Key Takeaways:
- Orbital atherectomy as a routine lesion preparation strategy prior to stenting did not reduce clinical events or improve stent expansion compared to balloon angioplasty alone for severely calcified coronary lesions.
- Use of intravascular imaging was associated with significantly improved clinical outcomes, highlighting its critical role in guiding PCI procedures in severely calcified lesions.
The multicenter ECLIPSE trial (ClinicalTrials.gov identifier: NCT03108456), presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) and simultaneously published in The Lancet, demonstrated that routine use of orbital atherectomy (OA) for lesion preparation before drug-eluting stent (DES) implantation did not improve clinical outcomes compared with balloon angioplasty (BA) in patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary lesions.
This randomized controlled trial enrolled 2,005 patients (median age 70 years; 73% men) with severely calcified lesions at 104 U.S. centers. Patients were randomly assigned (1:1) to undergo lesion preparation with either OA (n=1,008) or BA (n=997) prior to stenting. The coprimary endpoints were the 1-year rate of target vessel failure (TVF; cardiac death, target vessel myocardial infarction [MI], or ischemia-driven target vessel revascularization [TVR]) and the post-procedural minimal stent area assessed by optical coherence tomography (OCT).
At 1-year follow-up, TVF occurred in 11.5% of patients treated with OA and 10.0% with BA, showing no statistically significant difference (HR, 1.16; 96% CI, 0.87–1.54; p=0.28). Similarly, minimal stent area at the site of maximal calcification was not significantly greater with OA compared to BA (7.67 mm² vs. 7.42 mm²; p=0.078). Subgroup analyses revealed consistent results across most clinical groups, though nominal interactions suggested differential effects based on diabetes status and calcium length.
Notably, intravascular imaging (IVI; OCT or intravascular ultrasound [IVUS]) guidance, utilized in 62.1% of patients, was associated with significantly improved outcomes regardless of lesion preparation strategy. In patients guided by IVI, TVF was significantly lower compared to angiographic guidance alone (9.3% vs. 13.2%; adjusted HR, 0.74; 95% CI, 0.56–0.97; p=0.03). IVI also significantly reduced cardiac death, ischemia-driven TVR, and stent thrombosis.
Lead investigator Dr. Gregg W. Stone stated, “Routine orbital atherectomy for severely calcified lesions eligible for both OA and balloon angioplasty did not improve minimal stent area or reduce clinical events compared with balloon angioplasty alone. Our results also strongly support the critical role of intravascular imaging guidance for optimizing outcomes of PCI of severely calcified lesions.”