A ground-breaking development in coronary artery treatment has emerged from recent clinical research by Boston Scientific. The study demonstrated that a drug-coated balloon, designed to unblock coronary arteries, outperformed conventional drugless angioplasty procedures.
The experiment marked a significant milestone as it was the first in the United States to utilize a drug-coated balloon to effectively eliminate plaque and scar tissue from coronary stents. Named the Agent balloon, it not only reopens the stent but also delivers a precise dosage of paclitaxel, which helps to prevent blood artery constriction.
At the Transcatheter Cardiovascular Therapeutics Conference in San Francisco, the randomized study showed lower rates of coronary lesion failures after one year. This meant that the study's main goal was met. The agent balloon demonstrated a remarkable 38% reduction in blocked blood flow compared to uncoated balloons.
At the 12-month mark following the agent surgery, only 17.9% of targeted lesions failed, as opposed to 28.7% in the control arm. Additionally, Boston Scientific reported significantly lower incidences of myocardial infarctions and recurrent revascularizations associated with the treated artery. Remarkably, the drug-coated balloon arm recorded no instances of stent blood clotting, whereas standard angioplasty reported a 3.9% occurrence.
Beth Israel Deaconess Medical Center's section chief of interventional cardiology, Robert Yeh, lauded the positive outcomes of the complex trial. He highlighted the marked reduction in target lesion failure as well as the significant decrease in heart attacks and the absence of stent thromboses. This, he stated, supports the agent DCB as a viable alternative for treating coronary in-stent restenosis.
Post-procedure, the agent balloon achieved an impressive 92% technical and clinical success rate, slightly surpassing the 89% of uncoated balloons. This encompassed successfully reopening a portion of the narrowed artery with no reported in-hospital heart attacks, vessel revascularizations, or cardiac deaths.
In a trial involving 480 individuals, 51% had diabetes, and 44% had multiple metal stents in the target lesion. According to Boston Scientific, 10% of percutaneous coronary interventions (PCIs) in the U.S. treat in-stent restenosis. This is a major health concern.
These promising results add to a growing body of clinical evidence supporting the agent DCB, which spans nearly 7,400 patients across 14 completed and ongoing studies worldwide. Boston Scientific's interventional cardiology chief medical officer, Janarthanan Sathananthan, expressed anticipation for FDA clearance, aiming to make this critical advancement available to clinicians and patients in the U.S.
In 2014, the Agent balloon got CE certification in Europe for in-stent restenosis and untreated small vessel coronary artery disease. Earlier this year, it also got FDA breakthrough status and approval in Japan. It is noteworthy that U.S. coronary artery drug-coated balloons have not yet received licensure.
Boston Scientific reported robust third-quarter profits, with earnings of $3.53 billion, signifying an 11.2% increase from the previous year. Net profits totaled $504 million after deducting $1.73 billion in operating expenses. Notably, cardiovascular devices constituted a significant portion of the earnings, totaling $2.185 billion.
In light of these remarkable findings, the medical community eagerly awaits further developments in the approval and availability of this innovative treatment option for coronary artery blockages.