TASTE trial challenge current practice of blood clot aspiration after heart attack

Hot line I: Late breaking trials on thrombosis

2013-09-01

(Press-News.org) AMSTERDAM, The Netherlands -- Aspiration of the blood clot or "thrombus" that causes a heart attack before re-opening a patient's artery with a balloon catheter does not improve survival compared to performing balloon dilation and stenting alone according to the results of the Thrombus Aspiration in ST- Elevation myocardial infarction in Scandinavia (TASTE) trial.

"We believe that TASTE questions the usefulness of thrombus aspiration as a routine adjunct and the recommendation for its general use in international guidelines should probably be down-graded," said lead author Ole Fröbert, MD, PhD, from the Department of Cardiology at Örebro University Hospital, in Örebro, Sweden.

The multicenter, prospective, randomized, controlled open-label trial enrolled 7244 patients with STEMI from Sweden, Denmark and Iceland who had a diagnosis of ST-elevation myocardial infarction (STEMI).

Half of the patients were assigned to balloon treatment only (known as percutaneous coronary intervention, or PCI) and the other half had their blood clot aspirated before PCI.

The mortality rate at 30 days post-surgery procedure was not statistically different between the groups (3.0% versus 2.8% respectively).

Similarly, there was no difference between the two groups for secondary endpoints including risk of new heart attack, stroke and complications related to the treatment.

Even high risk groups such as smokers, patients with diabetes or patients with large clots had similar results with either approach.

"Our findings do not support a role for this additional procedure as a routine future treatment," said Dr. Fröbert.

The study results will likely have an immediate impact on clinical practice, he added.

Current European Society of Cardiology guidelines on treatment of patients with ST-elevation myocardial infarction (STEMI) recommend that thrombus aspiration should be considered and "most opinion leaders advocate its use," said study co-chair Stefan James MD, PhD, from the Department of Cardiology and Uppsala Clinical Research Center at Uppsala University Hospital in Uppsala, Sweden.

Since the presentation of the TAPAS trial that suggested a mortality benefit (N Engl J Med 2008;358:557-67) thrombus aspiration has "gained an enormous popularity," he explained. "The therapy is so popular among interventional cardiologists because it intuitively feels beneficial to aspirate the clot that closes the artery."

But recent research has suggested that thrombus aspiration also carries risks. In 2012, a meta-analysis associated the procedure with a borderline significantly higher rate of stroke (Int J Cardiol 2012;166:606-12.) and another study showed that systemic embolization can occur as result (Circ J 2009;73:1356-8).

The TASTE trial is the first large-scale randomized trial of thrombus aspiration for STEMI to be large enough to reveal meaningful findings on mortality and morbidity.

It enrolled more patients than all previous randomized trials of this procedure combined and included a much broader range of patients in order to make the results relevant to everyday clinical practice.

"An even more far-reaching impact is that our trial is the first trial ever to use the registry based trial concept, which we invented, " added Dr. Fröbert.

The study's unique Registry-Based Randomized Clinical Trial (RRCT) protocol used national registries as on-line platforms for randomization, case record forms and follow-up, making the trial economically and administratively feasible.

"This concept reduces costs to 1% or less of a conventional randomized trial and enables the testing of treatments that have no revenue potential. since commercial interest is often the main incentive behind large-scale randomized clinical trials," he said. "In general fewer of these trials are being performed because of the huge costs involved. This trial concept can help to break the deadlock of clinical trials."

###

SOURCES OF FUNDING:

The Swedish Association of Local Authorities and Regions; the Swedish Heart-Lung Foundation, The Swedish Research Council and by unrestricted grants from Terumo Medical Corporation, Medtronic and Vascular Solutions.

DISCLOSURES:

Dr. Frobert declared personal consultancy fees from Stentys and Biotronik, and grants to his institution from Terumo, Medtronic and Vascular Solutions. Dr. James declared grants to his institution from Terumo, Medtronic and Vascular Solutions.

Notes to editor

About the European Society of Cardiology

The European Society of Cardiology (ESC) represents more than 80 000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.

About ESC Congress 2013

The ESC Congress is currently the world's premier conference on the science, management and prevention of cardiovascular disease. The spotlight of this year's event is "The Heart Interacting with Systemic Organs". ESC Congress 2013 takes place from 31 August to 4 September at the RAI centre in Amsterdam, Netherlands. More information is available from the ESC Press Office at press@escardio.org

ELSE PRESS RELEASES FROM THIS DATE:

High dose statins prevent dementia

2013-08-31

Dr Lin said: "Statins are widely used in the older population to reduce the risk of cardiovascular disease. But recent reports of statin-associated cognitive impairment have led the US Food and Drug Administration (FDA) to list statin-induced cognitive changes, especially for the older population, in its safety communications." He added: "Previous studies had considered statin therapy to exert a beneficial effect on dementia. But few large-scale studies have focused on the impact of statins on new-onset, non-vascular dementia in the geriatric population." Accordingly, ...

Reimbursement systems influence achievement of cholesterol targets

2013-08-31

Dr Gitt said: "There are wide variations between European countries in the achievement of LDL-cholesterol (LDL-C) targets. However the effect of different reimbursement systems on meeting the targets was unknown." Between June 2008 and February 2009 DYSIS assessed the prevalence and types of persistent lipid abnormalities in patients receiving statins. Eligible patients were at high risk of a cardiovascular event, aged >45 years, and had been on chronic statin treatment for at least three months. A total of 22,063 patients were enrolled from 2,954 sites across 11 European ...

Statins reduce CV events in CAD patients with very low LDL-C

2013-08-31

Dr Nakano said: "Many randomised clinical trials, such as Treating to New Targets (TNT) and PROVE IT-TIMI, have shown that aggressive cholesterol lowering with statins improves clinical outcomes in patients with CAD and high LDL-C levels.1,2 But until now it was not known whether aggressive lipid lowering with statins would also benefit CAD patients with very low LDL-C levels." The current study used the Ibaraki Cardiovascular Assessment Study (ICAS), a registry of 2,238 patients from 12 hospitals in the Ibaraki region of Japan, who between 0 and 1 month underwent percutaneous ...

Impact of AF on stroke risk eliminated with multiple risk factors

2013-08-31

Dr Benn Christiansen said: "We know that atrial fibrillation increases the risk of ischemic stroke. And in patients with atrial fibrillation or previous ischemic stroke, the risk of stroke increases with the number of risk factors. But until now, little attention has been paid to the association between stroke risk and risk factors in patients without prior stroke or atrial fibrillation. We wanted to explore that association and to quantify if stroke risk was of comparable size in patients with numerous risk factors." The study included 4,198,119 people aged 18 to 90 ...

Mass screening identifies untreated AF in 5% of 75-76 year olds

2013-08-31

Stroke is the second cause of death worldwide. Atrial fibrillation is the most common clinically relevant cardiac arrhythmia in Europe, affecting approximately 1.5-2% of the general population.1 Prevalence is estimated to double in the next 50 years as the population ages. Patients with atrial fibrillation have a five-fold increased risk of ischaemic stroke even though around 30% have no symptoms. As blood is less adequately shifted from the heart during atrial fibrillation, blood clots can form and cause large ischaemic strokes. Strokes that occur in association with ...

CHADS2 risk score assigns over one-third of stroke patients to low or intermediate stroke risk

2013-08-31

In contrast, a CHA2DS2-VASc score of 0 identifies a subgroup of patients with very low stroke risk unlikely to benefit from anticoagulation treatment. Professor Nabauer said: "AF is the most frequent cardiac arrhythmia requiring hospitalisation and has a 1-2% prevalence in the general population. AF is associated with a significant risk of stroke with frequently disabling consequences. While oral anticoagulation is very effective in preventing ischaemic strokes in AF, it increases bleeding risk. Identification of patients with low risk of stroke not requiring oral anticoagulation ...

Statins prevent cataracts

2013-08-31

Cataracts are the leading cause of visual impairment worldwide affecting more than 20 million people. Statins are among the most commonly prescribed medications. In the USA they are prescribed to 1 in 3 people over 45 years of age at a cost of $35 billion annually. Professor Kostis said: "There is persistent concern among physicians and other health care providers about the possible cataractogenicity of statins.1 We therefore investigated the relationship of statins and cataracts in a meta-analysis of 14 studies selected after detailed review of the medical literature. ...

Diabetic stroke risk after AMI drops in 10 year period

2013-08-31

The findings were presented at the ESC Congress today by Ms Stina Jakobsson from Sweden. They reveal that reperfusion therapy and secondary prevention drugs produced the decline and brought stroke risk after AMI closer to that of non-diabetics. Ms Jakobsson said: "Ischemic stroke following an acute myocardial infarction is a fairly uncommon but devastating event with high mortality. It has long been recognized that patients with diabetes mellitus are at a particularly high risk of complications after an AMI but until now, the risk of ischemic stroke after an AMI in patients ...

Short-term smoking cessation reverses endothelial damage

2013-08-31

Dr Dohi said: "Smokers are twice as likely to have a heart attack as people who have never smoked. Quitting smoking is the most important thing people can do to reduce their risk of cardiovascular disease. But until now, studies have not examined whether the increased risk caused by smoking is completely reversed after smoking cessation." The current study investigated how the vascular system is altered by smoking and whether the changes can be normalised by smoking cessation. The researchers focused on the effects of smoking and smoking cessation on arterial endothelial ...

Smokers who survive to 70 still lose 4 years of life

2013-08-31

Dr Emberson said: "Despite recent declines in the numbers of people smoking and tar yields of cigarettes, smoking remains the leading preventable cause of death in Europe." He added: "Previous studies had demonstrated that prolonged cigarette smoking from early adult life was associated with about 10 years loss of life expectancy, with about one quarter of smokers killed by their habit before the age of 70. Stopping at ages 60, 50, 40 or 30 years gained back about 3, 6, 9 or the full 10 years. However, the hazards of continuing to smoke and the benefits of stopping in ...

LAST 30 PRESS RELEASES:

Scientists trace microplastics in fertilizer from fields to the beach

The Lancet Obstetrics, Gynecology, & Women’s Health: Taking paracetamol during pregnancy does not increase risk of autism, ADHD or intellectual disabilities, confirms new gold-standard evidence review