Design of IKISS-LM Randomized Controlled Trial: Impact of Kissing Balloon Inflation on Provisional Left-Main Bifurcation PCI.

BACKGROUND: Percutaneous coronary intervention (PCI) with drug-eluting stents is an alternative to coronary artery bypass graft surgery for distal left main bifurcation disease (dLMBD) lesions. In noncomplex dLMBD, provisional stenting strategy (PSS) is preferred. The European Bifurcation Club consensus recommends routine kissing balloon inflation (KBI) in distal left main (LM) bifurcation PCI using PSS, based on anecdotal reports and non-LM trials.

OBJECTIVES: This study evaluates routine KBI vs no KBI in noncomplex dLMBD undergoing PSS with intravascular imaging.

METHODS: This prospective, single-blind, multicenter randomized controlled trial is being conducted across 27 centers in India. Eligible patients have noncomplex dLMBD (defined by DEFINITION [Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents] criteria) and undergo LM crossover stenting to either the left anterior descending or left circumflex artery. All procedures use intravascular ultrasound or optical coherence tomography. Participants are randomized to KBI or no KBI. The primary endpoint is 1-year angiographic side branch ostium restenosis (>50% diameter stenosis). Secondary endpoints include: 1) target lesion failure (defined as the composite of cardiac death, target-vessel myocardial infarction, and clinically driven target lesion revascularization) at 1 year; 2) individual outcomes of all-cause mortality, cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis; and 3) angiographic restenosis of the main vessel or side branch. If angiographic follow-up is <70%, the 1-year target lesion failure rate will be assessed as a non-inferiority primary endpoint, with continued enrolment toward ≥1,000 patients to ensure adequate power.

CONCLUSIONS: The IKISS-LM (Impact of Kissing Balloon Inflation on Provisional Left Main Bifurcation Percutaneous Coronary Intervention: A Prospective Multicenter Randomized Controlled Trial) trial evaluates whether routine KBI improves side branch ostium patency and clinical outcomes after PSS in noncomplex dLMBD, aiming to refine evidence-based strategies for LM bifurcation PCI. (Impact of Kissing balloon inflation on provisional Left Main Percutaneous Coronary Intervention: A Prospective Multicenter Randomized Trial [IKISS-LM Trial]; CTRI/2024/09/073616).