Drug-coated balloons comparable to drug-eluting stents when PCI patients have a high bleeding risk

When treating patients at a high bleeding risk (HBR) with percutaneous coronary intervention (PCI), the use of a drug-coated balloon (DCB) appears to be as safe and effective as a current-generation drug-eluting stent (DES), according to new findings published in Circulation: Cardiovascular Interventions.[1]

“The use of drug-coated balloon allows shorter duration of dual antiplatelet therapy compared with drug-eluting stents and may reduce thrombotic risk due to the absence of a permanent implant,” wrote lead author Bruno Scheller, MD, of the department of clinical and experimental interventional cardiology at the University of Saarland in Germany, and colleagues.

The study’s authors noted that data from the BASKET-SMALL 2 trial, originally completed in 2018, had already demonstrated that DCB and DES treatment led to comparable outcomes among patients with small coronary artery disease over a three-year period. However, they added, the impact on HBR patients remains unclear.

The group performed a secondary analysis of the BASKET-SMALL 2 trial that took these HBP patients into consideration. Overall, the study included data from 758 patients with de novo lesions in coronary vessels smaller than 3 mm who underwent PCI. They were randomized to a DCB or a second-generation DES. Twenty percent of patients were classified as HBR, including 17% of DCB patients and 24% of DES patients.

Overall, HBR patients tended to have a higher mean age (71 years old) than the rest of the patient population (67 years old). HBR patients were also more likely to present with diabetes, heart failure or hypertension.

HBR patients were associated with an increased mortality rate at three years. However, there was no difference in the risk of a major adverse cardiovascular event between patients treated with a DCB and those treated with a DES — this was true for all patients, whether they were a HBR patient or not.

Among patients treated with a DCB, the authors added, there were signs of a significant benefit.

“Rates of major bleeding events were overall low, but tended to be lower after DCB vs. DES,” the authors wrote.

Scheller et al. also noted that “further prospective, randomized studies” are still needed to improve our understanding of this topic.

Related Vascular and Endovascular Content:

Is PCI without stenting safe for low-risk STEMI patients?

Australian tech company opens new US office, eyes FDA approval for AI CAD solution

COVID-19 linked to greater risk of deep vein thrombosis, pulmonary embolism and bleeding events long after recovery

TAVR vs. surgery, FFR-guided PCI and DCB safety: Day 3 at ACC.22

Salt restrictions, PCI breakthroughs and a social media primer for cardiologists: Day 1 at ACC.22

 

Reference:

1. Bruno Scheller, Tuomas T. Rissanen, Ahmed Farah, et al. Drug-Coated Balloon for Small Coronary Artery Disease in Patients With and Without High-Bleeding Risk in the BASKET-SMALL 2 Trial. Circulation: Cardiovascular Interventions. 2022;0:10.1161.

Michael Walter
Michael Walter, Managing Editor

Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

Around the web

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."