Rationale and Design of the PASSIVATE-CAP Trial: The Preventive Intervention Value of Drug-Coated Balloons in...

Patients with acute coronary syndrome (ACS) face a significantly increased risk of cardiovascular events due to vulnerable plaques. However, no clear evidence supports performing preventive percutaneous coronary intervention (PCI) for non-flow-limiting vulnerable plaques. To address this gap, the PASSIVATE-CAP study was designed to investigate the therapeutic potential of drug-coated balloon (DCB) for treating non-flow-limiting vulnerable plaques.

The PASSIVATE-CAP study is an investigator-initiated, prospective, randomized, multicenter, open-label superiority trial focusing on acute coronary syndrome (ACS) patients with non-flow-limiting vulnerable plaques in non-culprit vessels. In this study, eligible patients will be randomized at a 1:1 ratio into two groups: patients who received guideline-directed medical therapy (GDMT) and patients who received GDMT combined with a drug-coated balloon (DCB). The primary endpoint was the minimal lumen area of the target lesion 1 year after randomization. The secondary endpoints encompass a range of factors, including the proportion of patients with vulnerable plaques in the target vessel, fibrous cap thickness, lipid core arc of the target lesion, minimal lumen area of the target vessel, among others. The study has been registered on Clinicaltrials.gov (Identifier: NCT06416813).

The PASSIVATE-CAP study enrolled its first patient on July 14, 2025, with projected enrollment completion by January 31, 2027. As of December 28, 2025, 6 patients have been enrolled. The anticipated study end date, marking the completion of the follow-up period, is January 31, 2028.

The PASSIVATE-CAP study represents the first prospective, randomized, multicenter, open-label trial designed to explore the therapeutic value of DCB for the treatment of vulnerable plaques within the ACS patient population.