A recent study led by Mount Sinai has revealed that the routine use of an orbital atherectomy device to remove calcium from severely blocked coronary arteries does not enhance patient outcomes during cardiac stenting procedures.
The findings from the ECLIPSE study were presented at the Transcatheter Cardiovascular Therapeutics Annual Meeting on October 29. This research is notable as it is the first large-scale investigation into the effectiveness of this specific device on severely calcified lesions. The results suggest that the device should be reserved for extreme cases where standard methods may not suffice.
The ECLIPSE trial, a multicenter study, demonstrated that routine use of orbital atherectomy did not result in better stent expansion or improve one-year outcomes compared to traditional balloon angioplasty. Thus, the use of this device may be limited to situations where balloon angioplasty is unlikely to successfully treat the calcified blockage.
Patients suffering from coronary artery disease, which is characterized by plaque buildup in the arteries leading to chest pain and heart attacks, often undergo percutaneous coronary intervention (PCI). This non-surgical procedure involves cardiologists using a catheter to place stents in blocked arteries to restore blood flow. Typically, a balloon is first inserted to widen the artery for stent placement.
Heavily calcified blockages present greater challenges for balloon angioplasty, increasing the risk of complications, such as heart attacks. To address this, cardiologists sometimes use orbital atherectomy, a device approved by the FDA that fractures and sands away calcium, facilitating better balloon and stent expansion. Currently, atherectomy devices are utilized in over 10,000 PCI cases annually in the U.S., and in up to 10 percent of cases at some hospitals.
The ECLIPSE study aimed to determine if routine use of the orbital atherectomy device would lead to better stent expansion and improved clinical outcomes in cases where balloons could adequately treat the lesions. Researchers enrolled 2,005 patients across 104 sites in the U.S., randomly assigning half to receive orbital atherectomy and the other half to undergo balloon angioplasty, both followed by PCI with drug-eluting stents. The primary endpoints of the study were stent expansion and clinical outcomes after one year.
Using optical coherence tomography (OCT) imaging, researchers assessed the stent area in both groups. Results showed no significant difference in stent area at the end of the procedure between the two groups. The minimal stent area at the site of maximum calcification was 7.67 mm² in the atherectomy group compared to 7.42 mm² in the balloon angioplasty group.
Moreover, there was no reduction in the one-year rate of target vessel failure—a measure that includes cardiac death, heart attack, or the need for repeat interventions—between the groups. In the atherectomy group, 11.6 percent of patients experienced target vessel failure, compared to 9.8 percent in the balloon group.
Among secondary outcomes, the atherectomy group saw a higher rate of cardiac deaths within 30 days post-PCI, with eight cases compared to none in the balloon group. Over one year, 4.0 percent of patients in the atherectomy group experienced cardiac death, versus 2.7 percent in the balloon group, a difference that was not statistically significant. No significant disparities were noted in other major safety outcomes, such as vessel perforation or heart attack.
The study underscores the need for careful consideration when deciding the appropriate interventions for patients with severe coronary artery disease.
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