Intravascular Imaging vs Angiography Guidance for PCI of Severely Calcified Lesions: The ECLIPSE Trial.

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

IVI guidance was used in 1,246 of 2,005 patients (62.1%), including optical coherence tomography in 819 and/or IVUS in 513, while 759 of 2,005 patients (37.9%) underwent PCI with angiographic guidance alone. Median follow-up duration was 365 days (Q1-Q3: 365-365 days). The 1-year Kaplan-Meier estimated rate of TVF was lower among patients with IVI guidance compared with angiographic guidance alone (9.3% vs 13.2%; adjusted HR: 0.74; 95% CI: 0.56-0.97; P = 0.03). The effect of IVI guidance was consistent in patients randomized to OA vs BA (Pinteraction = 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.