ABSTRACT
BACKGROUND: Hydroxychloroquine combined with azithromycin (HCQ/AZI) has initially been used against coronavirus disease-2019 (COVID-19). In this retrospective study, we assessed the clinical effects of HCQ/AZI, with a 28-days follow-up. METHODS: In a registry-study which included patients hospitalized for COVID-19 between March 15 and April 2, 2020, we compared patients who received HCQ/AZI to those who did not, regarding a composite outcome of mortality and mechanical ventilation with a 28-days follow-up. QT was monitored for patients treated with HCQ/AZI. Were excluded patients in intensive care units, palliative care and ventilated within 24 hours of admission. Three analyses were performed to adjust for selection bias: propensity score matching, multivariable survival, and inverse probability score weighting (IPSW) analyses. RESULTS: Overall, 203 patients were included: 60 patients treated by HCQ/AZI and 143 control patients. During the 28-days follow-up, 32 (16.3%) patients presented the primary outcome and 23 (12.3%) patients died. Propensity-score matching identified 52 unique pairs of patients with similar characteristics. In the matched cohort (n = 104), HCQ/AZI was not associated with the primary composite outcome (log-rank p-value = 0.16). In the overall cohort (n = 203), survival and IPSW analyses also found no benefit from HCQ/AZI. In the HCQ/AZI group, 11 (18.3%) patients prolonged QT interval duration, requiring treatment cessation. CONCLUSIONS: HCQ/AZI combination therapy was not associated with lower in-hospital mortality and mechanical ventilation rate, with a 28-days follow-up. In the HCQ/AZI group, 18.3% of patients presented a prolonged QT interval requiring treatment cessation, however, control group was not monitored for this adverse event, making comparison impossible.
Subject(s)
Azithromycin/therapeutic use , COVID-19 Drug Treatment , Hydroxychloroquine/therapeutic use , SARS-CoV-2/drug effects , Anti-Bacterial Agents/therapeutic use , Antimalarials/therapeutic use , COVID-19/mortality , COVID-19/pathology , COVID-19/virology , Female , Follow-Up Studies , Humans , Intensive Care Units , Male , Middle Aged , Respiration, Artificial , Retrospective Studies , SARS-CoV-2/isolation & purification , Survival Rate , Treatment OutcomeABSTRACT
BACKGROUND: Coronary angiography (CA) is usually performed in patients with reduced left ventricular ejection fraction (LVEF) to search ischemic cardiomyopathy. Our aim was to examine the agreement between CA and cardiovascular magnetic resonance (CMR) imaging among a cohort of patients with unexplained reduced LVEF, and estimate what would have been the consequences of using CMR imaging as the first-line examination. METHODS: Three hundred five patients with unexplained reduced LVEF of ≤45% who underwent both CA and CMR imaging were retrospectively registered. Patients were classified as CMR+ or CMR- according to presence or absence of myocardial ischemic scar, and classified CA+ or CA- according to presence or absence of significant coronary artery disease. RESULTS: CMR+ (nâ¯=â¯89) included all 54 CA+ patients, except 2 with distal coronary artery disease in whom no revascularization was proposed. Among the 247 CA- patients, 15% were CMR+. CMR imaging had 96% sensitivity, 85% specificity, 99% negative predictive value, and 58% positive predictive value for detecting CA+ patients. Revascularization was performed in 6.5% of the patients (all CMR+). Performing CA only for CMR+ patients would have decreased the number of CAs by 71%. CONCLUSIONS: In reduced LVEF, performing CA only in CMR+ patients may significantly decrease the number of unnecessary CAs performed, without missing any patients requiring revascularization.
Subject(s)
Heart Failure , Ventricular Dysfunction, Left , Coronary Angiography , Humans , Magnetic Resonance Imaging , Magnetic Resonance Imaging, Cine , Magnetic Resonance Spectroscopy , Pilot Projects , Predictive Value of Tests , Retrospective Studies , Stroke Volume , Ventricular Dysfunction, Left/diagnostic imaging , Ventricular Function, LeftABSTRACT
BACKGROUND: Literature suggests that radial access is associated with higher radiation doses than femoral access. AIMS: To compare patient radiation exposure during coronary angiography (CA) and percutaneous coronary intervention (PCI) with radial versus femoral access. METHODS: RAY'ACT is a nationwide, multicentre, French survey evaluating patient radiation in interventional cardiology. Variables of patient exposure from 21,675 CAs and 17,109 PCIs performed at 44 centres during 2010 were analysed retrospectively. RESULTS: Radial access was used in 71% of CAs and 69% of PCIs. Although median fluoroscopy times were longer for radial versus femoral access (CA, 3.8 vs 3.5minutes [P<0.001]; PCI, 10.4 vs 10.1minutes [P=0.001]), the Kerma-area product (KAP) was lower with radial access (CA, 26.8 vs 28.1Gy·cm2; PCI, 55.6 vs 59.4Gy·cm2; both P=0.001). Differences in KAP remained significant in the multivariable analysis (P<0.01), and in a propensity score-matched analysis (P=0.01). A significant interaction was found between KAP and the percentage of procedures with radial access by centre (P<0.001). KAP was higher by radial versus femoral access in low-radial-volume centres, and lower in high-radial-volume centres. Radiation protection techniques, such as the use of low frame rates (7.5 frame/s), were used more frequently in high-radial-volume radial centres. CONCLUSIONS: In this multicentre study, radial access was associated with lower radiation doses to patient than femoral access in high-radial-volume centres. Provided that radioprotection methods are implemented, radial access could be associated with lower patient radiation exposure.
Subject(s)
Catheterization, Peripheral/methods , Coronary Angiography/methods , Femoral Artery , Hospitals, High-Volume , Percutaneous Coronary Intervention/methods , Radial Artery , Radiation Dosage , Radiation Exposure/prevention & control , Aged , Catheterization, Peripheral/adverse effects , Chi-Square Distribution , Coronary Angiography/adverse effects , Female , Femoral Artery/diagnostic imaging , France , Hospitals, Low-Volume , Humans , Linear Models , Logistic Models , Male , Middle Aged , Multivariate Analysis , Patient Safety , Percutaneous Coronary Intervention/adverse effects , Propensity Score , Punctures , Radial Artery/diagnostic imaging , Radiation Exposure/adverse effects , Radiation Injuries/etiology , Radiation Injuries/prevention & control , Radiation Protection , Radiography, Interventional , Retrospective Studies , Risk Assessment , Risk Factors , Time FactorsABSTRACT
BACKGROUND: Medically managed individuals represent a high-risk group among patients with non-ST-elevation acute myocardial infarction (NSTE-AMI). We hypothesized that prognosis in this group is heterogeneous, depending on whether medical management was decided with or without coronary angiography (CAG). METHODS: Using data from the French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction (FAST-MI), we analysed data from 798 patients with NSTE-AMI who were medically managed (i.e. without revascularization during the index hospitalization). Patients were categorized according to the performance of CAG and, if performed, to the extent of coronary artery disease (CAD). RESULTS: There were marked differences in baseline demographics, according to whether CAG was performed and to the extent of CAD. While the overall mortality rate at five years was high (56.2%), it differed greatly between groups, with patients who did not undergo CAG having a higher mortality rate (77.4%) than patients who underwent CAG (36.7%, p<0.001), and a higher mortality rate even than patients with multivessel CAD (54.2%, p<0.001). By multivariable analysis, non-performance of CAG was an independent predictor of all-cause mortality among medically managed NSTE-AMI patients (adjusted hazard ratios (95% confidence intervals) 3.19 (1.79-5.67) at 30 days, 2.28 (1.60-3.26) at one year, and 1.63 (1.28-2.07) at five years; all p<0.001). CONCLUSION: Medically managed patients with NSTE-AMI are a heterogeneous group in terms of baseline characteristics and outcomes. The highest risk patients are those who do not undergo CAG. Non-performance of CAG is a strong predictor of death. (FAST-MI, NCT00673036).
Subject(s)
Anticoagulants/therapeutic use , Coronary Angiography/methods , Coronary Artery Disease/diagnostic imaging , Non-ST Elevated Myocardial Infarction/drug therapy , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Mortality , Patient Admission , Prognosis , Survival Analysis , Treatment OutcomeABSTRACT
The objective of this study was to estimate the French national updated reference levels (RLs) for coronary angiography (CA) and percutaneous coronary intervention (PCI) by a dose audit from a large data set of unselected procedures and in standard-sized patients. Kerma-area product (PKA), air kerma at interventional point (Ka,r), fluoroscopy time (FT), and the number of registered frames (NFs) and runs (NRs) were collected from 51 229 CAs and 42 222 PCIs performed over a 12-month period at 61 French hospitals. RLs estimated by the 75th percentile in CAs and PCIs performed in unselected patients were 36 and 78 Gy.cm² for PKA, 498 and 1285 mGy for Ka,r, 6 and 15 min for FT, and 566 and 960 for NF, respectively. These values were consistent with the RLs calculated in standard-sized patients. The large difference in dose between sexes leads us to propose specific RLs in males and females. The results suggest a trend for a time-course reduction in RLs for interventional coronary procedures.
Subject(s)
Coronary Angiography , Fluoroscopy , Radiation Dosage , Female , Humans , Male , Percutaneous Coronary Intervention , Radiography, InterventionalABSTRACT
OBJECTIVE: To assess the association between early and prolonged ß blocker treatment and mortality after acute myocardial infarction. DESIGN: Multicentre prospective cohort study. SETTING: Nationwide French registry of Acute ST- and non-ST-elevation Myocardial Infarction (FAST-MI) (at 223 centres) at the end of 2005. PARTICIPANTS: 2679 consecutive patients with acute myocardial infarction and without heart failure or left ventricular dysfunction. MAIN OUTCOME MEASURES: Mortality was assessed at 30 days in relation to early use of ß blockers (≤48 hours of admission), at one year in relation to discharge prescription, and at five years in relation to one year use. RESULTS: ß blockers were used early in 77% (2050/2679) of patients, were prescribed at discharge in 80% (1783/2217), and were still being used in 89% (1230/1383) of those alive at one year. Thirty day mortality was lower in patients taking early ß blockers (adjusted hazard ratio 0.46, 95% confidence interval 0.26 to 0.82), whereas the hazard ratio for one year mortality associated with ß blockers at discharge was 0.77 (0.46 to 1.30). Persistence of ß blockers at one year was not associated with lower five year mortality (hazard ratio 1.19, 0.65 to 2.18). In contrast, five year mortality was lower in patients continuing statins at one year (hazard ratio 0.42, 0.25 to 0.72) compared with those discontinuing statins. Propensity score and sensitivity analyses showed consistent results. CONCLUSIONS: Early ß blocker use was associated with reduced 30 day mortality in patients with acute myocardial infarction, and discontinuation of ß blockers at one year was not associated with higher five year mortality. These findings question the utility of prolonged ß blocker treatment after acute myocardial infarction in patients without heart failure or left ventricular dysfunction.Trial registration Clinical trials NCT00673036.
Subject(s)
Adrenergic beta-Antagonists/therapeutic use , Myocardial Infarction/drug therapy , Myocardial Infarction/mortality , Acute Disease , Aged , Coronary Care Units , Female , Humans , Logistic Models , Male , Middle Aged , Patient Discharge/statistics & numerical data , Proportional Hazards Models , Prospective Studies , Survival Analysis , Time FactorsABSTRACT
AIM: This open-label, randomized, and multicentre trial tested the hypothesis that, on a background of aspirin, continuing clopidogrel would be superior to stopping clopidogrel at 12 months following drug-eluting stent (DES) implantation. METHODS AND RESULTS: Patients (N = 1799) who had undergone placement of ≥1 DES for stable coronary artery disease or acute coronary syndrome were included in 58 French sites (January 2009-January 2013). Patients (N = 1385) free of major cardiovascular/cerebrovascular events or major bleeding and on aspirin and clopidogrel 12 months after stenting were eligible for randomization (1:1) between continuing clopidogrel 75 mg daily (extended-dual antiplatelet therapy, DAPT, group) or discontinuing clopidogrel (aspirin group). The primary outcome was net adverse clinical events defined as the composite of death, myocardial infarction, stroke, or major bleeding. Follow-up was planned from a minimum of 6 to a maximum of 36 months after randomization. Owing to slow recruitment, the study was stopped after enrolment of 1385 of a planned 1966 patients. Median follow-up after stenting was 33.4 months. The primary outcome occurred in 40 patients (5.8%) in the extended-DAPT group and 52 in the aspirin group (7.5%; hazard ratio 0.75, 95% confidence interval 0.50-1.28; P = 0.17). Rates of death were 2.3% in the extended-DAPT group and 3.5% in the aspirin group (HR 0.65, 95% CI 0.34-1.22; P = 0.18). Rates of major bleeding were identical (2.0%, P = 0.95). CONCLUSIONS: Extended DAPT did not achieve superiority in reducing net adverse clinical events compared to 12 months of DAPT after DES placement. The power of the OPTIDUAL trial was however low and reduced by premature termination of enrolment. CLINICALTRIALSGOV NUMBER: NCT00822536.
Subject(s)
Acute Coronary Syndrome/drug therapy , Coronary Artery Disease/drug therapy , Drug-Eluting Stents , Platelet Aggregation Inhibitors/administration & dosage , Ticlopidine/analogs & derivatives , Acute Coronary Syndrome/mortality , Adult , Aftercare , Clopidogrel , Coronary Artery Disease/mortality , Drug Administration Schedule , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Ticlopidine/administration & dosage , Treatment OutcomeABSTRACT
BACKGROUND: Takotsubo cardiomyopathy (TTC) is a rare condition characterized by a sudden temporary weakening of the heart. TTC can mimic acute myocardial infarction and is associated with a minimal release of myocardial biomarkers in the absence of obstructive coronary artery disease. AIMS: To provide an extensive description of patients admitted to hospital for TTC throughout France and to study the management and outcomes of these patients. METHODS: In 14 non-academic hospitals, we collected clinical, electrocardiographic, biological, psychological and therapeutic data in patients with a diagnosis of TTC according to the Mayo Clinic criteria. RESULTS: Of 117 patients, 91.5% were women, mean ± SD age was 71.4 ± 12.1 years and the prevalence of risk factors was high (hypertension: 57.9%, dyslipidaemia: 33.0%, diabetes: 11.5%, obesity: 11.5%). The most common initial symptoms were chest pain (80.5%) and dyspnoea (24.1%). A triggering psychological event was detected in 64.3% of patients. ST-segment elevation was found in 41.7% of patients and T-wave inversion in 71.6%. Anterior leads were most frequently associated with ST-segment elevation, whereas T-wave inversion was more commonly associated with lateral leads, and Q-waves with septal leads. The ratio of peak B-type natriuretic peptide (BNP) or N-terminal prohormone BNP (NT-proBNP) level to peak troponin level was 1.01. No deaths occurred during the hospital phase. After 1 year of follow-up, 3 of 109 (2.8%) patients with available data died, including one cardiovascular death. Rehospitalizations occurred in 17.4% of patients: 2.8% due to acute heart failure and 14.7% due to non-cardiovascular causes. There was no recurrence of TTC. CONCLUSIONS: This observational study of TTC included primarily women with atherosclerotic risk factors and mental stress. T-wave inversion was more common than ST-segment elevation. There were few adverse cardiovascular outcomes in these patients after 1-year follow-up.
Subject(s)
Hospitalization , Takotsubo Cardiomyopathy/therapy , Ventricular Function, Left , Aged , Aged, 80 and over , Atherosclerosis/epidemiology , Biomarkers/blood , Diagnostic Imaging/methods , Electrocardiography , Female , France/epidemiology , Humans , Male , Middle Aged , Natriuretic Peptide, Brain/blood , Patient Readmission , Peptide Fragments/blood , Predictive Value of Tests , Prevalence , Prospective Studies , Recovery of Function , Registries , Retrospective Studies , Risk Factors , Stress, Psychological/epidemiology , Takotsubo Cardiomyopathy/blood , Takotsubo Cardiomyopathy/diagnosis , Takotsubo Cardiomyopathy/mortality , Takotsubo Cardiomyopathy/physiopathology , Time Factors , Treatment Outcome , Troponin/bloodABSTRACT
AIMS: The use of opioids is recommended for pain relief in patients with myocardial infarction (MI) but may delay antiplatelet agent absorption, potentially leading to decreased treatment efficacy. METHODS AND RESULTS: In-hospital complications (death, non-fatal re-MI, stroke, stent thrombosis, and bleeding) and 1-year survival according to pre-hospital morphine use were assessed in 2438 ST-elevation MI (STEMI) patients from the French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) 2010. The analyses were replicated in the 1726 STEMI patients of the FAST-MI 2005 cohort, in which polymorphisms of CYP2C19 and ABCB1 had been assessed. Specific subgroup analyses taking into account these genetic polymorphisms were performed in patients pre-treated with thienopyridines. The 453 patients (19%) receiving morphine pre-hospital were younger, more often male, with a lower GRACE score and higher chest pain levels. After adjustment for baseline differences, in-hospital complications and 1-year survival (hazard ratio = 0.69; 95% confidence interval: 0.35-1.37) were not increased according to pre-hospital morphine use. After propensity score matching, 1-year survival according to pre-hospital morphine was also similar. Consistent results were found in the replication cohort, including in those receiving pre-hospital thienopyridines and whatever the genetic polymorphisms of CYP2C19 and ABCB1. CONCLUSION: In two independent everyday-life cohorts, pre-hospital morphine use in STEMI patients was not associated with worse in-hospital complications and 1-year mortality. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT00673036 (FAST-MI 2005); NCT01237418 (FAST-MI 2010).
Subject(s)
Analgesics, Opioid/therapeutic use , Morphine/therapeutic use , Non-ST Elevated Myocardial Infarction/drug therapy , ST Elevation Myocardial Infarction/drug therapy , ATP Binding Cassette Transporter, Subfamily B/genetics , Aged , Cytochrome P-450 CYP2C19/genetics , Drug Interactions/genetics , Emergency Medical Services/methods , Female , France/epidemiology , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Non-ST Elevated Myocardial Infarction/genetics , Non-ST Elevated Myocardial Infarction/mortality , Pain/prevention & control , Platelet Aggregation Inhibitors/therapeutic use , Polymorphism, Genetic/genetics , Registries , Risk Factors , ST Elevation Myocardial Infarction/genetics , ST Elevation Myocardial Infarction/mortality , Treatment OutcomeABSTRACT
BACKGROUND: The optimal therapeutic strategy for patients with high-risk acute coronary syndrome without ST-segment elevation (NSTE-ACS) remains unclear. OBJECTIVE: Our aim was to compare the effectiveness of an early invasive strategy and a delayed invasive strategy in the management of high-risk NSTE-ACS patients. METHODS: This randomized clinical trial in a primarily pre-hospital setting enrolled patients with chest pain, electrocardiographic criteria for an NSTE-ACS, and at least one criterion of severity (ESC criterion or TIMI score >5). Patients were randomized to either an early invasive strategy (tirofiban infusion and coronary angiography within 6h) or delayed invasive strategy (as per guidelines and physician discretion; coronary angiography within 6h was not advised). The primary endpoint was the cumulative incidence of deaths, myocardial infarctions, or urgent revascularizations at 30days of follow-up. Secondary endpoints were failure of delayed management, length of hospital stay and long-term mortality. RESULTS: Between January 2007 and February 2010, 170 patients were enrolled. The cumulative incidence of adverse outcomes was significantly lower for early invasive than delayed management (2% [95% CI 0-9] vs. 24% [95% CI 16-35], p<10(-4)). Delayed management failed in 24% of cases. The length of hospital stay was significantly shorter in patients undergoing angioplasty or treated with tirofiban within 6h (p=0.0003). Long-term mortality was 16% in both arms after a median follow-up of 4.1years. CONCLUSION: An early invasive strategy reduced major adverse cardiac events in patients with high-risk NSTE-ACS. Early angiography or tirofiban (GP IIb/IIIa inhibitor) infusion proved necessary in a quarter of patients assigned to delayed management.
Subject(s)
Acute Coronary Syndrome/therapy , Coronary Angiography/methods , Electrocardiography , Myocardial Revascularization/methods , Practice Guidelines as Topic , Tyrosine/analogs & derivatives , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/mortality , Aged , Female , Follow-Up Studies , France/epidemiology , Humans , Infusions, Intravenous , Male , Middle Aged , Platelet Aggregation Inhibitors/administration & dosage , Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors , Retrospective Studies , Survival Rate/trends , Tirofiban , Tyrosine/administration & dosageABSTRACT
BACKGROUND: Improved early outcome in non-ST elevation myocardial infarction (NSTEMI) patients has been mainly attributed to a broader use of invasive strategies. Little is known about the impact of other changes in early management. METHODS: We aimed to assess 15-year trends in one-year mortality and their determinants in NSTEMI patients. We used data from 4 one-month French registries, conducted 5 years apart from 1995 to 2010 including 3903 NSTEMI patients admitted to intensive care units. RESULTS: From 1995 to 2010, no major change was observed in patient characteristics, while therapeutic management evolved considerably. Early use of antiplatelet agents, ß-blockers, ACE-inhibitors and statins increased over time (P < 0.001); use of newer anticoagulants (low-molecular-weight heparin, bivalirudin or fondaparinux) increased from 40.8% in 2000 to 78.9% in 2010 (P < 0.001); percutaneous coronary intervention (PCI)≤ 3 days of admission rose from 7.6% to 48.1% (P < 0.001). One-year death decreased from 20% to 9.8% (HR adjusted for baseline parameters, 2010 vs. 1995 = 0.47, 95% CI: 0.35-0.62). Early PCI (HR = 0.67; 95% CI: 0.49-0.90), use of newer anticoagulants (HR = 0.62; 95% CI: 0.48-0.78) and early use of evidence based medical therapy (HR = 0.54; 95% CI: 0.40-0.72) were predictors of improved one year-survival. CONCLUSIONS: One-year mortality of NSTEMI patients decreased by 50% in the past 15years. Our data support current guidelines recommending early invasive strategies and use of newer anticoagulants for NSTEMI, and also show a strong positive association between early use of appropriate medical therapies and one-year survival, suggesting that these medications should be used from the start.
Subject(s)
Cardiovascular Agents/therapeutic use , Electrocardiography , Forecasting , Myocardial Infarction/mortality , Percutaneous Coronary Intervention/methods , Registries , Aged , Female , Follow-Up Studies , France/epidemiology , Humans , Male , Myocardial Infarction/drug therapy , Myocardial Infarction/surgery , Prognosis , Retrospective Studies , Survival Rate/trendsABSTRACT
BACKGROUND: Improvements in the treatment of coronary artery disease mean that an increasing number of patients survive acute cardiovascular events and live as outpatients with or without anginal symptoms. AIM: To determine the characteristics and management of contemporary outpatients with stable coronary artery disease in Western Europe, and to compare France with the other Western European countries. METHODS: CLARIFY (prospeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease) is an international, prospective, observational, longitudinal study. Between November 2009 and July 2010, 32,954 adult outpatients with stable coronary artery disease (defined as a history of documented myocardial infarction [of >3 months], prior coronary revascularization, chest pain with myocardial ischaemia, or coronary stenosis of>50% proven by angiography) were enrolled in 45 countries. The demographics and management of CLARIFY patients enrolled in France were compared with those enrolled in other Western European countries (Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Switzerland and the UK). RESULTS: Of the 14,726 patients enrolled in Western Europe (mean age 66.2 [10.2] years; 79.6% male), 2432 (16.5%) were from France. The use of aspirin was lower in France than in other Western European countries (74.5% vs. 86.9%, respectively), whereas use of thienopyridines (48.5% vs. 21.7%), oral anticoagulants (12.3% vs. 9.0%) and lipid-lowering drugs (95.8% vs. 92.5%) was higher. Beta-blockers were used in 73% of both groups. Angina was less prevalent in France (6.3% vs. 15.5%) and French patients showed higher levels of physical activity than their counterparts in Western Europe. CONCLUSIONS: The management of patients with stable CAD in France appears favourable, with good adherence to guideline-based therapies, but there remains room for improvement in terms of symptom and risk factor control.
Subject(s)
Ambulatory Care , Coronary Artery Disease/drug therapy , Practice Patterns, Physicians' , Aged , Cardiovascular Agents/therapeutic use , Coronary Artery Disease/diagnosis , Coronary Artery Disease/epidemiology , Drug Utilization Review , Female , France/epidemiology , Guideline Adherence , Humans , Longitudinal Studies , Male , Middle Aged , Practice Guidelines as Topic , Prevalence , Prospective Studies , Registries , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVES: To evaluate practices for the protection from radiation of patients during coronary angiography (CA) and percutaneous coronary intervention (PCI), and to update reference values for the main radiation dose parameters. BACKGROUND: Few multicenter data from large populations exist on radiation doses to patients during CA and PCI. METHODS: RAY'ACT is a multicenter, nationwide French survey, with retrospective analysis of radiation parameters routinely registered in professional software from 33,937 CAs and 27,826 PCIs performed at 44 centers from January 1, through December 31, 2010. RESULTS: Kerma-area product (KAP) was registered in 91.7% (44/48) of centers and in 91.5% of procedures for CA (median, 27.2 Gy·cm(2) , interquartile range [IQR], 15.5-45.2) and 91.1% for PCI (median, 56.8 Gy·cm(2) , IQR, 32.8-94.6). Fluoroscopy time was registered in 87.5% (42/48) of centers and in 83.1% of procedures (median, 3.7 min, IQR, 2.3-6.3 for CA; 10.3 min, 6.7-16.2 for PCI). Variability across centers was high. Old equipment and routine left ventriculography were more common and number of registered frames and frame rate were higher in centers delivering high doses. The radial route was associated with lower doses than the femoral route (median KAP 26.8 Gy·cm(2) [15.1-44.25] vs. 28.1 [16.4-46.9] for CA, respectively; and 55.6 Gy·cm(2) [32.2-92.1] vs. 59.4 [24.6-99.9] for PCI, respectively; P < 0.01). CONCLUSIONS: This survey showed a very high rate of compliance with dose registration during CA and PCI in French nonacademic hospitals. Updated diagnostic reference values are established for the main dose parameters (KAP, 45 Gy·cm(2) for CA, 95 Gy·cm(2) for PCI).
Subject(s)
Coronary Angiography , Percutaneous Coronary Intervention , Radiation Dosage , Radiation Injuries/prevention & control , Radiography, Interventional , Aged , Coronary Angiography/adverse effects , Coronary Angiography/standards , Female , Femoral Artery/diagnostic imaging , Fluoroscopy , France , Guideline Adherence , Health Care Surveys , Humans , Male , Middle Aged , Patient Safety , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/standards , Practice Guidelines as Topic , Practice Patterns, Physicians' , Predictive Value of Tests , Radial Artery/diagnostic imaging , Radiation Injuries/etiology , Radiography, Interventional/adverse effects , Radiography, Interventional/standards , Reference Values , Retrospective Studies , Risk Assessment , Risk Factors , Time FactorsABSTRACT
BACKGROUND: Tako-Tsubo cardiomyopathy (TTC) is a recently described medical entity and the incidence of TTC in a global population is still uncertain. We sought to prospectively assess the incidence of TTC in a large urban area. METHODS AND RESULTS: We included all consecutive patients referred for coronary angiography in three hospitals located in Paris and its suburbs. We prospectively estimated the percentage of TTC among patients referred for coronary angiography and extrapolated the number of cases of TTC in the greater Paris area (11,598,866 inhabitants) according to the CARDIO-ARHIF registry (government agency). Among 2547 patients (2972 coronary angiographies) including 815 acute coronary syndromes, 20 patients presented with TTC (19 women, mean age 66 ± 13 years). The percentage of TTC among suspected acute coronary syndromes was 2.5% (8.2% in women versus 0.2% in men, p<0.001). In the CARDIO-ARHIF registry, we individualized 51,403 coronary angiographies performed in all catheterization laboratories in one year (13,820 women and 10,246 women ≥ 60 years). In this region, the yearly number of TTC cases is estimated to be 346 (95% CI: 216-520). The annual incidence of TTC is estimated to be 29.8 per 1,000,000 inhabitants (95% CI: 18.6-44.9), 48.2 per 1,000,000 inhabitants (95% CI: 29.7-73.0) among women and 187.4 per 1,000,000 inhabitants (95% CI: 103.3-307.2) among women ≥ 60 years. CONCLUSIONS: Within a large urban agglomeration, the incidence of TTC is high in women ≥ 60 years. The current rate of this recently described cardiomyopathy has been underestimated in previous retrospective studies and will probably rise with the increase of life expectancy.
Subject(s)
Takotsubo Cardiomyopathy/epidemiology , Aged , Female , Humans , Incidence , Male , Middle Aged , Paris/epidemiology , Prospective Studies , Urban HealthABSTRACT
BACKGROUND: Dual antiplatelet therapy with aspirin and thienopyridine is required after placement of coronary drug-eluting stents (DES) to prevent thrombotic complications. Current clinical guidelines recommend at least 6 to 12 months of treatment after a DES implantation, but it may be beneficial to apply dual antiplatelet therapy for a longer duration. METHODS/DESIGN: The optimal dual antiplatelet therapy (OPTIDUAL) study aims to compare the benefits and risks of dual antiplatelet therapy applied for either 12 or 48 months. We will examine the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing percutaneous coronary intervention with DES for the treatment of coronary lesions. The OPTIDUAL study is an open-label multicenter, randomized, national trial that will include 1,966 patients treated with DES. All patients will be treated with dual antiplatelet therapy for 12 months (+/- 3). Then, patients with no MACCE or major bleeding will be randomized to receive either 36 additional months of clopidogrel plus aspirin or aspirin only. The primary end-point is the combination of death from all causes, myocardial infarction, stroke and major bleeding. The secondary end points include the individual components of the primary end-point, stent thrombosis, repeat revascularization of the treated vessel and minor bleeding. DISCUSSION: This randomized trial is designed to assess the benefits and safety of 12 versus 48 months of dual antiplatelet therapy in patients that receive a DES. We aim to determine whether substantial prolongation of clopidogrel (a thienopyridine) after DES implantation offers an advantage over its discontinuation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00822536.
Subject(s)
Aspirin/administration & dosage , Drug-Eluting Stents , Percutaneous Coronary Intervention/instrumentation , Platelet Aggregation Inhibitors/administration & dosage , Research Design , Ticlopidine/analogs & derivatives , Aspirin/adverse effects , Clinical Protocols , Clopidogrel , Drug Administration Schedule , Drug Therapy, Combination , France , Hemorrhage/chemically induced , Hemorrhage/mortality , Humans , Myocardial Infarction/etiology , Myocardial Infarction/mortality , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Platelet Aggregation Inhibitors/adverse effects , Prosthesis Design , Stroke/etiology , Stroke/mortality , Thrombosis/etiology , Thrombosis/prevention & control , Ticlopidine/administration & dosage , Ticlopidine/adverse effects , Time Factors , Treatment OutcomeABSTRACT
AIM: Interleukin (IL)-17 pathway is being clinically targeted in immune-mediated diseases, most of which are associated with a significant cardiovascular risk. We investigated the relationship between serum levels of IL-17 and the risk of cardiovascular events in patients with acute myocardial infarction. METHODS AND RESULTS: We used data from 981 patients enrolled in the prospective, multicentre French registry of Acute ST elevation, or non-ST-elevation Myocardial Infarction (Fast-MI, NCT00673036). Serum levels of IL-17 were associated with the risk of all-cause death and recurrent MI at 2 years, with levels of IL-17 below the median indicative of a worse outcome. The impact of IL-17 remained significant after adjustment for known cardiovascular risk factors, C-reactive protein, and treatments including statins: hazard ratio (HR) = 1.40 (1.03-1.91); P = 0.03. IL-17 inhibited mononuclear cell adhesion to endothelium and reduced endothelial vascular cell adhesion molecule (VCAM-1) expression. Patients with low (below the median) IL-17 levels and high (above the median) soluble VCAM-1 (sVCAM-1) levels were at particularly increased risk of death and MI: adjusted HR = 2.22 (1.32-3.75) compared with the high IL-17/low sVCAM-1 group (P = 0.002). CONCLUSIONS: Low serum levels of IL-17 are associated with a higher risk of major cardiovascular events in Caucasian patients with acute MI. Our results raise possible concern about the use of inhibitors of the IL-17 pathway in clinical settings associated with a high cardiovascular risk. CLINICAL TRIALS REGISTRATION: NCT00673036.
Subject(s)
Human Umbilical Vein Endothelial Cells/metabolism , Interleukin-17/blood , Leukocytes, Mononuclear/metabolism , Myocardial Infarction/blood , Aged , Analysis of Variance , Enzyme-Linked Immunosorbent Assay , Female , Humans , Interleukin-17/physiology , Male , Middle Aged , Myocardial Infarction/mortality , Prognosis , Prospective Studies , Recurrence , Registries , Vascular Cell Adhesion Molecule-1/metabolismABSTRACT
CONTEXT: The contemporary decline in mortality reported in patients with ST-segment elevation myocardial infarction (STEMI) has been attributed mainly to improved use of reperfusion therapy. OBJECTIVE: To determine potential factors-beyond reperfusion therapy-associated with improved survival in patients with STEMI over a 15-year period. DESIGN, SETTING, AND PATIENTS: Four 1-month French nationwide registries, conducted 5 years apart (between 1995, 2000, 2005, 2010), including a total of 6707 STEMI patients admitted to intensive care or coronary care units. MAIN OUTCOME MEASURES: Changes over time in crude 30-day mortality, and mortality standardized to the 2010 population characteristics. RESULTS: Mean (SD) age decreased from 66.2 (14.0) to 63.3 (14.5) years, with a concomitant decline in history of cardiovascular events and comorbidities. The proportion of younger patients increased, particularly in women younger than 60 years (from 11.8% to 25.5%), in whom prevalence of current smoking (37.3% to 73.1%) and obesity (17.6% to 27.1%) increased. Time from symptom onset to hospital admission decreased, with a shorter time from onset to first call, and broader use of mobile intensive care units. Reperfusion therapy increased from 49.4% to 74.7%, driven by primary percutaneous coronary intervention (11.9% to 60.8%). Early use of recommended medications increased, particularly low-molecular-weight heparins and statins. Crude 30-day mortality decreased from 13.7% (95% CI, 12.0-15.4) to 4.4% (95% CI, 3.5-5.4), whereas standardized mortality decreased from 11.3% (95% CI, 9.5-13.2) to 4.4% (95% CI, 3.5-5.4). Multivariable analysis showed a consistent reduction in mortality from 1995 to 2010 after controlling for clinical characteristics in addition to the initial population risk score and use of reperfusion therapy, with odds mortality ratios of 0.39 (95%, 0.29-0.53, P <.001) in 2010 compared with 1995. CONCLUSION: In France, the overall rate of cardiovascular mortality among patients with STEMI decreased from 1995 to 2010, accompanied by an increase in the proportion of women younger than 60 years with STEMI, changes in other population characteristics, and greater use of reperfusion therapy and recommended medications.
Subject(s)
Myocardial Infarction/mortality , Myocardial Reperfusion/statistics & numerical data , Age Factors , Aged , Demography , Female , France/epidemiology , Humans , Male , Middle Aged , Mortality/trends , Myocardial Infarction/therapy , Registries/statistics & numerical data , Retrospective Studies , Sex Factors , Survival AnalysisABSTRACT
BACKGROUND: Coronary stents have evolved over time, from bare-metal stents to drug-eluting stents, and now to bioactive stents. AIMS: We sought to explore the immediate outcome of the titanium-nitride-oxide-coated bioactive stent, Titan2(®), in real-world practice, and the incidence of major cardiac events at follow-up. METHODS: Consecutive patients admitted for percutaneous intervention for at least one significant (≥50%) lesion in a native coronary artery were treated with Titan2(®) stent implantation. The primary endpoint was total major adverse cardiac events at 12-month follow-up. Secondary endpoints included target lesion revascularization at 12-month follow-up and the duration of dual antiplatelet therapy. RESULTS: Among 356 patients (mean age 67.4 ± 12.1 years), 77.2% were male and 39.3% were treated for myocardial infarction (MI). A total of 546 Titan2(®) stents were implanted in 420 lesions. Angiographic and clinical procedural success was achieved in all cases. No cases of in-hospital major adverse cardiac events or acute stent thrombosis were reported. Of 335 patients (94.1%) with 12-month clinical follow-up, four (1.2%) died, MI occurred in five (1.5%), target lesion revascularization was performed in 17 (5.1%) and major adverse cardiac events occurred in 24 (7.2%). One patient (0.3%) suffered late stent thrombosis during follow-up, but no cases of acute or subacute stent thrombosis occurred. Dual antiplatelet therapy continued beyond 6 months in 64.5% of patients. CONCLUSIONS: In real-world practice, Titan2(®) stent implantation achieves an excellent immediate outcome, with a low incidence of major adverse cardiac events at 12-month follow-up.