Improving the Design of Future PCI Trials for Stable Coronary Artery Disease: JACC State-of-the-Art Review.
The role of percutaneous coronary interventions in addition to medical therapy for patients with stable coronary artery disease continues to be debated in routine clinical practice, despite more than 2 decades of randomized controlled trials. The residual uncertainty arises from particular challenges facing revascularization trials. Which endpoint do doctors care about, and which do patients care about? Which participants should be enrolled? What background medical therapy should we use? When is placebo control relevant? In this paper, we discuss how these questions can be approached and examine the merits and disadvantages of possible options. Engaging multiple stakeholders, including patients, researchers, regulators, and funders, to ensure the design elements are methodologically valid and clinically meaningful should be an aspirational goal in the development of future trials.
Duke Scholars
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Related Subject Headings
- Research Design
- Randomized Controlled Trials as Topic
- Quality Improvement
- Percutaneous Coronary Intervention
- Humans
- Coronary Artery Disease
- Cardiovascular System & Hematology
- 3201 Cardiovascular medicine and haematology
- 1117 Public Health and Health Services
- 1102 Cardiorespiratory Medicine and Haematology
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Research Design
- Randomized Controlled Trials as Topic
- Quality Improvement
- Percutaneous Coronary Intervention
- Humans
- Coronary Artery Disease
- Cardiovascular System & Hematology
- 3201 Cardiovascular medicine and haematology
- 1117 Public Health and Health Services
- 1102 Cardiorespiratory Medicine and Haematology