MIAMI—Paclitaxel-eluting balloons should be the treatment of choice for drug-eluting stent (DES) restenosis because the balloon avoids the problem of additional stent layers, according to a study presented Oct. 26 at the Transcatheter Cardiovascular Therapeutics (TCT) conference.
Robert A. Byrne, MB, of the German Heart Center in Munich, presented the findings of the Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis-Three Treatment Approaches (ISAR-Desire 3) trial.
Despite the widespread use of DES in clinical practice over the past 10 years, Byrne explained that the optimal treatment for restenosis of a DES remains "undefined." He and his colleagues attempted to determine whether the use of paclitaxel-eluting balloons was an inferior treatment to repeat stenting with the paclitaxel-eluting stent, and whether both treatments would be superior to balloon angioplasty alone.
The researchers enrolled 402 patients with DES restenosis at three centers in Germany between August 2009 and October 2011. To be eligible, patients must have had greater than 50 percent stenosis in a limus-eluting DES and have symptoms of ischemia. The researchers excluded patients with lesions in the left main stem, STEMI or cardiogenic shock.
The patients were randomized into three groups: 137 received the paclitaxel-eluting balloon (SeQuent, B. Braun), 131 received the paclitaxel-eluting stent (Taxus, Boston Scientific) and 134 received balloon angiopasty alone. The primary endpoint was diameter stenosis at follow-up angiography six to eight months after intervention. Secondary endpoints were binary endpoints and target lesion revascularization.
The results showed little difference between patients who received drug-eluting balloons and those who received another drug-eluting stent. The mean diameter of stenosis was 38 percent in the balloon patients and 37.4 percent in the re-stent patients. In contrast, the mean diameter of stenosis among patients who received balloon angiography only was 54.1 percent.
Findings for the secondary endpoints were similar. Researchers reported that 26.1 percent drug-eluting balloon patients experienced binary restenosis, compared with 24 percent of re-stent patients and 56.7 percent of balloon angioplasty patients. Repeat DES performed slightly better than balloons for target lesion revascularization; 13.5 percent of DES patients experienced revascularization vs. 22.1 percent of drug-eluting balloon patients and 43.5 percent of balloon angiography patients.
Byrne and colleagues concluded that in patients with DES restenosis, therapy with drug-eluting balloons was not an inferior treatment to repeat stenting with DES, and "can suggest that by obviating the need for additional stent implantation, treatment with a a drug-eluting balloon should be the treatment of choice as a default strategy for these patients."
The researchers said there are some differences in restenosis in limus-eluting and paclitaxel-eluting stents, perhaps due to hypo-responsiveness and resistance to the initial agent, and therefore, "It's important to comment that these results are restricted to patients with limus-eluting DES."
Study discussant James B. Hermiller, Jr., MD, of St. Vincent Heart Center of Indiana in Indianapolis, commented that, "Although less common, instant restenosis within DES continues to be a problem, and these patients may have multiple layers of stents as they're treated over the years, so this is very important."
The ISAR-DESIRE 3 study will continue to follow these patients, and will report data at the two-year and five-year marks, Byrne said.