People with blocked heart arteries may have another treatment option in the future, as new research on drug-coated balloons. They can open up narrowed arteries to deliver medication without leaving a permanent metal stent inside the blood vessel.
Researchers at the University of East Anglia (UEA) in the UK have examined data from 10 randomised clinical trials involving 7,832 patients with coronary artery disease. Drug-coated balloons were found to work similarly to traditional stents in preventing heart attacks and deaths due to cardiovascular diseases.
The findings in the journal eClinicalMedicine add to the growing interest in treatment options to restore blood flow without permanently embedding any implant. But it’s not an approach that works for every patient or every type of blockage, they said.
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What is a drug-coated balloon?
A drug-coated balloon is a medical device used during angioplasty (the procedure of opening a blocked or narrowed artery).
Coronary artery disease develops when deposits such as cholesterol and other substances build up in the arteries that supply blood to the heart. That would cut off blood flow and increase the risk of chest pain and heart attacks.
In traditional angioplasty, a doctor guides a small balloon into the narrowed section of the artery and inflates it to widen the passage. A drug-eluting stent, a tiny metal mesh tube coated with medication, is usually placed in the artery to keep it open and reduce the risk of it narrowing again.
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Drug-coated balloons are a different approach. The balloon is inflated inside the narrowed artery and transfers medication directly to the vessel wall. The medicine also prevents tissue growth that can narrow the artery again.
Once the medication has been delivered, the balloon is removed. No permanent metal implant is left behind.
What Did the New Study Find?
The group evaluated 10 randomised clinical trials with 7,832 patients with coronary artery disease. The researchers compared drug-coated balloons with conventional drug-eluting stents.
The two approaches were found to have no difference in major outcomes (cardiovascular deaths and heart attacks).
The patients with drug-coated balloons were not more likely to die from cardiovascular causes, while heart attack rates were virtually identical between treatment groups.
This suggests that drug-coated balloons may be useful for select patients who require an artery-opening procedure.
But the findings do not indicate that balloons work for every kind of coronary blockage, they said. More studies are needed for larger arteries and more complicated lesions, they added.
Why are doctors trying treatment without permanent stents?
Permanent stents are widely used because they keep narrowed arteries open after angioplasty. But leaving a device inside an artery can come with some long-term consequences (complications and need for further treatment).
A drug-coated balloon is a different approach in the sense that it delivers medication without leaving behind a metal scaffold.
This would preserve the artery’s natural structure and leave more options if the patient develops further coronary disease and requires another procedure in the future.
It is also called “leave nothing behind.” It’s a way to restore blood flow but do not go for a permanent implant when the situation is right.
But avoiding a stent isn’t always better for everyone. The location and severity of the blockage, the size of the artery, and the patient’s overall health must be taken into account in order to determine treatment, doctors said.
What are the limitations of drug-coated balloons?
Although the findings are promising, drug-coated balloons have limitations.
The researchers found a potential drawback in patients with larger coronary arteries. These patients appeared more likely to require another procedure to reopen the artery after treatment with a drug-coated balloon.
Such procedures are known as revascularisation. They may be required if the treated artery narrows again or blood flow becomes restricted.
The researchers also noted that the results vary widely among the studies included in the analysis. The higher likelihood of repeat procedures seemed to be strongly influenced by one clinical trial.
The reason is that larger arteries have to be explored before firm conclusions can be reached about how well the treatment works in larger arteries.
We propose longer clinical trials with long follow-up periods in patients with complex coronary blockages.
Can drug-coated balloons replace stents completely?
No. The findings do not mean that permanent stents are no longer needed.
Drug-coated balloons are already used in some cases; small coronary arteries and re-narrowing of already treated arteries. Their suitability depends on the individual patient's condition and characteristics of the blockage.
In some cases a stent can still be the best option to keep the artery open. And doctors may also prescribe different treatments depending on whether a patient is in a stable blockage or a patient who has an acute heart attack.
The new study adds evidence for drug-coated balloons in some cases, but does not claim that they are a universal substitute for stents.
Patients should not delay or reject a recommended treatment based on early research results. The treatment should be reached by a cardiologist on the basis of the risks and benefits of each option.
What does this Breakthrough mean for Heart Patients?
The findings may expand the treatment options for people with coronary artery disease. Drug-coated balloons may restore blood flow without leaving a permanent metal device inside the artery.
The approach could also preserve future treatment options if further coronary disease develops.
To identify patients who are most likely to benefit, particularly those with larger arteries or complex blockages, such studies are needed.
So far drug-coated balloons are not yet a replacement for conventional stents and are a promising addition to the existing heart treatments, but rather a part of the existing heart treatment system.
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