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Frequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials: A Pooled Analysis of 9259 Deaths in 9 Trials A prospective natural-history study of coronary atherosclerosis Association between urinary dickkopf-3, acute kidney injury, and subsequent loss of kidney function in patients undergoing cardiac surgery: an observational cohort study Derivation and Validation of a Chronic Total Coronary Occlusion Intervention Procedural Success Score From the 20,000-Patient EuroCTO Registry:The EuroCTO (CASTLE) Score Percutaneous Coronary Intervention Readmissions Where Are the Solutions? Major infections after bypass surgery and stenting for multivessel coronary disease in the randomised SYNTAX trial Long-Term Outcomes of Biodegradable Versus Second-Generation Durable Polymer Drug-Eluting Stent Implantations for Myocardial Infarction Development and validation of a simple risk score to predict 30-day readmission after percutaneous coronary intervention in a cohort of medicare patients Safety and feasibility of robotic percutaneous coronary intervention: PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) Study Variation in Revascularization Practice and Outcomes in Asymptomatic Stable Ischemic Heart Disease

Review ArticleVolume 76, Issue 4, July 2020

JOURNAL:J Am Coll Cardiol. Article Link

Improving the Design of Future PCI Trials for Stable Coronary Artery Disease: JACC State-of-the-Art Review

G Marquis-Gravel, DJ Moliterno, SG Goodman et al. Keywords: PCI; trail design; SCAD

ABSTRACT

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.