Benefits of Drug-Eluting Balloons Shown in Studies at AHA Meeting

November 16, 2011—The American Heart Association (AHA) announced that two studies of drug-eluting balloons demonstrated that the devices are effective in treating restenosis in bare-metal stents and that they may also help patients who are at high risk for bleeding complications because they require a shorter course of anticlotting drugs. The studies, conducted by lead investigator Mariusz Zadura, MD, and colleagues, were presented as abstracts at the 2011 AHA scientific sessions in Orlando, Florida.

According to the AHA, the investigators retrospectively compared the responses of 84 patients who underwent revascularization procedures to reopen narrowed bare-metal stents and restore blood flow with paclitaxel-coated drug-eluting balloons. There were 91 lesions treated in men and women, who were an average age of 67.5 years. After 6 to 9 months, the balloon kept 85 of the lesions open. There were new narrowed areas in six stents, but only three patients required an additional procedure.

“The current approach of placing a metal drug-eluting stent inside an old bare-metal stent essentially creates a metal sandwich,” commented Dr. Zadura. “With drug-eluting balloons, we can reduce the body's reaction to a full-metal jacket placed in an artery because the biodegradable balloon coating material (matrix) decomposes in 24 hours and appears to create less of an immune reaction.”

These findings complement other studies and “give a new argument from the real-life conditions in how to better perform repeated procedures to clear in-stent stenosis,”  concluded Dr. Zadura. “We consider the drug-eluting balloon technique the best option for in-stent restenosis in clinical practice.”

In the second study, the investigators found that drug-eluting balloons are a feasible option for patients with a high risk of bleeding complications because balloon treatment requires a shorter anticoagulation period than drug-eluting stents, which require patients to receive aspirin and clopidogrel for at least 1 year. Patients who undergo drug-eluting balloon therapy receive dual-antiplatelet therapy for 1 month.

According to the AHA, high-risk patients include those with mechanical prosthetic heart valves, atrial fibrillation, and pulmonary embolism treated continuously with oral anticoagulants. The investigators followed 63 patients with de novo lesions being treated with drug-eluting balloons and, after 6 to 9 months, found no significant renarrowing in 69 of 73 lesions. Four lesions showed renarrowing; two patients required a subsequent targeted revascularization. Dr. Zadura stated, “This is a major benefit, especially in elderly or noncompliant patients. Due to the reduced need for dual-platelet inhibition, drug-eluting balloons seem to be an interesting alternative.”