SS24. Transcarotid Artery Revascularization versus Transfemoral Carotid Artery Stenting in the Society for Vascular Surgery Vascular Quality Initiative

Abstract

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 transfemoral carotid artery stenting (TFCAS). However, clinical trials have selection criteria that exclude many patients, and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transcarotid artery revascularization (TCAR) and TFCAS as reported in the Vascular Quality Initiative. The Society for Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project in collaboration with the Centers for Medicare and Medicaid Services and the Food and Drug Administration is designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in TCAR Surveillance Project were analyzed and compared with patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIA]) and in-hospital mortality. Patient in the two procedures were matched for age, race, coronary artery disease, congestive heart failure, prior coronary artery bypass grafting/percutaneous cardiac intervention, chronic kidney disease, diabetes, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, emergency status, and preoperative medication use. Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older and had more cardiac comorbidities. Patients in the TFCAS group were more likely to be symptomatic and to have a restenotic lesion (Table I). There was no change in the odds of stroke/death in TFCAS over the study period (P > .05). The rates of in-hospital TIA/stroke as well as TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). 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 (TCAR, 3.7% vs 1.4% [P = .06] and TFCAS, 5.3% vs 2.7% [P < .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. coarsened exact matching showed similar results (Table II). Patients undergoing TCAR had significantly higher medical comorbidities but one-half the risk of in-hospital TIA/stroke/death compared with patients undergoing TFCAS. These results persisted, despite rigorous adjustment and matching of potential confounders. This initial evaluation of Vascular Quality Initiative TCAR Surveillance Project demonstrates the ability to rapidly monitor new devices/procedures in real world practice. Although preliminary, this is the first study to confirm the benefit of TCAR compared with TFCAS in real-world practice.Table IComparison of baseline characteristics between transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS)TCARTFCASPNo. of patients63810,136DemographicsAge, median (IQR)74 (66-80)70 (63-77)<.001Female gender, No. (%)224 (35.1)3602 (35.5).83Race, No. (%).1 White574 (90.0)9187 (90.7) Black29 (4.6)549 (5.4) Others35 (5.5)397 (3.9)Hispanic or Latin ethnicity36 (5.6)306 (3.0)<.01Symptomatic status214 (33.5)4236 (41.9)<.001Coronary artery disease301 (47.3)3443 (34.0)<.001Prior congestive heart failure126 (19.8)1553 (15.3)<.01Prior CABG/PCI265 (41.5)1957 (19.5)<.001Hypertension582 (91.2)9111 (90.0).31COPD169 (26.5)2595 (25.7).64Diabetes238 (37.3)3841 (38.0).73GFR < 60 mL/min249 (39.8)3637 (36.7).12Smoker.01 Prior345 (54.1)4819 (47.6) Current155 (24.3)2831 (28.0)Prior ipsilateral CEA or CAS119 (18.7)2730 (26.9)<.001Prior contralateral CEA or CAS117 (18.3)1338 (13.2)<.001Preoperative medications Aspirin571 (89.5)8776 (86.7).04 Antiplatelet550 (86.2)7865 (77.7)<.001 Statins562 (88.1)8191 (80.9)<.001 Beta-blockers358 (56.1)5799 (57.3).56 Anticoagulants8 5 (13.3)883 (9.9).01 ACE inhibitors351 (55.0)4573 (51.5).08Anesthesia technique<.001 Local/regional608 (95.3)8951 (88.5) General30 (4.7)1161 (11.5)ACE, Angiotensin-converting enzyme; CABG, coronary artery bypass grafting; CAS, carotid stenting; CEA, carotid endarterectomy; COPD, chronic obstructive pulmonary disease; GFR, glomerular filtration rate; IQR, interquartile range; PCI, percuteanous coronary intervention. Open table in a new tab Table IIAdjusted analysis of in-hospital outcomes of transcarotid artery revascularization (TCAR) versus transfemoral carotid artery stenting (TFCAS)Univariate analysisMultivariate logistic regression1:1 Coarsened exact matchingTCAR, No. (%)TF-CAS, No. (%)PTFCAS (n = 10,136) vs TCAR (n = 638), OR (95% CI)PFemoral (n = 471) vs TCAR (n = 471), OR (95% CI)PTotal stroke9 (1.4)204 (2.0).291.62 (0.87-2.99).132.18 (0.82-5.77).12Stroke or death11(1.7)248 (2.5).251.75 (0.94-3.28).081.98 (0.80-4.87).14Any neurologic event (TIA/stroke)12(1.9)338 (3.3).042.21 (1.24-3.94).012.39(1.11-5.14).03Any neurologic events or death14 (2.2)382 (3.8).042.10(1.15-3.83).022.23 (1.08-4.62).03CI, Confidence interval; OR, odds ratio; TIA, transient ischemic attack.Multivariate analysis adjusted for gender, race, ethnicity, age, insurance status, coronary artery disease, congestive heart failure, prior coronary artery bypass grafting/percutaneous coronary intervention, diabetes, smoking, chronic kidney disease, diabetes, American Society of Anesthesiologists class, symptomatic status, restenosis, prior carotid endarterectomy/carotid stenting, prior amputation, medications (aspirin, antiplatelets, statin, anticoagulants, angiotensin-converting enzyme inhibitors), anatomic and medical high risk, and elective versus urgent or emergent procedures.Coarsened exact matching based on ethnicity, age, coronary artery disease, congestive heart failure, prior coronary artery bypass grafting/percutaneous coronary intervention, chronic kidney disease, diabetes, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical high risk, and elective versus urgent or emergent procedures. 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