News | Stents Carotid | June 13, 2019

TCAR Achieves Favorable Outcomes Versus Carotid Endarterectomy in CAD Patients

Updated results of TCAR Surveillance Project presented at Society for Vascular Surgery Vascular Annual Meeting

TCAR Achieves Favorable Outcomes Versus Carotid Endarterectomy in CAD Patients

June 13, 2019 — Silk Road Medical Inc. announced the presentation of real-world data for the treatment of patients with carotid artery disease at risk for stroke at the Society for Vascular Surgery 2019 Vascular Annual Meeting (VAM), June 12-15 in National Harbor, Md. In a headline presentation, Mahmoud Malas, M.D., of the University of California, San Diego School of Medicine shared updated results for the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project.

“The results of the TCAR Surveillance Project are overwhelmingly positive on a large dataset of patients, showing, for the first time, significantly lower odds of composite in-hospital stroke, death and myocardial infarction compared to CEA [carotid endarterectomy]. TCAR had statistically equivalent in-hospital stroke and death rates as CEA, with significantly lower odds of myocardial infarction and cranial nerve injury. Additionally, there was a significant reduction in mortality at 30 days and 1 year, likely attributable to the reduction in myocardial infarction,” Malas said. “Patients clearly benefit from TCAR’s less-invasive approach and with these data and future studies with similar results, I believe TCAR may become the standard of care.”

The presentation, “Outcomes of Transcarotid Revascularization with Dynamic Flow Reversal Versus Carotid Endarterectomy in the Transcarotid Revascularization Surveillance Project,” evaluated patients between 2015 and 2018, with 5,716 patients receiving TCAR compared to 44,442 patients receiving carotid endarterectomy (CEA). Propensity score matching was used to analyze 5,160 patients in each group. There were no statistical differences noted between TCAR and CEA for in-hospital stroke (odds ratio (OR) 0.80, p=0.19) or in-hospital stroke and death (OR: 0.77, p=0.09).

Other key findings for TCAR compared to CEA include:

  • Fifty-nine (59) percent lower odds of in-hospital myocardial infarction (OR: 0.41, p<.001);
  • Eighty-seven (87) percent lower odds of in-hospital cranial nerve injury (OR: 0.13, p<0.001);
  • Thirty-five (35) percent lower odds of in-hospital stroke, death and myocardial infarction (OR: 0.65, p<.01);
  • Twenty-six (26) percent lower odds of hospital stay longer than 1 day (OR: 0.74, p<0.001); and
  • Twenty-five (25) percent lower odds of non-home discharge (OR: 0.75, p<0.001).

In a separate risk adjusted analysis looking at 30-day and one-year followup, the results were as follows:

  • Thirty-four (34) percent lower odds of 30-day death (OR: 0.66, p=0.03);
  • Forty-six (46) percent lower odds of 30-day stroke and death (OR: 0.54, p=0.02);
  • Fifty-three (53) percent lower odds of 30-day stroke, death and MI (OR: 0.47, p<0.01);
  • Twenty-three (23) percent lower odds of 1-year mortality (OR: 0.77, p=0.02).

The TCAR Surveillance Project, a key initiative of the Society for Vascular Surgery’s Vascular Quality Initiative (VQI), is an open-ended registry intended to compare real-world patient outcomes between TCAR and CEA.

TCAR (TransCarotid Artery Revascularization) is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. The Enroute Transcarotid Stent is intended to be used in conjunction with the Enroute Transcarotid Neuroprotection System (NPS) during the TCAR procedure. The Enroute Transcarotid NPS is a first-in-class device used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the Enroute Transcarotid Stent.

For more information: www.silkroadmed.com

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init