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Drug-eluting balloons not supported for de novo coronary lesions
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A meta-analysis has concluded that current data do not support the use of drug-eluting balloons for de novo coronary lesions, especially simple ones.
Researchers from China performed a meta-analysis of seven randomized controlled trials comprising 1,355 patients. The trials examined a primary angiographic endpoint of in-segment diameter stenosis — which were compared by measuring weighted mean difference — and a primary clinical endpoint of MACE (defined as a composite of death, MI and target lesion revascularization) during 1-year follow-up.
For de novo native coronary lesions intervention, drug-eluting balloons plus bare-metal stents were not superior to BMS alone in both primary angiographic and clinical endpoints with regard to in-segment diameter stenosis (weighted mean difference, –2.59%; 95% CI, –9.13 to 3.94) and MACE (RR=0.83; 95% CI, 0.48-1.46).
Drug-eluting balloons with/without BMS was associated with worse outcomes when compared with drug-eluting stents alone in both in-segment diameter stenosis (weighted mean difference, 10.64%; 95% CI, 2.41-18.87) and MACE (RR=1.54; 95% CI, 0.91-2.61).
Subgroup analysis showed that drug-eluting balloons plus BMS significantly increased the risk of MACE for simple de novo coronary lesions intervention when compared with DES alone (RR=1.87; 95% CI, 1.33-2.63).
Researchers noted that four of the seven studies included in the meta-analysis looked specifically at a “DEB plus systematic BMS” strategy in simple de novo coronary lesions and found no support for the strategy.
“Our study revealed that application ‘DEB plus systematic BMS’ instead of DES may be harmful for simple de novo native coronary lesions intervention in unselected population and should not be recommended,” they wrote. “Whether ‘DEB plus systematic BMS’ is viable for highly selected population remains to be further tested.”
Disclosure: The researchers report no relevant financial disclosures.
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