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.