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Critical Appraisal of the 2018 ACC Scientific Sessions Late-Breaking Trials From a Statistician's Perspective
Stuart J Pocock1, Tim J Collier1
1Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom.
Insights
This review critically appraises 7 key late-breaking cardiovascular trials from the 2018 American College of Cardiology sessions. It offers balanced insights into findings, limitations, and potential "positive spin" for better clinical trial interpretation.
Area of Science:
- Cardiology
- Clinical Trials
- Evidence-Based Medicine
Background:
- Late-breaking clinical trials presented at major cardiology conferences represent significant advancements.
- Critical appraisal of these trials is essential for accurate interpretation and application in clinical practice.
Purpose of the Study:
- To provide a constructive critical appraisal of 7 key late-breaking cardiovascular trials from the American College of Cardiology Scientific Sessions in March 2018.
- To document and interpret main findings, identify potential "positive spin," and discuss limitations of each study.
- To offer general insights for critiquing clinical trial presentations and publications.
Main Methods:
- Critical appraisal of 7 selected late-breaking clinical trials.
- Analysis focused on main findings, study limitations, and interpretation of results.
- Comparative review of studies including ODYSSEY OUTCOMES, VEST, SECURE-PCI, TREAT, POISE, SMART-DATE, and CVD-REAL 2.
Main Results:
- Appraisal of ODYSSEY OUTCOMES, VEST, SECURE-PCI, TREAT, POISE, SMART-DATE, and CVD-REAL 2 trials.
- Identification of key findings and limitations for each study.
- Discussion on the nuances of interpreting trial results and potential biases.
Conclusions:
- The critical appraisal provides a balanced perspective on significant cardiovascular trials.
- Understanding trial limitations and potential biases is crucial for evidence-based cardiology.
- The review offers valuable guidance for interpreting future clinical trial data.
Abstract:
The late-breaking clinical trials presentations at the American College of Cardiology Scientific Sessions in March 2018 are an important contribution to the field of cardiology. This paper presents a constructive critical appraisal of 7 key studies: ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), VEST (Vest Prevention of Early Sudden Death Trial), SECURE-PCI (Statins Evaluation in Coronary Procedures and Revascularization), TREAT (Ticagrelor in Patients with ST-Elevation Myocardial Infarction treated with Pharmacological Thrombolysis), POISE (PeriOperative ISchemic Evaluation), SMART-DATE (Safety of 6-Month Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome), and CVD-REAL 2 (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors). For each study, our aim is to document and interpret the main findings, noting particularly when "positive spin" appears to occur, and to provide a balanced account of each study, paying attention to both constructive new findings and study limitations. These topical examples also provide useful general insights on what to look for when critiquing clinical trial presentations and publications.
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