View results from a randomized head-to-head trial comparing directional atherectomy to orbital atherectomy outcomes.
The randomized DIRECT Trial1 demonstrated that lesions treated with the HawkOne™ directional atherectomy system had greater plaque volume reduction and luminal gain — with similar safety profiles — than those treated with the CSI Diamondback 360™* peripheral orbital atherectomy system. Results confirmed through IVUS and angiography.
There was a non-significant numerical trend in restenosis and revascularization rates in the directional atherectomy (DA) arm compared to the orbital (OA) arm.
(p = 0.29)
(p = 0.47)
† ABI drop of ≥0.15 from immediate post-procedure baseline and/or if the patient became symptomatic with claudication or limb ischemia and these findings led to further confirmatory testing using noninvasive imaging (arterial duplex – PSV ratio > 2.5; CTA or MRA – stenosis of > 60%.
There was a greater reduction in stenosis following directional atherectomy (DA) compared to orbital atherectomy (OA).
(p = 0.48)
(p < 0.001)
(p < 0.001)
69.2%
54.1%
5.6%
Mechanism of lumen enlargement: plaque reduction and vessel stretch
84.2%
74.8%
59.8%
Mechanism of lumen enlargement: medical dissection and vessel stretch
Greater plaque volume reduction was achieved with directional atherectomy group compared to orbital atherectomy group. This difference in plaque volume reduction persisted following drug-coated balloon (DCB) utilization.
(p = 0.8)
(p = 0.0002)
(p = 0.003)
(p = 0.43)
(p = 0.06)
(p = 0.01)
(p = 0.02)
Overall directional and orbital atherectomy were found to be safe with minimal complications.
Results may not be indicative of clinical performance, and are dependent on experience and training. The DIRECT study was an investigator-initiated study supported by an institutional grant from Medtronic. Three-year follow-up is ongoing to determine whether these acute performance measures are associated with improved clinical outcomes.
Risks may include but are not limited to: arterial perforation, embolism or arterial thrombosis, arterial dissection, arterial spasm, and vascular complications that could require surgical repair.
TM* Third-party brands are trademarks of their respective owners.
† ABI drop of ≥0.15 from immediate post-procedure baseline and/or if the patient became symptomatic with claudication or limb ischemia and these findings led to further confirmatory testing using noninvasive imaging (arterial duplex – PSV ratio > 2.5; CTA or MRA – stenosis of > 60%.
‡ Values are expressed as median (interquartile range).
1. Babaev A, Halista M, Bakirova Z, et al. Directional versus orbital atherectomy of femoropopliteal artery lesions: Angiographic and intravascular ultrasound outcomes. Catheter Cardiovasc Interv. October 2022;100(4);687–695.
2. Babaev A. Directional Versus Orbital Atherectomy of Femoropopliteal Artery Lesions: Revascularization and Restenosis Rates at 24 months. VIVA 2023.
