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Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria , Paclitaxel , Placa Aterosclerótica , Humanos , Paclitaxel/administración & dosificación , Paclitaxel/uso terapéutico , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Materiales Biocompatibles Revestidos , Resultado del Tratamiento , Stents Liberadores de FármacosRESUMEN
The optimal antithrombotic management of atrial fibrillation (AF) patients who require oral anticoagulation (OAC) undergoing percutaneous coronary intervention (PCI) remains unclear. Current guidelines recommend dual antithrombotic therapy (DAT; OAC plus P2Y12 inhibitor - preferably clopidogrel) after a short course of triple antithrombotic therapy (TAT; DAT plus aspirin). Although DAT reduces bleeding risk compared to TAT, this is counterbalanced by an increase in ischaemic events. Aspirin provides early ischaemic benefit, but TAT is associated with an increased haemorrhagic burden; therefore, we propose a 30-day dual antiplatelet therapy (DAPT; aspirin plus P2Y12 inhibitor) strategy post-PCI, temporarily omitting OAC. The study aims to compare bleeding and ischaemic risk between a 30-day DAPT strategy following PCI and a guideline-directed therapy in AF patients requiring OAC. WOEST-3 (ClinicalTrials.gov: NCT04436978) is an investigator-initiated, international, open-label, randomised controlled trial (RCT). AF patients requiring OAC who have undergone successful PCI will be randomised within 72 hours after PCI to guideline-directed therapy (edoxaban plus P2Y12 inhibitor plus limited duration of aspirin) or a 30-day DAPT strategy (P2Y12 inhibitor plus aspirin, immediately discontinuing OAC) followed by DAT (edoxaban plus P2Y12 inhibitor). With a sample size of 2,000 patients, this trial is powered to assess both superiority for major or clinically relevant non-major bleeding and non-inferiority for a composite of all-cause death, myocardial infarction, stroke, systemic embolism or stent thrombosis. In summary, the WOEST-3 trial is the first RCT temporarily omitting OAC in AF patients, comparing a 30-day DAPT strategy with guideline-directed therapy post-PCI to reduce bleeding events without hampering efficacy.
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Anticoagulantes , Fibrilación Atrial , Hemorragia , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Humanos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Anticoagulantes/efectos adversos , Administración Oral , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/efectos adversos , Hemorragia/inducido químicamente , Aspirina/uso terapéutico , Aspirina/administración & dosificación , Aspirina/efectos adversos , Terapia Antiplaquetaria Doble/métodos , Masculino , Femenino , Anciano , Antagonistas del Receptor Purinérgico P2Y/administración & dosificación , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Antagonistas del Receptor Purinérgico P2Y/uso terapéutico , Resultado del Tratamiento , Persona de Mediana EdadRESUMEN
In the original publication [...].
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BACKGROUND: Patients with previous coronary artery bypass surgery (CABG) who require repeat revascularization frequently undergo percutaneous coronary intervention (PCI). We sought to identify factors associated with the decision to intervene on the native vessel versus a bypass graft and investigate their outcomes in a large nationwide prospective registry. METHODS: We identified patients who underwent PCI with a history of prior CABG from the Netherlands Heart Registration between 2017 and 2021 and stratified them by isolated native vessel PCI versus PCI including at least one venous- or arterial graft. The primary endpoint of major adverse cardiac events (MACE) was a composite of all-cause death and target vessel revascularization (TVR) at one-year post PCI. The key secondary endpoint was a composite of all-cause death, myocardial infarction (MI), and TVR at 30 days. RESULTS: Out of 154,146 patients who underwent PCI, 12,822 (8.3%) had a prior CABG. Isolated native vessel PCI was most frequently performed (75.2%), while an acute coronary syndrome (ACS) presentation was most strongly associated with graft interventions. The primary outcome of MACE at one-year post PCI occurred more frequently in interventions including grafts compared with native vessels alone (19.7% vs. 14.3%; adjOR 1.267; 95% CI 1.101-1.457); p < 0.001) driven by TVR. There was however no difference in mortality or the key secondary endpoint between the two groups. CONCLUSION: In this nationwide prospective registry, ACS presentation was strongly associated with bypass graft PCI. At one year after PCI, interventions including bypass grafts had a higher composite of MACE compared with isolated native vessel interventions.
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Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Sistema de Registros , Humanos , Masculino , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/tendencias , Intervención Coronaria Percutánea/efectos adversos , Femenino , Puente de Arteria Coronaria/efectos adversos , Puente de Arteria Coronaria/tendencias , Países Bajos/epidemiología , Anciano , Persona de Mediana Edad , Estudios Prospectivos , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/cirugía , Resultado del Tratamiento , Estudios de SeguimientoRESUMEN
Patients with non-obstructive lipid-rich plaques (LRPs) on combined intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) are at high risk for future events. Local pre-emptive percutaneous treatment of LRPs with a paclitaxel-eluting drug-coated balloon (PE-DCB) may be a novel therapeutic strategy to prevent future adverse coronary events without leaving behind permanent coronary implants. In this pilot study, we aim to investigate the safety and feasibility of pre-emptive treatment with a PE-DCB of non-culprit non-obstructive LRPs by evaluating the change in maximum lipid core burden in a 4 mm segment (maxLCBImm4) after 9 months of follow up. Therefore, patients with non-ST-segment elevation acute coronary syndrome underwent 3-vessel IVUS-NIRS after treatment of the culprit lesion to identify additional non-obstructive non-culprit LRPs, which were subsequently treated with PE-DCB sized 1:1 to the lumen. We enrolled 45 patients of whom 20 patients (44%) with a non-culprit LRP were treated with PE-DCB. After 9 months, repeat coronary angiography with IVUS-NIRS will be performed. The primary endpoint at 9 months is the change in maxLCBImm4 in PE-DCB-treated LRPs. Secondary endpoints include clinical adverse events and IVUS-derived parameters such as plaque burden and luminal area. Clinical follow-up will continue until 1 year after enrollment. In conclusion, this first-in-human study will investigate the safety and feasibility of targeted pre-emptive PE-DCB treatment of LRPs to promote stabilization of vulnerable coronary plaque at risk for developing future adverse events.
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Graphical AbstractClinical outcomes and treatment adherence during 12 months follow-up. *Second bleeding event in same patient. PCI, percutaneous coronary intervention; TVR, target vessel revascularization.
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BACKGROUND: Early aspirin withdrawal, also known as P2Y12-inhibitor monotherapy, following percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) can reduce bleeding without a trade-off in efficacy. Still the average daily bleeding risk is highest during the first months and it remains unclear if aspirin can be omitted immediately following PCI. METHODS: The LEGACY study is an open-label, multicenter randomized controlled trial evaluating the safety and efficacy of immediate P2Y12-inhibitor monotherapy versus dual antiplatelet therapy (DAPT) for 12 months in 3,090 patients. Patients are randomized immediately following successful PCI for NSTE-ACS to 75-100 mg aspirin once daily versus no aspirin. The primary hypothesis is that immediately omitting aspirin is superior to DAPT with respect to major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, while maintaining noninferiority for the composite of all-cause mortality, myocardial infarction and stroke compared to DAPT. CONCLUSIONS: The LEGACY study is the first randomized study that is specifically designed to evaluate the impact of immediately omitting aspirin, and thus treating patients with P2Y12-inhibitor monotherapy, as compared to DAPT for 12 months on bleeding and ischemic events within 12 months following PCI for NSTE-ACS.
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Síndrome Coronario Agudo , Intervención Coronaria Percutánea , Humanos , Aspirina , Inhibidores de Agregación Plaquetaria/efectos adversos , Síndrome Coronario Agudo/tratamiento farmacológico , Síndrome Coronario Agudo/cirugía , Intervención Coronaria Percutánea/métodos , Quimioterapia Combinada , Hemorragia/inducido químicamente , Resultado del TratamientoRESUMEN
BACKGROUND: Early P2Y12 inhibitor monotherapy has emerged as a promising alternative to 12 months of dual antiplatelet therapy following percutaneous coronary intervention (PCI). AIMS: In this single-arm pilot study, we evaluated the feasibility and safety of ticagrelor or prasugrel monotherapy directly following PCI in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS). METHODS: Patients received a loading dose of ticagrelor or prasugrel before undergoing platelet function testing and subsequent PCI using new-generation drug-eluting stents. The stent result was adjudicated with optical coherence tomography in the first 35 patients. Ticagrelor or prasugrel monotherapy was continued for 12 months. The primary ischaemic endpoint was the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis or stroke within 6 months. The primary bleeding endpoint was Bleeding Academic Research Consortium type 2, 3 or 5 bleeding within 6 months. RESULTS: From March 2021 to March 2022, 125 patients were enrolled, of whom 75 ultimately met all in- and exclusion criteria (mean age 64.5 years, 29.3% women). Overall, 70 out of 75 (93.3%) patients were treated with ticagrelor or prasugrel monotherapy directly following PCI. The primary ischaemic endpoint occurred in 3 (4.0%) patients within 6 months. No cases of stent thrombosis or spontaneous myocardial infarction occurred. The primary bleeding endpoint occurred in 7 (9.3%) patients within 6 months. CONCLUSIONS: This study provides first-in-human evidence that P2Y12 inhibitor monotherapy directly following PCI for NSTE-ACS is feasible, without any overt safety concerns, and highlights the need for randomised controlled trials comparing direct P2Y12 inhibitor monotherapy with the current standard of care.
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Síndrome Coronario Agudo , Infarto del Miocardio , Intervención Coronaria Percutánea , Humanos , Femenino , Persona de Mediana Edad , Masculino , Inhibidores de Agregación Plaquetaria , Clorhidrato de Prasugrel , Síndrome Coronario Agudo/tratamiento farmacológico , Síndrome Coronario Agudo/cirugía , Ticagrelor/uso terapéutico , Intervención Coronaria Percutánea/efectos adversos , Proyectos Piloto , Infarto del Miocardio/terapia , Hemorragia/inducido químicamente , Resultado del TratamientoRESUMEN
BACKGROUND: In order to facilitate fractional flow reserve (FFR)-guided lesion assessment, several 3-dimensional (3D)-angiography-based physiological indices have been recently validated. Thus far, limited data are available on the association of these indices with conventional forms of ischemia testing. AIM: The aim of the study was to determine the association between 3D-angiography-based vessel-FFR (vFFR) and myocardial ischemia as assessed by exercise electrocardiography (ECG) testing, dobutamine stress echocardiography, single photon emission computed tomography myocardial perfusion imaging (SPECTMPI), and stress cardiovascular magnetic resonance imaging (stress CMR). METHODS: FAST ISCHEMIA is a retrospective, single-center cohort study including patients who underwent non-invasive myocardial ischemia testing and subsequent coronary angiography (≤3 months). A total of 145 patients (340 vessels) were analyzed. The overall patient-based sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of vFFR ≤0.80 in any vessel for ischemia was 64% (95% confidence interval [CI], 53-74), 71% (95% CI, 54-84), 83% (95% CI, 72-91), 46% (95% CI, 33-60), 2.16 (95% CI, 1.25-3.74), and 0.52 (95% CI, 0.36-0.74), respectively. Multivariable logistic regression showed that vFFR ≤0.80 was significantly associated with ischemia on a patient level (odds ratio, 8.13; 95% CI, 2.51-30.06; P<.001) and on a vascular territory level (odds ratio, 2.75; 95% CI, 1.17-6.44; P<.01). CONCLUSION: Our study suggests that vFFR ≤0.80 has a modest association with non-invasive myocardial ischemia testing using either exercise ECG or stress imaging modalities. After correcting for independent confounders, vFFR was independently associated with ischemia on a non-invasive myocardial ischemia detection test.
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Enfermedad de la Arteria Coronaria , Estenosis Coronaria , Reserva del Flujo Fraccional Miocárdico , Isquemia Miocárdica , Imagen de Perfusión Miocárdica , Humanos , Reserva del Flujo Fraccional Miocárdico/fisiología , Estudios de Cohortes , Estudios Retrospectivos , Enfermedad de la Arteria Coronaria/diagnóstico , Isquemia Miocárdica/diagnóstico , Angiografía Coronaria/métodos , Valor Predictivo de las Pruebas , Isquemia , Imagen de Perfusión Miocárdica/métodosRESUMEN
INTRODUCTION: P2Y12-inhibitor monotherapy following 1-3 months of dual antiplatelet therapy (DAPT) reduces (major) bleeding without an apparent increase in ischemic events and has therefore emerged as an alternative to 6-12 months of DAPT following percutaneous coronary intervention (PCI). However, there are important differences between the available P2Y12-inhibitors (clopidogrel, prasugrel, and ticagrelor) as agents of choice for P2Y12-inhibitor monotherapy. AREAS COVERED: This review critically appraises the evidence for P2Y12-inhibitor monotherapy after PCI using either clopidogrel, prasugrel, or ticagrelor. Furthermore, we discuss ongoing trials and future directions for research. EXPERT OPINION: P2Y12-inhibitor monotherapy following 1-3 months of DAPT is an alternative to 6-12 months of DAPT following PCI. Ticagrelor may be considered the current preferred option due to its reliable effect on platelet reactivity and its predominant use in clinical trials. Prasugrel could serve as a useful substitute for those not tolerating ticagrelor, but more research into prasugrel monotherapy is warranted. Alternatively, clopidogrel can be used, although there are concerns of high platelet reactivity, especially when genotyping and/or platelet function testing are not used. Future research will need to address the minimal duration of DAPT before switching to P2Y12-inhibitor monotherapy and what the optimal antithrombotic therapy beyond 12 months is.