Drug-coated balloon remains superior to uncoated balloon for coronary in-stent restenosis
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Key takeaways:
- A paclitaxel-coated balloon bested conventional angioplasty in treating coronary in-stent restenosis.
- The coated balloon recently received FDA approval.
Confirming previously presented earlier results, a paclitaxel-coated balloon was superior to conventional balloon angioplasty for treatment of coronary in-stent restenosis.
As Healio previously reported, in a presentation of the AGENT IDE trial in October at TCT 2023, the paclitaxel-coated balloon (Agent, Boston Scientific) was superior to conventional balloon angioplasty for treatment of coronary in-stent restenosis at 1 year in 480 patients. Results for the full cohort of 600 patients (mean age, 68 years; 26% women) were published in JAMA and presented at Cardiovascular Research Technologies. The paclitaxel-coated balloon was approved by the FDA on March 1.
Among the full cohort, 574 completed 1-year follow-up.
The primary endpoint of target lesion failure, defined as the composite of ischemia-driven target lesion revascularization, target vessel-related MI or cardiac death, at 1 year occurred in 17.9% of the paclitaxel-coated balloon group and 28.6% in the uncoated balloon group (HR = 0.59; 95% CI, 0.42-0.84; P = .003), Robert W. Yeh, MD, MSc, MBA, FSCAI, director of the Richard A. and Susan F. Smith Center for Outcomes Research and section chief of interventional cardiology at the Beth Israel Deaconess Medical Center, and colleagues wrote.
Target lesion revascularization (HR = 0.5; 95% CI, 0.34-0.74; P = .001) and target vessel-related MI (HR = 0.51; 95% CI, 0.28-0.92; P = .02) both favored the paclitaxel-coated balloon group at 1 year, whereas there was no difference between the groups in cardiac death (HR = 1.75; 95% CI, 0.49-6.28; P = .38), the researchers wrote.
In a related editorial, Amartya Kundu, MD, and David J. Moliterno, MD, both from the division of cardiovascular medicine at University of Kentucky (UK) Gill Heart and Vascular Institute, Lexington, wrote that “a significant number of patients with in-stent restenosis in the U.S. are still treated with noncoated balloons for focal lesions, and the availability of [drug-coated balloons] will be a welcome addition to the armamentarium. 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 two or more stent layers.”
References:
- Kundu A, et al. JAMA. 2024;doi:10.1001/jama.2024.0813.
- Yeh RW, et al. Late-breaking clinical trials | Drug coated balloon & pharma. Presented at: Cardiovascular Research Technologies; March 9-12, 2024; Washington, D.C.
Perspective
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For patients with in-stent restenosis, paclitaxel-coated balloons will be an important and effective new therapy, superior to uncoated balloon angioplasty. Importantly, for high-risk patients with multiple prior stents at the site of the restenosis, where additional stenting would reduce lumen area and not be ideal, paclitaxel-coated technology will become first-line therapy for in-stent restenosis.
Future studies will need to address the optimal approach for patients with in-stent restenosis and examine the efficacy of a drug-coated balloon vs. an additional layer of a drug-eluting stent, particularly in those with a single layer of prior stents.
In-stent restenosis is commonly encountered even after PCI with latest generation of drug-eluting stents, with nearly 10% of all coronary interventions being performed for in-stent restenosis. Importantly, approximately 25% of patients with in-stent restenosis present with MI.
Currently, in the United States, limited treatment options exist for complex patient populations with in-stent restenosis, with new-generation drug-eluting stents being the best available therapeutic option.
The FDA approval on March 1, largely based on data from the AGENT IDE trial, of the first coronary drug-coated balloon for treatment of a challenging subset of patients with in-stent restenosis addresses an important and unmet need for treatment of restenosis, particularly for those with recurrent restenosis and multiple layers of previous stents.
Drug-coated balloons will become an important addition and perhaps a game changer in anatomical subsets where the use of drug-eluting stents would not be favorable. Such examples may include diffuse long coronary disease, bifurcation and ostial lesions, as well as small vessel disease. Of course, further studies will be needed to support drug-coated balloon utilization in such scenarios.
Drug-coated balloon technology has been available in Europe and other parts of the world for many years. The FDA approval of drug-coated balloon technology will offer U.S. patients with currently limited options for treatment of in-stent restenosis an effective therapy to reduce the risk for restenosis.
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