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Posts Tagged ‘CEA’

I am re-posting yet another article discussing carotid stenting, and how it is misleadingly advertised as being a safer alternative to surgery to prospective patients.   This article comes from Heartwire, which is a statement in itself – as Heartwire is a cardiology journal aimed at the very interventionalist making their bread and very rich butter off of selling this higher risk procedure to their frightened or misinformed patients.. 

It isn’t headline news – this data has actually been out and published for several years now – but it’s taken this long to actually get the people performing the procedures to concede that carotid stenting is not all candy corns and rainbows…  But we’ll talk about this some more in my next post..  First, read the article yourself..

Article reposted below:

Higher stroke and mortality rates with carotid stenting over endarterectomy

December 20, 2010 | Michael O’Riordan

Boston, MA – After adjustment for symptom and risk status, carotid stenting results in higher rates of stroke and death when compared with surgical endarterectomy in the general US population, according to the results of a new study [1]. Mortality and stroke rates were significantly higher for carotid artery stenting than endarterectomy in high-risk and non-high-risk patients, report investigators.

“These data suggest that further careful analysis should be made to be certain that the efficacy demonstrated in randomized trials with carefully selected patients being treated by highly trained physicians is translated into effectiveness with similar results in broad general practice,” write Dr Kristina Giles (Beth Israel Deaconess Medical Center, Boston, MA) and colleagues in the December 2010 issue of the Journal of Vascular Surgery.

The Centers for Medicare and Medicaid Services (CMS) reimburses for carotid artery stenting in patients at high risk for carotid endarterectomy with symptomatic >70% stenosis. The reimbursement decision is based primarily on the results of the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial, which showed the interventional procedure cut 30-day rates of death, MI, and stroke by more than 50%. Other studies comparing the two approaches have shown mixed results. The latest Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) did show similar net outcomes with carotid artery stenting and carotid endarterectomy, but debate continues over which procedure should be performed in patients with symptomatic carotid disease.
Population-based data
The newest analysis comparing the two procedures was undertaken in 56 564 carotid-artery-stenting and 482 394 carotid-endarterectomy patients included in a database of the Agency for Healthcare Research and Quality. Past comparisons, according to Giles and colleagues, might have biased the results, mainly due to the CMS criteria, by overrepresenting high-risk and symptomatic patients in the stenting cohorts. Typically, high-risk criteria for endarterectomy include cardiac conditions such as recent MI, severe congestive heart failure, need for revascularization or valve repair within 30 days, and unstable angina, as well as end-stage kidney disease and pulmonary hypertension.

Overall, the combined end point of stroke or death was significantly higher among high- and low-risk patients, including among those with and without symptoms, undergoing carotid artery stenting compared with endarterectomy. Similarly, the mortality rate was 1.5% among high-risk patients, symptomatic and asymptomatic, who underwent stenting compared with 0.8% among high-risk patients treated with surgery, a statistically significant difference. Stroke rates among the high-risk patients were also significantly higher in the carotid-stenting treatment arm.

Death or stroke outcomes following carotid repair

Patient group Carotid artery stenting, n=56 564 (%) Carotid endarterectomy, n=482 394 (%) p
All patients 3.2 1.4 <0.001
High-risk 3.2 1.8 <0.001
Nonhigh-risk 3.1 1.0 <0.001
High-risk, symptomatic 14.4 6.9 <0.001
High-risk, asymptomatic 1.5 1.2 <0.05
Nonhigh risk, symptomatic 11.8 4.9 <0.001
Nonhigh risk, asymptomatic 1.8 0.6 <0.001

 

Outcomes following carotid repair assessed by symptom status

End point Carotid artery stenting, n=56 564 (%) Carotid endarterectomy, n=482 394 (%) p
Stroke or death      
Symptomatic patients 13.1 5.9 <0.001
Asymptomatic patients 1.6 0.9 <0.001
Mortality      
Symptomatic patients 6.0 1.8 <0.001
Asymptomatic patients 0.8 0.4 <0.001
Stroke      
Symptomatic patients 8.1 4.6 <0.001
Asymptomatic patients 1.0 0.6 <0.006

 

In a multivariate analysis, carotid stenting was associated with a 2.4-fold greater risk of death or stroke compared with endarterectomy, while symptom status, high-risk status, and procedures performed in earlier years were also associated with higher risks of death or stroke. These variables were also predictive of death and stroke alone.

Predictors of combined stroke or death

Variable Odds ratio (95% CI)
Carotid stent vs endarterectomy 2.4 (2.1-2.8)
Symptomatic status 6.8 (6.1-7.6)
High-risk status 1.6 (1.4-1.8)
Later year of procedure 0.9 (0.8-0.97)

 Note: this sentence seems to be out of place (below) but I didn’t want to edit the article, so here it is..)

Combined CABG and valve repair was performed in 3.9% of all carotid revascularization procedures, but the results showed stenting was not associated with an increased risk of stroke or death compared with carotid endarterectomy.

As Giles and colleagues point out in their paper, numerous studies comparing stenting with endarterectomy have shown conflicting results. The CMS decision to approve stenting as an alternative to the surgical approach is based on trials showing similar efficacy in high-risk patients, but the authors believe their newest results suggest that previous trials might not reflect current national outcomes.

“As more randomized trials define the efficacy of carotid artery stenting relative to carotid endarterectomy, additional population-based analyses with well-defined high-risk criteria are needed to be certain that acceptable results are obtainable in the general population,” write Giles and colleagues. “Further work is also needed to define the appropriate role of either revascularization method in those with specified high-risk criteria.”

Recent attempts to allow stenting in patients with lesser degrees of stenosis have been denied, however, as previously reported by heartwire.”

End of article..

The last sentences is pretty telling.. That means both insurance companies and the supervisory organizations for interventionalists are against the procedure – pretty harsh language for the field, but certainly made to sound mild here..   Of course, cardiologists are still reeling from two other recent scandals:

– the unnecessary stent medical trial of a well-known cardiologist (drawing more scrutiny to current practices)

– the unmasking of a fraudulent cardiologist who was actually on a speaking tour..

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