Drug-coated balloons performed as well as drug-eluting stents on the most serious heart outcomes, according to a University of East Anglia (UEA) analysis published in eClinicalMedicine. The researchers pooled 10 randomised clinical trials involving 7,832 patients with coronary artery disease and found that patients treated with drug-coated balloons were no more likely to die from cardiovascular causes than those given stents, with heart attack rates virtually identical. This article is not medical advice.
What the drug-coated balloons analysis compared
In coronary artery disease, narrowed arteries reduce blood flow to the heart. Lead researcher Dr. Natasha Corballis of UEA’s Norwich Medical School explained that drug-releasing stents, tiny mesh tubes inserted into blocked arteries, are currently the standard treatment for many patients undergoing angioplasty, the common operation to open them.
A drug-coated balloon takes a different approach. Unlike a stent, which stays in the artery permanently, the balloon is removed after treatment. As it is inflated, it releases medicine into the artery wall to help prevent the vessel narrowing again. The study is a systematic review and meta-analysis of randomised controlled trials comparing the two in de novo coronary artery disease, meaning new blockages.
Comparable outcomes without a permanent implant
“Our work shows that there is no meaningful difference between these two treatments when it came to the most serious outcomes,” Corballis said. The findings remained unchanged even when the researchers excluded studies focused only on small coronary arteries, where drug-coated balloons already have an established evidence base.
The results add to growing interest in the so-called “leave nothing behind” strategy, which aims to restore blood flow without implanting a permanent device. Senior author Vassilios Vassiliou said this approach could reduce some longer-term complications associated with stents, while preserving future treatment options if patients develop further disease. The research was led by UEA with the Norfolk and Norwich University Hospital NHS Foundation Trust.
The other side: repeat procedures in larger arteries
The study also found a potential drawback. In larger arteries, patients treated with drug-coated balloons were more likely to need a repeat procedure to reopen the artery, a measure known as revascularisation. The researchers urged caution over this result, noting considerable variation between studies and that the finding appeared heavily influenced by a single clinical trial.
That caveat cuts both ways. A result driven by one trial is fragile, so it may not hold up with more data, but it also means the question of larger vessels is not settled. The team concluded that larger trials with longer follow-up are needed to determine whether balloons work equally well in larger vessels and in more complicated lesions.
Limits of the evidence
A meta-analysis combines existing trials, so it is only as strong as the studies inside it. The summary does not say how long patients were followed in each trial, which types of balloon or stent were used, or how the results might differ for individual patients. It also does not suggest that anyone should change their treatment. Decisions about stents or balloons depend on each patient’s arteries and health, and belong in a conversation with a cardiologist.
There are no direct security concerns in this research. Supporters of the balloon approach would point to avoiding a permanent implant; careful readers would point to the repeat-procedure signal and the call for longer trials.
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My view on drug-coated balloons
As a writer, I feel the appeal of “leave nothing behind” is easy to see, because a treatment that works without a permanent device keeps more options open for the future. But I would not read this as a verdict that balloons can replace stents. The evidence points to a good result on death and heart attack, and the team itself flags uncertainty for larger arteries. I would wait for the longer trials the researchers call for before drawing wider conclusions.
FAQ: drug-coated balloons versus stents
What is a drug-coated balloon?
It is a balloon that releases medicine into the artery wall as it is inflated during angioplasty and is then removed, so nothing is left behind, according to the UEA researchers.
How good were the results compared with stents?
Across 10 randomised trials and 7,832 patients, cardiovascular death and heart attack rates were no different between balloons and drug-releasing stents, according to the analysis.
Is there a downside?
In larger arteries, patients treated with balloons were more likely to need a repeat procedure, though the researchers say this result varied between studies and leaned heavily on one trial.