Drug-coated balloons reduce the need for permanent heart stents

A new sub-study suggests that using a sirolimus-eluting balloon (SEB), a drug-coated balloon, can reduce the number of stents a patient may need, making it a safe and effective way to treat certain heart attacks or unstable chest pain. Researchers presented the late-breaking data today at the Society for Cardiovascular Angiography & Interventions (SCAI) 2026 Scientific Sessions & Canadian Association of Interventional Cardiology/Association Canadienne de cardiologie d'intervention (CAIC-ACCI) Summit in Montreal.

Acute Coronary Syndrome (ACS) occurs when blood flow to the heart is suddenly reduced, putting the heart muscle at risk. ACS often leads to Non-ST-Elevation Myocardial Infarction (NSTEMI), which accounts for 70% of heart attacks. Most of these patients undergo percutaneous coronary intervention (PCI), or an angioplasty, to restore blood flow. Currently, during PCI, a cardiologist uses a drug-eluting stent (DES). A DES is a tiny metal mesh tube that keeps the artery permanently open. Studies have shown that there is a 1 to 4% annual rate of complications due to the permanent presence of metal in the artery. The SELUTION Drug Eluting Balloon (SEB) is a drug-coated balloon that delivers medication directly to the artery wall without leaving a stent behind. This 'Leave-Nothing-Behind' strategy, therefore, potentially reduces the long-term complications related to stents. However, the use of SEB in patients with ACS has not been assessed. 

The SELUTION DeNovo study is a prospective, randomized, open-label, multicenter, non-inferiority trial comparing DES to SEB in "all comers". This pre-specified sub-study of the SELUTION DeNovo trial analyzed 1,089 patients with NSTEMI or unstable angina to assess one-year heart-related problems. Patients were divided into two arms: one that received implantation of DES and one that underwent placement of SELUTION SLR™ SEB (Cordis) with provisional stenting.

The sub-study's findings support the use of SEB with minimal stenting as a safe and effective alternative to DES for patients with NSTEMI or unstable angina. At one year, the rates of target vessel failure (TVF) (5.3% vs. 4.9%, respectively) and cardiac death (0.6% vs. 0.8%, respectively) were low and similar between the SEB and DES groups. The target-vessel related myocardial infarction (TV-MI) and clinically-driven target vessel revascularization (cd-TVR) were also low in both groups (SEB: 3.1% and 3.1%, respectively; DES: 2.8% and 2.7%, respectively).

For many years, stents were the standard approach for these patients, but this study shows that we don't always need to leave a permanent implant behind. Using a selective drug-coated balloon strategy allows us to treat the blockage effectively while preserving the artery's natural structure, giving clinicians more flexibility for future treatments." 

Christian Spaulding, MD, PhD, FACC, FESC, professor of cardiology at Paris Descartes University in Paris, France

The authors note potential benefits of minimal stenting will require a longer-term study, including five-year outcomes.