The first US Food and Drug Administration (FDA) approval of a drug-coated balloon (DCB) for the treatment of coronary in-stent restenosis will ensure that the therapy becomes “an important new treatment option for patients with coronary stenosis in the USA”, an investigator in the trial that supported the approval has said.
Robert W Yeh (Beth Israel Deaconess Medical Center, Boston, USA) presented the primary outcomes from the full population of the AGENT IDE trial—comparing the use of the Agent DCB (Boston Scientific) to conventional balloon angioplasty in patients with coronary in-stent restenosis—during a late-breaking trial session at the 2024 Cardiovascular Research Technologies (CRT) meeting (9–12 March, Washington, DC, USA), with results simultaneously published in the Journal of the American Medical Association (JAMA).
The FDA approved Boston Scientific’s premarket approval application for the device, a paclitaxel-coated balloon, in early March 2024, a move that has been welcomed by many coronary interventionists in the country where around 10% of percutaneous coronary intervention (PCI) procedures are carried out for in-stent restenosis.
Yeh had presented initial data from the IDE trial, covering 480 of the 600 patients enrolled in the trial across 40 US sites, at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) meeting (23–26 October, San Francisco, USA) where he reported that the study had met its primary endpoint of target lesion failure (TLF)—defined as a composite of target lesion revascularisation, target vessel myocardial infarction (MI) or cardiac death—at 12 months with the AGENT DCB demonstrating statistical superiority to uncoated balloon angioplasty (17.9% vs. 28.7%; p=0.006).
At CRT 2024, Yeh presented data from the full 600-patient trial cohort, reporting the occurrence of the primary endpoint in 18.2% of patients in the Agent DCB arm at one year, compared to 29% in the conventional balloon angioplasty arm (p=0.003). This represented a reduction of around 40% of the primary endpoint on the relative scale, and an absolute risk reduction of 10.8%, Yeh noted.
Looking at the primary endpoint over time, there continued to be a separation of the two treatment arms in the first 12 months of follow up, Yeh added. Among the components that drove the primary endpoint, target-lesion revascularisation was reduced by around 50% (p=0.0005), as well as a 50% reduction in target-vessel MI.
Patients were also followed for the occurrence of definite and probable stent thrombosis with six stent thromboses occurring within the conventional balloon angioplasty arm and none within the investigational arm.
“AGENT IDE is the first randomised trial conducted in the USA examining the efficacy and safety of drug-coated balloons in the coronary circulation,” said Yeh. “The Agent DCB significantly reduced the occurrence of target-lesion failure at one year compared with conventional balloon angioplasty in patients with coronary in-stent restenosis.
“This is an FDA-designated breakthrough device and [the trial] was the primary evidence used to support FDA approval given the markedly superior results over conventional balloon angioplasty. It’s likely to become an important new treatment option for patients with coronary stenosis in the USA.”
