Greater plaque reduction, luminal gain with directional vs. orbital atherectomy system
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In adults with peripheral arterial disease, a directional atherectomy system significantly reduced vessel stenosis and plaque burden vs. an orbital atherectomy system, even after drug-coated balloon treatment, researchers reported.
As the use of atherectomy continues to grow for complex and calcified femoropopliteal PAD, so too does the need for comparative studies to inform device selection, Anvar Babaev, MD, PhD, clinical professor of medicine at NYU School of Medicine and director of endovascular interventions at the Cardiac Cath Lab at NYU Langone Medical Center, told Healio. The DIRECT study, a perspective, head-to-head randomized controlled trial, was the first to evaluate the impact of orbital vs. directional atherectomy on atherosclerotic plaque in patients with PAD.
“As emphasized by the 2018 American College of Cardiology/American Heart Association appropriate use criteria for peripheral artery disease interventions, there is shockingly little available data to justify the increased procedural costs associated with the use of atherectomy devices and no data to suggest superiority or even noninferiority of any one device over another,” Babaev told Healio.
“The widespread adoption of these tools speaks to the difficulty and inherent risk of approaching complex, heavily calcified lesions with balloon angioplasty and stenting alone. Despite their utility, however, continued use of these devices without acknowledging the real possibility of inadvertently offering individuals a suboptimal treatment modality is untenable.”
Head-to-head comparison
Babaev and colleagues evaluated the periprocedural characteristics of two devices — the Diamondback 360 (Cardiovascular Systems Inc.) peripheral orbital atherectomy system and the HawkOne (Medtronic) directional atherectomy system — by measuring both clinical and angiographic outcomes in 60 adults with PAD randomly assigned to either approach. Researchers assessed changes in plaque volume, plaque composition and vessel size using IVUS and conventional angiography. DCB angioplasty was performed after atherectomy with similar analysis repeated. Primary endpoints were treated percent of stenosis, luminal gain, as well as IVUS‐derived lumen and plaque volume characteristics for the two treatment modalities.
The findings were published in Catheterization and Cardiovascular Interventions.
Researchers found that the directional atherectomy system was associated with a greater reduction in plaque volume throughout the entire lesion compared with the orbital atherectomy system (5.9% vs. 1.1%; P = .003). This corresponded to a greater increase in total vessel volume and lumen volume as measured by IVUS (mean, 161.5 mm3 vs. 50.2 mm3; P = .001; 178.6 mm3 vs. 47 mm3; P = .004, respectively), as well as a reduction in angiographic stenosis (40% vs. 70%; P < .001).
After DCB, 10 patients required stenting for suboptimal results in the orbital atherectomy system group compared with two patients in the directional atherectomy system group (P = .021).
Reduced lesion stenosis observed
“Angiographically, lesion stenosis after directional atherectomy was significantly reduced compared with orbital atherectomy, despite similar pretreatment lesion and vessel characteristics,” Babaev told Healio. “This difference remained significant after application of a drug-coated balloon, as well. When serial measurements by IVUS were compared, we similarly found that area stenosis at the minimum lumen area site, a parameter found in previous studies to be closely correlated with durable clinical outcomes, was also significantly reduced following directional atherectomy vs. orbital atherectomy.”
Babaev said volumetric analysis supported the findings and that vessels treated with directional atherectomy showed correspondingly greater vessel and lumen volumes after treatment with these devices.
“Clinically, there were statistically fewer stents required in the group who underwent treatment with directional atherectomy,” Babaev said.
Babaev said the findings demonstrate differences in acute procedural effects between the two devices; however, more data are needed on long-term clinical outcomes.
“Although directional atherectomy had greater device success in debulking lesions with significantly fewer stents needed, it will be crucial to understand if these differences in procedural performance translate to long‐term clinical outcomes, especially in the setting of concurrent DCB use,” Babaev told Healio. “We aim to collect these data in the near future and provide further insight into the comparison of directional atherectomy and orbital atherectomy.”
Reference:
Bailey SR, et al. J Am Coll Cardiol. 2019;doi:10.1016/j.jacc.2018.10.002.
For more information:
Anvar Babaev, MD, can be reached at anvar.babaev@nyulangone.org.
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