A randomized trial in Spain found an everolimus-eluting stent (EES) was more effective than a drug-eluting balloon (DEB) in treating patients with drug-eluting stent in-stent restenosis.
One year after the procedures, the primary endpoint of cardiac death, MI and target vessel revascularization occurred in 10 percent of the EES group and 18 percent of the DEB group. The difference was statistically significant.
Fernando Alonso, MD, of Universitario La Princesa in Madrid, and colleagues published their findings online in the Journal of the American College of Cardiology on June 29.
The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent) trial enrolled 309 patients at 23 Spanish university hospitals from January 2010 to August 2013. They were randomized in a 1:1 ratio to receive EES or DEB. The DEB, which uses iopromide as a hydrophilic spacer, has been shown to be effective in patients with in-stent restenosis.
The groups were well balanced. The mean age was 66, and approximately 75 percent of patients were males. All patients had in-stent restenosis and angina or ischemia. Before their procedures, patients received aspirin and clopidogrel. They received unfractionated heparin during the procedures.
An angiography performed at a median of 247 days found the mean minimal lumen diameter and net lumen gain were significantly larger in the EES group compared with the DEB group. The EES group also had a lower percentage diameter stenosis and binary restenosis rate.
After a year, 8 percent of patients in the EES group and 16 percent of patients in the DEB group had target vessel revascularization. Further, seven patients died (three in the DEB group and four in the EES group) and seven patients had MI (five in the DEB group and two in the EES group). Three patients had definitive stent thrombosis: two in the DEB group and one in the EES group.
The researchers cited a few study limitations, including that they used a specific DES, so the results may not be generalizable to all second-generation DES. They also mentioned their subgroup analysis was underpowered to determine if EES was superior to DEB in relevant clinical and anatomic scenarios. In addition, they noted trials that enroll more patients and follow them for longer follow-up periods were needed to confirm these findings.