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Drug-eluting balloon appears safer than EES for DES in-stent restenosis
Results from a small observational study found that treating drug-eluting stent in-stent restenosis with a drug-eluting balloon was associated with fewer adverse events and a lower rate of target lesion revascularization at 1 year compared with a second-generation everolimus-eluting stent.
Researchers from the RWTH Aachen University Hospital in Germany compared clinical outcomes of a DEB with paclitaxel (n=46; SeQuent Please, Braun) with those of a second-generation everolimus-eluting stent (EES; n=40; Xience V, Abbott Vascular) for in-stent restenosis in 86 patients. Patients were eligible if they presented with angina pectoris, had a positive stress test or had angiographically proven significant in-stent restenosis >50%. Patients were not included in the study if they presented with MI.
At 1 year, MACE was 27.5% with EES vs. 8.6% for DEB (P=.046). TLR rates also were significantly lower with the DEB (4.3% vs. 22.5%; P=.029). Rates of definite stent thrombosis at 1-year follow-up were similar (EES, 2.5% vs. DEB, 0%; P=.945).
In other results, rates of MI (EES, 5% vs. DEB, 2%; P=.595) and mortality were similar. Use of DEB was associated with significantly less MACE compared with EES (log-rank test; P=.045) for complete follow-up periods, whereas TLR rates showed a trend in favor of DEB (P=.074).
For DEBs, the antiproliferative drug is delivered without the potential technical complications of a DES, such as malapposition, underexpansion of the stent, stent fracture or stent thrombosis, the researchers wrote. Additionally, the potential polymer hypersensitivity is eliminated and antiplatelet therapy is recommended for only 3 months.
“Although use of a DES for treatment of DES in-stent restenosis is a common treatment strategy, the use of a DEB should be considered to be more effective and safe in the treatment of DES in-stent restenosis,” they wrote.