Optical Coherence Tomography-Guided or Intravascular Ultrasound Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial.

Background: Intravascular imaging-guided percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) showed superior clinical outcomes compared to angiography-guided PCI. However, comparative effectiveness of OCT-guided and IVUS-guided PCI regarding clinical outcomes is unknown. Methods: In this prospective, multicenter, open-label, pragmatic trial, we randomly assigned 2008 patients with significant coronary-artery lesions undergoing PCI in a 1:1 ratio to undergo either an OCT-guided or IVUS-guided PCI. The primary end point was a composite of death from cardiac causes, target-vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year, which was powered for noninferiority of the OCT group as compared with the IVUS group. Safety outcomes were also assessed. Results: At 1 year, primary end-point events occurred in 25 of 1005 patients (Kaplan-Meier estimate, 2.5%) in the OCT group and in 31 of 1003 patients (Kaplan-Meier estimate, 3.1%) in the IVUS group (absolute difference, -0.6 percentage points; upper boundary of one-sided 97.5% confidence interval, 0.97 percentage points; P<0.001 for noninferiority). The incidence of contrast-induced nephropathy was similar (14 patients [1.4%] in the OCT group vs. 15 patients [1.5%] in the IVUS group, P=0.85). The incidence of major procedural complications was lower in the OCT group than in the IVUS group (22 [2.2%] vs. 37 [3.7%], P=0.047), although imaging procedure-related complications were not observed. Conclusions: In patients with significant coronary-artery lesions, OCT-guided PCI was noninferior to IVUS-guided PCI with respect to the incidence of a composite of death from cardiac causes, target-vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year. The selected study population and lower than expected event rates should be considered in interpreting the trial.