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.<\/p>\n
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.\u00a0<\/p>\n
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\u2122 SEB (Cordis) with provisional stenting.<\/p>\n
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).<\/p>\n
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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.”\u00a0<\/p>\n
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Christian Spaulding, MD, PhD, FACC, FESC, professor of cardiology at Paris Descartes University in Paris, France<\/p>\n
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The authors note potential benefits of minimal stenting will require a longer-term study, including five-year outcomes.\u00a0<\/p>\n
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