Orbital atherectomy not superior to balloon angioplasty for treatment of certain lesions
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Key takeaways:
- Orbital atherectomy was no better than balloon angioplasty for treatment of certain severely calcified coronary lesions.
- Atherectomy remains an option in lesions untreatable with balloons alone.
WASHINGTON — In patients with severely calcified coronary lesions eligible for either treatment, orbital atherectomy did not improve clinical or imaging outcomes compared with conventional balloon angioplasty, researchers reported.
The ECLIPSE trial, presented at TCT 2024, included 2,005 patients (mean age, 70 years; 73% men) with stable CAD, non-ST segment elevation ACS or stability after STEMI who had severely calcified lesions and were randomly assigned to orbital atherectomy (Diamondback 360 coronary orbital atherectomy system, Abbott Vascular/Cardiovascular Systems Inc.) or conventional balloon angioplasty before drug-eluting stent implantation.
Approximately 3% to 5% of patients undergoing PCI have lesions too calcified for balloons to work, Gregg W. Stone, MD, professor of cardiology and population health sciences at Icahn School of Medicine at Mount Sinai and director of academic affairs for the Mount Sinai Health System, told Healio.
“There have been numerous devices that have been developed over the years to try to help us deal with heavily calcified lesions,” Stone told Healio. “Orbital atherectomy ... takes an elliptical course and kind of sands the lesion as it goes around the vessel. Whether these devices used more frequently in a routine fashion in severely calcified lesions, the type we think we can probably get a balloon through to predilate, would lead to improved outcomes before we put a stent in has never been tested in an adequately powered trial.”
Among the cohort, 555 patients had an evaluable OCT and were included in an imaging endpoints analysis.
The primary imaging endpoint of minimal stent area at the maximal calcium site did not significantly differ between the groups (atherectomy, 7.67 mm2; angioplasty, 7.42 mm2; difference, 0.26; 99% CI, –0.31 to 0.82; P = .08), according to the researchers.
The primary clinical endpoint of target vessel failure, defined as cardiac death, target vessel MI or ischemia-driven target vessel revascularization, at 1 year was similar in both groups (atherectomy, 11.5%; angioplasty, 10%; HR = 1.16; 95% CI, 0.87-1.54; P = .28), the researchers found.
“Also of note, the orbital atherectomy procedure was more complex and took more time,” Stone told Healio.
At 30 days, there were eight cardiac deaths in the atherectomy group and none in the angioplasty group (P = .005), Stone told Healio. The trial’s Clinical Events Committee adjudicated two deaths as related to the device, two as possibly related and four as not related, he said. Aside from all-cause death (atherectomy, 1%; angioplasty, 0.3%; P = .05), there were no other differences in 30-day clinical outcomes. At 1 year, there were no differences in any clinical outcomes, according to the researchers.
“The cardiac death rates at 30 days were less than 1% in both groups, still very low, and the fact that there were zero [cardiac] deaths in the balloon angioplasty group is ... good fortune, because we do not expect that in this complex a population,” Stone told Healio.
The results were consistent regardless of whether patients were in the OCT cohort, but in both treatment groups, those in the OCT cohort had lower rates of the primary outcome than those not in it (7.2% vs. 12.2%; adjusted HR = 0.68; 95% CI, 0.55-0.84; P = .0003), Stone said.
“This once again shows that intravascular imaging improves outcomes of PCI of complex lesions, no matter what kinds of technologies you use,” Stone told Healio.
Stone said the findings do not apply to lesions so heavily calcified that they cannot be treated with balloon angioplasty alone, “so the 3% to 5% of patients in which these devices are commonly used today, that should not change. However, given that we were not able to show improved outcomes with routine use of orbital atherectomy in other types of severely calcified lesions that we might be able to treat with balloons only, and given that those types of lesions require more interventional cardiology resources ... we would not routinely recommend the use of orbital atherectomy for severely calcified lesions if the operator believes that standard balloon angioplasty would be effective for lesion preparation.”
For more information:
Gregg W. Stone, MD, can be reached at gregg.stone@mountsinai.org; X (Twitter): @greggwstone.
Perspective
Back to TopLaura Young, MD
The ECLIPSE trial plays an important role in our evolving understanding of how to manage calcific coronary lesions. The study shows that in balloon-crossable lesions, orbital atherectomy did not show superiority in terms of target vessel failure at 1 year. We must keep in mind that not all lesions are balloon-crossable, and so there are certainly still patients that will benefit from atherectomy.
The investigators must be commended for their discipline of incorporating intravascular imaging, as we have come to understand that this is a cornerstone of ensuring adequate lesion preparation and ultimately better clinical and procedural outcomes.
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Kirtane AJ, et al. Late-breaking clinical trials: Session II, in collaboration with The Lancet. Presented at: TCT Scientific Symposium; Oct. 27-30, 2024; Washington, D.C. (hybrid meeting).
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