Drug-coated balloons offer an alternative to permanent heart stents

Thousands of heart patients could be treated without having a metal stent permanently implanted in their arteries - according to research from the University of East Anglia (UEA).

A major analysis of more than 7,800 patients found that a newer treatment using drug-coated balloons performed just as well as conventional stents at preventing heart attacks and cardiovascular deaths.

These balloons are removed after treatment, and the findings suggest this approach could offer a safe alternative to permanent stents.

But the team warned that some patients treated with drug-coated balloons may be more likely to need a repeat procedure in the future.

The findings are published in The Lancet's eClinicalMedicine.

How the research happened

Researchers reviewed data from 10 randomised clinical trials involving 7,832 patients with coronary artery disease, where narrowed arteries can reduce blood flow to the heart and increase the risk of serious cardiac events.

Lead researcher Dr Natasha Corballis, from UEA's Norwich Medical School, said: "Drug-releasing stents are tiny mesh tubes inserted into blocked arteries. They are currently the standard treatment for many patients undergoing a common operation to open blocked heart arteries, known as angioplasty.

"But drug-coated balloons offer an alternative approach. Unlike a stent, which remains in the artery permanently, the drug-coated balloon is removed after treatment. As it is inflated, it releases medicine into the artery wall to help prevent the vessel becoming narrowed again."

"Our work shows that there is no meaningful difference between these two treatments when it came to the most serious outcomes.

"Patients treated with drug-coated balloons were no more likely to die from cardiovascular causes than those receiving stents. Rates of heart attack were also virtually identical between the two groups."

The findings remained unchanged even when researchers excluded studies focusing only on small coronary arteries, where drug-coated balloons already have an established evidence base.

But the study also revealed a potential drawback.

Dr Natasha Corballis, Lead Researcher, UEA's Norwich Medical SchoolWhen we looked at larger arteries, patients treated with drug-coated balloons were more likely to require a repeat procedure to reopen the artery - a measure known as revascularization."

Even so, the researchers urged caution over that result, noting there was considerable variation between studies and that the finding appeared heavily influenced by a single clinical trial.

Leaving nothing behind

The findings add to growing interest in the so-called "leave nothing behind" strategy, which aims to restore blood flow without implanting a permanent device inside the artery.

Senior author, Prof Vassilios Vassiliou, also from UEA's Norwich Medical School, said: "This approach could reduce some longer-term complications associated with stents, while preserving future treatment options if patients develop further disease."

The researchers concluded that larger clinical trials with longer follow-up periods are needed to determine whether drug-coated balloon treatment is equally effective in larger vessels and more complicated coronary lesions.

This research was led by UEA in collaboration with the Norfolk and Norwich University Hospital NHS Foundation Trust.

Source:

University of East Anglia

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