A recent study led by Mount Sinai, known as the ECLIPSE study, found that the routine use of an orbital atherectomy device does not improve outcomes for patients with severely calcified coronary arteries undergoing cardiac stenting.

The ECLIPSE study enrolled 2,005 patients with 2,492 lesions across 104 sites in the U.S., comparing the outcomes of those receiving orbital atherectomy with those undergoing balloon angioplasty before drug-eluting stent implantation.

Secondary outcomes indicated that the atherectomy group experienced a higher number of cardiac deaths within 30 days compared to the balloon group, although this difference was not statistically significant.

Furthermore, there was no significant difference in the one-year rate of target vessel failure between the two groups, with rates of 11.6% for the atherectomy group and 9.8% for the balloon group.

The study highlighted that the atherectomy procedure was more complex, requiring longer durations and additional interventional devices, without demonstrating clear benefits over balloon procedures.

Dr. Gregg W. Stone, the study chair, emphasized that while atherectomy devices are crucial for the most challenging cases, their routine application for less extreme lesions lacks safety and efficacy benefits.

This research marks the first large-scale study examining the effectiveness of orbital atherectomy in treating severely calcified coronary lesions, suggesting its use should be limited to extreme cases.

In contrast, the use of optical coherence tomography (OCT) during procedures was noted to improve outcomes in both groups, highlighting the importance of intravascular imaging.

The ECLIPSE study was funded by Abbott Vascular, the manufacturer of the orbital atherectomy device.

The findings from the ECLIPSE study were presented at the Transcatheter Cardiovascular Therapeutics Annual Meeting on October 29, 2024.

Mount Sinai Health System is recognized as a leading institution in cardiology, ranked No. 4 nationally for cardiology and heart surgery.