Why is this study important?

Drug-eluting stents are the dominant strategy for percutaneous coronary intervention across the world. Strategies to reduce metallic stent implants have generated recent interest in order to reduce adverse event rates. This trial compared the SELUTION SLR drug-eluting balloon (DEB) to routine drug-eluting stent (DES) in the treatment of de novo coronary artery disease (CAD).

What question was the study supposed to answer?

3,341 participants were randomized in a one-to-one fashion to either solution SLR DEB (n=1671) or DES strategy (n=1670) at 62 sites across 12 countries in Europe and Asia between August 2021 and July 2024. Patients were included if the reference vessel diameter was ≥2.0 and ≤5.0mm and all target lesions were amenable to either DEB or DES treatment. Left main lesions, STEMI's, saphenous vein or arterial conduit lesions, chronic total occlusions, and in-stent restenosis were all reasons for exclusion.

What did this study show?

The primary endpoint of target vessel failure at 1 year was 4.4% in the DES group and 5.3% in the DEB group with a noninferiority P value of 0.02. Target vessel failure was defined as a composite of cardiac death, target vessel-related MI, and clinically driven target vessel revascularization.

In assessing acute and late complications of the DEB arm, rates of lesion thrombosis (0.1% vs 0.3%), cardiac death (0.70% vs 1.0%), and target-vessel myocardial infarction (2.7% vs 2.6%) were comparable to those in the DES group.

Key insight

The SELUTION SLR DEB treatment strategy demonstrated non-inferiority to a DES treatment strategy with target vessel failure (TVF) at 12 months of 5.3% as compared to the DES arm with 4.4%. Evidence from this study supports a SELUTION SLR DEB treatment strategy of de novo lesions as a possible alternative to traditional DES treatment.