Gregg W. Stone, Philippe Généreux, Akiko Maehara, Bruce Lewis, Richard Shlofmitz, Suhail Dohad, Jithendra Choudary, Thom Dahle, Andrés M. Pineda, Kendrick Shunk, Ehtisham Mahmud, Giora Weisz, Michael Collins, Khaldoon Alaswad, Gautam Kumar, Naresh Solankhi, Daniel Dulas, John D. Altman, Carlye Kraemer, Krista M Stiefel, Denise Jones, Jana Buccola, Ajay J. Kirtane
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). RESULTS: = 0.48). 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.