Millions of individuals globally undergo coronary angioplasty each year, a procedure aimed at addressing blockages in the arteries leading to the heart. During balloon angioplasty, a catheter with an attached deflated balloon is navigated into a constricted artery, where it is then inflated to widen the artery and enhance blood flow to the heart. Despite its efficacy, a small percentage of patients—between 5% and 10%—face in-stent restenosis or blockages recurring within previously placed stents, within a year, thus requiring further intervention. Drug-coated balloons present an international alternative approach, yet until now, they have not undergone evaluation or received approval in the United States. Now, the first-of-its-kind U.S. randomized clinical trial has found the drug-coated balloon to be an effective treatment strategy for coronary in-stent restenosis.

The AGENT IDE trial, a multicenter randomized trial led by Beth Israel Deaconess Medical Center (BIDMC, Boston, MA, USA), involved participants with in-stent restenosis, a group predominantly at high coronary risk, including over half with diabetes and nearly 80% with two or more major coronary arteries blocked to varying degrees. Of the 600 enrolled participants, 406 were treated with the paclitaxel-coated balloon catheter, and 194 received an uncoated balloon catheter. Over a year, the participants underwent clinical follow-up at set intervals, with plans for continued observation up to five years. The study primarily monitored the participants for instances of revascularization requirement, myocardial infarction due to lack of blood flow to the heart, or sudden cardiac death.

Results at the one-year mark showed the drug-coated balloon’s superiority over an uncoated balloon in reducing the risk of these adverse outcomes. Eighteen percent of the drug-coated balloon group faced primary endpoints, compared to 29% in the control group. Notably, revascularization was less likely in the drug-coated balloon recipients (13% vs. 25%), as was myocardial infarction (6% vs. 11%). Cardiac death rates showed no significant difference between groups. The U.S. Food and Drug Administration has now granted approval to the paclitaxel-coated balloon assessed in this BIDMC-led trial, making it the first such balloon to be approved for coronary disease treatment in the U.S.

“The participants in this trial represented a patient group at very high risk for recurrent restenosis,” said lead investigator Robert W. Yeh, MD, MSc, MBA, from BIDMC. “More than 40 percent of participants had multiple prior stents. Nevertheless, treatment with the drug-coated balloon had a consistent relative risk reduction and numerically greater absolute risk reduction in events. A drug-coated balloon may be particularly useful in the setting where additional stenting would result in three or more layers of stent which would limit future therapeutic options.” 

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