Why is this study important?

This study is a 1-year follow-up to demonstrate non-inferiority of a sirolimus drug-eluting balloon (SEB) compared to a drug-eluting stent (DES) for de novo lesions in coronary arteries 2-5mm in diameter. The drug elution was from balloons with reservoirs eluting sirolimus with a phospholipid coating that allowed controlled release of the sirolimus over a 90-day period.

What question was this study supposed to answer?

Does sirolimus-eluting balloon (SEB) that elutes sirolimus over a 90-day period using a polymer micro-reservoir technology reduce target vessel failure (TVF) after percutaneous coronary intervention (PCI), suggesting that a “no stent strategy” can be a viable option for patients with coronary artery disease?

What did the study show?

• This multicenter, open-label, randomized trial included 3,323 participants across 62 sites.
• The primary endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization.
• Subjects were randomized 1:1 prior to PCI. Calcified lesions were present in 25% of patients, and PCI site was the proximal LAD in 18% of cases.
• At 1 year, TVF occurred in 5.3 % of patients who received SEB vs 4.4 % of patients who received DES, with p=0.02 for non-inferiority; per protocol outcomes did not confirm non-inferiority and were similar to the ITT in both magnitude and direction.
• Patients who were excluded had more complex lesion and procedure characteristics that probably contributed to inducing protocol violations and were accordingly associated with high rates of adverse events, especially in the DES arm.
• There were no acute or late safety concerns, including lesion thrombosis, which were low and similar in both groups.
• 80 % of patients with DEB did not require a stent
• Five year follow up is planned.