Sirolimus-Eluting Balloon Shows Non-Inferiority to Drug-Eluting Stent in ACS Patients at One Year

New Study Suggests Drug-Coated Balloon is a Safe Alternative to Stents for Heart Attack Patients

A pre-specified sub-study of the SELUTION DeNovo trial found that a sirolimus-eluting balloon (SEB) with provisional stenting was non-inferior to drug-eluting stent (DES) implantation in patients with non-ST-elevation myocardial infarction (NSTEMI) or unstable angina at one year.

The data were presented at the SCAI 2026 Scientific Sessions & CAIC-ACCI Summit in Montreal.

The sub-study analyzed 1,089 patients with NSTEMI or unstable angina from the larger SELUTION DeNovo trial. Patients were randomized to receive either a standard drug-eluting stent (DES) or the SELUTION SLR™ SEB (Cordis) with provisional stenting.

At one year, target vessel failure (TVF) rates were comparable:

• 5.3% in the SEB group vs. 4.9% in the DES group.

Further breakdown of outcomes showed no statistical difference in safety or effectiveness:

• Cardiac death: 0.6% (SEB) vs. 0.8% (DES)
• Target-vessel related myocardial infarction (TV-MI): 3.1% (SEB) vs. 2.8% (DES)
• Clinically-driven target vessel revascularization (cd-TVR): 3.1% (SEB) vs. 2.7% (DES)

"A selective drug-coated balloon strategy can treat blockages effectively without leaving a permanent implant, preserving the artery's natural structure and providing flexibility for future treatments."
— Christian Spaulding, MD, PhD, FACC, FESC, professor of cardiology at Paris Descartes University

The SELUTION DeNovo trial is a prospective, randomized, open-label, multicenter, non-inferiority study. It compares the use of drug-eluting stents (DES) to sirolimus-eluting balloons (SEB) in an "all-comers" population, offering a broad view of real-world patient outcomes.

Acute coronary syndrome (ACS) involves the sudden reduced blood flow to the heart. NSTEMI accounts for 70% of all heart attacks. The current standard treatment for many ACS patients is percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement—a permanent metal mesh tube that keeps the artery open. While effective, DES carries a reported 1–4% annual complication rate.

The SELUTION SLR™ SEB offers a different approach: it is a drug-coated balloon that delivers medication directly to the vessel wall without leaving a permanent implant.

The authors of the study caution that longer-term data, including five-year outcomes, are needed to confirm the potential benefits of this minimal-stenting strategy. While the one-year results are promising, the durability and long-term safety of the SEB approach remain under investigation.