Advancing the Understanding of Drug-Coated Balloons in Percutaneous Coronary Intervention

Innovations in Cardiovascular Medicine & Surgery | March 2025

Widely used throughout Europe, drug-coated balloons (DCBs) have emerged as a valuable tool in percutaneous coronary interventions. The U.S. Food and Drug Administration has approved DCBs in patients requiring in-stent restenosis (ISR). 

Bernardo Cortese, MD

DCBs work by delivering an antiproliferative drug, most commonly paclitaxel, directly to the vessel wall without leaving a permanent scaffold. European clinical trials demonstrate that DCBs reduce risks such as late stent thrombosis, vessel caging and stent-related restenosis. This makes them particularly useful in ISR, small vessel disease and bifurcation lesions.

“So far in the United States, drug-coated balloons are not approved for broad population usage,” says Bernardo Cortese, MD, Co-Director of the Coronary Center at University Hospitals (UH) Harrington Heart & Vascular Institute and a professor at Case Western Reserve University School of Medicine. “However, particularly in sick patients, they can have advantages over normal stenting, especially in terms of bleeding.” 

He explains that DCBs do not require prolonged dual antiplatelet therapy. “Usually, we give it for one to three months, compared to six to 12 months with stents,” he says. “And in cases where we need to interrupt therapy for bleeding, we can do it safely without the patient incurring risk from a foreign prosthesis.” Additionally, DCBs allow for the ability to preserve future treatment options.

International Leadership in Interventional Cardiology

Dr. Cortese is an internationally renowned interventional cardiologist specializing in the diagnosis and treatment of complex coronary artery disease and chronic total occlusions. Prior to coming to UH Harrington Heart & Vascular Institute in 2024, Dr. Cortese served as Director of Cardiology at San Carlo Multispecialty Clinic in Milano, Italy, and consultant interventional cardiologist for coronary and structural heart disease at Columbus Clinic and Fatebenefratelli Hospital in Milano, Italy. 

Along with his colleagues at UH Harrington Heart & Vascular Institute, Dr. Cortese is helping to advance understanding of the emerging role of DCBs in complex coronary repair.

• Dr. Cortese is the senior author of a late-breaking clinical trial on DCBs in elderly patients. He will present the study findings at CRT 2025 in Washington, D.C.
• The ANDROMEDA study was recently published in the prestigious European Heart Journal. Dr. Cortese is the senior author of the collaborative, investigator-initiated, individual meta-analysis comparing three-year clinical outcomes between paclitaxel-coated balloon (PCB) angioplasty and drug eluting stent (DES) implantation for the treatment of de novo SV-CAD. “In the first long-term follow-up, PCBs were associated with lower major cardiovascular events compared to stents, which is quite disruptive in the small-vessel disease setting,” he says. 
• The UH Harrington Heart & Vascular Institute is launching a robust scientific program of five upcoming industry-sponsored DCB trials, with plans to submit them for IRB approval in the coming months. “Three of the studies will test some of these technologies in the SV disease setting, and two in the ISR one,” Dr. Cortese says.
• In May, Dr. Cortese will present a live intervention for the Society for Cardiovascular Angiography & Interventions (SCAI), the U.S.’s leading nonprofit medical society representing invasive and interventional cardiology. “SCAI invited me for a second year to deliver a case,” he says. “We will highlight treatment of a patient with highly calcified, complex lesions, which is one of our fields of expertise.”
• Dr. Cortese is updating his pioneering 2019 monograph, Drug-Coated Balloons: Applications in Interventional Cardiology, published by Springer. “Over the past six years, there have been new investigations, and this technology has been boosted around the world,” he says. “We invited all the authors who worked on the first edition and will have new chapters written by opinion leaders in the field.” The publication is expected to be released later this year.
• UH Harrington Heart & Vascular Institute experts contributed to the Academic Research Consortium’s DCB consensus documents, which were accepted for publication in the European Heart Journal. “For the first time, we gathered the most influential experts on DCBs,” Dr. Cortese says.
• This year, the UH Harrington Heart & Vascular Institute plans to launch two training courses that will cover intravascular imaging optimization (optical coherence tomography and intravascular ultrasound) and lesion preparation. “We want to offer physicians around the country the opportunity to come to our institute and see how sophisticated imaging and complex lesion preparation contribute to excellent outcomes for patients,” Dr. Cortese says.

Choosing University Hospitals Harrington Heart & Vascular Institute

“What I love here is the system,” Dr. Cortese says. “We have the academic campus and several regional hospitals, and they work like a body. There is a direct connection to the providers each patient needs.”

Weekly CHIP meetings bring together subspecialists throughout the UH Harrington Heart & Vascular Institute to discuss and strategize interventions for the most complex patients.

“We treat individuals in a well-organized and multidisciplinary way, which is quite rare compared to European centers,” Dr. Cortese says. “Now we have the opportunity to bring greater international visibility to what we are achieving for patients.”

For more information, contact Dr. Cortese at Bernardo.Cortese@UHhospitals.org.

Contributing Expert:
Bernardo Cortese, MD
Co-Director, Coronary Center
University Hospitals Harrington Heart & Vascular Institute
Professor
Case Western Reserve University School of Medicine