Abstract

BackgroundThe efficacy and safety of polymer-free stent (PFS) versus permanent polymer drug-eluting stent (PPDES) in patients undergoing percutaneous coronary intervention (PCI) remain controversial. Our meta-analysis was undertaken to evaluate and compare the efficacy and safety of PFS with those of PPDES in patients undergoing PCI.MethodsWe searched PubMed, Cochrane Library, EMBASE, and Clinical Trials.gov databases for randomized controlled trials (RCTs). The primary endpoints were incidence of stent thrombosis (ST) and target-lesion revascularization (TLR). The secondary endpoints included the incidence of major adverse cardiovascular events (MACE), myocardial infarction (MI), cardiac death (CD), late lumen loss (LLL), and diameter stenosis (DS). Subgroup analyses were also conducted based on the follow-up time.ResultsEleven RCTs met the including criteria, and 8616 patients were included in the study. No significant differences were observed between PFS and PPDES treatments in the incidence of ST (RR 0.90; 95% CI: 0.62–1.31; P = 0.58; I2 = 0), TLR (RR 0.87; 95% CI: 0.76–1.00; P = 0.05; I2 = 37%), CD (RR 0.89; 95% CI: 0.72–1.10; P = 0.28; I2 = 0), MI (RR 0.87; 95% CI: 0.71–1.05; P = 0.15; I2 = 0), LLL (SMD 0.01; 95% CI: -0.29–0.30; P = 0.96; I2 = 90%), and DS (SMD -0.01; 95% CI: - 0.25 to 0.23; P = 0.93; I2 = 83%). Meanwhile, the patients with PFS had a lower incidence of MACE (RR 0.87; 95% CI: 0.78–0.97; P = 0.01; I2 = 0) than those with PPDES.ConclusionIn the overall analysis, patients with PFS presented a lower risk of MACE versus PPDES, but no significant difference were obtained in the risk of ST, TLR, MI, CD, DDD and DS. In the Short term follow up, patients with PSF presented a lower risk of TLR compared with PPDES.

Highlights

  • The efficacy and safety of polymer-free stent (PFS) versus permanent polymer drug-eluting stent (PPDES) in patients undergoing percutaneous coronary intervention (PCI) remain controversial

  • No significant differences were observed between PFS and PPDES treatments in the incidence of stent thrombosis (ST) (RR 0.90; 95% Confidence interval (CI): 0.62–1.31; P = 0.58; I2 = 0), target-lesion revascularization (TLR) (RR 0.87; 95% CI: 0.76–1.00; P = 0.05; I2 = 37%), cardiac death (CD) (RR 0.89; 95% CI: 0.72–1.10; P = 0.28; I2 = 0), myocardial infarction (MI) (RR 0.87; 95% CI: 0.71–1.05; P = 0.15; I2 = 0), late lumen loss (LLL) (SMD 0.01; 95% CI: -0.29–0.30; P = 0.96; I2 = 90%), and diameter stenosis (DS) (SMD -0.01; 95% CI: - 0.25 to 0.23; P = 0.93; I2 = 83%)

  • The patients with PFS had a lower incidence of major adverse cardiovascular events (MACE) (RR 0.87; 95% CI: 0.78–0.97; P = 0.01; I2 = 0) than those with PPDES

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Summary

Introduction

The efficacy and safety of polymer-free stent (PFS) versus permanent polymer drug-eluting stent (PPDES) in patients undergoing percutaneous coronary intervention (PCI) remain controversial. Several concerns emerged regarding the use of PPDES, which have been associated with higher rates of late stent thrombosis (ST), mainly attributed to delayed healing and reendothelization, is due to the presence of the durable polymer coating [3]. Another type of PPDES is the polymer-free stent (PFS), which is a promising device designed to offer an attractive prospect of controlled drug-release without the potential risk of late polymerassociated adverse effects [4]. No differences between PPDES and PFS in the endpoints of myocardial infarction (MI), stent thrombosis (ST), and target-lesion revascularization (TLR) were found in earlier clinical studies [6]

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