Optimal Stent Design for High Bleeding Risk Patients: Evidence From a Network Meta-Analysis.

OBJECTIVE To determine the best stent design for high bleeding risk (HBR) patients. BACKGROUND Polymer-free (PF) drug eluting stent (DES) devices have a proven benefit over bare-metal stent (BMS) devices in previous trials. It is unknown, however, whether polymer-based (PB)-DES devices are as safe as PF-DES devices. METHODS A network meta-analysis including all randomized controlled trials (RCTs) that compared different stent technology in HBR patients with a 1-month course of dual-antiplatelet therapy (DAPT) was performed. The main efficacy outcome was major adverse cardiac event (MACE) rate, defined as the composite of all-cause mortality, myocardial infarction (MI), and target-lesion revascularization (TLR). Secondary efficacy events included all-cause and cardiac mortality, MI, stroke, TLR, and target-vessel revascularization (TVR). Safety outcomes included all bleeding, major bleeding, and stent thrombosis (ST). RESULTS A total of 4 RCTs with 6456 patients were included. PF-DES and PB-DES yielded a reduced rate of MACE, MI, TLR, and TVR events compared with BMS (all P<.05). ST events were reduced in PB-DES compared with BMS (P=.01). No differences were found in all-cause death, cardiac death, or stroke events in PF-DES and PB-DES compared with BMS. Furthermore, no differences were found between PF-DES and PB-DES regarding any of the outcomes. CONCLUSION DES devices were associated with lower MACE and TVR rates compared with BMS, whereas there were no statistical differences in other efficacy endpoints. Also, PB-DES were associated with fewer ST events compared with BMS. There were no statistical differences between PB-DES and PF-DES with regard to any of the endpoints.