Carotid artery disease treatment options include optimal medical therapy, surgical carotid endarterectomy (CEA) and endovascular carotid artery stenting (CAS). Clinical trials from the past two decades, comparing CEA vs CAS reveal higher peri-procedural (up to 30 days) risk of stroke or death with CAS. The higher risk is primarily noted in symptomatic patients (>70 years old), while in younger and/or asymptomatic patients CEA and CAS outcomes are more comparable ‎(1). Contemporary CAS is carried out by operators of different specialties, including angiologists, (neuro)radiologists, cardiologists and vascular surgeons, the last of which are slightly underrepresented in the endovascular practice relative to other specialties. Newer generation dual-layer micromesh stents (DLMS), were specifically designed to further decrease the CAS-related peri-procedural cerebral embolization risk. Their short and long-term safety and efficacy is supported by a large body of clinical evidence ‎(2-5), but more studies in broader, unselected, patient populations are needed.

ROADSAVER is a large, pan-European, prospective, single arm, multicentre, multispecialty, observational CAS study. It enrolled 1967 patients at 52 centres across 13 countries, between January 2018 and February 2021, including symptomatic and asymptomatic patients with a non-occlusive/non-thrombotic carotid stenosis and >12-month life-expectancy, eligible for an elective endovascular procedure using the RoadsaverTM DLMS. All procedures were performed as per local standard practice. The primary study outcome is the cumulative incidence of any death or stroke up to 30 days post-procedure. An independent Clinical Events Committee adjudicated all deaths, strokes and carotid revascularizations up to 30 days. The 12 months follow-up is ongoing. This pre-defined sub-analysis aims to evaluate the impact of operator speciality on 30-day clinical CAS outcomes in a real-world pan-European patient cohort, comparing the performance of vascular surgeons (VS) to other specialties (OS).

Presented are 30-day outcomes of 1940 patients with the available follow-up, treated by 340 VS or. 1600 OS. Patients in the VS group were on average older (72.9 ± 8.5 vs 70.1 ± 8.8 years; p<0.0001), with more octogenarians (24.4% vs. 14.5%; p<0.0001). Male patients predominated in both groups to a similar extent (70.0% vs. 70.8%; p=0.77). Symptomatic cases were equally distributed in the two groups, constituting roughly a half of all patients (49.9% vs. 46.2%; 0.22). The VS group featured more frequently type III aortic arches (18.8 vs. 5.8%; p<0.0001) and more often aortic arch calcification (57.7 vs. 43.8%; p<0.0001). Lesions treated in the VS group were on average shorter (16.5 ±7.2 vs. 18.5 ±8.6 mm; p<0.0001), but had slightly higher pre-procedural percent diameter stenosis (DS), 82.6 ±10.8 vs. 79.7 ± 13.0%; p<0.0001), were more often calcified (70.3% vs. 55.8%; p<0.0001) and more often localized in severely (>90°) tortuous vessels (11.2 vs. 6.8%, p=0.006). The post-procedural angiographic assessment noted slightly lower residual DS (5.8 ± 8.6 vs 7.3 ± 9.5%; p=0.004) in the VS group. Lesion concentricity, ulceration and irregular surface were similarly distributed among the two groups. While femoral access was the preferred approach, particularly in the VS group (91.8 vs. 65.9%; p<0.0001), the radial access route was much less common in the VS group (1.5 vs. 30.8% p<0.0001). Also, lesion pre-dilatation was less common among the patients in the VS group (16.5 vs. 27.3 %; p<0.0001). The use of embolic protection devices was more common in the VS group (69.7 vs 62.5%; p=0.01), predominantly distal filters. The primary endpoint of 30-day cumulative incidence of any death or stroke was equal in the two groups (2.1% vs. 2.1%; p=1.0), much like the rates of any death (0.3 vs. 0.9%; p=0.27), stroke-related death (0.3 vs. 0.5; p=0.61) and any stroke (2.1 vs. 1.7%; p=0.64).

This 30-day analysis of the ROADSAVER study outcomes demonstrates low and comparable incidence of any death or stroke in elective CAS patients in both VS and OS groups, despite the fact that VS patients were on average older and presenting with more complex aortic arches and lesions. This confirms that irrespective of the operator specialty, the good CAS outcomes can be achieved in the contemporary CAS practice. The study provides further support for the good clinical safety of the RoadsaverTM in one of the largest real-world CAS datasets on a single stent to date. Although single arm, the results have the potential to impact future guidelines adaptation concerning CAS.

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