Preliminary data from the LASER ROCKS randomised comparison of Turbo-Booster laser atherectomy prior to stenting vs. stenting alone in complex superficial femoral artery lesions study were presented at LINC 2010 by Matthias Ulrich, angiologist, Leipzig, Germany. The study was a pilot study to assess the effect of debulking calcified stenoses in the superficial femoral artery.
Using the Spectranetics Turbo-Booster atherectomy device, the test group underwent excimer laser atherectomy after conventional wire crossing and creation of a pilot channel through the stenoses, followed by percutaneous transluminal angioplasty and stenting with a single Smart stent, while the control group received standard percutaneous transluminal angioplasty after conventional wire crossing and stenting with a single Smart stent.
The primary endpoints were safety: Serious adverse events or unanticipated device effects during hospitalisation, and efficacy: Achievement of a ≤30% residual stenosis, on average, by quantitative angiography in three planes after all treatments measured as minimal lumen diameter compared to reference diameter of the implanted stent. Secondary endpoints included target lesion revascularisation at six and 12 months, lumen diameters and stent apposition, and patency at six and 12 months, assessed by tranlesion pressure gradient post procedure, and stent integrity assessed by 12-month X-ray.
Forty patients were enrolled in January 2010, and Ulrich reported that eight patients are at the six-month interval while four are at the 12-month interval. There were 15 patients in the laser group and 17 in the percutaneous transluminal angioplasty group, with no differences in patient demographics between the two groups. Most of the lesions were severely calcified.
The ankle brachial index improvement pre-procedure compared to discharge in both groups showed a very good result that was similar in both groups. In terms of safety at six-month follow-up there was one rupture in the percutaneous transluminal angioplasty stent group, and two (12.0%) had pseudoaneurysm. In summary, Ulrich said that there were more serious adverse events in the percutaneous transluminal angioplasty group (35.3% vs. 13.3% for the laser goup) but added that this may not be device-related.
Christian Wissgott, Radiologist, Heide, Germany discussed the value of Straub’s Rotarex system in subacute and chronic lesions in a session devoted to mechanical thrombectomy at LINC 2010. While in reality there is currently no device capable of achieving complete removal of the thrombus in its entirety, to expose the culprit lesion, Straub Medical’s range of rotational catheters show promise, Wissgott told delegates. Fitted with a blunt, wedge-shaped rotating head with facets at the foremost tip, the Rotarex catheter is able to be advanced by prescribed back-and-forth movements. The blunt facets do not cut tissue, but abrade the occlusion material, he said.
As the thrombotic content of the lesion is effectively removed, the risk for distal embolization is reduced, thus reducing risk.