Treating CLTI with atherectomy fails to improve outcomes—is it worth the cost?
Performing atherectomy on patients undergoing endovascular interventions to treat chronic limb-threatening ischemia (CLTI) is not associated with improved outcomes, according to new research published in JACC: Cardiovascular Interventions.[1]
The study’s authors noted that atherectomy has been linked to potential benefits for some patients with peripheral artery disease (PAD), but few studies have specifically focused on CLTI.
“The use of atherectomy in the United States has rapidly increased over recent years,” wrote first author Caitlin W. Hicks MD, MS, an associate professor of surgery with Johns Hopkins Medicine, and colleagues. “Physicians who are in favor of atherectomy cite plaque debulking, reduced vessel wall trauma and lower bailout stenting rates as reasons to use the technology over other contemporary endovascular treatment techniques. In addition, there are some data suggesting atherectomy may be effective in highly calcified lesions and for the treatment of in-stent restenosis. However, total Medicare-allowed charges associated with PAD treatment have also significantly increased over time, an increase that has been largely attributed to the increased use of atherectomy. There is a critical need to understand the potential benefits of atherectomy in treating different PAD phenotypes in order to justify the added costs, and adjudicate its use moving forward.”
Hicks et al. explored data from more than 900 patients who underwent treatment as part of the BEST-CLI trial. The mean age was 67.3 years old, 71.1% were male and 72.3% were white. In total, 14.3% of these patients received an atherectomy during their endovascular interventions.
Patient characteristics between patients who did and did not receive an atherectomy were similar, the group noted, though the patients treated with an atherectomy were more likely to present with stage 3 or higher chronic kidney disease or infrapopliteal occlusive disease. Atherectomy was most likely to be used in a patient’s superficial femoral artery or above-knee popliteal artery. Below-knee popliteal or tibial arteries were the next most common location, followed by the common femoral or profunda arteries. Embolic protection devices were used for 15.9% of all atherectomies.
Intraprocedural technical success was higher for patients treated with the atherectomy—91.7% vs. 82.5%—but the atherectomy patients were more likely to experience arterial thrombi in their runoff vessels within 30 days after the endovascular intervention.
“Patients receiving atherectomy had a higher frequency of technical success, but also a higher frequency of intraoperative arterial thrombus,” the authors wrote. “The latter finding may reflect why we observed a higher volume of contrast utilization among patients who received atherectomy, which deserves consideration since a higher frequency of patients who received atherectomy had baseline chronic kidney disease.”
After a median follow-up time of 2.5 years, the major adverse limb event (MALE) rate was 35% for patients who received an atherectomy and 33% for patients who did not. The three-year estimated incidence of MALE was 43.5% for the atherectomy group and 36.5% for the no atherectomy group.
There were no significant differences in index limb reinterventions, above-ankle amputations or mortality between patients who did and did not receive an atherectomy.
“It is possible the late disadvantage of atherectomy is related to the higher frequency of intraprocedural arterial thrombus noted with atherectomy, although early bench models suggest it may be related to endothelial trauma or disruption as well,” the authors explained. “The late disadvantage we observed with atherectomy was confirmed in our sensitivity analysis limited to patients in whom technical success was achieved in the index operation; atherectomy was associated with a higher risk of MALE long term. More data are needed to understand whether atherectomy is associated with harm, or whether it has similar outcomes compared with other available technologies.”
Hicks and colleagues emphasized that atherectomy is associated with much higher healthcare costs. In 2019, for instance, it accounted for 90% of all Medicare spending related to endovascular PAD treatments. These costs, coupled with and the “lack of clear clinical benefits in select PAD populations,” are enough to make health systems think twice about the use of atherectomy.
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Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.