ABSTRACT
O número de pacientes submetidos a cirurgias não-cardíacas está aumentando no mundo todo. A fim de ministrar uma assistência eficiente aos pacientes durante a cirurgia, precisamos melhorar nosso conhecimento sobre como evitar eventos cardiovasculares perioperatórios maiores durante a cirurgia não-cardíaca. Para atingir este objetivo, é necessário realizar ensaios clínicos aleatórios, os quais podem fornecer resultados conclusivos e confiáveis neste campo. Esta revisão narrativa descreve uma proposta para o delineamento, condução e gerenciamento de ensaios clínicos aleatórios de larga escala em medicina cardiovascular perioperatória.
The number of patients undergoing noncardiac surgery is growing worldwide. To optimally assist patients during the perioperative period, we must improve our knowledge of how to prevent major perioperative cardiovascular events around the time of noncardiac surgery. To achieve this goal there is a need for large randomized controlled trials that can provide reliable and conclusive results in this field. This narrative review describes a proposal for the design, conduct and management of large controlled trials in perioperative cardiovascular medicine.
El número de pacientes sometidos a cirugías no-cardiacas está aumentando en todo el mundo. A fin de impartir una asistencia eficiente a los pacientes durante la cirugía, necesitamos mejorar nuestro conocimiento sobre como evitar eventos cardiovasculares perioperatorios mayores durante la cirugía no-cardiaca. Para alcanzar este objetivo, es necesario realizar ensayos clínicos aleatorios que pueden proveer resultados conclusivos y confiables en este campo. Esta revisión narrativa describe una propuesta para el delineamiento, la conducción y la gestión de ensayos clínicos aleatorios y a larga escala en medicina cardiovascular perioperatoria.
Subject(s)
Humans , Cardiovascular Diseases/prevention & control , Intraoperative Complications/prevention & control , Randomized Controlled Trials as Topic/methods , Cardiovascular Diseases/surgery , Randomized Controlled Trials as Topic/standardsABSTRACT
India is likely to have the highest absolute burden of cardiovascular disease (CVD) related morbidity and mortality in the world. The prevalence of risk-factors (RFs) is high, particularly in the young, and a strategy to reduce RF prevalence in a large population needs to be developed. It is possible to modify risk factors at the individual level or at the population level. The latter is likely to have a greater impact. Current evidence shows that the reduction of risk factors such as BP or serum cholesterol from any level (rather than above a particular threshold) confers potential benefits. At present, lifestyle interventions have not demonstrated the benefits in reducing CVD related mortality and morbidity. A polypharmacotherapy strategy (2-3 BP lowering drugs, a statin, and aspirin) has promise to considerably reduce CVD-related mortality and morbidity. Such a therapy could target a large proportion of the population, intervene simultaneously on multiple RFs, and have wide acceptability. Cost and adherence are important issues for the success of this strategy. Adherence is suboptimal even for secondary prevention. A fixed-dose combination (FDC) of these drugs may improve adherence and reduce costs. But prior to recommending the wide-spread use of an FDC polypharmacotherapy strategy, studies are required to systematically evaluate its efficacy and safety and then determine the adherence, cost, and acceptability in the population. Studies are ongoing in India and other countries to determine the role of FDC polypharmacotherapy in the primary prevention of CVD. Such FDC therapy may reduce costs, improve adherence, and reduce CVD events at the population level; especially in developing countries such as India.