Balloon Angioplasty Matches Stents for Small Blocked Arteries

Drug-coated balloons (DCB) are non-inferior to drug-eluting stents (DES) for treating small native coronary artery disease (CAD), according to a new study.

Researchers at University Hospital Basel (Switzerland), University Hospital Saarland (Homburg, Germany), and other institutions conducted a randomized non-inferiority trial involving 758 patients with small (under three mm) de-novo lesions in coronary vessels, who were randomly allocated to receive angioplasty with DCB or implantation of a second-generation DES; dual antiplatelet therapy was given according to current guidelines. The primary outcome was non-inferiority of DCB for major adverse cardiac events (MACE) after 12 months.

The results showed that after one year of follow-up, MACE were similar in both groups (7.5% for the DCB group versus 7.3% for the DES group). There were five (1.3%) cardiac-related deaths in the DES group and 12 (3.1%) in the DCB group. Probable or definite stent thrombosis occurred in three patients in the DCB group and four in the DES group, and major bleeding affected four patients in the DCB group compared to nine in the DES group. The study was presented at the European Society of Cardiology (ESC) annual congress, held during August 2018 in Munich (Germany).

“The potential benefits of a stent-free option to treat small blocked arteries are numerous. With no permanent implant left after the procedure, the problem of tissue growth and clot formation within the stent is eliminated,” said lead author Professor Raban Jeger, MD, of University Hospital Basel. “In addition, there may be no need for prolonged treatment with anticlotting medicines, which has been controversial since it increases the risk of bleeding. Drug coated balloon angioplasty has the possibility to become the standard treatment for small blocked arteries.”

One of the standard treatments for opening blocked arteries is to insert a permanent expandable DES via percutaneous coronary intervention (PCI). But in smaller arteries, there is a risk that tissue will grow inside the stent, causing the artery to become blocked a second time (in-stent restenosis), or that a blood clot will develop, which may lead to a heart attack or stroke. DCB are a novel therapeutic strategy approved in the European Union for treating restenosis; the balloon is removed after the procedure.

Related Links:
University Hospital Basel
University Hospital Saarland