The investigators say they have discontinued using the stent in patients with acute stroke requiring carotid angioplasty.
A high incidence of in-stent thrombus formation seen with the CASPER-RX dual-layer stent for the treatment of tandem lesions in acute ischemic stroke has prompted one group of investigators to discontinue using them for this indication. The case series that led to this decision was published online December 4, 2018, in the Journal of NeuroInterventional Surgery.
The Casper-RX (MicroVention, Tustin, CA) carotid artery stent is a double-layered, micromesh, low-profile, closed-cell stent with higher mesh density and smaller pore size than conventional stents. According to the study authors, led by Bruno Bartolini, MD (Lausanne University Hospital, Switzerland), it was developed to reduce the risk of distal embolism.
The investigators conducted a retrospective analysis of all 21 consecutive patients with large vessel intracranial occlusion associated with a tandem lesion treated with carotid Casper-RX stents in the ASTRAL database of acute ischemic stroke patients. Of these, 10 had tandem carotid occlusions and 11 had severe carotid stenosis, including eight patients who had hemodynamically significant stenosis.
Acute in-stent thrombus formation was found in 11 patients based on analysis of clinical, angiographic, and neuroimaging data. All patients with thrombus formation were treated with repeated in-stent balloon carotid angioplasty.
At 3 months of follow-up, there were no stroke recurrences, but two patients experienced symptomatic intracranial hemorrhage. At 90 days, 71% had mRS scores of 0-2, 14% had scores of 3-5, and 14% had a score of 6.
The authors note that they did not see any cases of stent occlusion prior to discharge. “However, in-stent thrombus formation during the procedure was frequent, and for three patients, previously treated with aspirin and rt-PA, additional heparin therapy was required followed by a fatal hemorrhagic complication in one patient,” they write.
“Due to the high rate of in-stent thrombus formation, we decided not to use dual layer stents in acute tandem occlusion therapy even though a prospective randomized controlled study has yet to demonstrate the noninferiority of these stents compared with a single-layer design, the researchers conclude.
Bartolini and colleagues say at least one prior retrospective case-control study found that patients with acute ischemic stroke treated with dual-layer stents had higher risk of acute occlusion than those treated with single-layer stents. The authors of that study, they add, suggested that the higher metal density of dual-layer stents may promote thrombogenicity among patients who have not received prior dual antiplatelet therapy.
Source:
Bartolini B, Puccinelli F, Mosimann PJ, et al. Evaluating the effectiveness and safety of the carotid Casper-RX stent for tandem lesions in acute ischemic stroke. J NeuroIntervent Surg. 2018;Epub ahead of print.
Disclosures:
Bartolini reports no relevant conflicts of interest.
