Abstract
BackgroundPolymer-free drug-eluting stents (PF-DES) were introduced with the aim of reducing the risk of stent thrombosis associated with durable polymer drug-eluting stents (DP-DES). The comparison of safety and efficacy profiles between these two stent platforms remains unclear.Materials and methodsWe conducted electronic database searches for randomized controlled trials (RCTs) comparing patients treated with either PF-DES or DP-DES. Outcomes included definite or probable stent thrombosis (ST), myocardial infarction (MI), cardiac death, all-cause death, target lesion revascularization (TLR), and target vessel revascularization (TVR). A random-effects model was used to derive risk ratios (RRs) with 95% confidence intervals (CIs). Subgroup analyses based on different variables were also performed. After screening a total of 1026 articles, the present meta-analysis included 13 RCTs comprising 8021 patients.ResultsNo significant differences were found for the risks of definite or probable ST (RR, 0.94; 95% CI, 0.62–1.43; P = 0.77), MI (RR, 1.06; 95% CI, 0.85–1.33; P = 0.61), cardiac death (RR, 0.98; 95% CI, 0.80–1.21; P = 0.88), all-cause death (RR, 0.87; 95% CI, 0.76–1.00; P = 0.06), TLR (RR, 1.12; 95% CI, 0.94–1.33; P = 0.22), and TVR (RR, 1.18; 95% CI, 0.87–1.61; P = 0.29). Similarly, no significant differences were found for all outcomes regardless of anti-proliferative drug, except for an increased risk of TLR for polymer-free paclitaxel-eluting stents compared with DP-DES (RR, 2.32, 95% CI, 1.30–4.14; P = 0.005).ConclusionsOur findings showed that PF-DES and DP-DES confer equivalent safety and efficacy profiles, with similar rates of stent thrombosis.
Highlights
Drug-eluting stents have been a major advance in percutaneous coronary intervention (PCI)
Polymer-free drug-eluting stents (PF-DES) were introduced with the aim of reducing the risk of stent thrombosis associated with durable polymer drug-eluting stents (DP-DES)
No significant differences were found for the risks of definite or probable stent thrombosis (ST) (RR, 0.94; 95% confidence intervals (CIs), 0.62–1.43; P = 0.77), myocardial infarction (MI) (RR, 1.06; 95% CI, 0.85–1.33; P = 0.61), cardiac death (RR, 0.98; 95% CI, 0.80–1.21; P = 0.88), all-cause death (RR, 0.87; 95% CI, 0.76–1.00; P = 0.06), target lesion revascularization (TLR) (RR, 1.12; 95% CI, 0.94–1.33; P = 0.22), and target vessel revascularization (TVR) (RR, 1.18; 95% CI, 0.87–1.61; P = 0.29)
Summary
Drug-eluting stents have been a major advance in percutaneous coronary intervention (PCI). The sequential generations of devices have represented significant milestones in stent design, structure, and component materials [1] These stent platforms have included bare metal stents (BMS), durable polymer drug-eluting stents (DP-DES) and polymer-free drug-eluting stents (PF-DES). The pathophysiology of stent thrombosis has been attributed to various factors, such as polymer-induced hypersensitivity reaction, stent malapposition, incomplete strut re-endothelialization, and accelerated neoatherosclerosis [4] To address this issue, a new generation of DPDES were developed, with improvements in anti-proliferative drugs, polymer coatings, and strut thickness [5]. No significant differences were found for all outcomes regardless of anti-proliferative drug, except for an increased risk of TLR for polymer-free paclitaxeleluting stents compared with DP-DES (RR, 2.32, 95% CI, 1.30–4.14; P = 0.005). Conclusions: Our findings showed that PF-DES and DP-DES confer equivalent safety and efficacy profiles, with similar rates of stent thrombosis
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