1. In this randomized controlled trial, percutaneous coronary intervention (PCI) performed under optical coherence tomography (OCT) was associated with fewer major adverse cardiac events (MACEs) as compared to conventional angiography-guided PCI.
2. OCT-guided PCI did not differ significantly from the angiography-guided approach in the risk of complications.
Evidence Rating Level: 1 (Excellent)
Study Rundown: In approximately 20% of patients with coronary artery disease eligible for revascularization, the index lesion involves a bifurcation of the coronary artery. PCI of these lesions is challenging with a heightened risk of mortality, recurrent disease, and complications. Although PCI is predominantly guided by angiography, this approach is limited by ambiguous vessel visualization. OCT offers an advantage as an intravascular imaging method with higher precision that could benefit these patients. This study was a randomized trial to compare OCT-guided PCI against angiography-guided PCI among patients with complex coronary-artery bifurcation lesions. The lesion characteristics, interventions performed, and angiographic procedural success were comparable across these groups. By two years, the OCT-guided PCI group reported a significantly lower composite incidence of MACEs than the control group. The rates of procedure-related complications were similar between the groups. The trial was limited by its open-label design, the small subgroup with left-main disease, and the utilization of intravascular ultrasound (IVUS) in the control group, which might underestimate baseline risks. However, these results demonstrated that OCT-guided PCI of complex coronary-artery bifurcation lesions was associated with lower composite risk MACEs.
Click here to read the study in NEJM
In-Depth [randomized controlled trial]: The current study was a multicenter, open-label, randomized, controlled trial to evaluate the use of OCT guidance against angiography guidance in PCI for patients with complex coronary-artery bifurcation ischemic lesions. Patients 18 years of age and older who had stable angina, unstable angina, or non-ST-segment-elevation myocardial infarction; in whom PCI was indicated and a coronary-artery bifurcation lesion was found on angiography; were eligible for inclusion. Exclusion criteria included ST-elevation myocardial infarction, cardiogenic shock, previous coronary-artery bypass grafting to the index vessel, or severe heart failure. Overall, 1,201 patients were randomized 1:1 to undergo OCT-guided PCI or angiography-guided PCI. The primary outcome was a composite of MACEs, which are death from cardiac causes, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at two years. In total, 18.5% of patients in the OCT-guided PCI group and 19.3% in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. Other lesion characteristics, specific PCIs performed, and procedural success as assessed by subsequent angiography were comparable between the two groups. At two years, the primary outcome had occurred in 10.1% of patients in the OCT-guided PCI group and 14.1% in the angiography-PCI group (hazard ratio, 0.70; 95% Confidence Interval [CI], 0.50-0.98; p=0.035). There was no statistically significant difference between the two groups in the incidences of individual MACEs and death from any cause. Procedure-related complications were reported in 6.8% of patients in the OCT-guided PCI group and 5.7% in the angiography-guided PCI group. These results demonstrated that for adult patients with complex coronary-artery bifurcation ischemic lesions, OCT-guided PCI was associated with a lower composite risk of MACEs compared to angiography-guided PCI.
Image: PD
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