RESUMEN
AIMS: The role of coronary calcification on clinical outcomes among different revascularization strategies in patients presenting with acute coronary syndromes (ACSs) has been rarely investigated. The aim of this investigation is to evaluate the role of coronary calcification, detected by coronary angiography, in the whole spectrum of patients presenting with acute ACS. METHODS AND RESULTS: The present study was a post hoc analysis of the MATRIX programme. The primary endpoint was major adverse cardiovascular events (MACE), defined as the composite of all-cause mortality, myocardial infarction (MI), or stroke up to 365 days. Among the 8404 patients randomized in the MATRIX trial, data about coronary calcification were available in 7446 (88.6%) and therefore were included in this post hoc analysis. Overall, 875 patients (11.7%) presented with severe coronary calcification, while 6571 patients (88.3%) did not present severe coronary calcification on coronary angiography. Fewer patients with severe coronary calcification underwent percutaneous coronary intervention whereas coronary artery bypass grafting or medical therapy-only was more frequent compared with patients without severe calcification. At 1-year follow-up, MACE occurred in 237 (27.1%) patients with severe calcified coronary lesions and 985 (15%) patients without severe coronary calcified lesions [hazard ratio (HR) 1.91; 95% confidence interval (CI) 1.66-2.20, P < 0.001]. All-cause mortality was 8.6% in patients presenting with and 3.7% in those without severe coronary calcification (HR 2.38, 1.84-3.09, P < 0.001). Patients with severe coronary calcification incurred higher rate of MI (20.1% vs. 11.5%, HR 1.81; 95% CI 1.53-2.1, P < 0.001) and similar rate of stroke (0.8% vs. 0.6%, HR 1.35; 95% CI 0.61-3.02, P = 0.46). CONCLUSION: Patients with ACS and severe coronary calcification, as compared to those without, are associated with worse clinical outcomes irrespective of the management strategy.
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Síndrome Coronario Agudo , Enfermedad de la Arteria Coronaria , Humanos , Síndrome Coronario Agudo/complicaciones , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/epidemiología , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Infarto del Miocardio/complicaciones , Intervención Coronaria Percutánea/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Accidente Cerebrovascular/etiología , Resultado del TratamientoRESUMEN
AIMS: The impact of reperfusion delay in ST-elevation myocardial infarction (STEMI) is well known. We aimed to describe the specific reasons for delay to primary percutaneous coronary intervention (pPCI), and their impact on mortality after adjusting for confounders, using the first-medical-contact-to-device (FMCTD) time to measure the delay. METHODS: Between January 2006 and December 2019, 2149 STEMI patients underwent pPCI at our centre. Delayed pPCI was defined as FMCTDâ>â90âmin orâ>â120âmin in the case of inter-hospital transfer. The causes of delay were classified as system-related (related to the network organization) or patient-related (related to the clinical condition of the patient). Primary outcome was 1-year all-cause mortality. RESULTS: The pPCI was timely in 69.9% of patients, delayed for system-related causes in 16.4% or for patient-related causes in 13.7%. Different patient-related causes induced variable median FMCTD time (from 114 min for technically difficult pPCI to 159 min for ECG and/or symptom resolution). By multivariable Cox-regression models, the main independent risk factors for mortality were delay due to comorbidities [hazard ratio (HR) 2.19 (1.22-3.91)], or hemodynamic instability [HR 2.05 (1.25-3.38)], after adjusting for Global Registry of Acute Coronary Events risk score tertiles and angiographic success. The difference in risk of mortality is maintained over the entire spectrum of time from symptom onset. CONCLUSIONS: Different causes of delay had different impacts on mortality, generally more important than the length of the delay. Causes of delay such as hemodynamic instability and comorbidities should prompt specific programs of performance improvement. Timely pPCI maintains prognostic advantages after several hours from symptom onset, mandating prompt reperfusion also in late-presenter patients.
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Reperfusión Miocárdica/métodos , Intervención Coronaria Percutánea , Sistema de Registros , Infarto del Miocardio con Elevación del ST/cirugía , Tiempo de Tratamiento , Anciano , Causas de Muerte/tendencias , Femenino , Estudios de Seguimiento , Humanos , Italia/epidemiología , Masculino , Pronóstico , Estudios Prospectivos , Infarto del Miocardio con Elevación del ST/mortalidad , Infarto del Miocardio con Elevación del ST/fisiopatología , Tasa de Supervivencia/tendencias , Factores de TiempoRESUMEN
Under-expanded coronary stent related to inadequate preparation of calcified lesion is associated with poor clinical outcomes.Off-label use of S-IVL to correct this clinical issue is effective and safe, probably more than other current techniques. However, this statement needs further evidence.
RESUMEN
This paper presents an architecture which has been developed in order to integrate a routinely used cardiologic EHR system into the health information infrastructure system of the region where the EHR is used. A Service Oriented Approach based on HL7 and FHIR was used, achieving interoperability, security and confidentiality at all levels. The system has been used for about a year and has brought about significant improvements in the provision of care.
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Registros Electrónicos de Salud , Sistemas de Información en SaludRESUMEN
BACKGROUND: The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) programme was designed to assess the comparative safety and effectiveness of radial versus femoral access and of bivalirudin versus unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors in patients with the whole spectrum of acute coronary syndrome undergoing invasive management. Here we describe the prespecified final 1-year outcomes of the entire programme. METHODS: MATRIX was a programme of three nested, randomised, multicentre, open-label, superiority trials in patients with acute coronary syndrome in 78 hospitals in Italy, the Netherlands, Spain, and Sweden. Patients with ST-elevation myocardial infarction were simultaneously randomly assigned (1:1) before coronary angiography to radial or femoral access and to bivalirudin, with or without post-percutaneous coronary intervention infusion or unfractionated heparin (one-step inclusion). Patients with non-ST-elevation acute coronary syndrome were randomly assigned (1:1) before coronary angiography to radial or femoral access and, only if deemed eligible to percutaneous coronary intervention after angiography (two-step inclusion), entered the antithrombin type and treatment duration programmes. Randomisation sequences were computer generated, blocked, and stratified by intended new or current use of P2Y12 inhibitor (clopidogrel vs ticagrelor or prasugrel), and acute coronary syndrome type (ST-elevation myocardial infarction, troponin-positive, or troponin-negative non-ST-elevation acute coronary syndrome). Bivalirudin was given as a bolus of 0·75 mg/kg, followed immediately by an infusion of 1·75 mg/kg per h until completion of percutaneous coronary intervention. Heparin was given at 70-100 units per kg in patients not receiving glycoprotein IIb/IIIa inhibitors, and at 50-70 units per kg in patients receiving glycoprotein IIb/IIIa inhibitors. Clinical follow-up was done at 30 days and 1 year. Co-primary outcomes for MATRIX access and MATRIX antithrombin type were major adverse cardiovascular events, defined as the composite of all-cause mortality, myocardial infarction, or stroke up to 30 days; and net adverse clinical events, defined as the composite of non-coronary artery bypass graft-related major bleeding, or major adverse cardiovascular events up to 30 days. The primary outcome for MATRIX treatment duration was the composite of urgent target vessel revascularisation, definite stent thrombosis, or net adverse clinical events up to 30 days. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01433627. FINDINGS: Between Oct 11, 2011, and Nov 7, 2014, we randomly assigned 8404 patients to receive radial (4197 patients) or femoral (4207 patients) access. Of these 8404 patients, 7213 were included in the MATRIX antithrombin type study and were randomly assigned to bivalirudin (3610 patients) or heparin (3603 patients). Patients assigned to bivalirudin were included in the MATRIX treatment duration study, and were randomly assigned to post-procedure infusion (1799 patients) or no post-procedure infusion (1811 patients). At 1 year, major adverse cardiovascular events did not differ between patients assigned to radial access compared with those assigned to femoral access (14·2% vs 15·7%; rate ratio 0·89, 95% CI 0·80-1·00; p=0·0526), but net adverse clinical events were fewer with radial than with femoral access (15·2% vs 17·2%; 0·87, 0·78-0·97; p=0·0128). Compared with heparin, bivalirudin was not associated with fewer major adverse cardiovascular (15·8% vs 16·8%; 0·94, 0·83-1·05; p=0·28) or net adverse clinical events (17·0% vs 18·4%; 0·91, 0·81-1·02; p=0·10). The composite of urgent target vessel revascularisation, stent thrombosis, or net adverse clinical events did not differ with or without post-procedure bivalirudin infusion (17·4% vs 17·4%; 0·99, 0·84-1·16; p=0·90). INTERPRETATION: In patients with acute coronary syndrome, radial access was associated with lower rates of net adverse clinical events compared with femoral access, but not major adverse cardiovascular events at 1 year. Bivalirudin with or without post-procedure infusion was not associated with lower rates of major adverse cardiovascular events or net adverse clinical events. Radial access should become the default approach in acute coronary syndrome patients undergoing invasive management. FUNDING: Italian Society of Invasive Cardiology, The Medicines Company, Terumo, amd Canada Research Chairs Programme.
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Síndrome Coronario Agudo/cirugía , Anticoagulantes/administración & dosificación , Antitrombinas/administración & dosificación , Arteria Femoral , Heparina/administración & dosificación , Hirudinas/administración & dosificación , Fragmentos de Péptidos/administración & dosificación , Intervención Coronaria Percutánea/métodos , Arteria Radial , Síndrome Coronario Agudo/complicaciones , Síndrome Coronario Agudo/diagnóstico por imagen , Anciano , Anticoagulantes/efectos adversos , Antitrombinas/efectos adversos , Angiografía Coronaria , Femenino , Hemorragia/inducido químicamente , Heparina/efectos adversos , Hirudinas/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Mortalidad , Infarto del Miocardio/etiología , Fragmentos de Péptidos/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Atención Perioperativa , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/antagonistas & inhibidores , Falla de Prótesis/etiología , Proteínas Recombinantes/administración & dosificación , Proteínas Recombinantes/efectos adversos , Stents/efectos adversos , Accidente Cerebrovascular/etiologíaRESUMEN
BACKGROUND: The RAD-MATRIX trial reported a large operator radiation exposure variability in right radial percutaneous coronary procedures. The reasons of these differences are not well understood. Our aim was to appraise the determinants of operator radiation exposure during coronary right transradial procedures. METHODS: Patient arrangement during transradial intervention was investigated across operators involved in the RAD-MATRIX trial. Operator radiation exposure was analyzed according to the position of the patient right arm (close or far from the body) and in relation to the size of the upper leaded glass. RESULTS: Among the 14 operators who agreed to participate, there was a greater than 10-fold difference in radiation dose at thorax level (from 21.5 to 267 µSv) that persisted after normalization by dose-area product (from 0.35 to 3.5 µSv/Gy*cm2). Among the operators who positioned the instrumented right arm far from the body (110.4 µSv, interquartile range 71.5-146.5 µSv), thorax dose was greater than that in those who placed the instrumented arm close to the right leg (46.1 µSv, 31.3-56.8 µSv, P = .02). This difference persisted after normalization by dose-area product (P = .028). The use of a smaller full glass shield was also associated with a higher radiation exposure compared with a larger composite shield (147.5 and 60 µSv, respectively, P = .016). CONCLUSIONS: In the context of the biggest radiation study conducted in patients undergoing transradial catheterization, the instrumented right arm arrangement close to the leg and greater upper leaded shield dimensions were associated with a lower operator radiation exposure. Our findings emphasize the importance of implementing simple preventive measures to mitigate the extra risks of radiation exposure with right radial as compared with femoral access.
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Exposición Profesional/efectos adversos , Salud Laboral , Intervención Coronaria Percutánea/efectos adversos , Exposición a la Radiación/efectos adversos , Protección Radiológica/métodos , Infarto del Miocardio con Elevación del ST/terapia , Anciano , Femenino , Arteria Femoral , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/métodos , Arteria Radial , Dosis de Radiación , Radiometría/métodos , Administración de la Seguridad , Estadísticas no ParamétricasRESUMEN
BACKGROUND: It remains unclear whether radial access increases the risk of operator or patient radiation exposure compared to transfemoral access when performed by expert operators. OBJECTIVES: This study sought to determine whether radial access increases radiation exposure. METHODS: A total of 8,404 patients, with or without ST-segment elevation acute coronary syndrome, were randomly assigned to radial or femoral access for coronary angiography and percutaneous intervention, and collected fluoroscopy time and dose-area product (DAP). RAD-MATRIX is a radiation sub-study of the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) trial. We anticipated that 13 or more operators, each wearing a thorax (primary endpoint), wrist, and head (secondary endpoints) lithium fluoride thermoluminescent dosimeter, and randomizing at least 13 patients per access site, were needed to establish noninferiority of radial versus femoral access. RESULTS: Among 18 operators, performing 777 procedures in 767 patients, the noninferiority primary endpoint was not achieved (p value for noninferiority = 0.843). Operator equivalent dose at the thorax (77 µSv) was significantly higher with radial than femoral access (41 µSv; p = 0.02). After normalization of operator radiation dose by fluoroscopy time or DAP, the difference remained significant. Radiation dose at wrist or head did not differ between radial and femoral access. Thorax operator dose did not differ for right radial (84 µSv) compared to left radial access (52 µSv; p = 0.15). In the overall MATRIX population, fluoroscopy time and DAP were higher with radial compared to femoral access: 10 min versus 9 min (p < 0.0001) and 65 Gy·cm2 versus 59 Gy·cm2 (p = 0.0001), respectively. CONCLUSIONS: Compared to femoral access, radial access is associated with greater operator and patient radiation exposure when performed by expert operators in current practice. Radial operators and institutions should be sensitized towards radiation risks and adopt adjunctive radioprotective measures. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX; NCT101433627).
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Síndrome Coronario Agudo/diagnóstico , Cateterismo Periférico , Angiografía Coronaria , Arteria Femoral , Exposición Profesional/prevención & control , Intervención Coronaria Percutánea , Arteria Radial , Exposición a la Radiación/prevención & control , Protección Radiológica/métodos , Adulto , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/métodos , Angiografía Coronaria/efectos adversos , Angiografía Coronaria/métodos , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/cirugía , Fluoroscopía/efectos adversos , Fluoroscopía/métodos , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Necesidades , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Arteria Radial/diagnóstico por imagen , Arteria Radial/cirugía , Radiografía Intervencional/efectos adversos , Radiografía Intervencional/métodos , Gestión de Riesgos/organización & administración , Factores de TiempoRESUMEN
BACKGROUND: Through contemporary literature, the optimal strategy to manage coronary chronic total occlusions (CTOs) remains under debate. OBJECTIVES: The aim of the Italian Registry of Chronic Total Occlusions (IRCTO) was to provide data on prevalence, characteristics, and outcome of CTO patients according to the management strategy. METHODS: The IRCTO is a prospective real world multicentre registry enrolling patients showing at least one CTO. Clinical and angiographic data were collected independently from the therapeutic strategy [optimal medical therapy (MT), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)]; a comparative 1-year clinical follow-up was performed. RESULTS: A total of 1777 patients were enrolled for an overall CTO prevalence of 13.3%. The adopted therapeutic strategies were as follows: MT in 826 patients (46.5%), PCI in 776 patients (43.7%), and CABG in the remaining 175 patients (9.8%). At 1-year follow-up, patients undergoing PCI showed lower rate of major adverse cardiac and cerebrovascular events (MACCE) (2.6% vs. 8.2% and vs. 6.9%; P < 0.001 and P < 0.01) and cardiac death (1.4% vs. 4.7% and vs. 6.3%; P < 0.001 and P < 0.001) in comparison with those treated with MT and CABG, respectively. After propensity score-matching analysis, patients treated with PCI showed lower incidence of cardiac death (1.5 vs. 4.4%; P < 0.001), acute myocardial infarction (1.1 vs. 2.9%; P = 0.03), and re-hospitalization (2.3 vs. 4.4% P = 0.04) in comparison with those managed by MT. CONCLUSIONS: Our data showed how CTO PCI might significantly improve the survival and decrease MACCE occurrence at 1 year follow-up in comparison with MT and/or CABG.
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Oclusión Coronaria/terapia , Anciano , Fármacos Cardiovasculares/uso terapéutico , Enfermedad Crónica , Angiografía Coronaria/mortalidad , Puente de Arteria Coronaria/mortalidad , Puente de Arteria Coronaria/estadística & datos numéricos , Oclusión Coronaria/mortalidad , Femenino , Humanos , Italia/epidemiología , Masculino , Intervención Coronaria Percutánea/mortalidad , Intervención Coronaria Percutánea/estadística & datos numéricos , Prevalencia , Estudios Prospectivos , Sistema de Registros , Resultado del Tratamiento , Disfunción Ventricular Izquierda/mortalidad , Disfunción Ventricular Izquierda/terapiaRESUMEN
BACKGROUND: Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. METHODS: We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. RESULTS: The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34). CONCLUSIONS: In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).
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Síndrome Coronario Agudo/tratamiento farmacológico , Anticoagulantes/uso terapéutico , Heparina/uso terapéutico , Fragmentos de Péptidos/uso terapéutico , Síndrome Coronario Agudo/mortalidad , Anciano , Anticoagulantes/efectos adversos , Terapia Combinada , Trombosis Coronaria/prevención & control , Femenino , Heparina/efectos adversos , Hirudinas/efectos adversos , Humanos , Incidencia , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Fragmentos de Péptidos/efectos adversos , Intervención Coronaria Percutánea/estadística & datos numéricos , Proteínas Recombinantes/efectos adversos , Proteínas Recombinantes/uso terapéutico , Stents , Accidente Cerebrovascular/epidemiologíaRESUMEN
A 63-year-old man was admitted with a clinical diagnosis of acute coronary syndrome (non-ST-segment elevation), characterized by regional hypokinesia of the left ventricular posterior and lateral walls and by positive cardiac biomarkers. The coronary angiogram showed a 12.5-mm-diameter aneurysm with a mural thrombus and possible distal embolism to the bifurcation of the left circumflex coronary artery and the 2nd marginal branch. The aneurysm was managed percutaneously by implanting 2 mesh-covered stents in accordance with the "simultaneous kissing stent" technique. Follow-up angiography and optical coherence tomography at 5 postprocedural months documented complete sealing of the aneurysm and diffuse in-stent restenosis. No sign of ischemia occurred during the subsequent follow-up.
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Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Aneurisma Coronario/terapia , Stents Liberadores de Fármacos , Angioplastia Coronaria con Balón/efectos adversos , Aneurisma Coronario/diagnóstico , Angiografía Coronaria , Reestenosis Coronaria/etiología , Humanos , Masculino , Persona de Mediana Edad , Neointima , Diseño de Prótesis , Tomografía de Coherencia Óptica , Resultado del TratamientoRESUMEN
Acute kidney injury (AKI) is an important complication of both diagnostic cardiac catheterization and percutaneous coronary intervention (PCI). A large body of evidence supports that AKI is related to volume of contrast used. Despite several measures are available to reduce the impact of contrast media on AKI, its incidence remains significant as other mechanisms of renal damage are involved. A new paradigm is established according to which bleeding prevention is at least as important as preventing recurrent ischemic events in the management of patients with acute coronary syndromes (ACS) undergoing an invasive approach. Periprocedural bleeding, which is consistently reduced by radial approach, is emerging as a risk factor for the development of AKI. Therefore, the role of vascular access as a measure to prevent AKI needs to be systematically assessed in randomized studies. To date, no prospective comparison on renal outcomes has been carried out in randomized trials between radial and femoral approach. The Minimizing Adverse hemorrhagic events by TRansradial access site and systemic Implementation of AngioX (MATRIX) trial (ClinicalTrials.gov identifier: NCT01433627) has been designed to test whether to minimize bleeding events by using radial access and bivalirudin, across the whole spectrum of patients with ACS undergoing PCI, will result in improved outcomes with respect to both ischemic and bleeding complications. The AKI-MATRIX sub-study will provide a unique opportunity to assess whether the advantages of radial approach may even contribute to the reduction of the risk of AKI in patients with ACS.
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Síndrome Coronario Agudo/terapia , Lesión Renal Aguda/prevención & control , Antitrombinas/administración & dosificación , Cateterismo Periférico/métodos , Hemorragia/prevención & control , Hirudinas/administración & dosificación , Fragmentos de Péptidos/administración & dosificación , Intervención Coronaria Percutánea/métodos , Arteria Radial , Síndrome Coronario Agudo/diagnóstico por imagen , Síndrome Coronario Agudo/mortalidad , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/etiología , Lesión Renal Aguda/mortalidad , Antitrombinas/efectos adversos , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/mortalidad , Protocolos Clínicos , Medios de Contraste/efectos adversos , Angiografía Coronaria/efectos adversos , Hemorragia/diagnóstico , Hemorragia/etiología , Hemorragia/mortalidad , Hirudinas/efectos adversos , Humanos , Incidencia , Fragmentos de Péptidos/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Estudios Prospectivos , Punciones , Arteria Radial/diagnóstico por imagen , Proteínas Recombinantes/administración & dosificación , Proteínas Recombinantes/efectos adversos , Proyectos de Investigación , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. METHODS: We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627. FINDINGS: We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74-0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73-0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49-0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53-0·99; p=0·045). INTERPRETATION: In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. FUNDING: The Medicines Company and Terumo.
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Síndrome Coronario Agudo/cirugía , Cateterismo Periférico/métodos , Arteria Femoral , Intervención Coronaria Percutánea/métodos , Arteria Radial , Síndrome Coronario Agudo/mortalidad , Anciano , Pérdida de Sangre Quirúrgica/mortalidad , Pérdida de Sangre Quirúrgica/prevención & control , Cateterismo Periférico/efectos adversos , Causas de Muerte , Angiografía Coronaria , Femenino , Humanos , Masculino , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
OBJECTIVES: This study sought to describe the change of first choice access site from transfemoral (TF) to transradial (TR) in primary percutaneous coronary intervention (pPCI) in a single center. BACKGROUND: TR-pPCI, when performed by experienced operators, can reduce bleeding events and improve clinical outcome. However, little is known about the learning curve of TR-pPCI and the results obtained by less experienced operators. METHODS: Time to reperfusion, contrast and radiation doses, and 30-day clinical events were evaluated. The relationship between operator experience and procedural results was assessed. RESULTS: During 6.5 years, 1,045 patients with STEMI underwent pPCI. The rate of TR-pPCI increased gradually from about 40% to 90% and remained stable thereafter. The crossover from TR to TFpPCI occurred in 4.6% of patients and was not related to the operator experience. Patients selected for TR-pPCI had a lower risk profile and lower incidence of 30-day mortality and bleeding events. Time to reperfusion, contrast volume, fluoroscopy time, and angiographic success was not significantly different between the 2 vascular approaches, nor was it associated to the operator experience. At roughly 200 PCIs as operator experience, a slight adjusted reduction in the time form first coronary angiogram to balloon was detected with both vascular approaches. CONCLUSIONS: A progressive transition from TF to TR-pPCI could be implemented over a 4-year period without increasing overall treatment delay. The impact of operator experience on procedural results appeared to be modest and it did not differ in the study access groups.
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Arteria Femoral , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea/métodos , Arteria Radial , Anciano , Anciano de 80 o más Años , Competencia Clínica , Femenino , Humanos , Curva de Aprendizaje , MasculinoAsunto(s)
Lesión Renal Aguda/prevención & control , Poscondicionamiento Isquémico/métodos , Infarto del Miocardio/cirugía , Intervención Coronaria Percutánea/efectos adversos , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/etiología , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnósticoRESUMEN
BACKGROUND: Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue. Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access. METHODS: The randomized multicentre MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site (transfemoral vs. transradial) and to the anticoagulant therapy (bivalirudin vs. heparin). Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access. For each access we evaluate the radiation dose absorbed at wrist, at thorax and at eye level. Consequently the operator is equipped with three sets (transfemoral, right transradial or left transradial access) of three different dosimeters (wrist, thorax and eye dosimeter). Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax. An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach. Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach. A further randomization for the radial approach is performed to compare right and left transradial access. CONCLUSIONS: The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes.
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Síndrome Coronario Agudo/diagnóstico por imagen , Síndrome Coronario Agudo/terapia , Cateterismo Cardíaco/métodos , Cateterismo Periférico/métodos , Angiografía Coronaria , Arteria Femoral/diagnóstico por imagen , Hemorragia/prevención & control , Exposición Profesional , Intervención Coronaria Percutánea/métodos , Arteria Radial/diagnóstico por imagen , Dosis de Radiación , Radiografía Intervencional , Proyectos de Investigación , Absorción de Radiación , Anticoagulantes/efectos adversos , Cateterismo Cardíaco/efectos adversos , Cateterismo Periférico/efectos adversos , Protocolos Clínicos , Angiografía Coronaria/efectos adversos , Europa (Continente) , Hemorragia/etiología , Heparina/efectos adversos , Hirudinas/efectos adversos , Humanos , Exposición Profesional/efectos adversos , Salud Laboral , Fragmentos de Péptidos/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Radiografía Intervencional/efectos adversos , Proteínas Recombinantes/efectos adversos , Factores de Riesgo , Dosimetría Termoluminiscente , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Serum cystatin C (Cys-C), a good marker of renal function, predicts prognosis in non-ST-elevation acute coronary syndromes (NSTE-ACS). However, no data are available on the time course of Cys-C values after discharge. In this study, Cys-C was measured during admission (ACS sample) and 6 weeks after discharge, and was correlated with troponin (c-TNT), high-sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6) and the N-terminal portion of the pro-brain natriuretic peptide (proBNP) peptide (NT-proBNP) in a highly selected homogeneous group of NSTE-ACS patients. METHODS: In this prospective, multicentre study, patients with a first NSTE-ACS, single-vessel disease and successful percutaneous coronary interventions (PCIs) had their sera collected, aliquoted and stored at the enrolling site and then shipped for analysis to the clinical chemistry core laboratory. RESULTS: Cys-C values slightly, but significantly, increased from the ACS samples to the 6-week samples. In contrast, hsCRP, NT-proBNP and IL-6 values significantly decreased from the ACS to the 6-week sample. Patients with elevated c-TNT levels had higher hsCRP, NT-proBNP and IL-6 values than patients with normal c-TNT levels in the ACS sample, whereas Cys-C levels were similar in patients with and without elevated c-TNT. Cys-C was highly correlated with estimated glomerular filtration rate in both the ACS and 6-week samples. CONCLUSIONS: In contrast to inflammatory and biochemical stress markers, Cys-C is not affected by the occurrence of myocardial necrosis or by acute left-ventricular impairment, being a reliable marker of renal function during NSTE-ACS.
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Síndrome Coronario Agudo/sangre , Cistatina C/sangre , Mediadores de Inflamación/sangre , Infarto del Miocardio/sangre , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/fisiopatología , Síndrome Coronario Agudo/terapia , Biomarcadores/sangre , Proteína C-Reactiva/metabolismo , Femenino , Humanos , Interleucina-6/sangre , Italia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/fisiopatología , Infarto del Miocardio/terapia , Miocardio/metabolismo , Miocardio/patología , Péptido Natriurético Encefálico/sangre , Necrosis , Admisión del Paciente , Alta del Paciente , Fragmentos de Péptidos/sangre , Intervención Coronaria Percutánea , Estudios Prospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Troponina/sangre , Función Ventricular IzquierdaRESUMEN
Early invasive management and the use of combined antithrombotic therapies have decreased the risk of recurrent ischaemia in patients with acute coronary syndrome (ACS) but have also increased the bleeding risk. Transradial intervention (TRI) and bivalirudin infusion compared to transfemoral intervention (TFI) or unfractionated heparin (UFH) plus glycoprotein IIb/IIIa inhibitors (GPI) decrease bleeding complications in patients with ACS. To what extent, a bleeding preventive strategy incorporating at least one of these two treatment options translates into improved outcomes is a matter of debate. The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX study is a large-scale, multicenter, prospective, open-label trial, conducted at approximately 100 sites in Europe aiming to primarily assess whether TRI and bivalirudin infusion, as compared to TFI and UFH plus provisional GPI, decrease the 30-day incidence of death, myocardial infarction or stroke across the whole spectrum of ACS patients.
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Síndrome Coronario Agudo/terapia , Anticoagulantes/administración & dosificación , Antitrombinas/administración & dosificación , Arteria Femoral , Hemorragia/prevención & control , Intervención Coronaria Percutánea/métodos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Arteria Radial , Proyectos de Investigación , Síndrome Coronario Agudo/sangre , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/mortalidad , Anticoagulantes/efectos adversos , Antitrombinas/efectos adversos , Protocolos Clínicos , Quimioterapia Combinada , Europa (Continente) , Hemorragia/inducido químicamente , Hemorragia/mortalidad , Heparina/administración & dosificación , Heparina/efectos adversos , Hirudinas/administración & dosificación , Hirudinas/efectos adversos , Humanos , Fragmentos de Péptidos/administración & dosificación , Fragmentos de Péptidos/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Inhibidores de Agregación Plaquetaria/efectos adversos , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/antagonistas & inhibidores , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/metabolismo , Estudios Prospectivos , Punciones , Proteínas Recombinantes/administración & dosificación , Proteínas Recombinantes/efectos adversos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
AIMS: Little is known regarding the overall prevalence of syncope in a population of workers and the risk of occurrence during working time. METHODS AND RESULTS: A total of 452 consecutive workers (mean age: 46 ± 9 years) were invited to answer an anonymous questionnaire. They had been employed for 22 ± 10 years for a total of 9765 years worked. In the cohort, 160 subjects (35%) reported a total of 465 episodes of syncope during their lives; 64 (14%) suffered a syncopal episode after the start of employment, but only 26 (5.7%) reported syncope at work, 7 (1.5%) having had 2 episodes, and 1 (0.2%) 3 episodes (total: 36 episodes). The risk of syncope during work was 4.6 times higher for those who had a prior history of syncope [18 of 138 (13%)] than for those who did not [8 of 314 (3%), P = 0.001]. The occurrence of syncope during work for the patients with a history of syncope was one syncopal episode in every 99 years worked and for those who had already had an episode during work, one episode in every 16 years worked. Only one patient experienced minor trauma as a consequence of syncope during work and three were referred to the emergency department. All patients continued their employment without any problems. CONCLUSION: The prevalence of syncope during work is low and its impact is benign. The probability of syncope during work is higher for subjects with a history of syncope.
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Enfermedades Profesionales/epidemiología , Síncope/epidemiología , Adulto , Estudios Transversales , Femenino , Encuestas Epidemiológicas , Humanos , Incidencia , Italia/epidemiología , Masculino , Persona de Mediana Edad , Enfermedades Profesionales/diagnóstico , Salud Laboral , Prevalencia , Medición de Riesgo , Factores de Riesgo , Encuestas y Cuestionarios , Síncope/diagnóstico , Factores de TiempoRESUMEN
OBJECTIVES: This study sought to evaluate whether remote ischemic post-conditioning (RIPC) could reduce enzymatic infarct size in patients with anterior ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (pPCI). BACKGROUND: Myocardial reperfusion injury may attenuate the benefit of pPCI. In animal models, RIPC mitigates myocardial reperfusion injury. METHODS: One hundred patients with anterior ST-segment elevation myocardial infarction and occluded left anterior descending artery were randomized to pPCI + RIPC (n = 50) or conventional pPCI (n = 50). RIPC consisted of 3 cycles of 5 min/5 min ischemia/reperfusion by cuff inflation/deflation of the lower limb. The primary endpoint was infarct size assessed by the area under the curve of creatinine kinase-myocardial band release (CK-MB). Secondary endpoints included the following: infarct size assessed by cardiac magnetic resonance delayed enhancement volume; T2-weighted edema volume; ST-segment resolution >50%; TIMI (Thrombolysis In Myocardial Infarction) frame count; and myocardial blush grading. RESULTS: Four patients (2 RIPC, 2 controls) were excluded due to missing samples of CK-MB. A total of 96 patients were analyzed; median area under the curve CK-MB was 8,814 (interquartile range [IQR]: 5,567 to 11,325) arbitrary units in the RIPC group and 10,065 (IQR: 7,465 to 14,004) arbitrary units in control subjects (relative reduction: 20%, 95% confidence interval: 0.2% to 28.7%; p = 0.043). Seventy-seven patients underwent a cardiac magnetic resonance scan 3 to 5 days after randomization, and 66 patients repeated a second scan after 4 months. T2-weighted edema volume was 37 ± 16 cc in RIPC patients and 47 ± 22 cc in control subjects (p = 0.049). ST-segment resolution >50% was 66% in RIPC and 37% in control subjects (p = 0.015). We observed no significant differences in TIMI frame count, myocardial blush grading, and delayed enhancement volume. CONCLUSIONS: In patients with anterior ST-segment elevation myocardial infarction, RIPC at the time of pPCI reduced enzymatic infarct size and was also associated with an improvement of T2-weighted edema volume and ST-segment resolution >50%. (Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention [PCI] [RemPostCon]; NCT00865722).