The Safety and Efficacy Study for Reverse Flow Used during Carotid Artery Stenting Procedure (ROADSTER) multicenter trial reported the lowest stroke rate in high-risk patients compared with any prospective trial of TFCAS, according to Mahmoud B. Malas, MD, of the Johns Hopkins Hospital and his colleagues. However, clinical trials have selection criteria that exclude many patients, and are highly selective of operators performing the procedures, which limit generalizability. Dr. Malas will present a study in Scientific Session S4 that he and his colleagues did to compare in-hospital outcomes after TCAR and TFCAS as reported in VQI.
They analyzed data from the initial 646 patients enrolled in the SVS VQI TCAR Surveillance Project (TSP) and compared it with that of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. They used multivariable logistic regression and 1:1 coarsened exact matching (CEM) to analyze neurologic adverse events [stroke and transient ischemic attacks (TIAs)] and in-hospital mortality. Patients in the two procedures were matched on age, race, coronary artery disease, congestive heart failure, prior CABG/PCI, chronic kidney disease, diabetes, ASA class, symptomatic status, restenosis, anatomical and medical risk, emergency status, and preoperative medication use.
Compared with more than 10,000 patients undergoing TFCAS, the 638 undergoing TCAR were significantly older and had more cardiac comorbidities. In contrast, patients in the TFCAS group were more likely to be symptomatic and to have a restenotic lesion. There was no significant change in the odds of stroke/death in TFCAS over the study period.
The rates of in-hospital TIA/stroke as well as TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs.1.9% and 3.8% vs.2.2%, respectively; both P = .04). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients; however, the difference was significant only in the TFCAS (5.3% vs. 2.7%, P less than .001). On multivariable analysis, TFCAS was associated with twice the odds of in-hospital neurologic events and TIA/stroke/death compared with TCAR, independent of symptomatic status. CEM showed similar results.
“Our results show that patients undergoing TCAR had significantly higher medical comorbidities, but half the risk of in-hospital TIA/stroke/death compared to patients undergoing TFCAS. This initial evaluation of VQI TSP demonstrates the ability to rapidly monitor new devices/procedures in real world practice. While preliminary, this is the first study to confirm the benefit of TCAR compared to TFCAS in real-world practice,” Dr. Malas concluded.
Friday, June 22
3:30 – 5 p.m.
HCC, Ballroom A/B
SS24: Transcarotid Artery Revascularization (TCAR) vs. Transfemoral Carotid Artery Stenting (TFCAS) in the SVS Vascular Quality Initiative