Nine thousand patients will take part in a clinical trial to determine the best method of opening narrowed coronary arteries. The results of the study may lead to substantial cost savings - and save lives.
A stent is a tiny metal tube inserted into and expanded within an artery to keep it open. A new type of stent was introduced in 2002 which releases a drug designed to limit the growth of scar tissue, thereby reducing the likelihood of a renarrowing of the artery, new symptoms, and in the worst case, heart attack.
"When drug-eluting stents were launched, we thought that many of the problems associated with opening blocked arteries had been solved. However, after several years we experienced that renarrowing could also occur with this type of stent. Now there is uncertainty as to whether the new drug-eluting stents or the conventional bare-metal stents are the most effective. That is what we are trying to find out with the NorStent study," explains the project manager, Dr Kaare Harald Bønaa.
A stent is a tiny metal tube inserted into and expanded within an artery to keep it open. A new type of stent was introduced in 2002 which releases a drug designed to limit the growth of scar tissue, thereby reducing the likelihood of a renarrowing of the artery, new symptoms, and in the worst case, heart attack.
"When drug-eluting stents were launched, we thought that many of the problems associated with opening blocked arteries had been solved. However, after several years we experienced that renarrowing could also occur with this type of stent. Now there is uncertainty as to whether the new drug-eluting stents or the conventional bare-metal stents are the most effective. That is what we are trying to find out with the NorStent study," explains the project manager, Dr Kaare Harald Bønaa.
The clinical trial has received funding from the Research Council under the Research Programme on Clinical Research (KLINISKFORSKNING).
Can save NOK 100 million a year
Dr Bønaa is a senior medical officer in cardiology at St. Olavs Hospital and a professor at the Norwegian University of Science and Technology (NTNU), both located in Trondheim. He is one of the few medical professionals in the country with experience of large randomised clinical trials whose objective is often to evaluate whether a method of treatment works and if one method is more effective than another.
A stent is a tiny metal tube inserted into and expanded within an artery to keep it open. "The study will give us a clear answer to what many consider to be one of the most pressing problems in cardiology," says Dr Bønaa.
"If we find out that the older, less costly stent works just as well as the new one, the Norwegian health services would save some NOK 100 million each year. But of course, our highest priority is to determine which stent is the most effective so we can give patients the best possible treatment."
According to Dr Bønaa, the NorStent study will be the largest independent randomised clinical trial ever conducted in Norway as well as the first international mega study in its field.
Pharmaceutical industry uninterested
Due to their high cost, clinical trials of this magnitude are usually conducted by the pharmaceutical industry. However, in this case the industry has expressed little interest. Dr Bønaa suggests that this may be due to the fact that drug-eluting stents are more profitable than conventional bare-metal stents.
Dr Bønaa firmly believes that clinical trials of this type should not be the responsibility of the pharmaceutical industry alone. A monopoly could mean that important topics are not investigated at all, or that there is bias in the research approach employed or the way results are analysed and used, he asserts.
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