Drug-coated balloon bests uncoated balloon for coronary in-stent restenosis in AGENT IDE trial
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Key takeaways:
- A drug-coated balloon produced better clinical outcomes than angioplasty at 1 year in patients with coronary in-stent restenosis.
- If approved, the device could address an unmet need.
SAN FRANCISCO — A paclitaxel-coated balloon was superior to conventional balloon angioplasty for treatment of coronary in-stent restenosis, according to the results of the AGENT IDE trial presented at TCT 2023.
“In the United States, we don’t currently have a drug-coated balloon for any treatment in the coronary circulation,” Robert W. Yeh, MD, MSc, MBA, FSCAI, director of the Richard A. and Susan F. Smith Center for Outcomes Research, section chief of interventional cardiology at Beth Israel Deaconess Medical Center and the Katz-Silver Family Professor of Medicine at Harvard Medical School, told Healio. “More than 10% of PCIs in the U.S. are performed for in-stent restenosis. These patients, when they are treated, continue to have recurrent events related to their stent. These data go a long way toward supporting regulatory approval that would put the device in the hands of clinicians.”
The researchers randomly assigned 480 patients (mean age, 68 years; 27% women) with coronary in-stent restenosis on a 2:1 basis to receive the paclitaxel-coated balloon (Agent, Boston Scientific) or conventional balloon angioplasty.
The primary endpoint of target lesion failure, defined as target lesion revascularization, MI attributed to the target vessel or cardiac death at 1 year, occurred less often in the paclitaxel-coated balloon group compared with the angioplasty group (difference, –10.7%; 95% CI, –19.2 to –2.3; P = .0063), Yeh said at a press conference.
At 1 year, TLR was lower in the paclitaxel-coated balloon group (12.4% vs. 24%; HR = 0.49; 95% CI, 0.31-0.78; P = .002), as was target vessel-related MI (6.4% vs. 12.3%; HR = 0.51; 95% CI, 0.27-0.95; P = .03), Yeh said.
No patients in the paclitaxel-coated balloon group had stent thrombosis at 1 year compared with 3.9% of the angioplasty group (P = .001), according to the results.
“All of these results suggest that the Agent balloon was quite superior compared with the non-drug-coated balloon in events that are deeply meaningful to patients,” Yeh told Healio.
Despite inadequate existing treatments for in-stent restenosis, “these devices have ... not been available in the United States in part because there was concern that a trial might not succeed, that the regulatory pathway for approval was risky,” Yeh told Healio. “The Agent IDE trial helps dispel that myth. It took courage for Boston Scientific to be the first company that was going to put forward a pathway for this device, when companies had stayed away from this. Even companies that have approved devices elsewhere stayed away from the U.S. because of concern for the potential failure of a trial and a difficult pathway for regulatory approval. After discussion here with the FDA, and the conduct of what turned out to be a highly successful trial, some of those fears may have been allayed.”
Perspective
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This is a very positive study for showing that drug-coated balloons can be used for treating in-stent restenosis, which is a big problem. We have had at least 2 decades of great success with drug-eluting stents, but they still have a low but significant rate of reblockage. All the treatments so far have not been effective long-term for preventing that from happening again; that includes repeat balloon angioplasty as was used in the control group here, putting in another layer of stent, radiation treatment and atherectomy. Using the drug-coated balloon was shown to be effective in just about all parameters. Compared with angioplasty, it reduced reblockage and postprocedure MI by 50%, and reduced the overall combined endpoint, including the need for revascularization, by almost half. This is very promising, and we could see approval for this indication in the coronary arteries fairly soon. If approved, I think this will become the primary treatment for patients who have in-stent restenosis. After 20 years, this is welcome.
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Yeh RW, et al. Late-breaking clinical trials: Session II, in collaboration with The Lancet. Presented at: TCT Scientific Symposium; Oct. 23-26, 2023; San Francisco (hybrid meeting).
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