RESUMO
BACKGROUND: Testing of factor Xa inhibitors for the prevention of cardiovascular events in patients with rheumatic heart disease-associated atrial fibrillation has been limited. METHODS: We enrolled patients with atrial fibrillation and echocardiographically documented rheumatic heart disease who had any of the following: a CHA2DS2VASc score of at least 2 (on a scale from 0 to 9, with higher scores indicating a higher risk of stroke), a mitral-valve area of no more than 2 cm2, left atrial spontaneous echo contrast, or left atrial thrombus. Patients were randomly assigned to receive standard doses of rivaroxaban or dose-adjusted vitamin K antagonist. The primary efficacy outcome was a composite of stroke, systemic embolism, myocardial infarction, or death from vascular (cardiac or noncardiac) or unknown causes. We hypothesized that rivaroxaban therapy would be noninferior to vitamin K antagonist therapy. The primary safety outcome was major bleeding according to the International Society of Thrombosis and Hemostasis. RESULTS: Of 4565 enrolled patients, 4531 were included in the final analysis. The mean age of the patients was 50.5 years, and 72.3% were women. Permanent discontinuation of trial medication was more common with rivaroxaban than with vitamin K antagonist therapy at all visits. In the intention-to-treat analysis, 560 patients in the rivaroxaban group and 446 in the vitamin K antagonist group had a primary-outcome event. Survival curves were nonproportional. The restricted mean survival time was 1599 days in the rivaroxaban group and 1675 days in the vitamin K antagonist group (difference, -76 days; 95% confidence interval [CI], -121 to -31; P<0.001). A higher incidence of death occurred in the rivaroxaban group than in the vitamin K antagonist group (restricted mean survival time, 1608 days vs. 1680 days; difference, -72 days; 95% CI, -117 to -28). No significant between-group difference in the rate of major bleeding was noted. CONCLUSIONS: Among patients with rheumatic heart disease-associated atrial fibrillation, vitamin K antagonist therapy led to a lower rate of a composite of cardiovascular events or death than rivaroxaban therapy, without a higher rate of bleeding. (Funded by Bayer; INVICTUS ClinicalTrials.gov number, NCT02832544.).
Assuntos
Anticoagulantes , Fibrilação Atrial , Inibidores do Fator Xa , Cardiopatia Reumática , Rivaroxabana , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/etiologia , Ecocardiografia , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Cardiopatia Reumática/complicações , Cardiopatia Reumática/diagnóstico , Cardiopatia Reumática/diagnóstico por imagem , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento , Vitamina K/antagonistas & inibidores , Varfarina/efeitos adversos , Varfarina/uso terapêuticoRESUMO
Rheumatic heart disease (RHD) as a chronic sequela of repeated episodes of acute rheumatic fever (ARF), remains a cause of cardiac morbidity in Egypt although it is given full attention through a national RHD prevention and control program. The present report reviews our experience with subjects presenting with ARF or its sequelae in a single RHD centre and describes the disease pattern over the last decade. A cross-sectional study was conducted in El-Mahalla RHD centre between 2006 and 2018. A total of 17014 individual were enrolled and evaluated. Diagnosis ARF was based on the 2015 revised Jones criteria and RHD was ruled in by echocardiography. The majority of the screened subjects were female (63.2%), in the age group 5-15 years (64.6%), rural residents (61.2%), had primary education (43.0%), and of low socioeconomic standard (50.2%). The total percentage of cases presenting with ARF sequelae was 29.3% [carditis/RHD (10.8%), rheumatic arthritis (Rh.A) (14.9%), and Sydenham's chorea (0.05%)]. Noticeably, 72% were free of any cardiac insult, of which 37.7% were victims of misdiagnoses made elsewhere by untrained practitioners who prescribed for them long term injectable long-acting penicillin [Benzathine Penicillin G (BPG)] without need. About 54% of the study cohort reported the occurrence of recurrent attacks of tonsillitis of which 65.2% underwent tonsillectomy. Among those who experienced tonsillectomy and/or received BPG in the past, 14.5% and 22.3% respectively had eventually developed RHD. Screening of family members of some RHD cases who needed cardiac surgery revealed 20.7% with undiagnosed ARF sequalae [RHD (56.0%) and Rh.A (52.2%)]. Upon the follow-up of RHD cases, 1.2% had improved, 98.4% were stable and 0.4% had their heart condition deteriorated. Misdiagnosis of ARF or its sequelae and poor compliance with BPG use may affect efforts being exerted to curtail the disease. Updating national guidelines, capacity building, and reliance on appropriate investigations should be emphasized. Since the genetic basis of RHD is literally confirmed, a family history of RHD warrants screening of all family members for early detection of the disease.
Assuntos
Cardiopatia Reumática/diagnóstico , Cardiopatia Reumática/prevenção & controle , Adolescente , Criança , Pré-Escolar , Estudos de Coortes , Progressão da Doença , Ecocardiografia , Egito , Feminino , Humanos , Programas de Rastreamento , Penicilina G Benzatina/uso terapêutico , Febre Reumática/prevenção & controle , Cardiopatia Reumática/epidemiologiaRESUMO
Rheumatic heart disease (RHD) is a preventable disease that is prevalent in developing regions of the world. Its eradication from most of the developed world indicates that this disease can be controlled and eliminated. Aim: To conduct an in-depth analysis of the trends and challenges of controlling RHD in the Eastern Mediterranean region (EMR). Methodology: Global data from the World Health Organization (WHO) data banks were retrieved for total deaths and age standardized death rate per 100,000 (ASDR) by age group, sex, and year (from 2000 to 2015). The data was compared with the five other WHO regions of the world. We also performed in-depth analysis by socio-economic groups in relation to other attributes in the region related to population growth, illiteracy, and nutritional status. Indicators of service delivery were correlated with ASDR from RHD. Findings: Prevalence of RHD in 2015 in the EMR region was one-third of that of the total deaths reported in the Asian and West Pacific regions. The total deaths for the region peaked twice: in early adulthood and again later in old age, and was higher in females than in males. There was a rising trend in deaths from RHD from 2000 to 2015. The highest total deaths were reported from Egypt, Pakistan, Iran, Afghanistan, and Yemen, representing 80% of the total death rates for the region (35,248). The highest ASDR was Afghanistan (27.5), followed by Yemen (18.78) and Egypt (15.59). The ASDR for RHD was highest in low income countries. It correlated highly, in all income groups, with anemia during pregnancy. Conclusions: Trends and patterns of deaths from RHD in the EMR have shifted to a later age group and are linked with poverty related to inequalities in development and service delivery for certain age groups and gender.