The current debate in cardiology centers on the use of drug-eluting balloons (DEBs) vs drug-eluting stents (DESs) in de novo lesions. However, to reach this conclusion, it must be shown that the balloon is superior to the stent, the standard treatment in patients presenting with acute myocardial infarction. A recent study concluded that in patients with diffuse de novo coronary artery disease, intervention with a balloon was associated with a significant reduction in major adverse cardiovascular events compared with intervention with a stent.

“The advantage of the balloon is that there is less risk of thrombosis because there is no metal left in the body, unlike with the stent, so the patient does not require dual antiplatelet therapy. And, if restenosis (re-blockage of the artery) recurs in that lesion, the vessel is clean since it is not metallic,” Pablo Salinas, board member of the Interventional Cardiology Association of the Spanish Society of Cardiology, told Univadis Spain, part of the Medscape Professional Network. In his view, the DEB will not eliminate the DES; they will coexist, and the two techniques may even be combined in the same patient. He also acknowledged that the balloon will have to compete with the stent: Right now the stent is the standard technique, with restenosis rates that are very low (less than 5%).

Disadvantages of the balloon angioplasty? “Sometimes, when the artery is dilated with a balloon, ruptures of the vessel wall occur — that’s why the stent was invented, to treat those dissections, since it works as a scaffold,” Salinas explained. Currently, balloon angioplasty is more developed in countries such as Germany and Switzerland, where market share, he said, is nearly 30%-40%, whereas in Spain it may be nearly 20%-25%.

Balloon vs Stent

In this line of debate, the COPERNICAN study design has been presented — a prospective, randomized clinical trial initiated by investigators at 20 Spanish centers with the aim of comparing a revascularization strategy based on a DEBs with a conventional strategy using DES in patients with acute ST-segment elevation myocardial infarction (STEMI).

“The primary objective of the study is to see whether the balloon strategy is superior to the stent in the acute setting of myocardial infarction — an area that has not been studied. If it shows superiority, it will completely change the management of this problem because what it seeks to demonstrate is that fewer patients die and fewer interventions will be needed per year,” Ignacio Amat-Santos, interventional cardiologist at the University Clinical Hospital of Valladolid, Valladolid, Spain, and one of the authors of the COPERNICAN study, told Univadis Spain.

The trial, which plans to complete enrollment in December 2026, will include 1400 patients who will be randomized into two groups at hospital admission to receive either a balloon or a stent. “We already have enrolled 700 patients. Thanks to a European grant we secured, we can expand the number of centers; we started with 14, and now there will be a total of 20,” Amat-Santos said. He explained that the investigators do not have access to preliminary results from the ongoing trial, but an external committee is monitoring it and would stop the study if it detected clearly negative outcomes in either group. So far, what they have reported to us is that the two groups are proceeding very similarly, so at least we already know the balloon is probably not inferior to the stent.

Stent Problems

Primary percutaneous coronary intervention with implantation of a DES is the standard treatment in patients presenting with STEMI. “Stents have been used since the 1990s to scaffold the artery so it does not reclose on follow-up. The problem is that when a stent is placed in the context of a heart attack, the artery often has spasm and thrombus — in other words, it is narrower. When the patient exits the acute phase, the artery dilates and the thrombus disappears. Therefore, the stent often ends up being too small for the artery, and the risk of thrombosis or re-narrowing is higher,” Amat-Santos explained.

Stent restenosis is the re-narrowing of a coronary artery at the site where a stent was previously placed, caused by excessive scarring. The problem with the stent is that it can scar excessively inward, which leads to progressive closure. It can also cause an acute thrombosis, which can lead to a heart attack — less frequent but much more serious.

Another issue is that stents are never removed from the artery. “If the patient undergoes surgery, the stent remains there forever, whereas the drug-eluting balloon — the strategy we are exploring — is like a balloon we inflate within the artery. It has a coating that releases a drug into the arterial wall, and the balloon is withdrawn, so when the artery returns to its normal size naturally, there is no prosthesis left in the vessel,” he concluded. 

Amat-Santos and Salinas declared having no conflicts of interest. The other authors of the articles also declared having no conflicts of interest.

This story was translated from Univadis Spain.