Why is this study important?
Current percutaneous coronary intervention (PCI) for patients presenting with acute coronary syndrome (ACS) is based on the implantation of drug-eluting stents (DES), but these may be associated with specific adverse events over a prolonged follow-up. Use of drug-coated balloons (DCB) may help decrease the occurrence of DES-associated problems, but the evidence concerning their use for ACS patients is limited.
What question was the study supposed to answer?
A pre-specified SELUTION DeNovo sub-study in patients with NSTEMI or unstable angina assessed the one-year rate of TVF, a composite of cardiac death, target-vessel-related myocardial infarction (TV-MI), and clinically-driven Target Vessel Revascularization (cd-TVR).
| Results | SEB Arm | DES Arm |
| Number of patients | 553 | 529 |
| Age | 65.9+10.3 | 65.4+11.4 |
| Female sex | 153/553 (27.7%) | 136/529 (25.7%) |
| NSTEMI presentation | 404/553 (73.1%) | 384/529 (72.6%) |
| Unstable angina presentation | 149/553 (26.9%) | 145/529 (27.4%) |
| Multi-lesion procedure | 157/553 (28.4%) | 144/529 (27.2%) |
| Bail-out stenting/lesion | 138/750 (18.4%) | N/A |
| Bail-out stenting/patient | 116/553 (21%) | N/A |
| TVF | 29/553 (5.3%) | 26/529 (4.9%) |
| Cardiac death | 3/553 (0.6%) | 4/529 (0.8%) |
| TV-MI | 17/553 (3.1%) | 15/529 (2.8%) |
| cd-TVR | 17/553 (3.1%) | 14/529 (2.7%) |
What did the study show?
- Using a drug-eluting balloon (DEB) strategy with minimal stenting is a safe and effective alternative to full stent implantation for ACS patients with NSTEMI or unstable angina.
- 1-year outcomes of TVF (target vessel failure) rates were low and similar between the DEB and DES groups, aligning with outcomes in comparable stable patients.
- No major safety concerns were observed; DEB showed low rates of death, thrombosis, and heart attacks. Long-term benefits will be assessed with up to a 5-year follow-up.
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