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
BACKGROUND: Limited empirical evidence is available regarding the effect of technology-assisted cardiac rehabilitation (TACR) among coronary heart disease (CHD) patients with central obesity. AIM: To determine the effects of 12-week TACR on health outcomes of patients with CHD. DESIGN: Two-arm randomized controlled trial. SETTING: Cardiovascular department of a regional hospital. POPULATION: Coronary heart disease patients with central obesity. METHODS: The study randomized 78 hospitalized CHD patients to receive either the 12-week TACR intervention or usual care. Guided by social cognitive theory, the intervention began with an in-person assessment and orientation session to assess and identify individual risks and familiarize with the e-platform/device before discharge. After discharge, patients were encouraged to visit the interactive CR website for knowledge and skills acquisition, data uploading, use the pedometer for daily step tracking, and interact with peers and professionals via social media for problem-solving and mutual support. Data were collected at baseline (T0), six-week (T1), and 12-week (T2). RESULTS: Participants in the intervention group showed significant improvement in daily steps at six weeks but not 12 weeks (T1: β=2713.48, P=0.03; T2:β=2450.70, P=0.08), weekly sitting minutes (T1: β=-665.17, P=0.002; T2: β=-722.29, P=0.02), and total (vigorous, moderate, and walking) exercise at 12-week (β=-2445.99, P=0.008). Improvement in health-promoting lifestyle profile (T1: β=24.9, P<0.001; T2: β=15.50, P<0.001), smoking cessation (T2: β=-2.28, P<0.04), self-efficacy (T2: β=0.63, P=0.02), body mass index (T1:β =-0.97, P=0.03; T2: β=-0.73, P=0.04) and waist circumferences (T1: β =-1.97, P=0.003; T2: β =-3.14, P=0.002) were identified. CONCLUSIONS: Results indicated the effectiveness of the TACR intervention in improving healthy behaviors and anthropometric parameters for CHD patients with central obesity. Individual assessment, collaborative action planning, and ongoing obesity management support should be highlighted in TACR programs for CHD patients. CLINICAL REHABILITATION IMPACT: Central obesity should be assessed and highlighted in TACR intervention as an independent risk factor that requires corresponding behavior change and body fat management.
BACKGROUND: Limited data are available to guide the management of coronary artery aneurysms (CAAs). OBJECTIVES: The authors sought to define the clinical characteristics, identify variables that predict outcomes, and provide long-term data on CAAs. METHODS: We describe outcomes from 1,729 consecutive patients with CAAs included in an ambispective international registry (CAAR [Coronary Artery Aneurysm Registry]; NCT02563626) involving 33 hospitals across 9 countries in America and Europe. RESULTS: Patients were predominantly male (78.6%; 1,359/1,729) with a mean age of 66 years. Classic cardiovascular risk factors were common, as well as coronary artery disease (85.8%; 1,484/1,729), peripheral vascular disease (10.9%; 188/1,729), and chronic kidney disease (8.0%; 138/1,729). The median number of aneurysms per patient was 1.0 (Q1-Q3: 1.0-1.0), with the most affected territory being the left anterior descending artery (49.6%; 857/1,729). The majority underwent any revascularization procedure (68.5%; 1,184/1,729), mainly percutaneous coronary intervention (50.7%; 877/1,729), and were discharged on dual antiplatelet therapy (65.6%; 1,134/1,729). After a median follow-up of 44.8 months (Q1-Q3: 14.9-88.1), 379 died (21.9%), and 641 (37.1%) developed a major adverse cardiovascular event (MACE) (all-cause death, heart failure, unstable angina, and reinfarction). In a multivariable analysis, age (HR: 1.03; 95% CI: 1.02-1.04; P < 0.001), diabetes mellitus (HR: 1.47; 95% CI: 1.23-1.75; P < 0.001), renal insufficiency (HR: 1.53; 95% CI: 1.19-1.96; P = 0.010), peripheral vessel disease (HR: 1.43; 95% CI: 1.13-1.82; P = 0.003), reduced left ventricular ejection fraction (HR: 0.98; 95% CI: 0.98-0.99; P < 0.001), acute indication for the index coronary angiography (HR: 1.30; 95% CI: 1.08-1.55; P = 0.005), and the number of coronary vessels presenting severe stenosis (HR: 1.11; 95% CI: 1.02-1.20; P = 0.015) were independent predictors of MACEs. Remarkably, only 37 patients presented with local aneurysm complications during follow-up. CONCLUSIONS: The long-term prognosis of CAAs is not favorable, with MACEs associated with the underlying risk factor profile for atherosclerotic heart disease.
- MeSH
- časové faktory MeSH
- hodnocení rizik MeSH
- kohortové studie MeSH
- koronární aneurysma * diagnostické zobrazování mortalita terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- registrace * MeSH
- rizikové faktory MeSH
- senioři 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
- multicentrická studie MeSH
- pozorovací studie MeSH
- Geografické názvy
- Evropa MeSH
- Severní Amerika MeSH
OBJECTIVES: To investigate if the effect of cardiac computed tomography (CT) vs. invasive coronary angiography (ICA) on cardiovascular events differs based on smoking status. MATERIALS AND METHODS: This pre-specified subgroup analysis of the pragmatic, prospective, multicentre, randomised DISCHARGE trial (NCT02400229) involved 3561 patients with suspected coronary artery disease (CAD). The primary endpoint was major adverse cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, or stroke). Secondary endpoints included an expanded MACE composite (MACE, transient ischaemic attack, or major procedure-related complications). RESULTS: Of 3445 randomised patients with smoking data (mean age 59.1 years + / - 9.7, 1151 men), at 3.5-year follow-up, the effect of CT vs. ICA on MACE was consistent across smoking groups (p for interaction = 0.98). The percutaneous coronary intervention rate was significantly lower with a CT-first strategy in smokers and former smokers (p = 0.01 for both). A CT-first strategy reduced the hazard of major procedure-related complications (HR: 0.21, 95% CI: 0.03, 0.81; p = 0.045) across smoking groups. In current smokers, the expanded MACE composite was lower in the CT- compared to the ICA-first strategy (2.3% (8) vs 6.0% (18), HR: 0.38; 95% CI: 0.17, 0.88). The rate of non-obstructive CAD was significantly higher in all three smoking groups in the CT-first strategy. CONCLUSION: For patients with stable chest pain referred for ICA, the clinical outcomes of CT were consistent across smoking status. The CT-first approach led to a higher detection rate of non-obstructive CAD and fewer major procedure-related complications in smokers. CLINICAL RELEVANCE STATEMENT: This pre-specified sub-analysis of the DISCHARGE trial confirms that a CT-first strategy in patients with stable chest pain referred for invasive coronary angiography with an intermediate pre-test probability of coronary artery disease is as effective as and safer than invasive coronary angiography, irrespective of smoking status. TRIAL REGISTRATION: ClinicalTrials.gov NCT02400229. KEY POINTS: • No randomised studies have assessed smoking status on CT effectiveness in symptomatic patients referred for invasive coronary angiography. • A CT-first strategy results in comparable adverse events, fewer complications, and increased coronary artery disease detection, irrespective of smoking status. • A CT-first strategy is safe and effective for stable chest pain patients with intermediate pre-test probability for CAD, including never smokers.
- MeSH
- koronární angiografie * metody MeSH
- kouření * škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci koronárních tepen * diagnostické zobrazování komplikace MeSH
- počítačová rentgenová tomografie * metody MeSH
- propuštění pacienta MeSH
- prospektivní studie MeSH
- rizikové faktory MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pragmatická klinická studie MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: The clinical impact of a chronic total occlusion (CTO) in patients with 3-vessel coronary artery disease undergoing fractional flow reserve-guided percutaneous coronary intervention (PCI) with current-generation drug-eluting stents or coronary artery bypass grafting (CABG) is unclear. METHODS: The FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3) compared fractional flow reserve-guided PCI with CABG in patients with 3-vessel coronary artery disease. The primary end point was major adverse cardiac and cerebrovascular events, a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. In this substudy, the 3-year outcomes were analyzed in patients with or without a CTO. RESULTS: Of the patients randomized to PCI or CABG in the FAME 3 trial, 305 (21%) had a CTO. In the PCI arm, revascularization of the CTO was attempted in 61% with a procedural success rate of 88%. The incidence of major adverse cardiac and cerebrovascular events at 3 years was not significantly different between those with or without a CTO in both the PCI (15.2% versus 20.1%; adjusted hazard ratio, 0.62 [95% CI, 0.38-1.03]; P=0.07) and the CABG (13.0% versus 12.9%; adjusted hazard ratio, 0.96 [95% CI, 0.55-1.66]; P=0.88) arms. In those without a CTO, PCI was associated with a significantly higher risk of major adverse cardiac and cerebrovascular events compared with CABG (adjusted hazard ratio, 1.61 [95% CI, 1.20-2.17]; P<0.01) but not in those with a CTO (adjusted hazard ratio, 1.21 [95% CI, 0.64-2.28]; P=0.56; Pinteraction=0.31). CONCLUSIONS: The presence of a CTO did not significantly impact the treatment effect of PCI versus CABG at 3 years in patients with 3-vessel coronary artery disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02100722.
- MeSH
- časové faktory MeSH
- chronická nemoc MeSH
- frakční průtoková rezerva myokardu * MeSH
- koronární angiografie * MeSH
- koronární angioplastika * škodlivé účinky mortalita MeSH
- koronární bypass * škodlivé účinky mortalita MeSH
- koronární okluze * diagnostické zobrazování mortalita terapie patofyziologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci koronárních tepen terapie mortalita diagnostické zobrazování patofyziologie MeSH
- prediktivní hodnota testů MeSH
- rizikové faktory MeSH
- senioři MeSH
- stenty uvolňující léky * 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
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Klíčová slova
- chronické koronární syndromy,
- MeSH
- angina pectoris MeSH
- chronická nemoc MeSH
- lidé MeSH
- nemoci koronárních tepen * diagnóza terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- přehledy MeSH
The retrograde approach in chronic total occlusion (CTO) interventions often encounters significant challenges, particularly, when aligning the retrograde microcatheter (MC) with the antegrade system is difficult, complicating or even preventing standard externalization. To address these issues, techniques like the "tip-in" have proven to be effective backup strategies. We introduce the "Manual Microcatheter-tip Modification" (MMM) technique as an alternative when the "tip-in" method faces complications. We present a case of a left anterior descending CTO where MMM was successfully employed for the first time, enabling successful revascularization by manually modifying the MC tip to engage the retrograde guidewire. We explore the technical details within the framework of contemporary CTO PCI. This new technique could enhance the management of CTO interventions, offering innovative solutions when traditional externalization methods are problematic.
- MeSH
- balónková koronární angioplastika přístrojové vybavení MeSH
- chronická nemoc MeSH
- design vybavení * MeSH
- koronární angiografie * MeSH
- koronární angioplastika přístrojové vybavení MeSH
- koronární okluze * diagnostické zobrazování terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- miniaturizace * MeSH
- senioři MeSH
- srdeční katetrizace přístrojové vybavení MeSH
- srdeční katétry * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
Dual antiplatelet therapy (DAPT) remains the gold standard in patients who underwent percutaneous coronary intervention (PCI). This meta-analysis aims to evaluate the clinical safety of 1-month DAPT followed by aspirin or a P2Y12 receptor inhibitor after PCI with drug-eluting stents (DES). We searched PubMed, MEDLINE, Embase, Scopus, Google Scholar, Cochrane Central Registry, and ClinicalTrials.gov databases and identified 5 randomized controlled trials with 29,831 patients who underwent PCI with DES and compared 1-month versus >1-month DAPT. The primary end point was major bleeding, and the co-primary end point was stent thrombosis. The secondary end point included all-cause mortality, cardiovascular death, myocardial infarction, stroke, and major adverse cardiovascular or cerebrovascular events. Compared with >1-month DAPT, the 1-month DAPT was associated with a lower rate of major bleeding (odds ratio [OR] 0.66, 95% confidence interval [CI] 0.45 to 0.97, p = 0.03, I2 = 71%), whereas stent thrombosis had a similar rate in both study groups (OR 1.08, 95% CI 0.81 to 1.44, p = 0.60, I2 = 0.0%). The study groups had similar risks for all-cause mortality (OR 0.89, 95% CI 0.77 to 1.04, p = 0.14, I2 = 0.0%), cardiovascular death (OR 0.84, 95% CI 0.59 to 1.19, p = 0.32, I2 = 0.0%), myocardial infarction (OR 1.04, 95% CI 0.89 to 1.21, p = 0.62, I2 = 0.0%), and stroke (OR 0.82, 95% CI 0.64 to 1.05, p = 0.11, I2 = 6%). The risk of major adverse cardiovascular or cerebrovascular events was lower (OR 0.86, 95% CI 0.76 to 0.97, p = 0.02, I2 = 25%) in the 1-month DAPT compared with >1-month DAPT. In conclusion, in patients who underwent PCI with DES, 1-month DAPT followed by aspirin or a P2Y12 receptor inhibitor reduced major bleeding with no risk of increased thrombotic risk compared with longer-term DAPT.
- MeSH
- Aspirin aplikace a dávkování škodlivé účinky MeSH
- časové faktory MeSH
- duální protidestičková léčba * škodlivé účinky metody MeSH
- inhibitory agregace trombocytů * aplikace a dávkování škodlivé účinky MeSH
- koronární angioplastika * škodlivé účinky MeSH
- koronární trombóza prevence a kontrola epidemiologie MeSH
- krvácení * chemicky indukované epidemiologie MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- stenty uvolňující léky * škodlivé účinky MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- systematický přehled MeSH
