CAROTID STENTING NOT AS EFFECTIVE AT PREVENTING STROKE OR AS SAFE AS STANDARD SURGERY IN THE SHORT-TERM
Carotid endarterectomy (CEA), surgery that removes material causing the narrowing of the artery that supplies blood to the brain, is safer than implantation of a carotid artery stent, in which a wire mesh stent is inserted to hold open the artery, as a treatment for carotid blockages that can lead to stroke. Surgery almost halves the risk of stroke and death within 30 days after treatment compared to stenting, and significantly reduces the risk of stroke, death, and treatment-related heart attacks in the first few months after diagnosis. These are the findings of two Articles published Online First in The Lancet and The Lancet Neurology.
The standard treatment for symptomatic carotid stenosis (narrowing of the arteries that supply blood to the brain), one of the main causes of stroke, is surgery (endarterectomy) to remove fatty deposits via an incision in the neck. Stenting, a less invasive treatment which does not require general anaesthesia, and has potentially fewer complications and a faster recovery time, is also used as an alternative treatment option. However, although studies comparing CEA and carotid artery stenting (CAS) have been published, none have established whether stenting is equivalent to surgery in terms of safety and efficacy.
The International Carotid Stenting Study (ICSS) investigators assessed the effectiveness of stenting and endarterectomy at preventing stroke, death, and procedure-related heart attacks in 1713 patients with recently symptomatic carotid stenosis. Patients were randomly assigned to stenting (n=855) or surgery (n=858) and followed for up to 120 days after randomisation.
Findings showed that patients in the stent group had a significantly greater risk of stroke, death, or procedure-related heart attack within 120 days of randomisation—absolute risk 8.5% compared with 5.2% in the surgery group. Additionally, within 30 days of treatment the rate of stroke or death in the stent group was nearly twice the rate recorded in the surgery group. This difference was mainly due to a higher number of non-disabling strokes recorded in the stent group (36 vs 11 within 30 days of treatment), whereas the number of disabling strokes or deaths did not differ significantly (26 vs 18).
The authors conclude: "Completion of long-term follow-up is needed to establish the efficacy of treatment with a carotid artery stent compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for symptomatic patients suitable for surgery."
Because investigators who assessed patients during follow-up were not blinded to treatment allocation, there was the possibility of ascertainment bias (distortion of the results) which might explain the higher incidence of non-disabling strokes found in the stent group. Therefore the second Article, published in The Lancet Neurology, reports a blinded analysis of the ICSS trial to assess the rate of ischaemic brain injury on MRI after treatment in the two groups.
231 patients (124 from the stenting group and 107 from the surgery group) had MRI scans before and after treatment which were assessed by investigators who were masked to treatment.
MRI results showed that about three times as many patients had new ischaemic lesions after stenting than after surgery (50% vs 17%).
The authors conclude that these neuroimaging data confirm that carotid surgery is safer then carotid stenting. They point out that the increased risk of non-disabling stroke after stent treatment is unlikely to have been caused by ascertainment bias. Most of the new ischaemic lesions were not associated with symptoms of stroke at the time of stenting and the authors suggest that the most likely explanation is that particles of atheromatous plaque are released during implantation of the stent, which are too small to cause any noticeable symptoms at the time but nevertheless lead to small areas of brain damage.
Contact:
Professor Martin Brown, UCL Institute of Neurology, The National Hospital for Neurology and Neurosurgery, London, UK.
T) +44 (0)207 829 8753 or +44 (0)77 0100 7446 (mobile)
E) m.brown@ion.ucl.ac.uk
For full Articles and Comment, see: http://press.thelancet.com/icss.pdf
COGNITIVE BEHAVIOURAL THERAPY IMPROVES BACK PAIN
Group cognitive behavioural therapy (CBT) can reduce low-back pain, and at a low cost to the health-care provider. Moreover, the improvement was sustained at 1 year after the start of treatment. These are the conclusions published in an Article in this week's issue of The Lancet.
Persistent low-back pain is increasingly common, and it can be debilitating, ranking as one of the top three most disabling conditions in the developed world. Since it is so common, back pain is also costly to treat.
Professor Sarah E Lamb, at the Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK, and colleagues undertook a randomised controlled trial of 701 patients with troublesome subacute or chronic low-back pain from general practices across England. The researchers' goal was to determine whether group cognitive behavioural therapy would offer any additional benefit to best practice advice in primary care. This advice included guidance on staying active and appropriate use of pain medication.
The patients were then randomly assigned to two groups: 468 participants were given up to six sessions of group CBT, and 233 controls were given no additional treatment. 85% of participants in each group completed the study. Primary outcomes were the change at 1 year from baseline in Roland Morris disability questionnaire and modified Von Korff scores, both of which measure pain and disability.
The team found that at 1 year, CBT had significantly improved both disability scores. The change from baseline in the Roland Morris questionnaire was 2·4 points in the CBT group compared with 1·1 points in controls. The Von Korff score changed by 13·8% in the CBT group and 5·4% in controls. Crucially, the treatment was cost-effective. The cost per quality-adjusted life-year was £1786, which is about half that of competing treatments such as acupuncture.
The authors say: "Effective treatments that result in sustained improvements in low-back pain are elusive. This trial shows that a bespoke cognitive behavioural intervention package, BeST, is effective in managing subacute and chronic low-back pain in primary care. The short-term effects (≤4 months) are similar to those seen in high-quality studies and systematic reviews of manipulation, exercise, acupuncture, and postural approaches in primary care."
The authors believe that the treatment could have a wide applicability because the participants were representative of the ethnic mix of the UK, and they came from a mix of rural and urban areas. They also note that 95% of the CBT session time was directed towards achieving psychological goals rather than on supervised exercise.
They conclude: "A bespoke cognitive behavioural intervention package for low-back pain has an important and sustained effect at 1 year on disability from low-back pain at a low cost to the health-care provider."
In an accompanying Comment, Dr Laxmaiah Manchikanti, Pain Management Center of Paducah, Paducah, KY, USA, says that Lamb and colleagues' study "showed rather impressive results".
Manchikanti sounds a note of caution about the routine availability of group CBT for low-back pain in primary care. It "might be feasible in countries with national health-care systems, but not in a country like the USA".
He concludes that "the results suggest that cognitive behavioural therapy is an excellent option for primary care physicians before they seek specialty consultations for their patients."
Contact:
Professor Sarah E Lamb, the Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
T) 44 2476 150404
E) s.lamb@warwick.ac.uk
Dr Laxmaiah Manchikanti, Pain Management Center of Paducah, Paducah, KY, USA.
E) drlm@thepainmd.com
For full Article and Comment, see: http://press.thelancet.com/cbt.pdf
ISCHAEMIC CONDITIONING PREVENTS DAMAGE AFTER HEART ATTACK
Ischaemic conditioning, a technique that uses the body's own protective mechanisms, can reduce the amount of damage to the heart tissue after acute myocardial infarction, according to an Article in this week's issue of The Lancet.
After a myocardial infarction, the size of the infarct (the area of tissue that undergoes necrosis because of blocked blood supply) is a key determinant of the outcome for the patient. Ischaemic conditioning is a process by which the blood supply to the heart is stopped and started a few times using a blood-pressure cuff, for a few minutes each time. This "conditions" the heart tissue to damage caused by low blood flow (ischaemia) and subsequent re-establishment of blood flow (reperfusion).
Hans Erik Bøtker, Department of Cardiology, Aarhus University Hospital, Skejby, Denmark, and colleagues, tested whether remote ischaemic conditioning would increase the heart tissue that could be salvaged, measured through the myocardial salvage index. They undertook a randomised trial in which some patients with acute myocardial infarction being taken to hospital for primary percutaneous coronary intervention were given ischaemic conditioning in the ambulance (n=73) and others were not (n=69). The primary endpoint was myocardial salvage index at 30 days after coronary intervention.
Myocardial salvage was higher in patients who had had ischaemic conditioning. The median salvage index was 0·75 in the ischaemic conditioning group compared with 0·55 in the control group, and mean salvage index was 0·69 versus 0·57.
The authors say: "This protective effect seemed to be strongest in patient with totally occluded vessels and with infarcts in the left anterior descending artery—both of which were associated with almost double the area at risk—but we did not record an interaction of remote conditioning with occluded vessels or infarct location. Since the safety profile of remote conditioning is favourable, no patient should be denied this treatment."
They conclude: "The effectiveness of remote conditioning after onset of target-organ ischaemia could have implications for myocardial infarction and stroke treated with thrombolytics. Moreover, the intervention's simplicity, low cost, and effectiveness make it attractive for testing in large-scale clinical trials."
In an accompanying Comment, Professor Michel Ovize and Professor Eric Bonnefoy, Hospices Civils de Lyon, Hôpital Cardio-vasculaire et Pneumologique, Lyon, France say that "At a time of major difficulties in supporting the cost of our health-care systems, Bøtker and colleagues have shown that a non-invasive, simple, safe, and cheap intervention, possibly done by a paramedic before hospital admission, can significantly increase myocardial salvage. [They] were able to show that remote conditioning can significantly increase myocardial salvage in patients with ST-elevation acute myocardial infarction (STEMI), which suggests that the technique might represent a new powerful treatment option for such patients."
They conclude: "Their study confirms proof-of-concept clinical studies and suggests that lethal reperfusion injury is the next major target for the treatment of patients with acute myocardial infarction. Any enthusiasm arising from this encouraging study must, however, be tempered by the need to show actual clinical benefit in larger-scale clinical studies."
Contact:
Professor Hans Erik Bøtker, Department of Cardiology, Aarhus University Hospital, Skejby, DK-8200 Aarhus N, Denmark.
T) +45 89496116, +45 20985282
E) heb@dadlnet.dk
Professor Michel Ovize, Hospices Civils de Lyon, Hôpital Cardio-vasculaire et Pneumologique and INSERM 886, 69008 Lyon, France.
E) michel.ovize@chu-lyon.fr
For full Article and Comment, see: http://press.thelancet.com/ischaemic.pdf
EDITORIAL: HEART DISEASE REMAINS LEADING CAUSE OF DEATH IN USA
The lead Editorial in this week's issue says that according to the latest report on health in the USA, heart disease remains the biggest killer. In 2006, 631636 Americans died from heart disease. The report entitled Health, United States, 2009 was prepared for the US President and Congress by the National Center for Health Statistics at the US Centers for Disease Control and Prevention (CDC).
What the report makes clear is that much more could be done to stop these deaths. While the USA's use of advanced medical technology such as pacemakers and cardioverters has risen, the statistics on the numbers of people changing their lifestyles are gloomy: one in five adult Americans smokes cigarettes, a third over 20 years are obese, and only about one-third adults are regularly active.
The Editorial concludes: "Chronic heart disease places an unnecessary burden on the American people and the US health-care system. Strategic resource reallocation directed at local communities (hospitals and primary care physicians) can reach a large number of individuals to provide substantial improvements in population wellbeing. Small changes can make big differences."
Contact: The Lancet Press Office. T) +44 (0) 20 7424 4949 E) pressoffice@lancet.com
For full Editorial see: http://press.thelancet.com/editorials2402.pdf
OTHER EDITORIALS THIS WEEK
BANNING CLUSTER BOMBS £1 MILLION TO FIGHT AGEING
For all Editorials, see: http://press.thelancet.com/editorials2402.pdf
Journal
The Lancet