A tiny medicated balloon can clear a blocked heart artery and leave nothing permanent behind, and a new analysis of nearly 8,000 patients found it guards the heart about as well as a traditional metal stent. Across 10 clinical trials, people treated with these drug-coated balloons had the same rates of heart attacks and cardiovascular death as those who got a modern drug-eluting stent, even when the artery being treated was larger than the small vessels balloons have traditionally been used for. There is one catch: in trials covering those larger arteries, balloon patients needed a second procedure to reopen the same artery more often than stent patients.
Published in eClinicalMedicine, a journal in the Lancet family, the pooled analysis drew on data from those 10 separate clinical trials comparing drug-coated balloons against modern drug-eluting stents. All patients had new, previously untreated blockages, not blockages inside an already-placed stent, which is a different problem altogether.
A closer look at the repeat-procedure finding shows it is less solid than it first appears. Removing just one trial made the difference disappear entirely, a point worth revisiting below.
How Researchers Compared Drug-Coated Balloons and Stents
Rather than run a new experiment, the team combined and re-analyzed data from existing studies, a method known as a meta-analysis. They searched major medical research databases for every trial comparing balloon-only treatment to stent-only treatment for new coronary blockages, from the start of record-keeping through the end of May 2026.
From nearly 3,000 search results, the researchers narrowed the field to 10 trials that met their criteria, covering 7,832 patients in total. Each study had to compare a drug-coated balloon directly with a modern drug-eluting stent, follow patients for at least a year, and exclude cases where doctors treated a stent that had narrowed again rather than a new blockage. Four of the 10 trials focused only on patients with small blood vessels. Others, including two large, more recent trials called REC-CAGEFREE I and SELUTION De Novo, enrolled patients regardless of vessel size and included a wider mix of heart conditions. Even in the balloon group, doctors could still place a stent if the balloon alone didn’t open the artery well enough, and those patients stayed in the balloon group for the count.
Two researchers independently reviewed each study and extracted the data, with a third resolving any disagreements. The team tracked three outcomes: heart-related deaths, heart attacks, and the need for a repeat procedure on the treated artery. Follow-up time ranged from 12 months to 5 years. Researchers also checked each trial for potential bias using a standard tool and found most studies held up well, though a few raised some concerns.
Hearts Fared Equally Well With Balloons or Stents
Across all 10 trials, the two treatments showed no meaningful difference in heart-related deaths. That held true even after researchers set aside the small-vessel trials and looked only at patients with a broader range of artery sizes. Heart attacks followed the same pattern: no real difference between balloon and stent patients, whether researchers combined all trials or looked only at those involving larger arteries.
Researchers also ran a separate check on patients with a more urgent, higher-risk form of heart disease called acute coronary syndrome. Even in that group, death rates were about the same no matter which treatment patients received.
One Catch: More Repeat Procedures With Drug-Coated Balloons
Where things got messier was the question of needing a follow-up procedure to reopen the same artery, something doctors call revascularization. Across all 10 trials combined, balloon and stent patients showed no real difference. But once researchers removed the small-vessel trials, leaving a broader patient population, the balloon group needed repeat procedures at a clearly higher rate.
That result deserves a second look, though. When researchers removed just one trial, REC-CAGEFREE I, the difference vanished entirely. REC-CAGEFREE I was one of the larger, more recent studies in the group, and it found that its balloon treatment did not work as well as stenting, mostly because more patients needed follow-up procedures. Another large trial, SELUTION De Novo, tested a different drug-coated balloon and met the bar for matching stent performance.
Timing mattered too. Studies that followed patients for up to a year showed more repeat procedures with balloons, but studies tracking them for two years or longer found no clear difference. A separate safety check on blood clots at the treatment site found no real difference between the two approaches, with numbers leaning slightly in favor of balloons, though not enough to call it a real difference.
Not all drug-coated balloons are built the same way, and that may explain some of the conflicting results. Most balloons used in these trials were coated with paclitaxel, a chemotherapy drug that helps keep arteries from narrowing again. The balloon used in REC-CAGEFREE I was also paclitaxel-coated, but it was used almost entirely within that trial program, and little published research explains how it delivers its drug into the artery wall. SELUTION De Novo, by contrast, tested a balloon coated with a different drug altogether. The research team stressed that differences between balloon brands and drug types mean nobody should assume all drug-coated balloons work the same way, a caution they spelled out directly in their paper.
Source : https://studyfinds.com/heart-patients-may-not-always-need-permanent-stent-new-study-finds/
