As a learning organization committed to enhancing the health of current and future generations through research, the CVC relentlessly pursues the generation, translation, and dissemination of new knowledge addressing unmet clinical needs. This section highlights important publications produced by the CVC faculty and our body of research in recent months.
Composite End Points in Clinical Research: A Time for Reappraisal
This article evaluates the criticisms leveled at the conventional approach of collating patient outcomes into a composite end point, explores what is to be anticipated from the large cohort of as-yet unpublished clinical trials, and proposes novel approaches to composite end points. Setting a new standard for clinical end points should not only bring welcome light to the darkness, but also should better inform a diverse audience of stakeholders, including patients, regulators, clinicians, and providers.
Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial
The interpretation of the findings from this study indicates that substituting rivaroxaban for aspirin in patients with acute coronary syndromes (ACS) appears to cause no significant increase in bleeding risk. Dr. Robert Welsh explains “This phase-2 trial provides the first evidence for safety of a dual pathway approach in ACS patients, specifically the combination of a low dose anticoagulant and single antiplatelet is as safe as DAPT, the current standard of care. Determining the net clinical impact in ACS patients will require further research based upon these phase 2 trials results.”
Identifying low-risk patients for early discharge from emergency department without using subjective descriptions of chest pain: Insights from Providing Rapid Out of hospital Acute Cardiovascular Treatment (PROACT) 3 and 4 trials
Chest discomfort is a common presenting complaint at emergency departments, and several prediction models and clinical decision rules have been developed to allow ED physicians to assess patients with chest discomfort and identify the low-risk ones that could be safely discharged directly from ED. Most of these diagnostic protocols include components related to the chest pain characteristics as a part of their prediction model. However, due to the subjective nature of chest pain and reporting and ascertainment bias, there is a controversy about the diagnostic value of pain characteristics. In a study recently published in the journal of Academic Emergency Medicine, a group of CVC investigators explored the performance of these chest pain rules using the data from PROACT-3 and 4 trials and showed that they perform well without their pain characteristics component. The findings could refine the need to use chest pain characteristics in accelerated diagnostic protocols for the purpose of risk stratifying patients at ED, hence it could be practice-changing.