Carotid Stenting Shows Steady Improvement in Patients at High Surgical Risk

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Better equipment and devices as well as more experience has led to improved outcomes for carotid stenting plus embolic protection in high-risk patients, according to a nonrandomized study published online January 9, 2012, ahead of print in the Journal of Vascular Surgery.

In the PROTECT (Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy) trial, Jon S. Matsumura, MD, of the University of Wisconsin School of Medicine and Public Health (Madison, WI), and colleagues prospectively enrolled 220 consecutive patients between November 2006 and January 2008, followed by a second group of 102 subjects between January and June 2008. The first group underwent CAS with use of a new distal embolic protection device that possessed a large-diameter filter, and—in accordance with the study protocol—the second group had the procedure using an older embolic protection device that is no longer manufactured. All were treated with a dedicated carotid stent (Xact; Abbott Vascular, Abbott Park, IL).

Periprocedural adverse events—the composite of death, stroke, or MI—occurred at a rate of 2.3% in the initial 220-patient cohort at 30 days. The combined death and stroke rate was 1.8%, while death and major stroke were observed in 0.5% of patients.

Over a median follow-up of 2.8 years, freedom from death, stroke, or MI plus subsequent ipsilateral stroke in the entire 322-patient study was 95.4%. The annualized ipsilateral stroke rate was 0.4%.

An Encouraging Trend

Such results compare favorably with earlier findings from randomized trials involving CAS and embolic protection, the researchers say, especially since subjects were considered high risk (table 1).

Table 1. Recent CAS Trials

“This trend may represent not only the improvement of the study device systems but also better understanding of factors associated with high risk for CAS,” Dr. Matsumura and colleagues note.

Even within the current study, the 2 embolic protection devices produced different outcomes, they point out. The newer device resulted in a 30-day death, stroke, MI rate of 2.3%, while the “obsolete” model used in the second cohort had a rate of 5.9%.

The researchers acknowledge that there are barriers to comparing PROTECT with other trials, such as inconsistent methods of ascertaining outcomes and varying levels of patient risk among studies. Moreover, they write, “[a]lthough this trial reports relatively low rates of events in octogenarians, indications for carotid intervention for elderly patients are still controversial. Careful patient selection is necessary in these patients to ensure net benefit.” Thirty percent of PROTECT patients were octogenarians.

PROTECT also fails to address the questions of whether embolic protection improves outcomes and how medical therapy compares with CAS, they add.

But Is This Enough for CMS?

In a telephone interview with TCTMD, Christopher J. White, MD, of Ochsner Medical Center (New Orleans, LA), said the PROTECT trial encapsulates the trend toward “dramatically better” outcomes that have been obtained with modern equipment and devices as well as with more experience.

“If you go back and construct a time line, from the early 2000s when carotid stenting trials for [US Food and Drug Administration (FDA)] approval started to happen, you’ll see that there’s a linear decrease in the complication rates over time as we approach 2008 and 2009,” he commented.

However, not much has changed since PROTECT, Dr. White noted. “Device development has been markedly slowed in the past year or two, because [the Centers for Medicare and Medicaid Services (CMS)] is really sending signals to the industry that they’re not going to pay for carotid stenting.”

According to Dr. White, PROTECT is “not an earth shattering” study, but it does come at an opportune time. On January 25, the Medicare Evidence Development and Coverage Advisory Committee is meeting to discuss payment for CAS.

“It’s a very big deal for us. Without funding, the device companies don’t iterate and don’t innovate. They don’t make things. And what’s crazy is it’s clear that CAS is competitive with surgery,” he said. “These are all FDA-approved devices; but if Medicare chooses not to pay, we’re dead. They’ll kill this technology.”

Study Details

Seventy-three percent of patients had CAD, 56% had current contralateral carotid disease, and 12% were symptomatic.

Note: Study coauthor William A. Gray, MD, of Columbia University Medical Center (New York, NY), is a faculty member of the Cardiovascular Research Foundation, which owns and operates TCTMD.

 

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Source:
Matsumura JS, Gray W, Chaturvedi S, et al. Results of carotid artery stenting with distal embolic protection with improved systems: Protected carotid artery stenting in patients at high risk for carotid endarterectomy (PROTECT) trial. J Vasc Surg. 2012;Epub ahead of print.

 

 

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