Comparison of Provisional 1-Stent Strategy With Drug-Eluting Balloon Versus Planned 2-Stent Strategy in Patients With Non-LM Coronary True-Bifurcation Lesions (PROVISION-DEB)

Abstract

Percutaneous coronary intervention (PCI) for bifurcation lesions presents several difficulties and often results in suboptimal procedural, postprocedural clinical outcomes. While the provisional 1-stent strategy is generally favored for its simplicity and favorable outcomes, a few studies suggest no significant difference between 1-stent and 2-stent techniques for true bifurcation lesions. Drug-eluting balloons (DEBs) have demonstrated potential in small vessel disease, including bifurcation side branches. However, no studies have compared the 2-stent strategy with the provisional 1-stent plus DEB strategy in non-LM true bifurcation lesions. Our study aims to address this gap by comparing these strategies, with a focus on real-world practice and detailed endpoint analysis. The PROVISION-DEB study is an open-label, randomized, multicenter clinical trial designed to investigate noninferiority and compare a 1-stent strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation lesions. A total of 750 patients with de novo non-LM coronary bifurcation lesions undergoing coronary interventions will be randomized 1:1 to either a provisional 1-stent plus DEB strategy or a 2-stent strategy with stratified Diabetes. The primary endpoint is a target lesion failure, composite outcome of cardiac death, target vessel myocardial infarction, or target lesion revascularization at the anticipated 3 years follow-up (6, 12, and 36 months). In conclusion, PROVISION-DEB study is a randomized, multicenter, noninferior clinical trial and will compare a 1-setnt strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation.