ASSIST Trial Comparing Anatomic Versus Physiologic Guidance for Complete Revascularization with Drug-Eluting Stents in Patients with Coronary Artery Disease

What this Trial Is About

Researchers are comparing two methods for guiding complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention (PCI) using drug-eluting stents. The study evaluates anatomical guidance using quantitative coronary angiography (QCA) versus physiological guidance using fractional flow reserve (FFR) to determine which approach leads to better clinical outcomes. This open-label, randomized trial includes patients with symptomatic or ischemic evidence and coronary artery lesions suitable for PCI. Participants are randomly assigned to either the QCA-guided group, where PCI is performed on lesions with diameter stenosis of 50% or more as measured by QCA, or the FFR-guided group, where PCI is performed on lesions with FFR values of 0.80 or less. Imaging guidance during PCI is left to the operator's discretion, with routine high-pressure post-dilation recommended to optimize stent expansion. Follow-up visits occur at 1, 6, and 12 months, with continued observation up to 5 years after the initial procedure. During the study, researchers will monitor and evaluate clinical outcomes such as death, myocardial infarction, and repeat unplanned revascularization within 12 months. Participants will undergo clinical assessments at scheduled follow-ups to track safety and effectiveness. The study aims to provide insights into the best guidance strategy for complete revascularization in patients with coronary artery disease treated with drug-eluting stents.

Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD