PURPOSE

To perform a meta-analysis of randomized controlled trials (RCTs) of drug-eluting balloon (DEB) angioplasty and drug-eluting stents (DESs) for infrainguinal peripheral arterial disease.

MATERIALS AND METHODS

Systematic searches were performed for all relevant RCTs.

RESULTS

Eight RCTs for DEB angioplasty and 12 RCTs for a DES in peripheral arterial disease were identified. Meta-analysis demonstrated statistically significant superiority of DEB over plain balloon angioplasty of femoral-popliteal disease for late lumen loss, restenosis, and target lesion revascularization, with no benefit in major amputation or mortality. Statistically significant superiority of DEB over percutaneous transluminal angioplasty (PTA) was demonstrated for infrapopliteal disease for restenosis and target lesion revascularization. Drug-eluting stents showed statistically significant superiority over bare metal stents (BMSs) of femoral-popliteal disease for late lumen loss and restenosis, with no benefit in mortality or amputation. Drug-eluting stents showed statistically significant superiority over BMSs of infrapopliteal disease restenosis and target lesion revascularization, with no benefit in amputation or mortality.

CONCLUSIONS

Drug-eluting balloon angioplasty and DESs demonstrated superior outcomes compared to PTA and BMS, with no difference in amputation or mortality.