombolytická terapie metody MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
- MeSH
- chronická nemoc MeSH
- katetrizační ablace škodlivé účinky MeSH
- koronární angiografie MeSH
- koronární cévy diagnostické zobrazování MeSH
- koronární vazospasmus * patofyziologie etiologie diagnostické zobrazování MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci koronárních tepen chirurgie patofyziologie MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- dopisy MeSH
- kazuistiky 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
BACKGROUND: Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel coronary disease not involving the left main have shown significantly lower rates of death, myocardial infarction (MI), or stroke after CABG. These studies did not routinely use current-generation drug-eluting stents or fractional flow reserve (FFR) to guide PCI. METHODS: FAME 3 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) is an investigator-initiated, multicenter, international, randomized trial involving patients with 3-vessel coronary artery disease (not involving the left main coronary artery) in 48 centers worldwide. Patients were randomly assigned to receive FFR-guided PCI using zotarolimus drug-eluting stents or CABG. The prespecified key secondary end point of the trial reported here is the 3-year incidence of the composite of death, MI, or stroke. RESULTS: A total of 1500 patients were randomized to FFR-guided PCI or CABG. Follow-up was achieved in >96% of patients in both groups. There was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI compared with CABG (12.0% versus 9.2%; hazard ratio [HR], 1.3 [95% CI, 0.98-1.83]; P=0.07). The rates of death (4.1% versus 3.9%; HR, 1.0 [95% CI, 0.6-1.7]; P=0.88) and stroke (1.6% versus 2.0%; HR, 0.8 [95% CI, 0.4-1.7]; P=0.56) were not different. MI occurred more frequently after PCI (7.0% versus 4.2%; HR, 1.7 [95% CI, 1.1-2.7]; P=0.02). CONCLUSIONS: At 3-year follow-up, there was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI with current-generation drug-eluting stents compared with CABG. There was a higher incidence of MI after PCI compared with CABG, with no difference in death or stroke. These results provide contemporary data to allow improved shared decision-making between physicians and patients with 3-vessel coronary artery disease. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02100722.
- MeSH
- cévní mozková příhoda * epidemiologie etiologie MeSH
- frakční průtoková rezerva myokardu * MeSH
- infarkt myokardu * MeSH
- koronární angioplastika * škodlivé účinky MeSH
- koronární bypass škodlivé účinky MeSH
- lidé MeSH
- následné studie MeSH
- nemoci koronárních tepen * chirurgie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
Atherosclerosis is the most common cause of coronary steno-occlusive disease and acute myocardial infarction is the leading cause of death in industrialized countries. In patients with acute ST elevation myocardial infarction (STEMI), there is unquestionable evidence that primary percutaneous coronary intervention providing recanalization of the infarct related artery (IRA) is the preferred reperfusion strategy. Nevertheless, up to 50% of patients with STEMI have multivessel coronary artery disease defined as at least 50% stenosis exclusive of IRA. There is conflicting data regarding the optimal treatment strategy and timing in such patients. Currently, it is assumed that stable patients might benefit from complete revascularization particularly in reducing the need for future unplanned procedures but only culprit lesion should be treated during index procedure in unstable patients. In this article, we provide a comprehensive overview of this important and currently highly debated topic.
- MeSH
- akutní koronární syndrom * etiologie chirurgie MeSH
- infarkt myokardu s elevacemi ST úseků * etiologie chirurgie MeSH
- infarkt myokardu * MeSH
- koronární angioplastika * škodlivé účinky MeSH
- lidé MeSH
- nemoci koronárních tepen * komplikace chirurgie MeSH
- srdeční arytmie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
(1) Background: C1q TNF-related protein 3 (CTRP3) is an adipokine with anti-inflammatory and cardioprotective properties. In our study, we explored changes in serum CTRP3 and its gene expression in epicardial (EAT) and subcutaneous (SAT) adipose tissue in patients with and without coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) undergoing elective cardiac surgery. (2) Methods: SAT, EAT, and blood samples were collected at the start and end of surgery from 34 patients: (i) 11 without CAD or T2DM, (ii) 14 with CAD and without T2DM, and (iii) 9 with both CAD and T2DM. mRNA levels of CTRP3 were assessed by quantitative reverse transcription PCR. Circulating levels of CTRP3 and other factors were measured using ELISA and Luminex Multiplex commercial kits. (3) Results: Baseline plasma levels of TNF-α and IL6 did not differ among the groups and increased at the end of surgery. Baseline circulating levels of CTRP3 did not differ among the groups and decreased after surgery. In contrast, baseline CTRP3 mRNA levels in EAT were significantly decreased in CAD/T2DM group, while no differences were found for TNF-α and IL6 gene expression. (4) Conclusions: Our data suggest that decreased EAT mRNA levels of CTRP3 could contribute to higher risk of atherosclerosis in patients with CAD and T2DM.
- MeSH
- diabetes mellitus 2. typu * komplikace genetika chirurgie MeSH
- interleukin-6 metabolismus MeSH
- kardiochirurgické výkony * MeSH
- lidé MeSH
- messenger RNA metabolismus MeSH
- nemoci koronárních tepen * komplikace genetika chirurgie MeSH
- perikard metabolismus MeSH
- TNF-alfa genetika metabolismus MeSH
- tuková tkáň metabolismus MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- MeSH
- anomálie koronárních cév * diagnóza chirurgie MeSH
- cévní píštěle * diagnóza chirurgie MeSH
- lidé MeSH
- nemoci koronárních tepen * diagnóza chirurgie MeSH
- píštěle * MeSH
- septální okluder * MeSH
- srdeční katetrizace MeSH
- vrozené srdeční vady * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Kontrastem indukovaná nefropatie je asociována s horšími klinickými výsledky u pacientů podstupujících koronární intervence. Největší riziko je pak u pacientů s pokročilou chronickou renální insuficiencí. Vzhledem k rostoucí četnosti intervenčních zákroků i u výrazně polymorbidních pacientů je snaha najít moderní přístupy redukující množství podané kontrastní látky téměř na absolutní minimum. Autoři zde prezentují kazuistiku 68letého pacienta s chronickou renální insuficiencí vyžadující elektivní perkutánní koronární intervenci (PCI) pro nález významné léze na ramus interventricularis anterior. Důraz při této intervenci byl kladen na maximální redukci množství kontrastní látky během PCI, při které bylo využito přesného posouzení koronárního postižení pomocí intrakoronárního ultrazvuku jako alternativy konvenčně vedené intervence ("IVUS‐zero PCI"). Dle našeho průzkumu literatury se jednalo o první takovou intervenci na území České republiky.
Contrast induced nephropathy is associated with worse clinical outcome in patients undergoing coronary intervention. The most profound risk factor is advanced chronic renal insufficiency. Due to the increasing number of coronary interventions on severally ill patients, there is a need of modern therapeutic approach that could reduce the volume of contrast media to minimum or even zero. Herein, the authors present a case report of a 68-year-old patient with chronic kidney disease, who required elective coronary intervention (PCI) due to a significant lesion of the left anterior descending coronary artery. During this intervention, maximum emphasis was given on reduction of contrast media. To the best of our knowledge, this was the first similar intervention performed in the Czech Republic. Minimum contrast PCI guided by the intracoronary ultrasound, i.e. the IVUS-guided zero-contrast PCI may serve as a potential alternative to standard, angiography-guided PCI.
- MeSH
- chronická renální insuficience komplikace MeSH
- intervenční ultrasonografie * metody MeSH
- kontrastní látky terapeutické užití MeSH
- koronární angioplastika * metody MeSH
- koronární cévy chirurgie zranění MeSH
- lidé MeSH
- nemoci koronárních tepen chirurgie MeSH
- poranění cév chirurgie MeSH
- rizikové faktory MeSH
- senioři MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- kazuistiky MeSH
- práce podpořená grantem MeSH