Presenting first-time data from large multicentre European studies at this year’s Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany), Arne Schwindt (St Franziskus Hospital Münster, Münster, Germany) and Ralf Langhoff (Sankt Gertrauden Hospital, Berlin, Germany) delivered results that “confirm” the safety and efficacy of the Roadsaver (Terumo) dual-layer micromesh carotid stent (DLMS).
First to the podium, Schwindt identified 30-day outcomes in male versus female patients treated using the Roadsaver device. He defined that the majority of patients were treated using a femoral approach, adding that radial access was more common in the female group. The researchers found no difference in the use of embolic protection in their cohort, however Schwindt noted that in the cases where protection was employed, female patients more frequently received distal protection.
Their primary endpoint concerned any major adverse event (MAE) between the female and male groups. Additionally, Schwindt explained that of their 2,000-patient cohort, participants were evenly split between symptomatic and asymptomatic.
Schwindt and his team found that the MAE rate in their patient population was 2.2%— recorded as 2.0% for males and 2.6% for females—which he reported to the LINC 2023 audience—was not statistically significant. Schwindt did pinpoint a trend toward higher stroke risk in their study’s female group, however this was also not statistically significant. Among the entire cohort, stroke risk was seen in 1.9%—which expanded to 1.6% in male and 2.6% in female patients.
“We saw that the majority of these events still take place within 48 hours to three days after the procedure,” Schwindt noted, “but we see these curves flatten out and nothing much happens towards the end of the 30-day period.” Concluding his presentation, Schwindt emphasised the “very low” MAE rate in both male and female patients and “[similarly]” low 30-day rates of minor or major stroke, despite a “small trend” toward lower incidence in males. Schwindt stated: “Given that both groups undercut the stroke rates defined by the S2 guidelines from Germany, the currently most strict guidelines concerning clinical outcome, CAS with dual layer micromesh stent can be concerned as a valid treatment option for males and females alike.”
Following Schwindt, Langhoff subsequently presented first-time data on the 30-day safety results in patients treated using the Roadsaver device—their investigation assessed the influence of predilatation on outcomes. “A major difference,” Langhoff posited, became apparent when observing transient ischaemic attack (TIA), which in patients who had received predilatation, was seen to be “significantly” more prevalent. His team identified a 1.6% to 2.0% split, which emphasised the effect of predilatation that Langhoff himself “did not expect”.
Summarising their findings, Langhoff stated that there was low overall need for predilatation in real-world elective carotid artery stenting (CAS) patients treated with the Roadsaver DLMS. Equally, he noted that there were low and comparable 30-day MAE rates between the groups with and without predilatation, “[confirming]” the safety of the Roadsaver device when performing CAS.