In a meta-analysis of five recent trials, researchers found that treating in-stent restenosis with drug-eluting balloons (DEB) reduced the risk of major adverse cardiac events (MACE) when compared with uncoated balloon angioplasty or restenting with a Taxus Liberte (Boston Scientific) drug-eluting stent (DES). The results were published online Jan. 18 in Heart.
PCI with DES has become the revascularization treatment of choice, but in-stent restenosis (ISR) remains a problem, despite the reduced rates of restenosis associated with new generation DES. Andreas Indermuehle, MD, of University College London Hospital, and colleagues reviewed the literature to determine whether ISR treatment with DEB is effective and safe compared with uncoated balloon angioplasty or implanting an additional stent.
The researchers identified five randomized, controlled trials published between 2005 and 2012 that evaluated DEB for restenosis using paclitaxel-eluting balloons. Three studies compared DEB with uncoated balloon angioplasty and two compared DEB with a first-generation paclitaxel-eluting stent. The five trials included a total of 801 patients. Endpoints for the meta-analysis were MACE, target lesion revascularization, all-cause mortality, MI, ISR and late lumen loss.
Indermuehle et al found that DEB treatment significantly reduced the risk of MACE (risk ratio 0.46) compared with plain balloon angioplasty or DES. The DEB group also had a reduced risk of target lesion revascularization (0.34) and in-stent restenosis (0.28) than the control groups. The differences in all-cause mortality and MI were not statistically significant. The rate of late lumen loss was lower in the DEB group, with a mean difference of -0.38 mm. One stent thrombosis was observed in the DEB group and one in the control group.
Noting that both the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions guidelines and the European Society of Cardiology guidelines recommend DES for the treatment of ISR, the authors suggested that the data supporting this recommendation were weak, and pointed out that DEB has several advantages over DES. Those include delivery of medication precisely at the time it is needed, avoiding the need for permanent implantation of multiple layers of stent and the potential complications associated with repeat stenting.
Indermuehle et al acknowledged that their pooled cohort was small, and that they were not able to test for covariants. “The results of MI, ST [stent thrombosis] and death need to be interpreted with care since the meta-analysis might be too small to detect statistical differences in such rare events,” they wrote. “Nevertheless, we find it reassuring that there is no difference between DES and DEB from a safety standpoint.” The authors also suggested that the relative effectiveness of DEB may be reduced when compared with the newer generation of DES.