Study Supports Drug-Eluting Balloon Angioplasty for In-Stent Restenosis

January 18, 2013—Andreas Indermuehle, MD, et al published findings from a systematic review and meta-analysis of randomized controlled trials of drug-eluting balloon (DEB) angioplasty for in-stent restenosis. The study is available online ahead of print in Heart, an affiliated publication of the British Medical Journal.

In the Heart abstract, the investigators stated that the study was conducted because the optimal treatment option for in-stent restenosis is currently unclear. The investigation involved a literature search from 2005 through November 7, 2012, of randomized clinical trials comparing DEB angioplasty with a control treatment of either plain balloon angioplasty or drug-eluting stents. Main endpoints of interest were major adverse cardiac events (MACE), target lesion revascularization, binary in-segment restenosis, stent thrombosis, myocardial infarction, and mortality. A random-effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals.

As summarized online in Heart, five studies and a total of 801 patients were included in this analysis. Follow-up duration ranged from 12 to 60 months. Most endpoints were significantly reduced for DEB angioplasty compared with the control groups. For MACE, RR = 0.46 (0.31 to 0.7); P < .001. For target lesion revascularization, RR = 0.34 (0.16 to 0.73); P = .006. For angiographic in-segment restenosis, RR = 0.28 (0.14 to 0.58); P < .001. There was a lower mortality for DEB: RR = 0.48 (0.24 to 0.95); P = .034. The incidence of myocardial infarction was numerically lower, but the differences were not statistically significant: RR = 0.68 (0.32 to 1.48); P = .337. There was no difference in the risk of stent thrombosis: RR = 1.12 (0.23 to 5.5); P = .891.

From these data, the investigators concluded that DEB angioplasty is a promising treatment option for in-stent restenosis related to coronary angioplasty because it reduces the risk for MACE compared with plain balloon angioplasty or implantation of a drug-eluting stent.