Short and long term safety of polymer-free versus durable polymer drug-eluting stents for coronary artery disease: A comprehensive meta-analysis of randomized trials including 6,943 patients.

Abstract

BACKGROUND Polymer-free drug-eluting stents(PF-DES) were developed to mitigate the risk of late ischemic events observed with durable-polymer DES (DP-DES). However, trial results are inconsistent with longer-term safety and efficacy of PF-DES unknown. We performed a meta-analysis of randomized controlled trials (RCTs) assessing outcomes of patients receiving PF-DES versus DP-DES for coronary artery disease (CAD). METHODS Electronic databases, conference proceedings, and trial registries were searched to identify RCTs comparing outcomes between PF-DES and DP-DES. Trials reporting major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis (ST), all-cause death, target lesion/vessel revascularization (TLR/ TVR), and late-lumen-loss (LLL) were included. Analyses were performed at longest follow-up and land marked beyond one-year. RESULTS Twelve trials including 6,943 patients were included, demonstrating no significant difference in MACE between PF-DES and DP-DES at longest follow-up (Odds Ratio (OR) 0.96, 95% CI 0.85-1.10, p=0.59) or landmark analysis (OR 0.93, 95%CI 0.76-1.13, p=0.46). PF-DES significantly reduced all-cause death (OR 0.85, 95% CI 0.72 - 1.00, p<0.05), but not on landmark analysis (OR 0.76, 95% CI 0.55-1.05, p=0.10). No differences were observed for MI (OR 1.00, 95% CI 0.7 -1.28, p=0.99) or ST (OR 0.95, 95%CI 0.54-1.68, p=0.86), TVR (OR 1.07, 95% CI 0.91-1.26, p=0.42), TLR (OR 1.03, 95% CI 0.88 - 1.21, p=0.68) and LLL (pooled mean difference 0.01 mm, 95% CI: -0.08-0.11, p=0.76). CONCLUSION PF-DES are as safe and efficacious as DP-DES for treatment of patients with CAD but do not significantly reduce the likelihood of recurrent adverse cardiovascular events.