A clinical study from Boston Scientific showed that a drug-coated balloon small enough to reach and reopen the heart’s coronary arteries could outperform traditional drugless angioplasty procedures.
The company described the trial as the first in the U.S. to examine the use of a drug-coated balloon to clear a path through previously placed coronary stents that have become obstructed over time by buildups of plaque or the growth of scar tissue. The Agent balloon inflates to reopen the stent and deliver a low dose of paclitaxel to the blood vessel wall to help slow further narrowing.
Presented as a late-breaking trial at the Transcatheter Cardiovascular Therapeutics Conference in San Francisco, the randomized study met its primary endpoint by demonstrating improved rates of coronary lesion failures after one year—with the Agent balloon showing about a 38% reduction in the risk of blocked blood flow compared to uncoated balloons.
Targeted lesion failure rates at 12 months after the Agent procedure totaled 17.9%, compared to 28.7% in the control arm. According to Boston Scientific, the differences were linked with significantly reduced rates of myocardial infarctions related to the treated artery, as well as the need for repeated revascularization procedures.
The drug-coated balloon arm also reported zero cases of blood clotting within the stent, compared to a rate of 3.9% with typical angioplasty.
“Positive outcomes in this complex trial population—from the markedly lower rate of target lesion failure to the significant reduction in heart attack and no stent thromboses—support the Agent DCB as an alternative treatment option for coronary in-stent restenosis,” the study’s principal investigator and presenter Robert Yeh, section chief of interventional cardiology at the Beth Israel Deaconess Medical Center, said in a statement.
Immediately following the procedure, the Agent balloon posted technical and clinical success rates of about 92%, edging slightly higher than uncoated balloons’ 89%. This included reopening the narrowed artery by a certain percentage while also reporting no in-hospital cases of heart attack, vessel revascularization or cardiac-related death.
“Meaningful therapy advancements for this condition are critical, and the ability to reduce the risk of restenosis without using radiation or introducing another layer of metal stenting is a promising step forward,” added Yeh, who also serves as the Katz-Silver Family Professor of Medicine at Harvard Medical School.
The study analyzed 480 patients, including 51% with diabetes and 44% who had multiple layers of metal stents placed within the target lesion. Boston Scientific estimates that cases of in-stent restenosis are treated during 10% of percutaneous coronary interventions in the U.S.
“These encouraging results add to the growing body of clinical evidence supporting the Agent DCB, spanning nearly 7,400 patients in 14 completed and ongoing studies worldwide,” said Janarthanan Sathananthan, Boston Scientific’s chief medical officer for interventional cardiology therapies. “In light of the successful real-world use of the device outside the U.S., we look forward to using these encouraging data to support FDA approval and bringing this important therapy to more physicians and patients in need.”
The Agent balloon previously obtained a CE mark in Europe in 2014, both for in-stent restenosis and previously untreated small vessel coronary artery disease. It was also approved in Japan earlier this year and previously received a breakthrough designation from the FDA. There are currently no drug-coated balloons approved in the U.S. for use in the coronary arteries.
This week, Boston Scientific also announced its third-quarter earnings. The company collected $3.53 billion in revenue, up 11.2% over the $3.17 billion earned during the same period last year. About $1.73 billion in operating expenses resulted in a net income of $504 million.
Cardiovascular devices brought in $2.185 billion, split between $1.647 billion in cardiology and $538 million in peripheral vascular interventions. Sales in Boston Scientific’s MedSurg division, which includes endoscopy, urology and neuromodulation, accounted for $1.341 billion.
The company also narrowed its previous financial guidance for the year: After predicting growth between 10.5% and 11.5% earlier this year, it has settled on the midpoint of that range, with a new forecast of about 11%.