A new sub-study suggests that sirolimus-eluting balloons (SEBs), drug-coated balloons, can reduce the number of stents patients need, making them a safe and effective way to treat certain types of heart attacks and unstable chest pain. Researchers presented their latest data today at the Society of Cardiovascular Angiography and Interventions (SCAI) 2026 Scientific Sessions and Canadian Society of Interventional Cardiology/Consortium on Cardiac Interventions (CAIC-ACCI) Summit in Montreal.
Acute coronary syndrome (ACS) occurs when blood flow to the heart suddenly decreases, 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 angioplasty (PCI) or angioplasty to restore blood flow. Currently, cardiologists use drug-eluting stents (DES) during PCI. A DES is a small metal mesh tube that permanently holds an artery open. Studies show that the persistent presence of metal in the arteries has a 1-4% annual complication rate. SELUTION Drug-eluting balloons (SEBs) are drug-coated balloons that deliver drugs directly to the artery wall without leaving behind a stent. Therefore, this “leave nothing behind” strategy potentially reduces long-term complications associated with stents. However, the use of SEB in patients with ACS has not been evaluated.
The SELUTION DeNovo study is a prospective, randomized, open-label, multicenter, non-inferiority trial comparing DES and SEB in an “all” population. This prespecified substudy of the SELUTION DeNovo trial analyzed 1,089 patients with NSTEMI or unstable angina and evaluated heart-related problems over a 1-year period. Patients were divided into two groups: one received DES implantation and the other received SELUTION SLR™ SEB (Cordis) placement with provisional stent placement.
The results of this substudy support the use of SEB with minimal stenting as a safe and effective alternative to DES for patients with NSTEMI or unstable angina. At 1 year, target vessel failure (TVF) rates (5.3% vs. 4.9%, respectively) and cardiac death (0.6% vs. 0.8%, respectively) were lower and similar in the SEB and DES groups. Target vessel-related myocardial infarction (TV-MI) and clinically directed target vessel revascularization (CD-TVR) were also lower in both groups (SEB: 3.1% and 3.1%, respectively; DES: 2.8% and 2.7%, respectively).
For many years, stents have been the standard approach for these patients, but this study shows that it is not always necessary to leave a permanent implant. Using a selective drug-coated balloon strategy, occlusions can be effectively treated while preserving the natural architecture of the artery, giving clinicians more flexibility for future treatments. ”
Christian Spaulding, MD, PhD, FACC, FESC, Professor of Cardiology, Paris Descartes University, Paris, France
The authors note that the potential benefits of minimal stenting require long-term studies with 5-year outcomes.
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Society of Cardiovascular Angiography and Interventions
