RIBS-IV Addresses Efficacy of Drug-Eluting Balloons

Drug-eluting balloons rather than drug-eluting stents may have a place in certain clinical scenarios, cardiologists said at the Transcatheter Cardiovascular Therapeutics scientific session. While drug-eluting stents are more effective in treating stenosis and in providing patients better long-term outcomes, drug-eluting balloons appear to be a sound alternative for patients who need to transition quickly from antiplatelet therapy for other surgical interventions.

The first-report on the RIBS-IV trial focused on treating patients with in-stent restenosis by comparing the effectiveness of drug-eluting balloons against stents. Fernando Alfonso, M.D., Ph.D., head of the Cardiac Department at the Hospital Universitario de La Princesa in Madrid, Spain, noted that while comparative effectiveness was done on prior generations of balloons and stents, little was known about second generation drug-eluting stents compared with drug-eluting balloons.

The RIBS-IV trial enrolled 272 patients, randomized between balloon and stent treatment. Follow-up occurred at one year.
The median minimum lumen diameter at follow-up with the drug-eluting stent was 2.03 mm in segment and 2.2 mm in lesion. In vessels treated by drug-eluting balloon, in segment was about 1.80 mm and in lesion 1.89 mm.

Major adverse cardiac events occurred in 7 percent of drug-eluting stent patients and 13 percent of drug-eluting balloon patients. Rates of death and CABG target lesion revascularization (TLR) were the same between the two groups; however, rates of acute myocardial infarction (MI) and percutaneous coronary intervention TLR were higher among the patients in the balloon group. Patients treated with drug-eluting stents had 96 percent freedom from TLR, as opposed to balloon at 87 percent. Freedom from major adverse events was better for stent patients than for balloon patients (90 percent vs. 82 percent).

“This has important implications, especially for patients,” said discussant David G. Rizik, M.D., director of the Heart & Vascular Division at Scottsdale Healthcare in Arizona. “The results in the drug-eluting balloon arm were admirable for patients who might need to go under surgery and are found in their preoperative work-up to have stent restenosis. Anesthesiologists are very reluctant to work on patients who have recurrent coronary disease and so the performance of the drug-eluting balloon really may provide practitioners with another option. Surgeons may be reluctant to cut with antiplatelet therapy on board. The use of a drug-eluting balloon may allow surgeons to cut sooner to perform life-saving surgery.”

Cardiologists, however, noted that stenting is the best practice in the long term and future repeat stenting should carefully consider how it affects vessel diameter as well.