Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Ensaio clínico randomizado comparando implante de próteses intracoronárias com e sem revestimento de carbeto de silício amorfo

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Ensaio clínico randomizado comparando implante de próteses intracoronárias com e sem revestimento de carbeto de silício amorfo

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Prevalência de estenose das artérias renais em 1.656 pacientes que realizaram cateterismo cardíaco Prevalence of renal artery stenosis in 1,656 patients who have undergone cardiac catheterization

OBJETIVO: Determinar a prevalência de estenose da artéria renal (EAR) em pacientes submetidos a cineangiocoronariografia. MÉTODOS: Estudo prospectivo, considerando 1.656 cinean-giocoronariografias seguidas de aortografia, entre janeiro/2002 e fevereiro/2004, de pacientes encaminhados à cineangiocoronariografia diagnóstica com história ou não de hipertensão arterial sistêmica (HAS). RESULTADOS: Dos 1.656 pacientes, a idade média foi de 61,6 ± 11,8 anos, 53,8% eram do sexo masculino, 10,2% eram diabéticos, 63,8% apresentavam coronariopatia obstrutiva. A presença de EAR maior que 50% foi observada em 228 (13,8%) pacientes, e em 25 (1,5%) destes, ocorreu bilateralmente. A coronariopatia obstrutiva foi definida como estenose que causa redução do lúmen do vaso em 50% ou mais, em um, dois ou três vasos principais, denominados uniarterial, biarterial ou triarterial, respectivamente.A quantificação era realizada através da análise visual da angiografia. Comparando os grupos com e sem EAR > 50%, observou-se diferença estatisticamente significativa quanto a gênero, idade, ocorrência de diabete melito, PA e função ventricular esquerda. Não houve diferença significativa, no entanto, quanto à ocorrência de obstrução coronariana > 50%. Quando, porém, a EAR considerada é > 70%, observa-se diferença significativa quanto a PA, associação à obstrução coronariana > 50% e à disfunção ventricular esquerda, maiores no grupo com EAR. CONCLUSÃO: A prevalência de EAR neste estudo foi comparável àquela das grandes casuísticas da literatura e, em razão de sua importância pela associação com HAS e doença renal terminal (DRT) e suas seqüelas, devemos estar atentos para seu diagnóstico angiográfico.<br>OBJECTIVE: To determine the prevalence of renal artery stenosis (RAS) in patients who have undergone cineangiocoronariography. METHODS: Prospective study of cineangiocoronariography and aortography examinations conducted between January 2002 and February 2004 on 1,656 hypertensive and normotensive patients who underwent the examinations to confirm the diagnosis of obstructive coronary artery disease or valve disease. RESULTS: The average age of the 1,656 patients was 61.6 ± 11.8 years. Eight hundred and ninety-one (53.8%) were male, 169 (10.2%) were diabetic and 1,054 (63.8%) presented obstructive coronary artery disease. Renal stenosis greater than 50% was observed in 228 (13.8%) patients, and 25 (1.5%) had bilateral stenosis. Obstructive coronary artery disease was defined as stenosis greater than or equal to 50% of the vessel lumen, in one, two or three main arteries, classified as single, double or triple vessels, respectively. Quantification was conducted using visual analysis of the angiography. Comparison of the groups with and without renal artery obstruction > 50%, revealed significant statistical differences in relation to gender, age, diabetes mellitus, blood pressure and left ventricular function. However, no statistical difference was noted in relation to the occurrence of coronary artery obstructions > 50%. Nevertheless, renal artery obstructions > 70%, revealed significant differences in relation to blood pressure, coronary artery obstructions > 50% and left ventricular function, which were all higher in the renal artery obstruction group. CONCLUSION: The prevalence of RAS found in our study was comparable to that reported by major medical literature case studies. RAS is associated with systemic hypertension (SH), end-stage renal disease (ESRD) and its sequelae, emphasizing how important it is that we are aware of possible candidates for angiographic diagnosis of this disease

Implante de endoprótese na via de entrada do átrio direito monitorado por ultra-som intracardíaco Endoprosthesis implantation at the entry pathway of the right atrium monitored by intracardiac ultrasound

As obstruções do sistema venoso superior podem ocorrer por trombose espontânea ou na presença de cateteres de hemodiálise ou quimioterapia, e mesmo na presença de compressão extrínseca por tumores intratorácicos. O uso de endopróteses para o tratamento dessas obstruções vem se tornando prática comum e sua indicação inclui situações de risco de embolia pulmonar, síndrome da veia cava superior e perda do acesso vascular. Nesse contexto, o uso do ultra-som intracardíaco pode ser útil na avaliação da extensão e da gravidade da obstrução, além de fornecer informações morfológicas murais e intramurais do sistema venoso. Relatamos o caso de uma paciente com síndrome da veia cava superior por trombose da via de entrada do átrio direito, submetida a implante de endoprótese monitorado por ultra-som intracardíaco, além de discutir o tema por meio de revisão da literatura.<br>Obstructions of the upper venous system may be due to spontaneous thrombosis or the presence of hemodialysis or chemotherapy catheters, or even the presence of extrinsic compression due to intra-thoracic tumors. The use of endoprosthesis for the treatment of these obstructions has become common practice, and its indications include situations of risk for pulmonary embolism, superior vena cava syndrome, and loss of vascular access. Within this context, the use of intracardiac ultrasound may be useful in evaluating the extension and severity of the obstructive lesion, besides providing important information about the mural and intraluminal morphology of the venous system. The authors report the case of a patient with superior vena cava syndrome caused by thrombosis at the entry pathway of the right atrium, besides discussing the subject by means of literature review

International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation: Results from the GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries

Background Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world. We aimed to provide comprehensive data on international patterns of AF stroke prevention treatment