Intravascular Imaging vs Angiography Guidance for PCI of Severely Calcified Lesions

BACKGROUND: Few studies have examined whether intravascular imaging (IVI) guidance during percutaneous coronary intervention (PCI) of calcified lesions improves clinical outcomes. OBJECTIVES: The aim of this study was to determine from a large-scale randomized trial of PCI in severely calcified lesions whether IVI guidance improves event-free survival. METHODS: In the ECLIPSE (Evaluation of Treatment Strategies for Severe Calcific Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting Stents) trial, 2,005 patients with severely calcified lesions were randomized to orbital atherectomy (OA) vs balloon angioplasty (BA) prior to drug-eluting stent placement. IVI with optical coherence tomography or intravascular ultrasound (IVUS) was allowed at operator discretion. The primary clinical outcome was the 1-year rate of target vessel failure (TVF). The 1-year rate of TVF was 7.7% after optical coherence tomographic guidance compared with 12.2% after IVUS guidance (adjusted HR: 0.78; 95% CI: 0.52-1.18; P = 0.24). CONCLUSIONS: IVI guidance during PCI of severely calcified lesions was associated with improved 1-year clinical outcomes compared with angiographic guidance alone, whether OA or BA was used for vessel preparation prior to drug-eluting stent placement. The adjusted difference in 1-year TVF rates were not significantly different with optical coherence tomographic guidance and IVUS guidance.