FDA approves drug-coated balloon for the treatment of coronary in-stent restenosis
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Key takeaways:
- The FDA approved a paclitaxel-coated balloon as an alternative treatment of coronary in-stent restenosis.
- The approval was based on the positive results of the AGENT IDE trial.
Boston Scientific announced the FDA approval of its drug-coated balloon indicated for the treatment of coronary in-stent restenosis in patients with coronary artery disease.
The paclitaxel-coated balloon catheter (Agent) is designed as an alternative to balloon angioplasty, additional layers of stenting or radiation, and the drug-eluting balloon is intended to prevent in-stent restenosis reoccurrence, according to an industry press release.
FDA approval was based on the results of the multicenter, prospective, randomized-controlled AGENT IDE trial, which included 600 patients at 40 sites in the U.S.
As Healio previously reported, the paclitaxel-coated balloon was superior compared with conventional balloon angioplasty for treatment of coronary in-stent restenosis, with lower target lesion revascularization (12.4% vs. 24%; HR = 0.49; 95% CI, 0.31-0.78; P = .002), lower target vessel-related MI (6.4% vs. 12.3%; HR = 0.51; 95% CI, 0.27-0.95; P = .03) and no stent thrombosis at 1 year compared with 3.9% of the angioplasty group (P = .001).
“The AGENT IDE trial demonstrated that the Agent DCB is an effective and safe treatment option for coronary in-stent restenosis, even in a high-risk population, which included many individuals with multilayer stents or diabetes,” 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, said in the release. “Treating ISR has been challenging in the U.S. with limited therapies available, and this new technology will help physicians reduce the risk of restenosis without radiation or introducing additional metal layers, which do not provide an adequate result for some patients.”
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