medwireNews: Patients undergoing coronary angioplasty for in-stent restenosis have a significantly lower risk for target lesion failure when treated with a paclitaxel-coated balloon than with an uncoated balloon, US study findings indicate.
“Current treatment of coronary in-stent restenosis in the United States commonly involves angioplasty followed by the placement of additional drug-eluting stents, which have been demonstrated to be superior to balloon angioplasty and vascular brachytherapy in reducing subsequent restenosis,” explain Robert Yeh (Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA) and co-authors in JAMA.
They add: “Drug-coated balloons, designed to administer antiproliferative agents to coronary lesions without the use of a metallic stent, were developed as an alternative treatment for coronary artery disease, and specifically for in-stent restenosis, where the introduction of additional layers of stent that further reduce lumen area may be undesirable.”
Yet, to date, none have been evaluated or approved for use in the USA.
To address this, Yeh et al carried out the AGENT IDE trial, which included 600 patients (mean age 68 years, 74% men) undergoing percutaneous coronary intervention for in-stent restenosis. All participants had a visually estimated lesion length of less than 26.0 mm, reference vessel diameter greater than 2.0 mm to a maximum of 4.0 mm, and target lesion diameter stenosis of less than 100% but greater than 50% (in symptomatic patients) or greater than 70% (in asymptomatic patients).
Just over half (50.7%) of participants had diabetes, 78.9% had a history of multi-vessel coronary artery disease, and 30.1% had a history of coronary artery bypass grafting.
At 1-year post-procedure, the researchers found that the 406 participants randomly assigned to be treated with a paclitaxel-coated balloon had a significantly lower risk for target lesion failure than the 194 treated with an uncoated balloon. Target lesion failure was defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death, and this occurred in 17.9% of patients given a paclitaxel-coated balloon versus 28.6% of those given an uncoated balloon.
Among the individual components of the primary outcome, the risk for target lesion revascularization was a significant 50% lower with a coated versus uncoated balloon, occurring in 13.0% and 24.7%, respectively. The risk for target vessel-related myocardial infarction was a significant 49% lower with the paclitaxel coating relative to no coating (5.8 vs 11.1%) but there was no significant difference between the two arms in the risk for cardiac death (2.9 vs 1.6%).
Yeh and co-authors therefore conclude: “Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis.”
In an accompanying editorial, Amartya Kundu and David Moliterno, both from the University of Kentucky in Lexington, USA, say that although “the trial was conducted primarily to obtain Food and Drug Administration approval for [the drug-coated balloon] and its design directly tests the effect of the drug coating, using noncoated balloons as the control does not represent the standard of care for treating in-stent restenosis in current practice.”
However, they also point out that “a significant number of patients with in-stent restenosis in the US are still treated with noncoated balloons for focal lesions, and the availability of [drug-coated balloons] will be a welcome addition to the armamentarium.”
Kundu and Moliterno also note that “[drug-coated balloons] are particularly appealing in cases of in-stent restenosis where placing an additional layer of metal may be problematic, such as in bifurcation lesions and in-stent restenosis lesions that already have 2 or more stent layers.”
They conclude: “AGENT IDE provides strong evidence for regulatory approval of coronary [drug-coated balloons] in the US, potentially providing numerous patients access to this established technology.”
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JAMA 2024; doi:10.1001/jama.2024.1361
JAMA 2024; doi:10.1001/jama.2024.0813