2024-03-13 15:27:49
“This is the first trial conducted in the United States allowing approval of the use of this device by the Food and Drug Administration (FDA). This device is available in Europe, but no randomized trial of this magnitude had never demonstrated its effectiveness,” said Robert Yeh of Beth Israel Deaconess Medical Center in Boston, contacted by APMnews.
“This trial provides conclusive evidence of the effectiveness of the device and should assure the European Community of its usefulness.” Especially since this trial included “a very high-risk population, including a large number of patients whose stents had failed several times in the past”.
The FDA approved Boston Scientific’s Agent* balloon application on February 29. “This first-of-its-kind drug-coated balloon is intended for use in adult patients undergoing percutaneous coronary intervention in certain arteries and coronary lesions with the goal of improving myocardial perfusion during the treatment of in-stent restenosis , a condition in which a diseased artery previously treated with a stent becomes diseased again and restricts normal blood flow,” explains the FDA on its website.
A device already recommended in Europe
“Drug-coated balloons have emerged internationally as a treatment option that can offer the benefits of localized drug delivery to reduce neointimal growth, while avoiding additional stent layers within existing stents. The use of these devices has been approved internationally, mainly on the basis of smaller randomized trials,” the authors explain. “Drug-coated balloons currently have a Class IA recommendation for the treatment of coronary restenosis in European guidelines.”
Between May 2021 and August 2022, 600 patients with in-stent restenosis and managed in 40 centers in the United States were included in the AGENT IDE trial designed to obtain American approval and were followed for a year. 406 of them were treated with a paclitaxel-coated balloon and 194 with an uncoated balloon.
The primary endpoint was target lesion failure at one year, defined as a composite endpoint combining ischemia-induced target lesion revascularization, target vessel-related myocardial infarction, and death. cardiac.
In the paclitaxel-coated balloon group, the failure rate at the target lesion at one year was 17.9% compared to 28.6% in the uncoated balloon group, representing a reduced relative risk of 31%.
The risk of target lesion revascularization was reduced by 50%, with a rate of 13% in the paclitaxel-covered balloon group and 24.7% in the uncovered balloon group. As for the risk of myocardial infarction of the target vessel, the risk was also reduced, by 49%, with a respective rate of 5.8% and 11.1%.
In contrast, the rate of cardiac death was 2.9% in the paclitaxel-coated balloon group versus 1.6% in the uncoated balloon group, but the difference between the two groups was not significant.
Efficacy also demonstrated in high-risk patients
A subgroup analysis also showed that among patients treated with several layers of stent at the target lesion (i.e. more than 40% of patients in the trial), at high risk of recurrence of restenosis, the rate The rate of target lesion failure was 23.8% in the paclitaxel-coated balloon group and 40% in the uncoated balloon group, corresponding to a reduction in failure risk of 45%.
“A drug-coated balloon may be particularly useful in this high-risk setting, where an additional stent would result in the creation of three or more layers of stents that could further reduce the lumen surface area and limit future therapeutic options by further constraining the vascular wall”, emphasize the authors.
(JAMA, __publication online from March 9)
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