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Tuesday, October 19, 2021



VAM 2019: TCAR Data Challenge CEA as Standard of Care

At the recent Society for Vascular Surgery Vascular Annual Meeting, significant clinical study results were presented for TransCarotid Artery Revascularization (TCAR) that physicians say will challenge carotid endartectomy (CEA) as the standard of care.

TCAR Surveillance Project: Significantly Lower Odds of Composite in-Hospital Stroke, Death, and Myocardial Infarction

In a headline presentation that served to open the plenary session of the meeting, Dr. Mahmoud Malas of the University of California San Diego School of Medicine shared the updated results for the TCAR Surveillance Project, which evaluated 5,716 patients receiving TCAR compared to 44,442 patients receiving carotid endarterectomy or CEA between 2015 and 2018. In addition, 5,160 patients from each group were matched based on comorbidities and demographics and analyzed using propensity score matching.

The results showed for the first time significantly lower odds of composite in-hospital stroke, death, and myocardial infarction compared to CEA. Specifically, patients receiving a TCAR procedure were 59% less likely to have an in-hospital myocardial infarction or heart attack and 87% less likely to have an in-hospital cranial nerve injury. In addition, there was a significant reduction in mortality at 30 days and one year, likely attributable to the reduction in myocardial infarction.

ROADSTER 2: Compelling Patient Outcomes with Low Stroke Risk

Final results from ROADSTER-2 post-market study were also presented at VAM in the late-breaking session by Dr. Vikram Kashyap of University Hospitals Cleveland Medical Center. The study evaluated real-world use of the TCAR procedure in 632 high-surgical risk patients enrolled across 42 sites.

Data demonstrated compelling patient outcomes with low stroke and combined stroke and death rates of 0.6% and 0.8%, respectively. Of note, 80% of physicians participating in ROADSTER 2 were new to the TCAR procedure and these physicians enrolled approximately 70% of the patients, confirming the short learning curve for the procedure.

Find out more about VAM data and predictions for the future of carotid artery treatment in this video featuring perspectives from: 

  • Frank Arko of Sanger Heart and Vascular Institute
  • Matthew Smeds of Saint Louis University
  • Adel Barkat of Oklahoma Heart Institute
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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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