A real-world study of the Prevail (Medtronic) drug-coated balloon (DCB), comparing the device to other contemporary DCBs, has shown similar outcomes with the devices.
The data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), were presented as a late-breaking clinical trial at Cardiovascular Research Technologies (CRT) 2025 (8–11 March, Washington DC, USA) by Sacharias von Koch (Lund University, Lund, Sweden). SCAAR is a nationwide registry including data on all patients in Sweden undergoing coronary angiography. The real-world analysis is the largest study to date comparing different types of DCBs, and it is the largest dataset evaluating the Prevail DCB, with 1,797 patients.
The SCAAR data compared the Prevail paclitaxel-coated DCB to four other DCBs that are frequently used in Sweden—SeQuent Please (B Braun), Agent (Boston Scientific), Pantera Lux (Biotronik) and Selution—in a complex patient population, including 61% patients with acute coronary syndrome, 31.8% with diabetes, 55.3% with complex lesions, 22.8% with bifurcation lesions, and 28% in-stent restenosis (ISR).
Outcomes included all-cause mortality, myocardial infarction (MI), new revascularisation with percutaneous coronary intervention (PCI), target lesion definite thrombosis, and target lesion revascularisation.
The analysis demonstrated that Prevail DCB had low mortality event rates at one year (4.7%) and two years (7.2%) post-procedure, compared to 5% and 8.2% in the group that included patients treated with the other DCB platforms. Additionally, the outcomes showed a 98.7% procedure success rate with the Prevail DCB and very low rates of target lesion thrombosis (0.8% at two years compared to 1.3% with other DCBs). In hybrid PCIs (defined as DCB and stent in the same vessel), Prevail showed lower new MI rates versus other contemporary DCBs.
“As physicians encounter and treat an increasing number of patients with complex lesions, it is crucial to continuously gather data on our Prevail DCB,” Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Medtronic Cardiovascular Portfolio was quoted as saying in a press release issued by the company. “With its differentiated design, Prevail has seen strong market adoptions since 2021, and we are eager to see how this new data will further advance the Prevail DCB in the market. These findings reaffirm Medtronic’s dedication to advancing complex PCI solutions, ultimately bringing this procedure to patients worldwide.”
The Prevail DCB is commercially available in more than 80 countries globally and received approval from the US Food and Drug Administration (FDA) in October 2024 for an investigational device exemption (IDE) to begin the Prevail Global study, which recently enrolled its first patient. Prevail is not approved or sold in the USA or Japan, and the use of the DCB in the Prevail Global study is investigational.
