Internal and emergency medicine
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Depending on the scientific hypothesis to be addressed, randomized-controlled trials (RCT) are accordingly designed. RCTs that aim to determine whether a novel, experimental therapeutic intervention (either a drug or a treatment) is superior to a placebo or control intervention, are called superiority trials. ⋯ In equivalence and non-inferiority RCTs, the efficacy of the reference intervention (active comparator) is already established, and therefore, an untreated control group would not be ethical. In this review, using a series of examples derived from equivalence and non-inferiority/superiority RCTs, we describe the main differences and methodological aspects among these three different types of RCTs.
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Pulmonary embolism (PE) is the third most frequent acute cardiovascular syndrome. Annual PE incidence and PE-related mortality rates rise exponentially with age, and consequently, the disease burden imposed by PE on the society continues to rise as the population ages worldwide. Recently published landmark trials provided the basis for new or changed recommendations included in the 2019 update of the European Society of Cardiology Guidelines (developed in cooperation with the European Respiratory Society). ⋯ Besides, the 2019 Guidelines endorse multidisciplinary teams for coordinating the acute-phase management of high-risk and (in selected cases) intermediate-risk PE. For normotensive patients, physicians are advised to include the assessment of the right ventricle on top of clinical severity scores in further risk stratification, especially if early discharge of the patient is envisaged. Further important updates include guidance (1) on extended anticoagulation after PE, taking into account the improved safety profile of NOACs; and (2) on the overall care and follow-up of patients who have suffered PE, with the aim to prevent, detect and treat late sequelae of venous thromboembolism.
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Antithrombotic treatment in patients with atrial fibrillation undergoing percutaneous coronary intervention is still debated. We conducted a meta-analysis of recent randomized controlled trials to evaluate the benefit of different antithrombotic strategies. Data were analyzed between May and September 2019. ⋯ DAT was as effective and safer than TAT in patients with stable coronary artery disease, while a trend towards increased ischemic events was seen in ACS patients. DAT with a DOAC showed similar efficacy and less bleeding than TAT with a VKA. However, increased stent thrombosis with DAT may be present, and TAT should be considered in patients at high ischemic risk, such as ACS patients.
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Antithrombotic treatment in patients with atrial fibrillation undergoing percutaneous coronary intervention is still debated. We conducted a meta-analysis of recent randomized controlled trials to evaluate the benefit of different antithrombotic strategies. Data were analyzed between May and September 2019. ⋯ DAT was as effective and safer than TAT in patients with stable coronary artery disease, while a trend towards increased ischemic events was seen in ACS patients. DAT with a DOAC showed similar efficacy and less bleeding than TAT with a VKA. However, increased stent thrombosis with DAT may be present, and TAT should be considered in patients at high ischemic risk, such as ACS patients.