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BACKGROUND: Trials of patent foramen ovale (PFO) closure to prevent recurrent stroke have been inconclusive. We investigated whether patients with cryptogenic stroke and echocardiographic features representing risk of stroke would benefit from PFO closure or anticoagulation, as compared with antiplatelet therapy. METHODS: In a multicenter, randomized, open-label trial, we assigned, in a 1:1:1 ratio, patients 16 to 60 years of age who had had a recent stroke attributed to PFO, with an associated atrial septal aneurysm or large interatrial shunt, to transcatheter PFO closure plus long-term antiplatelet therapy (PFO closure group), antiplatelet therapy alone (antiplatelet-only group), or oral anticoagulation (anticoagulation group) (randomization group 1). Patients with contraindications to anticoagulants or to PFO closure were randomly assigned to the alternative noncontraindicated treatment or to antiplatelet therapy (randomization groups 2 and 3). The primary outcome was occurrence of stroke. The comparison of PFO closure plus antiplatelet therapy with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 2, and the comparison of oral anticoagulation with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 3. RESULTS: A total of 663 patients underwent randomization and were followed for a mean (±SD) of 5.3±2.0 years. In the analysis of randomization groups 1 and 2, no stroke occurred among the 238 patients in the PFO closure group, whereas stroke occurred in 14 of the 235 patients in the antiplatelet-only group (hazard ratio, 0.03; 95% confidence interval, 0 to 0.26; P<0.001). Procedural complications from PFO closure occurred in 14 patients (5.9%). The rate of atrial fibrillation was higher in the PFO closure group than in the antiplatelet-only group (4.6% vs. 0.9%, P=0.02). The number of serious adverse events did not differ significantly between the treatment groups (P=0.56). In the analysis of randomization groups 1 and 3, stroke occurred in 3 of 187 patients assigned to oral anticoagulants and in 7 of 174 patients assigned to antiplatelet therapy alone. CONCLUSIONS: Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. PFO closure was associated with an increased risk of atrial fibrillation. (Funded by the French Ministry of Health; CLOSE ClinicalTrials.gov number, NCT00562289 .).
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Anticoagulantes/uso terapêutico , Forame Oval Patente/tratamento farmacológico , Forame Oval Patente/terapia , Inibidores da Agregação Plaquetária/uso terapêutico , Prevenção Secundária/métodos , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Adolescente , Adulto , Anticoagulantes/efeitos adversos , Fibrilação Atrial/etiologia , Terapia Combinada , Feminino , Seguimentos , Forame Oval Patente/complicações , Aneurisma Cardíaco/complicações , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/efeitos adversos , Recidiva , Dispositivo para Oclusão Septal/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Adulto JovemRESUMO
BACKGROUND: Dilatation of the ascending aorta has an important role in the anatomical conformation of interatrial septum (IAS) especially when a patent foramen ovale (PFO) is present. The aim of the study was to investigate the relationship between ascending aortic dilation and PFO-related cryptogenic stroke in a cohort of cryptogenic strokes. METHODS: It is a retrospective, single-center echocardiographic study assessing aortic root dilatation in 315 consecutive patients with cryptogenic stroke between January 2011 and January 2019. Aortic root dilatation was defined by a diameter of the Valsalva sinuses of the proximal aorta >40 mm. Predictive factors of PFO were assessed by a multivariate analysis. Propensity score matching was applied to account for clinical differences. RESULTS: Of the 315 patients, 68 (22%) had an aortic root dilatation and 167 (53%) had a PFO. In the aortic root dilation group, PFO was more often diagnosed (n = 47/68 [69%], vs n = 120/247 [49%], P = .004). In the PFO group with aortic dilatation, IAS was more mobile (n = 37/47[79%] vs n = 69/120[57%], P < .012) and smaller (2.3 ± 0.5 vs 2.5 ± 0.5 mm, P < .009). On multivariate analysis, aortic root dilatation (OR: 2.6; 95% CI [1.2-5.6]; P = .001) and IAS hypermobility (OR: 5.2 95% CI [2.7-10]; P = .001) were associated with PFO. After propensity matching, aortic root dilatation remained strongly associated with PFO (n = 34/107 [32%] vs 15/107[14%], P = .002). CONCLUSION: Aortic root dilation and IAS hypermobility were strongly associated with PFO-related cryptogenic stroke.
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Forame Oval Patente , AVC Isquêmico , Acidente Vascular Cerebral , Dilatação , Forame Oval Patente/complicações , Forame Oval Patente/diagnóstico por imagem , Humanos , Pontuação de Propensão , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/complicaçõesRESUMO
BACKGROUND: There is no large report of the impact of fractional flow reserve (FFR) on the reclassification of the coronary revascularization strategy on individual patients referred for diagnostic angiography. METHODS AND RESULTS: The Registre Français de la FFR (R3F) investigated 1075 consecutive patients undergoing diagnostic angiography including an FFR investigation at 20 French centers. Investigators were asked to define prospectively their revascularization strategy a priori based on angiography before performing the FFR. The final revascularization strategy, reclassification of the strategy by FFR, and 1-year clinical follow-up were prospectively recorded. The strategy a priori based on angiography was medical therapy in 55% and revascularization in 45% (percutaneous coronary intervention, 38%; coronary artery bypass surgery, 7%). Patients were treated according to FFR in 1028/1075 (95.7%). The applied strategy after FFR was medical therapy in 58% and revascularization in 42% (percutaneous coronary intervention, 32%; coronary artery bypass surgery, 10%). The final strategy applied differed from the strategy a priori in 43% of cases: in 33% of a priori medical patients, in 56% of patients undergoing a priori percutaneous coronary intervention, and in 51% of patients undergoing a priori coronary artery bypass surgery. In reclassified patients treated based on FFR and in disagreement with the angiography-based a priori decision (n=464), the 1-year outcome (major cardiac event, 11.2%) was as good as in patients in whom final applied strategy concurred with the angiography-based a priori decision (n=611; major cardiac event, 11.9%; log-rank, P=0.78). At 1 year, >93% patients were asymptomatic without difference between reclassified and nonreclassified patients (Generalized Linear Mixed Model, P=0.75). Reclassification safety was preserved in high-risk patients. CONCLUSION: This study shows that performing FFR during diagnostic angiography is associated with reclassification of the revascularization decision in about half of the patients. It further demonstrates that it is safe to pursue a revascularization strategy divergent from that suggested by angiography but guided by FFR.
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Angiografia Coronária , Doença da Artéria Coronariana/fisiopatologia , Doença da Artéria Coronariana/terapia , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Intervenção Coronária Percutânea/classificação , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Tomada de Decisões , Determinação de Ponto Final , Feminino , Seguimentos , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Sistema de Registros , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Right ventricular systolic dysfunction (RVsD) frequently occurs in patients with ST-elevation myocardial infarction (STEMI). However, the diagnosis depends on the echocardiographic parameters to define RVsD. The right ventricle longitudinal shortening fraction (RV-LSF) is an accurate and reproducible 2-dimensional speckle-tracking parameter associated with clinical events in various pathologies. This study aimed to evaluate the association between RVsD and major adverse cardiovascular event (MACE) occurrence in a cohort of patients with STEMI. Adult patients with STEMI admitted to Amiens University Hospital's cardiovascular intensive care unit between May 2021 and November 2022 who underwent coronary angiography and transthoracic echocardiography within 48 hours of admission were included. RVsD was defined as RV-LSF <20%. The primary outcome was MACE occurrence, including heart failure, myocardial infarction, stroke, and death within 6 months of admission. A multivariable Cox regression analysis with proportional hazard ratio models assessed the association between RVsD and MACEs. In the 164 included patients, 72 (44%) had RVsD and 92 (56%) did not. The RVsD group had a significantly higher proportion of MACEs during the 6-month follow-up (n = 23 of 72, 33%) than the group without RVsD (n = 8 of 92, 9%, p = 0.001). RVsD showed an independent association with MACEs at 6 months (hazard ratio 3.1, 95% confidence interval [CI] 1.35 to 7.30, p = 0.008). Left ventricular ejection fraction <40% and Thrombolysis in Myocardial Infarction score >4 were independently associated with RVsD (odds ratio 2.80, 95% CI 1.34 to 5.98 and odds ratio 2.15, 95% CI 1.18 to 4.39, respectively, p = 0.015). The cumulative risk of MACEs at 6 months was 33% for RV-LSF <20% and 9% for RV-LSF ≥20% (log-rank test p <0.001). RVsD, defined by RV-LSF <20%, is associated with an increased risk of MACEs after STEMI.
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Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Adulto , Humanos , Prognóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/complicações , Volume Sistólico , Ventrículos do Coração/diagnóstico por imagem , Estudos Prospectivos , Função Ventricular Esquerda , Ecocardiografia/métodos , Infarto do Miocárdio/complicações , Intervenção Coronária Percutânea/efeitos adversosRESUMO
Introduction: Right-ventricular-to-pulmonary artery (RV-PA) coupling, measured as the ratio of tricuspid annular plane systolic excursion (TAPSE) to pulmonary artery systolic pressure (PASP), has emerged as a predictor factor in patients undergoing transcatheter aortic valvular replacement (TAVR). Right ventricular longitudinal shortening fraction (RV-LSF) outperformed TAPSE as a prognostic parameter in several diseases. We aimed to compare the prognostic ability of two RV-PA coupling parameters (TAPSE/PASP and the RV-LSF/PASP ratio) in identifying MACE occurrences. Method: A prospective and single-center study involving 197 patients who underwent TAVR was conducted. MACE (heart failure, myocardial infarction, stroke, and death within six months) constituted the primary outcome. ROC curve analysis determined cutoff values for RV-PA ratios. Multivariable Cox regression analysis explored the association between RV-PA ratios and MACE. Results: Forty-six patients (23%) experienced the primary outcome. No significant difference in ROC curve analysis was found (RV-LSF/PASP with AUC = 0.67, 95%CI = [0.58-0.77] vs. TAPSE/PASP with AUC = 0.62, 95%CI = [0.49-0.69]; p = 0.16). RV-LSF/PASP < 0.30%.mmHg-1 was independently associated with the primary outcome. The 6-month cumulative risk of MACE was 59% (95%CI = [38-74]) for patients with RV-LSF/PASP < 0.30%.mmHg-1 and 17% (95%CI = [12-23]) for those with RV-LSF/PASP ≥ 0.30%.mmHg-1; (p < 0.0001). Conclusions: In a contemporary cohort of patients undergoing TAVR, RV-PA uncoupling defined by an RV-LSF/PASP < 0.30%.mmHg-1 was associated with MACE at 6 months.
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BACKGROUND: New-onset atrial fibrillation (NOAF) is a well-known complication of ST-segment elevation myocardial infarction (STEMI), probably due to left atrial (LA) remodelling. LA strain (LAS) can predict NOAF in several cardiovascular diseases. OBJECTIVE: To assess whether LAS predicts NOAF in sinus rhythm patients with STEMI during hospitalization. METHODS: Adults with a STEMI and transthoracic echocardiography performed within 48hours of admission were included. LAS analysis, performed by automated software, recorded LAS during the reservoir phase (LASr), the conduit phase (LAScd) and the contraction phase (LASct). RESULTS: From May 2021 to November 2022, 175 patients were included, 21 (12%) of whom developed NOAF. NOAF patients were older (median [Q1-Q3]: 67 [59-80] vs 59 [51-67]years; P=0.006) and had a higher Thrombolysis In Myocardial Infarction scores (4 [2-7] vs 3 [1-4]; P=0.005). All LAS parameters were significantly impaired in NOAF patients, especially LASr (13.0% [10.5-28.4] vs 36.6% [29.0-44.9]; P=0.001). An LASr cut-off of 27% had a sensitivity of 81% and a specificity of 80% to identify patients with NOAF. In a multivariable model, LASr was significantly associated with NOAF (odds ratio 1.18, 95% confidence interval 1.09-1.26; P=0.003). The cumulative risk of NOAF during hospital stay was 30% (18-43 with LASr<27% and 4% [1.5-8.5] with LASr≥27% [P<0.0001]). CONCLUSION: NOAF is a frequent complication of STEMI. LASr seems helpful for identifying patients at high risk of NOAF during hospitalization.
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Fibrilação Atrial , Infarto do Miocárdio , Infarto do Miocárdio com Supradesnível do Segmento ST , Adulto , Humanos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Infarto do Miocárdio com Supradesnível do Segmento ST/complicações , Estudos Prospectivos , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/terapia , Infarto do Miocárdio/complicações , EcocardiografiaRESUMO
AIMS: Increased rates of structural abnormalities including externalized conductors have been reported in the Riata family of implantable cardioverter-defibrillator leads (St Jude Medical). Little is known about their reliability and the time lag for emergence of functional or structural abnormalities. METHODS AND RESULTS: Thirty-six patients who received small-caliber leads of the Riata family and who completed face-profile flouroscopies, repeated at every 6 months were included. We assessed the prevalence of conductors' externalization and its relation to abnormal electrical parameters or adverse events. Thirty-six patients, mean age = 64 ± 10 years, with at least 7-month completed fluoroscopy follow-up were included in the analysis. Externalized conductors were identified in 12 (33%) patients after a 53-month (13-114) mean delay. A higher left ventricular ejection fraction (LVEF): 47 ± 13 vs. 33 ± 12%, P = 0.04, and a progressive decrease (≥30% of the initial value) in amplitude of ventricular electrogram 9/12 (75%) vs. 4/24 (17%), P = 0.03 were independently associated with the fluoroscopic failures. Detection of the conductors' externalization was preceded by an electrical lead abnormality in 10 (83%) patients. CONCLUSION: Repeated face-profile fluoroscopies allowed detection of conductors' externalization in 33% of patients implanted with Riata leads. Better LVEF and a progressive decrease in amplitude of intracardiac ventricular electrogram were independently associated with externalized conductors. The structural abnormality was preceded by an electrical lead dysfunction 83% of patients.
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Desfibriladores Implantáveis/efeitos adversos , Traumatismos por Eletricidade/diagnóstico , Traumatismos por Eletricidade/etiologia , Eletrodos Implantados/efeitos adversos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/prevenção & controle , Volume Sistólico , Idoso , Condutividade Elétrica , Eletrocardiografia Ambulatorial , Desenho de Equipamento , Falha de Equipamento , Análise de Falha de Equipamento , Feminino , Humanos , Masculino , Resultado do TratamentoRESUMO
BACKGROUND: The first wave of the coronavirus disease 2019 pandemic significantly changed behaviour in terms of access to healthcare. AIM: To assess the effects of the pandemic and initial lockdown on the incidence of acute coronary syndrome and its long-term prognosis. METHODS: Patients admitted for acute coronary syndrome from 17 March to 6 July 2020 and from 17 March to 6 July 2019 were included. The number of admissions for acute coronary syndrome, acute complication rates and 2-year rates of survival free from major adverse cardiovascular events or death from any cause were compared according to the period of hospitalization. RESULTS: In total, 289 patients were included. We observed a 30±3% drop in acute coronary syndrome admissions during the first lockdown, which did not recover in the 2months after it was lifted. At 2years, there were no significant differences in the combined endpoint of major adverse cardiovascular events or death from any cause between the different periods (P=0.34). Being hospitalized during lockdown was not predictive of adverse events during follow-up (hazard ratio 0.87, 95% confidence interval 0.45-1.66; P=0.67). CONCLUSIONS: We did not observe an increased risk of major cardiovascular events or death at 2years from initial hospitalization for patients hospitalized during the first lockdown, adopted in March 2020 in response to the coronavirus disease 2019 pandemic, potentially as a result of the lack of power of the study.
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Síndrome Coronariana Aguda , COVID-19 , Humanos , COVID-19/epidemiologia , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/epidemiologia , Síndrome Coronariana Aguda/terapia , Pandemias , Controle de Doenças Transmissíveis , PrognósticoRESUMO
AIMS: Temporary dual antiplatelet therapy (DAPT) is recommended following patent foramen ovale (PFO) percutaneous closure although its benefit, compared to single antiplatelet therapy (SAPT), has not been demonstrated in this setting. We aimed at assessing outcomes following PFO closure according to the antiplatelet strategy at discharge. METHODS AND RESULTS: The ambispective AIR-FORCE cohort included consecutive patients from seven centres in France and Canada undergoing PFO closure and discharged without anticoagulation. Patients treated in French and Canadian centres were mostly discharged with DAPT and SAPT, respectively. The primary endpoint was the composite of death, stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, or BARC type ≥2 bleeding with up to 5 years of follow-up. The impact of the antiplatelet strategy on outcomes was evaluated with a marginal Cox model (cluster analyses per country) with inverse probability weighting according to propensity score. A total of 1532 patients (42.2% female, median age: 49 [40-57] years) were included from 2001 to 2022, of whom 599 (39.1%) were discharged with SAPT and 933 (60.9%) with DAPT, for ≤3 months in 894/923 (96.9%) cases. After a median follow-up of 2.4 [1.1-4.4] years, a total of 58 events were observed. In the weighted analysis, the rate of the primary endpoint up to 5 years was 7.8% in the SAPT strategy and 7.3% in the DAPT strategy (weighted hazard ratio 1.04, 95% confidence interval 0.59-1.83). CONCLUSION: The antiplatelet strategy following PFO closure did not seem to impact clinical outcomes, thus challenging the current recommendations of temporary DAPT.
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Forame Oval Patente , Inibidores da Agregação Plaquetária , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Inibidores da Agregação Plaquetária/efeitos adversos , Forame Oval Patente/tratamento farmacológico , Prevenção Secundária/métodos , Canadá , Pontuação de PropensãoRESUMO
Idiopathic dilated cardiomyopathy (IDCM) is one of the most common forms of nonischemic cardiomyopathy worldwide, possibly leading to cardiogenic shock (CS). Despite this heavy burden, the outcomes of CS in IDCM are poorly reported. Based on a large registry of unselected CS, our aim was to shed light on the 1-year outcomes after CS in patients with and without IDCM. FRENSHOCK was a prospective registry including 772 patients with CS from 49 centers. The 1-year outcomes (rehospitalizations, mortality, heart transplantation [HTx], ventricular assist devices [VAD]) were analyzed and adjusted on independent predictive factors. Within 772 CS included, 78 occurred in IDCM (10.1%). Patients with IDCM had more frequent history of chronic kidney failure and implantable cardioverter-defibrillator implantation. No difference was found in 1-month all-cause mortality between groups (28.2 vs 25.8%for IDCM and others, respectively; adjusted hazard ratio 1.14 [0.73 to 1.77], p = 0.57). Patients without IDCM were more frequently treated with noninvasive ventilation and intra-aortic balloon pump. At 1 year, IDCM led to higher rates of death or cardiovascular rehospitalizations (adjusted odds ratio 4.77 [95% confidence interval 1.13 to 20.1], p = 0.03) and higher rates of HTx or VAD for patients aged <65 years (adjusted odds ratio 2.68 [1.21 to 5.91], p = 0.02). In conclusion, CS in IDCM is a very common scenario and is associated with a higher rate of 1-year death or cardiovascular rehospitalizations and a more frequent recourse to HTx or VAD for patients aged <65 years, encouraging the consideration of it as a red flag for myocardial decline and urging for a closer follow-up and earlier evaluation for advanced heart failure therapies.
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BACKGROUND: Data on cardiogenic shock in adults with congenital heart disease (ACHD) are scarce. AIM: We sought to describe cardiogenic shock in ACHD patients in a nationwide cardiogenic shock registry. METHODS: From the multicentric FRENSHOCK registry (772 patients with cardiogenic shock from 49 French centres between April and October 2016), ACHD patients were compared with adults without congenital heart disease (non-ACHD). The primary outcome was defined by all-cause mortality, chronic ventricular assist device or heart transplantation at 1year. RESULTS: Out of the 772 patients, seven (0.9%) were ACHD, who were younger (median age: 56 vs. 67years), had fewer cardiovascular risk factors, such as hypertension (14.3% vs. 47.5%) and diabetes (14.3% vs. 28.3%), and no previous ischaemic cardiopathy (0 vs. 61.5%). Right heart catheterization (57.1% vs. 15.4%), pacemakers (28.6% vs. 4.6%) and implantable cardioverter-defibrillators (28.6% vs. 4.8%) were indicated more frequently in the management of ACHD patients compared with non-ACHD patients, whereas temporary mechanical circulatory support (0 vs. 18.7%) and invasive mechanical ventilation (14.3% vs. 38.1%) were less likely to be used in ACHD patients. At 1year, the primary outcome occurred in 85.7% (95% confidence interval: 42.1-99.6) ACHD patients and 52.3% (95% confidence interval: 48.7-55.9) non-ACHD patients. Although 1-year mortality was not significantly different between ACHD patients (42.9%) and non-ACHD patients (45.4%), ventricular assist devices and heart transplantation tended to be more frequent in the ACHD group. CONCLUSIONS: Cardiogenic shock in ACHD patients is rare, accounting for only 0.9% of an unselected cardiogenic shock population. Despite being younger and having fewer co-morbidities, the prognosis of ACHD patients with cardiogenic shock remains severe, and is similar to that of other patients.
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Cardiopatias Congênitas , Transplante de Coração , Coração Auxiliar , Humanos , Adulto , Pessoa de Meia-Idade , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/epidemiologia , Choque Cardiogênico/terapia , Cardiopatias Congênitas/complicações , Cardiopatias Congênitas/diagnóstico , Cardiopatias Congênitas/epidemiologia , Transplante de Coração/efeitos adversos , Coração Auxiliar/efeitos adversos , Sistema de RegistrosRESUMO
BACKGROUND: Systolic blood pressure (SBP) at hospital admission predicts in-hospital and postdischarge mortality in patients with left ventricular systolic dysfunction. The relationship between admission SBP and mortality in heart failure with preserved (≥50%) ejection fraction (HFPEF) is still unclear. METHODS AND RESULTS: We aimed to investigate the relationship between admission SBP and 5-year outcome in 368 consecutive patients hospitalized for new-onset HFPEF. Five-year all-cause mortality rates according to admission SBP categories (<120, 120-139, 140-159, 160-179, and ≥180 mm Hg) were 75 ± 7%, 53 ± 6%, 52 ± 7%, 55 ± 4%, and 60 ± 7%, respectively (P = .029). Survival analysis showed an inverse relation between admission SBP and mortality with increased risk of death for SBP <120 mm Hg. SBP <120 mm Hg independently predicted 5-year all-cause mortality (adjusted hazard ratio [HR] 1.69, 95% confidence interval [CI] 1.08-2.63) and cardiovascular mortality (adjusted HR 1.89, 95% CI 1.21-2.97). In patients discharged alive, after adjustment for medical treatment at discharge, admission SBP <120 mm Hg remained predictive of all-cause mortality (adjusted HR 1.52, 95% CI 1.04-2.43) and cardiovascular mortality (adjusted HR 1.69, 95% CI 1.06-2.73). There was no interaction between any of the therapeutic classes and outcome prediction of SBP. CONCLUSIONS: In HFPEF, low SBP (<120 mm Hg) at the time of hospital admission is associated with excess long-term mortality. Further studies are required to determine the mechanism of this association.
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Pressão Sanguínea , Insuficiência Cardíaca Sistólica/mortalidade , Hipotensão , Idoso , Intervalos de Confiança , Diástole , Progressão da Doença , Feminino , França , Insuficiência Cardíaca Sistólica/patologia , Mortalidade Hospitalar , Humanos , Incidência , Masculino , Prognóstico , Modelos de Riscos Proporcionais , Medição de Risco , Volume Sistólico , Análise de Sobrevida , Sístole , Fatores de Tempo , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
BACKGROUND: There is limited evidence that fractional flow reserve (FFR) is effective in guiding therapeutic strategy in multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates. OBJECTIVES: The FUTURE (FUnctional Testing Underlying coronary REvascularization) trial aimed to evaluate whether a treatment strategy based on FFR was superior to a traditional strategy without FFR in the treatment of multivessel CAD. METHODS: The FUTURE trial is a prospective, randomized, open-label superiority trial. Multivessel CAD candidates were randomly assigned (1:1) to treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR. In the FFR group, revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events at 1 year. RESULTS: The trial was stopped prematurely by the data safety and monitoring board after a safety analysis and 927 patients were enrolled. At 1-year follow-up, by intention to treat, there were no significant differences in major adverse cardiac or cerebrovascular events rates between groups (14.6% in the FFR group vs 14.4% in the control group; hazard ratio: 0.97; 95% confidence interval: 0.69-1.36; P = 0.85). The difference in all-cause mortality was nonsignificant, 3.7% in the FFR group versus 1.5% in the control group (hazard ratio: 2.34; 95% confidence interval: 0.97-5.18; P = 0.06), and this was confirmed with a 24 months' extended follow-up. FFR significantly reduced the proportion of revascularized patients, with more patients referred to exclusively medical treatment (P = 0.02). CONCLUSIONS: In patients with multivessel CAD, we did not find evidence that an FFR-guided treatment strategy reduced the risk of ischemic cardiovascular events or death at 1-year follow-up. (Functional Testing Underlying Coronary Revascularisation; NCT01881555).
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Ponte de Artéria Coronária , Doença da Artéria Coronariana , Estenose Coronária , Vasos Coronários , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Intervenção Coronária Percutânea , Complicações Pós-Operatórias/mortalidade , Idoso , Angiografia Coronária/métodos , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/fisiopatologia , Doença da Artéria Coronariana/cirurgia , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/etiologia , Estenose Coronária/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/fisiopatologia , Término Precoce de Ensaios Clínicos , Feminino , Humanos , Efeitos Adversos de Longa Duração/mortalidade , Masculino , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Valor Preditivo dos Testes , Medição de Risco/métodos , Índice de Gravidade de DoençaRESUMO
Importance: Approximately one-third of patients considered for coronary revascularization have diabetes, which is a major determinant of clinical outcomes, often influencing the choice of the revascularization strategy. The usefulness of fractional flow reserve (FFR) to guide treatment in this population is understudied and has been questioned. Objective: To evaluate the usefulness and rate of major adverse cardiovascular events (MACE) of integrating FFR in management decisions for patients with diabetes who undergo coronary angiography. Design, Setting, and Participants: This cross-sectional study used data from the PRIME-FFR study derived from the merger of the POST-IT study (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease [March 2012-November 2013]) and R3F study (French Study of FFR Integrated Multicenter Registries Implementation of FFR in Routine Practice [October 2008-June 2010]), 2 prospective multicenter registries that shared a common design. A population of all-comers for whom angiography disclosed ambiguous lesions was analyzed for rates, patterns, and outcomes associated with management reclassification, including revascularization deferral, in patients with vs without diabetes. Data analysis was performed from June to August 2018. Main Outcomes and Measures: Death from any cause, myocardial infarction, or unplanned revascularization (MACE) at 1 year. Results: Among 1983 patients (1503 [77%] male; mean [SD] age, 65 [10] years), 701 had diabetes, and FFR was performed for 1.4 lesions per patient (58.2% of lesions in the left anterior descending artery; mean [SD] stenosis, 56% [11%]; mean [SD] FFR, 0.81 [0.01]). Reclassification by FFR was high and similar in patients with and without diabetes (41.2% vs 37.5%, P = .13), but reclassification from medical treatment to revascularization was more frequent in the former (142 of 342 [41.5%] vs 230 of 730 [31.5%], P = .001). There was no statistical difference between the 1-year rates of MACE in reclassified (9.7%) and nonreclassified patients (12.0%) (P = .37). Among patients with diabetes, FFR-based deferral identified patients with a lower risk of MACE at 12 months (25 of 296 [8.4%]) compared with those undergoing revascularization (47 of 257 [13.1%]) (P = .04), and the rate was of the same magnitude of the observed rate among deferred patients without diabetes (7.9%, P = .87). Status of insulin treatment had no association with outcomes. Patients (6.6% of the population) in whom FFR was disregarded had the highest MACE rates regardless of diabetes status. Conclusions and Relevance: Routine integration of FFR for the management of coronary artery disease in patients with diabetes may be associated with a high rate of treatment reclassification. Management strategies guided by FFR, including revascularization deferral, may be useful for patients with diabetes.
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Tomada de Decisão Clínica , Doença da Artéria Coronariana/terapia , Diabetes Mellitus , Reserva Fracionada de Fluxo Miocárdico , Idoso , Fármacos Cardiovasculares/uso terapêutico , Angiografia Coronária , Ponte de Artéria Coronária , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/terapia , Estudos Transversais , Feminino , Humanos , Masculino , Infarto do Miocárdio/epidemiologia , Intervenção Coronária Percutânea , Estudos ProspectivosRESUMO
The angiotensin-converting enzyme (ACE) inhibitor has a well defined place in the treatment of systolic heart failure (HF). Evidence for routine prescription of an ACE inhibitor in patients with diastolic HF (DHF) is inconsistent. Therefore, our aim was to evaluate the prognostic impact of ACE inhibitor in patients with DHF. The present prospective study included patients with normal or slightly impaired ejection fraction (> or =50%) surviving a first hospitalization for HF. We assessed the long-term prognosis of these patients according to prescription of an ACE inhibitor at discharge. ACE inhibitor therapy prescribed at discharge in 46% (n = 165) of the 358 included patients was associated with a 30% relative decrease in the risk of 5-year mortality (hazard ratio 0.70, 95% confidence interval 0.53 to 0.93, p = 0.013). On multivariable Cox analysis, the relation between ACE inhibitor prescription and mortality remained significant (hazard ratio 0.73, 95% confidence interval 0.54 to 0.99, p = 0.045). Using propensity score analysis, 120 patients receiving an ACE inhibitor were matched with 120 patients not receiving this medication. In the postmatch group, prescription of ACE inhibitor was associated with a significant decrease in the risk of 5-year mortality (hazard ratio 0.61, 95% confidence interval 0.43 to 0.87, p = 0.006). Five-year relative survival (observed/expected survival) of the ACE inhibitor group was better than that of the no-ACE inhibitor group (65% vs 57%). In conclusion, we demonstrate that in this cohort of patients with DHF, prescription of ACE inhibitor was associated with a significant decrease in long-term mortality.
Assuntos
Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Insuficiência Cardíaca Diastólica/tratamento farmacológico , Insuficiência Cardíaca Diastólica/mortalidade , Idoso , Feminino , Seguimentos , Humanos , Masculino , Análise Multivariada , Alta do Paciente , Prognóstico , Estudos Prospectivos , Análise de SobrevidaRESUMO
BACKGROUND: The prognostic importance of atrial fibrillation (AF) in heart failure (HF) is not clearly established. Studies conducted in systolic HF have led to discordant results. AIMS: To evaluate the relation between AF and long-term survival in patients with heart failure and preserved ejection fraction (HFPEF). METHODS AND RESULTS: We prospectively included 368 consecutive patients hospitalised for a first episode of HFPEF during 2000 and compared the 5-year outcome of patients according to the presence or absence of AF on the baseline electrocardiogram. Propensity scores were used to reduce imbalance in baseline characteristics. Baseline AF was observed in 36% (n=132) of the study population. Patients with AF were older and more often had hypertensive heart disease. On univariate analysis, baseline AF was associated with an increased risk of 5-year overall mortality (HR=1.36; 95%CI 1.03-1.79; p=0.03). After adjustment for covariates, baseline AF was no longer a predictor of reduced survival. The risk of adjusted cardiovascular death in patients with and without AF was comparable. In the propensity-matched patients, AF was not related to a poorer outcome (HR=1.08; 95%CI 0.78-1.51; p=0.63). CONCLUSION: In patients hospitalised for HFPEF, AF is frequent and associated with an excess mortality mainly related to the advanced age of these patients. After adjustment for covariates, baseline AF is not an independent predictor of long-term mortality.
Assuntos
Fibrilação Atrial/complicações , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Estudos de Coortes , Feminino , Insuficiência Cardíaca/complicações , Hospitalização , Humanos , Estimativa de Kaplan-Meier , Masculino , Volume Sistólico , Taxa de SobrevidaRESUMO
BACKGROUND: Fractional flow reserve (FFR) is not firmly established as a guide to treatment in patients with acute coronary syndromes (ACS). Primary goals were to evaluate the impact of integrating FFR on management decisions and on clinical outcome of patients with ACS undergoing coronary angiography, as compared with patients with stable coronary artery disease. METHODS AND RESULTS: R3F (French FFR Registry) and POST-IT (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease), sharing a common design, were pooled as PRIME-FFR (Insights From the POST-IT and R3F Integrated Multicenter Registries - Implementation of FFR in Routine Practice). Investigators prospectively defined management strategy based on angiography before performing FFR. Final decision after FFR and 1-year clinical outcome were recorded. From 1983 patients, in whom FFR was prospectively used to guide treatment, 533 sustained ACS (excluding acute ST-segment-elevation myocardial infarction). In ACS, FFR was performed in 1.4 lesions per patient, mostly in left anterior descending (58%), with a mean percent stenosis of 58±12% and a mean FFR of 0.82±0.09. In patients with ACS, reclassification by FFR was high and similar to those with non-ACS (38% versus 39%; P=NS). The pattern of reclassification was different, however, with less patients with ACS reclassified from revascularization to medical treatment compared with those with non-ACS (P=0.01). In ACS, 1-year outcome of patients reclassified based on FFR (FFR against angiography) was as good as that of nonreclassified patients (FFR concordant with angiography), with no difference in major cardiovascular event (8.0% versus 11.6%; P=0.20) or symptoms (92.3% versus 94.8% angina free; P=0.25). Moreover, FFR-based deferral to medical treatment was as safe in patients with ACS as in patients with non-ACS (major cardiovascular event, 8.0% versus 8.5%; P=0.83; revascularization, 3.8% versus 5.9%; P=0.24; and freedom from angina, 93.6% versus 90.2%; P=0.35). These findings were confirmed in ACS explored at the culprit lesion. In patients (6%) in whom the information derived from FFR was disregarded, a dire outcome was observed. CONCLUSIONS: Routine integration of FFR into the decision-making process of ACS patients with obstructive coronary artery disease is associated with a high reclassification rate of treatment (38%). A management strategy guided by FFR, divergent from that suggested by angiography, including revascularization deferral, is safe in ACS.
Assuntos
Síndrome Coronariana Aguda/diagnóstico , Cateterismo Cardíaco , Tomada de Decisão Clínica , Doença da Artéria Coronariana/diagnóstico , Estenose Coronária/diagnóstico , Técnicas de Apoio para a Decisão , Reserva Fracionada de Fluxo Miocárdico , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/fisiopatologia , Síndrome Coronariana Aguda/terapia , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/fisiopatologia , Doença da Artéria Coronariana/terapia , Estenose Coronária/mortalidade , Estenose Coronária/fisiopatologia , Estenose Coronária/terapia , Feminino , França , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Portugal , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Sistema de Registros , Fatores de Risco , Índice de Gravidade de Doença , Fatores de TempoRESUMO
BACKGROUND: Intracoronary gamma-radiation reduces recurrent in-stent restenosis (ISR). Late thrombosis was attenuated with 6 months of aspirin and clopidogrel. We aimed to find out whether 12 months of aspirin plus clopidogrel is superior to a strategy of 6 months after radiation therapy for patients with ISR. METHODS AND RESULTS: One hundred twenty consecutive patients with diffuse ISR in native coronaries and vein grafts with lesions <80 mm in length underwent PTCA, laser ablation, or rotational atherectomy. Additional stents were placed in 39 patients (33%). After the intervention, a ribbon with different trains of radioactive 192Ir seeds was positioned to cover the treated site, and a dose of 14 Gy to 2 mm was prescribed. Patients were discharged with clopidogrel and aspirin for 12 months and followed up clinically. The cardiac clinical event rates at 15 months were compared with the gamma-treated (n=120) patients of the WRIST PLUS study (only 6 months of antiplatelet therapy). Whereas the late thrombosis rates were similar (3.3% for the group given 12 months of antiplatelet therapy versus 4.2% for the group given 6 months, P=0.72), the group treated with 12 months of antiplatelet therapy had a rate of 21% for major adverse cardiac events and 20% for target-lesion revascularization compared with 36% (P=0.01) and 35% (P=0.009), respectively, in patients who were treated with only 6 months of clopidogrel. CONCLUSIONS: Twelve months of clopidogrel is superior to 6 months in reducing overall major cardiac events and revascularization rates at 15 months for patients with ISR treated with gamma-radiation. At least 12 months of clopidogrel therapy should be recommended for patients undergoing radiation therapy for ISR.
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Braquiterapia , Reestenose Coronária/terapia , Cardiopatias/prevenção & controle , Inibidores da Agregação Plaquetária/uso terapêutico , Ticlopidina/uso terapêutico , Aspirina/uso terapêutico , Clopidogrel , Reestenose Coronária/prevenção & controle , Esquema de Medicação , Feminino , Raios gama , Oclusão de Enxerto Vascular/radioterapia , Humanos , Radioisótopos de Irídio/uso terapêutico , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Risco , Stents/efeitos adversos , Ticlopidina/análogos & derivados , Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Edge stenosis remains a serious limitation of catheter-based vascular brachytherapy (VBT). This study aims to identify the mechanisms and evaluate strategies to minimize edge restenosis in patients treated with VBT. METHODS AND RESULTS: Thirty-four porcine stented coronary arteries were irradiated (doses of 15 or 22 Gy) with (192)Ir trains of either 6 seeds (23 mm) with 0 mm coverage at the distal stent edge and 10 mm at the proximal stent edge or 14 seeds (55 mm) centered at the distal edge of the stent with 27.5 and 14.5 mm coverage at the distal and proximal edges, respectively. After VBT, an additional 13-mm stent was positioned overlapping the distal margin of the first stent. Animals were killed at 28 days, and arteries were analyzed. Longer radiation margins were associated with reduced intimal area (IA) at the stent edge: 2.3+/-0.9, 3.6+/-2.0, and 5.3+/-2.2 mm(2) with 15 Gy for a radiation margin of 14.5, 10, and -13 mm (-13 versus 10, P=0.06; 10 versus 14.5, P=0.06). Additional stenting was associated with an increase of IA: 4.0+/-2.3 mm(2) at the overlapped segment. Increasing the dose to 22 Gy resulted in a reduction of the IA at the overlap segment to 1.31+/-0.57 mm(2) with 14 seeds (27.5 mm coverage) but was not helpful with 6 seeds (0 mm coverage): IA, 5.56+/-2.28 mm(2). CONCLUSIONS: Extending the radiation margins to 14.5 mm from each end of the stent minimized the edge-effect phenomenon. A higher dose is essential to eliminate further increases in IA at the overlapped segment with additional stents.
Assuntos
Braquiterapia/métodos , Cateterismo Cardíaco , Reestenose Coronária/radioterapia , Vasos Coronários/efeitos da radiação , Stents/efeitos adversos , Animais , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Reestenose Coronária/patologia , Vasos Coronários/patologia , Vasos Coronários/cirurgia , Relação Dose-Resposta à Radiação , Suínos , UltrassonografiaRESUMO
BACKGROUND: Late total occlusion after vascular brachytherapy (VBT) continues to be a serious complication. Delayed reendothelialization was suggested as a pivotal cause, but the time course for complete healing is unknown. METHODS AND RESULTS: Seventy-two rabbit iliac arteries underwent stent implantation and were treated with gamma-radiation using 192Ir. The prescribed doses were 0 Gy (controls, n=24 arteries), 15 Gy (n=24), or 30 Gy (n=24) at 2 mm. Animals were killed at 1 month (n=24), 3 months (n=24), or 6 months (n=24) and were analyzed for histomorphometry or scanning electron microscopy. Intimal area was reduced after VBT at 3 months with 15 and 30 Gy (0.66+/-0.07 and 0.66+/-0.04 mm2, respectively) compared with controls (1.01+/-0.11 mm2, P<0.05) and at 6 months with 30 Gy (0.75+/-0.09 versus 1.28+/-0.26 mm2 in controls, P<0.01). Intimal area was similar at 6 months between 15 Gy and controls. At 1 month, 92+/-4% of the control stented segment was covered with endothelial cells, whereas only 37+/-4% and 37+/-8% was covered in the 15- and 30-Gy arteries, respectively. Similarly, at 3 and 6 months, there was a difference in the extent of reendothelialized areas (at 3 months, 95+/-2%, 32+/-12%, and 29+/-13%; and at 6 months, 98+/-2%, 40+/-8%, and 35+/-12% in control, 15-Gy, and 30-Gy arteries, respectively). Excess platelets and leukocytes were seen in irradiated arteries without complete coverage of endothelium. CONCLUSIONS: Reendothelialization after VBT is not completed at 6 months after VBT. Special care with prolonged antiplatelet therapy should be considered beyond that time point.