Boston Scientific (NYSE: BSX) today shared findings from new analyses of its Agent drug-coated balloon (DCB).
Agent serves as an alternative to traditional therapies like balloon angioplasty, additional layers of stenting or radiation. The paclitaxel-coated balloon transfers a therapeutic dose of drug to the vessel wall, helping to prevent in-stent restenosis (ISR) reoccurrence. The FDA approved the balloon in March 2024.
Boston Scientific reported its findings at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.
First, an observational, prospective, non-randomized, multi-center registry used real-world data from the CathPCI registry. It evaluated more than 12,000 patients treated with the Agent DCB during a 2-year enrollment period (April 2024-June 2025). The study took place across more than 700 U.S. sites.
Dr. Christina Lalani presented the findings at TCT. Findings demonstrated rapid uptake of the therapy and strong in-hospital safety outcomes comparable to drug-eluting stent (DES) patients.
Boston Scientific reports that DCB adoption continues to grow, with approximately 17.5% of patients undergoing percutaneous coronary intervention (PCI) for ISR now treated with a DCB. DCBs more often accompany intravascular imaging and adjunctive prep devices.
Agent delivered 0.9% all-cause mortality, compared to 1.4% for DES. Myocardial infarction came in even at 0.4% for both, with Agent bleeding totaling 0.9% vs. 1.4% in DES. Agent saw 0.8% heart failure compared to 1.2% for DES and 0.2% ischemic stroke compared to 0.3% for DES.
Additional data shared by Boston Scientific
Boston Scientific also reported findings from the ALLIANCE registry looking at 1,800 Agent patients in Japan. It assessed the safety and effectiveness of Agent for real-world PCI. Patients received either standalone DCB or a hybrid drug-eluting stent and DCB strategy.
Dr. Masato Nakamura presented findings from ALLIANCE. Paclitaxel DCBs met the primary endpoint of target lesion failure (TLF) at one year for complex and varied de novo lesions. DCBs met the prespecified 7.5% TLF performance goal, with a one-year TLF rate of 4.7%.
Low, clinically-driven target lesion revascularization (TLR) of 2.9% drove the TLF. Myocardial infarction related to the target vessel came in at 0.4%. Boston Scientific plans to submit results to support expanded workhorse indications in Japan.
