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Archive for the ‘carotid stenosis’ Category

A new article has been published in Neurosurgical Focus discussing carotid stenosis, carotid artery stenting and carotid endarterectomy.  It discusses previous trial results including the limitations of previous results and controversies.  The authors also spend a significant portion of the article examining previous trial designs – and how these trial designs may have skewed some of the previously reported results.  Young et. al also discuss the implications of these results in both symptomatic and symptomatic patients with carotid stenosis and compares the outcomes of both stenting and surgery in these groups, including current and on-going studies.

Reminder:

CAS = carotid artery stenting

CEA = carotid endarterectomy (open surgery)

BMT = Basic Medical Treatment (medications)

It’s several pages long, so I have only re-posted partial sections below.

Kate C. Young, Ph.D., M.P.H.; Anunaya Jain, M.B.B.S. M.C.E.M.; Minal Jain, M.B.B.S.; Robert E. Replogle, M.D.; Curtis G. Benesch, M.D., M.P.H.; Babak S. Jahromi, M.D., Ph.D.  (2011, June).  Evidence-based Treatment of Carotid Artery Stenosis. Neurosurg Focus. 2011;30(6).

Abstract

Carotid atheromatous disease is an important cause of stroke. Carotid endarterectomy (CEA) is a well-established option for reducing the risk of subsequent stroke due to symptomatic stenosis (> 50%). With adequately low perioperative risk (< 3%) and sufficient life expectancy, CEA may be used for asymptomatic stenosis (> 60%). Recently, carotid angioplasty and stent placement (CAS) has emerged as an alternative revascularization technique. Trial design considerations are discussed in relation to trial results to provide an understanding of why some trials were considered positive whereas others were not. This review then addresses both the original randomized studies showing that CEA is superior to best medical management and the newer studies comparing the procedure to stent insertion in both symptomatic and asymptomatic populations. Additionally, recent population-based studies show that improvements in best medical management may be lowering the stroke risk for asymptomatic stenosis. Finally, the choice of revascularization technique is discussed with respect to symptom status. Based on current evidence, CAS should remain limited to specific indications.

Introduction

Stroke accounts for 1 in every 18 deaths in the US, and leaves nearly 30% of those afflicted permanently disabled.[3,49] Worldwide, stroke is a leading cause of disability and the third leading cause of death, with 5 million deaths reported annually.[7] In the US alone, each year nearly 800,000 individuals suffer a stroke, with one-quarter of those cases being recurrent strokes.[49] Despite advances in stroke prevention, imaging, treatment, and rehabilitation, the costs of care continue to increase. In 2008, the costs of stroke care were $65 billion/year.[16] The estimated cost of care for patients with stroke in 2010 is $73.7 billion, with overall costs expected to exceed $2 trillion by 2050.[49]

One of the most important causes of ischemic stroke is carotid atheromatous disease, representing approximately 20% of the total incidence of this type of stroke.[31] Severe carotid stenosis is the most important risk factor for recurrent stroke in symptomatic patients with carotid atheromatous disease. Several large randomized trials have shown marked early benefit from CEA. Timely CEA (within 2 weeks from onset of symptoms) results in an absolute risk reduction of 15.6% and a relative risk reduction of 52% over best medical management.[4,18,35,37,41] Results of these large-scale trials and their pooled patient-level meta-analyses have made CEA the standard of care in patients with severe (> 70%) symptomatic carotid stenosis, and have provided Level I/A evidence for decisions regarding symptomatic patients with lesser degrees of stenosis by demonstrating modest benefits of CEA for symptomatic 50%–69% stenosis, and no benefit for stenosis < 50%.[10,41] In contrast, patients with asymptomatic carotid stenosis have a vastly different natural history, with much lower upfront risks of stroke. Two large-scale randomized controlled trials have demonstrated modest benefits achieved over several years from treatment.[18,28] Indeed, significant improvements in stroke prophylaxis achieved by BMT have led to a reappraisal of CEA for asymptomatic stenosis, with current and upcoming trials of carotid revascularization now including an arm for BMT.[1,39]

Over the past decade, CAS has emerged as a potential alternative to CEA. The appeal of CAS has been driven in part by patient, physician, and hospital preferences for less invasive procedures, with underlying assumptions that this would lead to a reduction in complications, length of stay, and cost, although the latter 2 appear to not be borne out in practice.[25,28,38,51] The choice between CEA and CAS has therefore been primarily centered around which technique provides better clinical outcomes. Multiple CAS case series and registries have emerged, of mixed quality and with conflicting data, which will not be reviewed here. Unfortunately, large-scale randomized controlled trials comparing the 2 revascularization techniques have proven controversial, and have not convincingly identified a superior technique.[11,17,22,26,33,34,40,50] The most recent trial, CREST, was designed to avoid prior pitfalls and to reach definitive conclusions regarding choice of revascularization technique for carotid stenosis, although interpretation of its results has not been free of controversy either.[2,5]

Health care is undergoing a radical transformation. The economic environment has challenged health care organizations to deliver optimal services in the face of compromised cash flows, reduced resources, and declining margins. There is an overwhelming need for health care policy makers to audit current practices to ensure incorporation of cost-effective guidelines without compromising quality and outcomes of care. Our objective in this review of trials comparing CEA, CAS, and BMT in patients with carotid artery stenosis was to analyze existing evidence and cite comparative measures to consider while making such treatment decisions.

Young et al summarizes their findings:

Summary

Patients with symptomatic stenosis > 70% should undergo carotid revascularization. There is clear evidence that CEA is superior to BMT for such a group, with an absolute risk reduction of 15.6%. The benefits of CEA for 50%–69% stenosis, although significant, were modest compared with those in patients with 70% stenosis. Therefore, revascularization is recommended for 50%–69% symptomatic stenosis, with the understanding that aggressive lipid management and other antiplatelet agents have been added to the BMT regimen since NASCET and ECST were conducted, and may be useful in this population. Based on meta-analysis and recent data, CEA remains the procedure of choice for revascularization of symptomatic stenosis ≥ 50%; however, CAS is a potential alternative for patients with specific high-risk factors for CEA (for example, contralateral occlusion, radiation therapy, restenosis). Also, CAS has other, less well-defined indications, such as severe chronic obstructive pulmonary disease or the somewhat ambiguous “high risk” criteria.

We found that CEA has a modest benefit for asymptomatic stenosis, given at least a 3–5 year life expectancy after surgery. In contrast, CAS has a dubious benefit for asymptomatic stenosis; procedural morbidity and mortality rates approach or exceed 3%, whereas the procedural risks with CEA remain much lower. With the declining incidence of stroke due to asymptomatic lesions and the current natural history, SPACE-2 and other trials are well justified to compare BMT against CAS or CEA. The CAS procedure for asymptomatic stenosis should remain relegated to clinical trials, which should also include an arm for BMT.

What  does all of this mean:

Surgery is better than medications for severe stenosis, particularly in symptomatic patients.

Stenting is a viable option is symptomatic patients with high risks of surgical complications (complications as defined above).  Stenting should not be used in asymptomatic patients.

Basic medical treatment is a useful therapy, particularly in patients with borderline asymptomatic (50-60%) surgical stenosis, and combined with other treatments in patients with greater stenosis (or symptomatic).

Note:

Does this preclude stent technology in the future – No.  as stenting technology advances, stenting may become a more viable option for larger groups of people.

 

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Now all of my long-term readers should be able to spot the flaws in the logic here. One study, funded by a drug company with results that are at odds with just about every other study ever published – and that’s the one the FDA uses to approve/ expand the indications for stenting? Guess it’s just another ‘easy’ solution to sell to patients / primary care providers who don’t have the time and resources to review the literature themselves.  No surprise, since I am guessing that cardiologists will be placing the majority of these stents..

From HeartWire:
FDA approves expanded indication for carotid stenting
May 6, 2011 | Susan Jeffrey

Adapted from Medscape Medical News—a professional news service of WebMD
Silver Spring, MD – The US Food and Drug Administration announced today it approved an expanded indication for the RX Acculink carotid stent system (Abbott Vascular, Santa Clara, CA) to include patients at standard surgical risk for carotid endarterectomy [1].

Previously, the RX Acculink stent, used in conjunction with Abbott’s Accunet or Emboshield embolic-protection devices, was approved for use only in patients requiring carotid revascularization who were at high surgical risk. These high-risk patients were also required to have a reference vessel diameter ranging from 4.0 mm to 9.0 mm at the target lesion and be symptomatic with a stenosis of the common or internal carotid artery of >50%.

The stent was also previously approved in high-risk patients without neurological symptoms but with a stenosis of the common or internal carotid artery >80%.

In January, the FDA’s Circulatory System Devices Panel voted 7 to 3 in favor of this expanded indication for the system, saying the benefits of carotid stenting in patients at standard risk for adverse events from endarterectomy outweighed the risks. wait – are you sure about that?? because most of the data shows that surgical risk is actually well under 1% – and that’s looking at VA studies involving tens of thousands of patients, with multi-year follow-up..

The panel also voted 6 to 4, with one abstention, in support of the safety of carotid stenting in standard-risk surgical patients and 8 to 2, again with one abstention, in a vote that asked about the effectiveness of therapy in this expanded patient population.

“Expanded access to RX Acculink means patients and their healthcare providers have another option for treating clogged neck arteries,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement.

The FDA based its approval on the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), a 10-year study of 2502 symptomatic and asymptomatic patients at 119 clinical sites in the US and Canada, funded by the National Institute of Neurological Disorders and Stroke with supplemental funding by Abbott.

Patients were treated and followed for at least one year. Results of that study, published in the New England Journal of Medicine, showed that patients treated with stenting had a similar combined rate of death, stroke, and MIs those who underwent surgery [2].

Those who underwent surgery, however, had fewer strokes, and those who had stenting had fewer MIs over follow-up. There was also an effect of age, where older patients had fewer events with surgery, while younger patients had slightly fewer events with stenting. Wait a minute – older patients – surgery is actually safer.. but remember, that’s the excuse we received from the beginning – ‘stents are for the frail old people’.. define ‘slightly fewer’ – does that mean ‘not statistically significant’ because that’s what it sounds like. [cartagena surgery]

The FDA advisory panel emphasized the need for additional long-term follow-up information and the importance of the stent’s use in conjunction with an embolic-protection device.

As a condition of the approval, Abbott is required to conduct a postapproval study that will follow new patients treated with the stent system for at least three years to confirm the results identified in CREST.

The postapproval study will also evaluate how patients age 80 years and older respond to treatment, whether treatment success is affected by operator experience, and whether symptomatic and asymptomatic patients have different outcomes.

“The study is consistent with recommendations made by the expert advisory panel,” the FDA statement notes

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Once again – it looks like technology pushes ahead past patient care.  Despite continued questions about the use of carotid stenting, and questions about research methods used in some of the most recent trials – the FDA is discussing expanding the guidelines for carotid stenting. 

 As readers know, I have a difficult time with this because I consider it to be catering/ fostering patient fears.. Patients are (understandably) afraid of surgery – so let’s just sell them something easier..  even if surgery remains the gold standard, and the safer option..

Frank Veith, famous vascular surgeon shares these sentiments – which I have re-posted here.  As my long time readers know from previous discussions CAS= carotid artery stenting  and CEA = carotid artery endarterectomy.

(transcript from video speech – Medscape) 

Carotid Guidelines: CAS equal to CEA?

Good morning. I’m Frank Veith, Professor of Vascular Surgery at New York University Medical Center and the Cleveland Clinic. This morning I’m going to talk a little bit about the recent guidelines from the American Heart Association,[1] and a number of other important organizations, that have been recently published, and although it’s a little premature to comment on them because they haven’t been read and absorbed completely, I think it’s worth making a comment.

The guidelines appeared to state that carotid stenting was equivalent to carotid endarterectomy, and even though prestigious organizations produced these guidelines, it is my opinion that this conclusion is a little bit premature and unjustified, in view of the data that have accumulated over the past 5 years. The 1 trial that suggested equivalence of carotid endarterectomy and carotid stenting, was the CREST [Carotid Revascularization Endarterectomy versus Stenting Trial], and even though the article in the New England Journal of Medicine [2] stated as a conclusion, that equivalent results could be achieved by the 2 procedures, I believe that this conclusion is flawed, because the conclusion was only reached on the basis of a common composite endpoint, which included not only stroke and death, but also myocardial infarction.

The carotid stenting patients suffered more strokes and deaths, whereas the carotid endarterectomy patients suffered more myocardial infarctions, and when all those adverse events were added up, they were in fact, equivalent, but the flaw is, at least in my opinion, that it’s not justified to equate a minor stroke with a minor myocardial infarction. A minor myocardial infarction, although it can have some serious adverse consequences, is not the equivalent of a minor stroke. In a minor stroke, even though the patient may recover measurable neurologic function completely, his brain is not the same. He has immeasurable defects in mood, intelligence, attitude, and so forth, so I believe that a minor stroke (strokes being what both procedures are designed to prevent) is not the equivalent of a minor myocardial infarction.

In addition, all the other trials and population-based studies demonstrate a significantly higher incidence of strokes following carotid stenting than following carotid endarterectomy. You can’t ignore these trials and certainly can’t ignore the population-based studies, which are other valid pieces of evidence. So I believe, as an enthusiast for carotid stenting, that carotid stenting will ultimately play a very major role in the treatment of carotid artery disease, but I don’t think the data yet justify the conclusion that the 2 treatments are equivalent, or that carotid stenting should generally be an acceptable alternative to carotid endarterectomy.

At present, we really don’t have that evidence in hand, although I believe it will come in the future. I might add in closing that, many of the points that I made were made by other speakers at our 2010 Veith symposium,[3] held here in New York in November, and many additional points will be made at next year’s meeting, which will be held in November of 2011. Thank you.

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If you’ve been following the cardiology and vascular surgery journals – then you’ve been bombarded with articles about strokes in the last two days.

The first series has blazing headlines linking the increased rate of strokes in young people with diet soda consumption (excess salt consumption, obesity, poor dietary habits).

The second series of articles discuss the very topics we’ve been discussing here at Cartagena Surgery.. Surgery versus Stenting..  But as people have been asking, are the two related??

Probably not.  The proposed causes of the increased incidence of stroke in people aged 15 – 44 is theorized to be related to increased sodium intake – which in turn causes hypertension.  Hypertension itself may increase the ‘chipping’ effect on plaques in the carotid artery (in people with pre-existing carotid disease)

or may cause strokes themselves by causing blood vessels in the brain to rupture from the increased pressure.  In young people, it is usually the latter.. (because it usually takes a long time to accumulate carotid plaques.) Unfortunately, it’s this younger population that often goes undetected/ untreated or fails to realize the significance of the diagnosis.  Hypertension/ high blood pressure is a serious condition, and aggressive treatment is warrented.. It’s never just high blood pressure.. It’s THE number one cause of kidney failure, the number one cause of heart failure, and a major cause of stroke (just to name a few.)  and it’s usually easily treatable.

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So your doctor (or nurse practitioner / physician assistant) ordered a carotid ultrasound, now what?

The ultrasound – carotid duplex

This is a great screening tool – to screen if you have blockages or not.  It doesn’t hurt, there is very little risk, it’s fairly quick and can be done almost everywhere.  (Really – sometimes you can get carotid ultrasounds at the mall during health screenings..)

If the results show carotid stenosis or elevated velocities suggesting stenosis of 70% or better – it’s decision time.  Now some test interpretations are a bit complicated – a lot of tests rate stenosis using ranges, and my least favorite range is 60-79% because it’s such a wide range at a point where 70-79% means possible surgical treatment yet 60-69% doesn’t.

** Some of my more proactive patients ask about surgery for lesser stenosis – such as 60% or even 40% – this really isn’t practical for a couple of reasons:

1.  a 60% may stay at that level of disease (particularly with medications) for a very long time

2.  The risk of stroke with this level of stenosis is much, much less than once a person crosses the 70-80% barrier, so the risk from surgery/ stenting may outweigh the risk of ‘watchful waiting’.  While surgical risk is low (we will talk about this later – it’s not zero – so taking additional risks when the stenosis is not severe is unwise.)

Additional Diagnostic Tests:

At this point it’s time to make a few preliminary decisions; if you absolutely do not want surgery – don’t bother with the additional tests.  We can prescribe medications using the information from the Ultrasound..

But – if you haven’t ruled out surgery – The CTA or MRA are essential!  These tests are more accurate – which is important for those people with ‘shoulder’ results (the 60-79% category) .

These tests also give surgeons a road map to work from. 

1. CTA 0r computerized tomography (CT scan) with angiography:

Most surgeons that I have worked with prefer the CTA over the MRA for surgical planning.  It’s less expensive, and the imaging is excellent for vascular structures.  Now a CTA includes contrast dye – usually in amounts that equal or exceed a cardiac cath (about 100ml) so people with kidney disease or risk for kidney complications either receive prophylaxis or an MRA. 

At a previous position, I developed CTA protocols to prevent contrast-induced kidney damage using criteria set forth by the international radiology community.

Special Procedure Orders

  This helped protect people at higher risk for complications – after all you shouldn’t develop problems from a test used to detect other problems..  But it made the test an all day procedure, so the patients could receive IV fluids and other medications.

According to the international radiology guidelines, the following individuals are at higher risk of developing complications:

– age greater than 75        – elevated BUN/Creatinine (kidney labs)*

-hx of chemotherapy/ radiation      – diabetes

-solitary kidney                                      -known kidney disease/ previous failure

– organ transplant hx                           -several other conditions (see protocol)

*usually creatinine greater than 1.2

I have attached the form for interested readers.

2. MRA – magnetic resonance angiography

this test is based on a MRI which gives much greater detail of soft tissue structures (not particularly needed for vascular surgery but good for other diagnoses).  This test uses a different dye which is less toxic to people with bad kidneys.  (However, if there is severe kidney disease or on dialysis – this dye has it’s own risks of complications.  For patients on dialysis, CTA is generally preferred – and the test is done the day before the regularly scheduled dialysis day.)

After the tests confirm that both: 1.) the stenosis is as severe as previously estimated on ultrasound  and 2.) the blockage is somewhere we can reach either surgically or in the lab –

It’s time to talk about treatment options.

Treatment options include: (and risk of stroke with each)

1. Do nothing (it’s always an option) – but for a blockage of 70-80% the risk of stroke is about 15% or 1 in 6.  This climbs to 25% for people with a history of stroke or TIAs.  Since I don’t have a crystal ball – I can’t tell people who will be that 1 in six.

2. Medical Management  (aka medications)  – medications are actually reasonable effective for many people.  Clopidogrel, ASA 81mg, and a statin drug are the usual drugs prescribed.  People with heart history should already be on most, if not all of these.  This has been reported in the literature to bring risk of stroke down to 8%

 (Of course, this is assuming that people actually take them regularly – and surprisingly, most people don’t/ won’t.)  The cost of the clopidogrel (plavix) is sometimes an issue for people, it is quite pricey.  There are statins available on the $4 formulary .  It’s also not a great choice for people with bleeding problems – previous bleeding strokes, bleeding ulcers or a history of falls.

3. Carotid Endartarectomy (CEA) – surgery to clean out the artery.  This requires a trip to the operating room, and often an overnight stay.  Surgery is actually fairly safe (we’ll discuss more at next post) even for the very elderly (proven safe for people in middle and late 90’s in several studies.  Surgery brings the risk of stroke down to about 1% (it’s slightly less than one percent but I rounded up to a full percent).  This risk of stroke is basically centered around the time of surgery (during surgery and first thirty days after).

4.  Carotid Stenting – this option was heralded (by the people doing it) as the second coming, and stents were placed in LOTS of people for flimsy reasons “patient refused surgery” (not mentioning that they scared the poop out of patients over surgery) yet research has failed to confirm the safety or efficacy of the procedure with the rate of stroke ranging from 7% to a full FIFTEEN percent in some studies.  (Now remember, for many people  – fifteen percent means they should have just stayed home/ picked option one.)  Now the interventionalists (the doctors who perform this procedure) are in big doo – doo because they have been misleading patients for several years, or overplaying (vastly) the risks and fears of surgery and downplaying the risks with stents..

We will talk more about the last two options in the next post..

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Carotid stenting sounds like a wonderful solution to the layperson.  But the truth is always more complicated.  I’ll talk about it more here to give a better understanding of the disease, diagnosis, and treatment options.

The carotid arteries

The carotid arteries (along with the vertebral arteries) bring blood to the brain. Plaque embolization (or flecks of plaque breaking off diseased or blocked arteries) is one of the main causes of embolic (or non-bleeding) strokes.  In people with blockages in this artery, treating or removing the plaque can prevent stroke.

Today we will talk about screening and diagnosis.. Next time: treatment options.

Detecting Carotid Stenosis:

These blockages can be detected with the use of a carotid doppler (or ultrasound) to listen to the speed of the blood (velocities) in the carotid artery and to visualize blockages.  Some blockages can also be heard on physical exam –  as a bruit (bru-ee) but this is not always a reliable indicator, as the most severe stenoses (or narrowing from plaque) usually don’t have a bruit.

Results are reported as a range – and this decides treatment options.  Generally, in people that have NOT had a stroke – surgical treatment is not advised until the blockage is 70 – 80% blocked.  This is because the risk of stroke increases with the amount of blockage, as the speed of the blood increases to pass through the narrowed space.  (Picture a garden hose, now put your thumb over the end, covering most of it and make the water shoot out – that’s what we mean by increased velocity.)

If you have had a stroke or mini stroke from a plaque breaking off and travelling to the small vessels of the brain, the doctors will usually operate with lesser blockages – because you have already demonstrated a tendency to have pieces break off.

Now this is important – strokes usually happen because of high grade (70 or higher stenosis) not occlusions (or 100% blockages).  That’s because there is more than one vessel bringing blood to the brain – (remember the vertebrals we mentioned earlier..)  Doctors do not undo occlusions because that actually increases the risk of stroke at the time of surgery.

If you have an occlusion – count yourself as lucky that you didn’t have a stroke when it was 99%  and worry about keeping the remaining vessels as clean as possible with medicines.

Screening for Carotid Stenosis:

Currently there are no screening guidelines for asymptomatic individuals.  Since symptomatic means the person has had a stroke or TIA (mini-stroke) knowing when to screen is important.

Generally screening should be done in people at high risk for developing accelerated plaque formation – and in people with vasculopathic disease history (people with a history of plaque or blockages other places.)

High risk for accelerated plaques:

1. Diabetes – diabetes accelerates plaque formation, which is why new guidelines suggest ALL people with Diabetes, regardless of blood cholesterol tests should be on a statin drug (simvastatin, rosuvastatin, lovastatin, atorvastatin, pravastatin)*

2. History of smoking – smoking causes similar effects inside blood vessels as diabetes.  As I explain to patients in the office, it makes plaque form faster by irritating blood vessels and making plaque more likely to stick.  This is also important when we talk about ‘medical management’ of plaque diseases.

Note: ‘Medical Management’ is a term that means exactly that – managing conditions (not curing or fixing) by use of medications.  The disease won’t go away but the thought is that medicines will slow the worsening of the conditioning.

People with history of vasculopathic disease:  these people should be screened because they already have a history of artery blockages – but people don’t always realize that carotid arteries and other arteries are essentially the same highway, so to speak.

This includes:

1. People with a history of Coronary artery disease (CAD) such as people with previous heart stents or bypass surgery.  In fact, one-third of people screened for carotid artery while awaiting bypass surgery (also called CABG) have significant carotid disease or stenosis.

2. People with blockages elsewhere: Renal artery stenosis (kidneys), peripheral artery disease (PAD) aka blockages in the legs, mesenteric artery disease (abdomen).

3. People with an abnormal eye exam or Amarosis fugax – this is basically a small stroke or mini-stroke to the eye.  Sometimes people develop symptoms (amarosis fugax – which is described as a sudden loss of vision, like a shade coming down over your eye).  Other times, the ophthalmologist sees a plaque in the artery to the eye on exam.

I’ll talk about more in my next post – and I am happy to answer condition related questions but not offer medical advice.  My legal eagles have a fit otherwise..

*as I have previously mentioned in Hidden Gem – it is vitally important patients know the generic names of their medications, along with dosages and administration information.

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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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