NEW YORK (Reuters Health) – Using a drug-eluting balloon followed by a bare metal stent in occluded coronary arteries theoretically might improve outcomes over bare metal stenting alone or drug-eluting stents – but it didn’t, in a recent trial in the Netherlands and Italy.
The drug eluted by the balloon – paclitaxel — is known to cause an inflammatory reaction in the vessels over a long period of time, which is why researchers hoped delivering it via the surface of the balloon would be safer than long-term delivery with a stent.
They failed to see any advantage of the drug-eluting balloon/bare metal stent (DEB/BMS) approach, however.
All of the patients in the trial had ST-segment elevation myocardial infarction (STEMI). Lead author Dr. Pieter R. Stella, a visiting professor at University Medical Center in Utrecht, told Reuters Health by email that the research was undertaken because the choice between bare metal stents (BMS) and drug-eluting stents (DES) for STEMI is still being debated.
He said, “DES results in fewer late restenoses, but with a slightly higher chance of late stent thrombosis, a dangerous complication, while BMS is more prone to restenosis, but with less stent thrombosis.”
As reported in the June 19/26, 2012 issue of the Journal of the American College of Cardiology, the two-center trial involved 150 patients who were randomly assigned to treatment with the second-generation Dior drug-eluting balloon (DEB) followed by a BMS, or to a BMS or DES after predilation with a standard balloon.
The DEB was coated with paclitaxel to prevent restenosis and shellac to prevent the drug from washing off during placement of the balloon.
Baseline parameters were similar in all patients, and the procedures were completed for nearly all patients in the three groups. Subjects were eligible for inclusion if they presented within 12 hours of STEMI with single-vessel disease and were candidates for primary percutaneous coronary intervention (PCI). Typical adjunctive medications such as aspirin, clopidogrel and heparin were administered.
At six months, the DES group had significantly better rates of target lesion revascularization (p=0.017) and major cardiac adverse events (p=0.019). That group also had significantly better angiographic results with larger luminal diameters (p=0.01) and lesser percentages of stenosis (p=0.01).
DEB/BMS was no better than BMS alone for any angiographic or clinical outcome.
Dr. Gregg W. Stone, Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy of the New York Presbyterian Hospital/Columbia University Medical Center did not participate in the study. In a phone interview, he called the study “methodologically sound” and said he believes further research on this intervention was no longer warranted. Other drugs or coatings might still have promise, however, he said.
Dr. Stella concluded, “The combination of DEB/BMS is not as good as hoped. Maybe DEB alone should be studied.” He added that practicing cardiologists can take from his paper that the use of DES in single-vessel thrombosis is safe with good six month outcomes.
The study was funded by Eurocor, the company that makes the DEB used in this study. Dr. Stella is a member of its advisory board.
J Am Coll Cardiol 2012.