Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial.

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.

Late results of percutaneous mitral commissurotomy up to 20 years: development and validation of a risk score predicting late functional results from a series of 912 patients.

BACKGROUND: Long-term follow-up after percutaneous mitral commissurotomy enables predictive factors of late results to be identified. METHODS AND RESULTS: Late results of percutaneous mitral commissurotomy were assessed in 1024 consecutive patients. Good immediate results, defined as valve area ≥1.5 cm(2) without mitral regurgitation >2/4, were obtained in 912 patients (89%). These 912 patients were randomly split into 2 cohorts comprising 609 and 303 patients that were used to develop and validate, respectively, a scoring system predicting late functional results. The 20-year rate of good functional results (survival without cardiovascular death, mitral surgery, or repeat percutaneous mitral commissurotomy and in New York Heart Association class I or II) was 30.2 ± 2.0%. A multivariable Cox model identified 7 predictive factors of poor late functional results: higher final mean gradient (P<0.0001), interaction between age and final mitral valve area (P<0.0001) showing that the impact of valve area decreases with age, interaction between sex and valve calcification (P<0.0001) showing that the impact of valve anatomy is stronger in men, and interaction between rhythm and New York Heart Association class showing an impact of New York Heart Association class only in patients in atrial fibrillation (P<0.0001). A 13-point score enabled 3 risk groups to be defined, corresponding to predicted good functional results of 55.1%, 29.1%, and 10.5% at 20 years in the validation cohort. CONCLUSIONS: Twenty years after percutaneous mitral commissurotomy in a population of patients with varied characteristics, 30% still had good functional results. Prediction of late functional results is multifactorial and strongly determined by age and the quality of immediate results. A simple validated scoring system is useful for estimating individual patient outcome.

Low level exercise echocardiography helps diagnose early stage heart failure with preserved ejection fraction: a study of echocardiography versus catheterization.

BACKGROUND: Increased left ventricular end-diastolic pressure (LVEDP) with exercise is an early sign of heart failure with preserved left ventricular ejection fraction (LVEF). The abnormal exercise increase in LVEDP is nonlinear, with most change occurring at low-level exercise. Data on non-invasive approach of this condition are scarce. Our objective was assessing E/e' to estimate low level exercise LVEDP using a direct invasive measurement as the reference method. METHODS AND RESULTS: Sixty patients with LVEF >50 % prospectively underwent both exercise cardiac catheterization and echocardiography. E/e' was measured at rest and during low-level exercise. Abnormal LVEDP was defined as >16 mmHg. Patients with a history of coronary artery disease and/or abnormal LV morphology were classified as having apparent cardiac disease (CD). Thirty-four (57 %) patients had elevated LVEDP only during exercise. Most of the change in LVEDP occurred since the first exercise level (25 W). There was a correlation between LVEDP and septal E/e' at rest and during exercise. Lateral E/e' and E/average e' ratio had worse correlations with LVEDP. In the whole population, exercise septal E/e' at 25 W had the best accuracy for abnormal exercise LVEDP, area under curve (AUC) = 0.79. However, while low-level exercise septal E/e' had a high accuracy in CD patients (n = 26, AUC = 0.96), E/e' was not linked to LVEDP in patients without CD (n = 34). CONCLUSION: Low-level exercise septal E/e' is valuable for predicting abnormal exercise LVEDP in patients with preserved LVEF and apparent CD. However, this new diagnosis approach appears not reliable in patients with normal LV morphology and without coronary artery disease. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov . Unique identifier: NCT01714752.

Prognostic significance of renal insufficiency in patients presenting with acute coronary syndrome (the Prospective Multicenter SYCOMORE study).

This prospective, multicenter, observational study was designed to assess the in-hospital prognostic importance of renal insufficiency among patients presenting with acute coronary syndrome (ACS). One third of patients with ACS presented with renal insufficiency. After adjustment for potential confounders, decreasing renal function was independently associated with in-hospital death, bleeding, and contrast-induced nephropathy.

Evaluation of kryptor cardiac troponin I immunoassay.

BACKGROUND AND METHODS: Cardiac troponin I (cTnl) is well recognized as a specific marker for myocardial infarction. A fully automated, random access, fluorescent immunoassay for cTnl was evaluated in comparison with an established assay (Stratus cTnl) using samples from healthy subjects and from patients with cardiac disease. RESULTS: The detection and precision were acceptable, and no interference was observed from bilirubin, triglycerides, haemoglobin, rheumatoid factor, drugs (aspirin, dopamine, digoxin) or heparin. Results on the Kryptor cTnl assay correlated with those on the Stratus II cTnI assay. The optimum Kryptor cTnl concentration for acute myocardial infarction was 0.63 microg/L, with a sensitivity of 89% [95% confidence interval (CI): 75.9-96.3] and specificity of 98.9% (95% CI: 93.9-99.8). CONCLUSION: Kryptor cTnl immunoassay is suitable for use in the diagnosis of myocardial infarction.

Three-dimensional transesophageal echocardiography for descending aortic atheroma: a preliminary study.

Transesophageal echocardiography (TEE) is an efficient method for characterization of aortic atherosclerotic plaques (AAP). The aim of our study was to evaluate the feasibility and the additional contribution of three-dimensional (3D) TEE in the evaluation of AAPs in descending thoracic aorta. We studied 82 patients referred for TEE regardless of the indication. All patients underwent two-dimensional (2D) conventional acquisitions. A 3D TEE study was performed for all AAPs localized in the descending thoracic aorta. Thickness, degree of calcification, the presence of ulceration or mobile debris were compared for 2D and 3D modes. From 3D data, three types of AAPs were defined according to their morphological characteristics (surface and contours). Among 192 AAPs found on 2D acquisition, 189 (98.4 %) were also identified by 3D TEE. For AAP characterization, agreement was good between 2D TEE and 2D extracted from 3D with the multiplanar reconstruction mode: 83.6 % (k = 0.69) for thickness and 82.5 % (k = 0.72) for degree of calcification. All AAPs ulcerations (n = 13) and mobile debris (n = 3) seen in 2D were identified in 3D. 2D characteristics of the 3D AAPs' morphological types were different: type I plaques were thin and rarely calcified; type III plaques were thicker and often calcified; and type II presented intermediate characteristics. There was overlap among groups and the 3D morphology could not be predicted from 2D data. 3D TEE is a feasible method for the analysis of AAPs. In addition to conventional characterization, 3D TEE provides a new morphological approach to AAPs.

Subclinical left ventricular systolic impairment in steady state young adult patients with sickle-cell anemia.

Chronic volume overload in sickle-cell anemia (SCA) is associated with left ventricular (LV) enlargement and hypertrophy. The effect of the disease on LV systolic function remains debated. The aim of our study was to investigate LV systolic function in SCA patients using 2D speckle-tracking imaging. We compared 30 steady state asymptomatic adult SCA patients (17 women, mean age 24.7 ± 5.1 years) with 30 age and sex-matched healthy subjects (17 women, mean age 25.0 ± 4.9 years). In addition to conventional echocardiographic parameters including LV ejection fraction (LVEF) and LV mass index (LVMi), global longitudinal strain (GLS) and strain rate (GLSR) were measured. GLS (-17.9 ± 2.0 vs. -19.7 ± 2.5 %, p = 0.004) and GLSR (-0.92 ± 0.09 vs. -1.07 ± 0.17 s(-1), p < 0.0001) values were lower in SCA patients while LVEF values (60.1 ± 3.8 vs. 61.7 ± 4.7 %, p = 0.30) were not different. LVMi was increased in SCA patients (100.7 ± 23.5 vs. 72.4 ± 15.2 g/m(2), p = 0.0001) and GLSR was significantly lower in the subgroup of patients with LV hypertrophy (-0.88 ± 0.09 vs. -0.96 ± 0.08 s(-1), p = 0.02). In SCA patients LVMi was correlated to GLS (r = 0.58, p = 0.001) and GLSR (r = 0.45, p = 0.015) pleading in favor of a pathological LV remodeling. Asymptomatic SCA patients exhibited a subclinical alteration of LV systolic function. Myocardial dysfunction appears to be linked to the degree of LV hypertrophy. 2D speckle-tracking imaging might be useful for long-term follow-up and to study the natural course of LV dysfunction in SCA patients.

An education program for risk factor management after an acute coronary syndrome: a randomized clinical trial.

IMPORTANCE: Lifestyle improvements after an acute coronary syndrome reduce cardiovascular risk but are difficult to achieve. OBJECTIVE: To determine whether a nurse-led or dietician-led cardiovascular risk factor education program would improve risk factor reduction over the long term after an acute coronary syndrome. DESIGN, SETTING, AND PARTICIPANTS: The Réseau Insuffisance Cardiaque (RESICARD) PREVENTION: study was a 2-arm, parallel-group, multicenter, randomized clinical trial at 6 tertiary care hospitals in France. Patients hospitalized in a cardiac intensive care unit for an acute coronary syndrome with at least 1 lifestyle risk factor (current smoking, sedentary lifestyle, or overweight or obesity) were randomized according to a computer-generated list with sequentially numbered, sealed envelopes. INTERVENTION: Patients underwent an education program in a unique non-hospital setting (a House of Education) or were treated according to physicians' usual standard of care. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite that included at least 1 of the following: smoking cessation, at least 3 hours per week of physical activity, at least 5% reduction in weight, and at least 4% reduction in waist circumference. Patients were followed up for 1 year. An intent-to-treat analysis was performed. RESULTS From June 21, 2006, to July 30, 2008, a total of 251 patients were randomized to the House of Education and 251 to conventional care. The 2 groups did not differ significantly at 12 months in the primary composite outcome (51.8% vs 49.8% success rate; adjusted relative risk [aRR], 1.11; 95% CI, 0.90-1.37) or with correction of all risk factors (aRR, 1.22; 95% CI, 0.89-1.66). Similarly, the 2 groups did not differ by physical activity (aRR, 1.05; 95% CI, 0.92-1.21), smoking cessation (aRR, 0.99; 95% CI, 0.87-1.13), and weight or waist reduction (aRR, 1.07; 95% CI, 0.84-1.36). CONCLUSIONS AND RELEVANCE: Compared with conventional care, the House of Education did not result in superior improvement in lifestyle-related cardiovascular risk factors after an acute coronary syndrome. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00337480.

Cannabis induced acute coronary syndrome in a young female.

Nowadays cannabis is the most common substance of drug abuse and pathophysiological effects have been described on the cardiovascular system. Yet there is limited information concerning cannabis induced acute coronary syndrome and the exact contribution of cannabis smoking to coronary artery disease and its mechanism are not known. We describe a case of acute coronary syndrome following cannabis smoking in a young female with no predisposing causes for thrombosis.

Mesalamine-induced myocarditis.

Nowadays mesalamine is a common treatment for Crohn's disease and hypersensitive reactions to this product have been reported. Yet there is limited information concerning mesalamine-induced myocarditis and its mechanism is not known. We described a case of mesalamine-induced myocarditis in Crohn's disease of the colon.

RESICARD: East Paris network for the management of heart failure: absence of effect on mortality and rehospitalization in patients with severe heart failure admitted following severe decompensation.

BACKGROUND: Heart failure presents a major public health problem due to its high prevalence and the increasing number of hospital admissions for this condition. A coordinated healthcare network involving general practitioners and cardiologists was set up in the east of Paris in an effort to improve the management and outcomes of patients with severe heart failure. AIMS: To reinforce patient education, improve compliance with medications and identify symptoms requiring treatment modification. METHODS: In this 'before and after' study, the control group comprised patients hospitalized for severe heart failure who received conventional management in the year preceding the network set-up. The comparative group consisted of patients hospitalized for severe heart failure who underwent network-led care. RESULTS: No significant differences were found between rates of first rehospitalization and all-cause mortality at 1 year between control and network groups, or between rates of first hospitalization due to cardiac causes, time to the first event, duration of hospitalization, rates of cardiac death or time to death. CONCLUSIONS: In this non-randomized study, we found no benefit from management according to the RESICARD healthcare network in terms of mortality or hospitalization in patients with severe chronic heart failure.