Meeting News

Transcarotid artery revascularization safe, effective in two real-world studies

In two real-world studies presented at the Society for Vascular Surgery Vascular Annual Meeting, transcarotid artery revascularization was associated with low rates of stroke, death and other clinical outcomes.

Both studies evaluated transcarotid artery revascularization (TCAR) with a transcarotid stent and neuroprotection system (Enroute, Silk Road Medical) in patients with carotid artery stenosis at high risk for carotid endarterectomy, and build on the 30-day and 1-year results of the ROADSTER trial, which was the basis for FDA approval of the system.

ROADSTER 2

Vikram Kashyap, MD, FACS, professor of surgery and chief of the division of vascular surgery and endovascular therapy at University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, presented 30-day results from the ROADSTER 2 FDA-mandated postapproval study of TCAR, in which 70% of sites had to be different from those used in the original ROADSTER trial.

The primary endpoint was procedural success, defined as technical success without stroke, death or MI, at 30 days.

All patients had symptomatic stenosis of at least 50% or asymptomatic stenosis of at least 80%, life expectancy of at least 3 years and at least one high physiologic or anatomic risk factor, Kashyap said during a presentation. Risk factors included age 75 years or older, multivessel CAD, congestive HF, left ventricular ejection fraction less than 30%, chronic obstructive pulmonary disease, contralateral occlusion, prior carotid endarterectomy, bilateral stenosis requiring treatment and hostile necks.

Among the 632 patients included, 41.8% were aged 75 years or older, 32.3% were women, 26.1% were symptomatic and 10.1% had contralateral carotid artery occlusion, Kashyap said.

Compared with the ROADSTER population, the ROADSTER 2 population more often had general anesthesia and less often had a hematoma requiring treatment, he said.

1 image with caption 1 col
In two real-world studies presented at the Society for Vascular Surgery Vascular Annual Meeting, transcarotid artery revascularization was associated with low rates of stroke, death and other clinical outcomes.
Source: Adobe Stock

The 30-day procedural success rate was 97.9%, which was greater than a prespecified threshold of 85% (P < .0001), according to the researchers.

In the ROADSTER 2 cohort, the 30-day rate of stroke/death/MI was 1.7%, whereas 30-day stroke occurred in 0.64% and 30-day stroke/death occurred in 0.8%, Kashyap said, noting that rates of 30-day clinical outcomes did not significantly differ from those in ROADSTER in the overall, symptomatic and asymptomatic populations.

Among women in ROADSTER 2, the 30-day rate of stroke/death/MI was 1.5% and the 30-day rate of stroke/death was 0.5%, whereas among those aged 75 years or older, the 30-day rate of stroke/death/MI was 3% and the 30-day rate of stroke/death was 1.1%, according to the researchers.

“TCAR is a safe and effective treatment for patients with extracranial carotid stenosis,” Kashyap said during the presentation. “The outcomes in ROADSTER 2 are excellent even in patients deemed at high risk for stroke, including patients with symptomatic disease and older age. Outcomes with TCAR are consistent across physicians with varying levels of experience. The outcomes in this trial are due to the excellent performance of the investigators as well as the resilience of the TCAR procedure.”

TCAR Surveillance Project

Mahmoud B. Malas, MD, MHS, FACS, professor and Chief of Vascular and Endovascular Surgery at the University of California San Diego, and professor of epidemiology at The Johns Hopkins Bloomberg School of Public Health, presented results from the TCAR Surveillance Project comparing outcomes of TCAR with carotid endarterectomy at centers participating in the SVS Vascular Quality Initiative.

Malas and colleagues evaluated patients from the cohort at high surgical risk who underwent TCAR (n = 5,716; median age, 74 years; 36% women) or carotid endarterectomy (n = 44,442; median age, 71 years; 39% women) between September 2016 and May 2019. Patients undergoing TCAR were more likely to be symptomatic (38.6% vs. 29.6%) and had more severe comorbidities (CAD, 51.8% vs. 26.7%; Congestive HF, 18.8% vs. 11.1%).

The primary outcome was in-hospital stroke, death or MI.

In multivariable analyses, compared with the surgery group, the TCAR group had lower risk for the following in-hospital outcomes:

  • MI (OR = 0.46; 95% CI, 0.3-0.72);
  • stroke/death/MI (OR = 0.69; 95% CI, 0.54-0.89);
  • cranial nerve injury (OR = 0.12; 95% CI, 0.07-0.19);
  • postprocedural hypertension (OR = 0.58; 95% CI, 0.48-0.71);
  • ·non-home discharge (OR = 0.73; 95% CI, 0.61-0.88); and
  • hospital stay of more than 1 day (OR = 0.74; 95% CI, 0.64-0.84).

There were no differences between the groups in in-hospital death (OR = 0.94; 95% CI, 0.57-1.53), ipsilateral stroke (OR = 0.99; 95% CI, 0.72-1.39), any stroke (OR = 0.89; 95% CI, 0.66-1.19) stroke/death (OR = 0.85; 95% CI, 0.65-1.13) or bleeding requiring intervention (OR = 1.12; 95% CI, 0.84-1.5), and the TCAR group had greater risk for postprocedural hypotension (OR = 1.59; 95% CI, 1.3-1.94), Malas said during a presentation.

Propensity score and coarsened-exact analyses yielded similar results, and the results did not vary based on symptomatic status, he said.

Among those with 30-day follow-up, results were similar to the in-hospital data, in terms of a similar stroke rate and the reduction in odds of MI and composite outcomes, however there was significant reduction in the odds of death among patients undergoing TCAR (OR = 0.66; 95% CI, 0.46-0.95), Malas said.

Among those with 1-year follow-up, after propensity matching, mortality risk was lower in the TCAR group (HR = 0.77; 95% CI, 0.62-0.96), according to the researchers.

“Patients undergoing TCAR have significant reductions in the odds of in-hospital stroke/death/MI and cranial nerve injury compared with [carotid endarterectomy],” Malas said during the presentation. “Better follow-up and a larger sample size are needed to create more information for future coverage decisions.” – by Erik Swain

Disclosures: ROADSTER 2 was funded by Silk Road Medical. The TCAR Surveillance Project is funded by the SVS Patient Safety Organization. Kashyap reports he is co-principal investigator for ROADSTER 2 without remuneration and consulted/proctored for Silk Road Medical in 2017. Malas reports he is international principal investigator for a trial sponsored by Silk Road Medical and proctors for Silk Road Medical.

Editor’s Note: This article was modified on June 17, 2019 to update the data and make other changes from Dr. Kashyap and Dr. Malas.

In two real-world studies presented at the Society for Vascular Surgery Vascular Annual Meeting, transcarotid artery revascularization was associated with low rates of stroke, death and other clinical outcomes.

Both studies evaluated transcarotid artery revascularization (TCAR) with a transcarotid stent and neuroprotection system (Enroute, Silk Road Medical) in patients with carotid artery stenosis at high risk for carotid endarterectomy, and build on the 30-day and 1-year results of the ROADSTER trial, which was the basis for FDA approval of the system.

ROADSTER 2

Vikram Kashyap, MD, FACS, professor of surgery and chief of the division of vascular surgery and endovascular therapy at University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, presented 30-day results from the ROADSTER 2 FDA-mandated postapproval study of TCAR, in which 70% of sites had to be different from those used in the original ROADSTER trial.

The primary endpoint was procedural success, defined as technical success without stroke, death or MI, at 30 days.

All patients had symptomatic stenosis of at least 50% or asymptomatic stenosis of at least 80%, life expectancy of at least 3 years and at least one high physiologic or anatomic risk factor, Kashyap said during a presentation. Risk factors included age 75 years or older, multivessel CAD, congestive HF, left ventricular ejection fraction less than 30%, chronic obstructive pulmonary disease, contralateral occlusion, prior carotid endarterectomy, bilateral stenosis requiring treatment and hostile necks.

Among the 632 patients included, 41.8% were aged 75 years or older, 32.3% were women, 26.1% were symptomatic and 10.1% had contralateral carotid artery occlusion, Kashyap said.

Compared with the ROADSTER population, the ROADSTER 2 population more often had general anesthesia and less often had a hematoma requiring treatment, he said.

1 image with caption 1 col
In two real-world studies presented at the Society for Vascular Surgery Vascular Annual Meeting, transcarotid artery revascularization was associated with low rates of stroke, death and other clinical outcomes.
Source: Adobe Stock

The 30-day procedural success rate was 97.9%, which was greater than a prespecified threshold of 85% (P < .0001), according to the researchers.

In the ROADSTER 2 cohort, the 30-day rate of stroke/death/MI was 1.7%, whereas 30-day stroke occurred in 0.64% and 30-day stroke/death occurred in 0.8%, Kashyap said, noting that rates of 30-day clinical outcomes did not significantly differ from those in ROADSTER in the overall, symptomatic and asymptomatic populations.

Among women in ROADSTER 2, the 30-day rate of stroke/death/MI was 1.5% and the 30-day rate of stroke/death was 0.5%, whereas among those aged 75 years or older, the 30-day rate of stroke/death/MI was 3% and the 30-day rate of stroke/death was 1.1%, according to the researchers.

“TCAR is a safe and effective treatment for patients with extracranial carotid stenosis,” Kashyap said during the presentation. “The outcomes in ROADSTER 2 are excellent even in patients deemed at high risk for stroke, including patients with symptomatic disease and older age. Outcomes with TCAR are consistent across physicians with varying levels of experience. The outcomes in this trial are due to the excellent performance of the investigators as well as the resilience of the TCAR procedure.”

TCAR Surveillance Project

Mahmoud B. Malas, MD, MHS, FACS, professor and Chief of Vascular and Endovascular Surgery at the University of California San Diego, and professor of epidemiology at The Johns Hopkins Bloomberg School of Public Health, presented results from the TCAR Surveillance Project comparing outcomes of TCAR with carotid endarterectomy at centers participating in the SVS Vascular Quality Initiative.

Malas and colleagues evaluated patients from the cohort at high surgical risk who underwent TCAR (n = 5,716; median age, 74 years; 36% women) or carotid endarterectomy (n = 44,442; median age, 71 years; 39% women) between September 2016 and May 2019. Patients undergoing TCAR were more likely to be symptomatic (38.6% vs. 29.6%) and had more severe comorbidities (CAD, 51.8% vs. 26.7%; Congestive HF, 18.8% vs. 11.1%).

The primary outcome was in-hospital stroke, death or MI.

In multivariable analyses, compared with the surgery group, the TCAR group had lower risk for the following in-hospital outcomes:

  • MI (OR = 0.46; 95% CI, 0.3-0.72);
  • stroke/death/MI (OR = 0.69; 95% CI, 0.54-0.89);
  • cranial nerve injury (OR = 0.12; 95% CI, 0.07-0.19);
  • postprocedural hypertension (OR = 0.58; 95% CI, 0.48-0.71);
  • ·non-home discharge (OR = 0.73; 95% CI, 0.61-0.88); and
  • hospital stay of more than 1 day (OR = 0.74; 95% CI, 0.64-0.84).

There were no differences between the groups in in-hospital death (OR = 0.94; 95% CI, 0.57-1.53), ipsilateral stroke (OR = 0.99; 95% CI, 0.72-1.39), any stroke (OR = 0.89; 95% CI, 0.66-1.19) stroke/death (OR = 0.85; 95% CI, 0.65-1.13) or bleeding requiring intervention (OR = 1.12; 95% CI, 0.84-1.5), and the TCAR group had greater risk for postprocedural hypotension (OR = 1.59; 95% CI, 1.3-1.94), Malas said during a presentation.

Propensity score and coarsened-exact analyses yielded similar results, and the results did not vary based on symptomatic status, he said.

Among those with 30-day follow-up, results were similar to the in-hospital data, in terms of a similar stroke rate and the reduction in odds of MI and composite outcomes, however there was significant reduction in the odds of death among patients undergoing TCAR (OR = 0.66; 95% CI, 0.46-0.95), Malas said.

Among those with 1-year follow-up, after propensity matching, mortality risk was lower in the TCAR group (HR = 0.77; 95% CI, 0.62-0.96), according to the researchers.

“Patients undergoing TCAR have significant reductions in the odds of in-hospital stroke/death/MI and cranial nerve injury compared with [carotid endarterectomy],” Malas said during the presentation. “Better follow-up and a larger sample size are needed to create more information for future coverage decisions.” – by Erik Swain

Disclosures: ROADSTER 2 was funded by Silk Road Medical. The TCAR Surveillance Project is funded by the SVS Patient Safety Organization. Kashyap reports he is co-principal investigator for ROADSTER 2 without remuneration and consulted/proctored for Silk Road Medical in 2017. Malas reports he is international principal investigator for a trial sponsored by Silk Road Medical and proctors for Silk Road Medical.

Editor’s Note: This article was modified on June 17, 2019 to update the data and make other changes from Dr. Kashyap and Dr. Malas.