Background: Polymer-coating represents one of components of drug-eluting stents (DES) to have experienced a more intensive technological evolution. Polymer-free DES (PF-DES) have offered promising angiographic results, with earlier complete re-endothelization, potentially reducing the thrombotic risk and offering the option of a shorter antiplatelet therapy. However, contrasting prognostic data have been reported so far with PF-DES. Therefore, the aim of the present study was to perform a comprehensive updated meta-analysis of randomized trials (RCT) comparing the impact of PF-DES vs polymer- coated DES (PC-DES) on clinical outcome.Methods: Literature and main scientific session abstracts were searched for RCTs comparing PF-DES vs PC-DES for the treatment of CAD. The primary efficacy endpoint was mortality, secondary endpoints were cardiovascular death, myocardial infarction, target lesion revascularization (TLR) and stent thrombosis.Results: We included 16 randomized clinical trials, with a total of 15,689 patients, including 50.6% randomized to PF-DES. At a median follow-up of 24 months, PF-DES were associated to a significant reduction in mortality as compared to PC-DES (0.82 [0.68, 0.99], p=.03, I2 = 0%; phet = 0.93). However, no significant benefit was observed in terms of cardiovascular death or major ischemic endpoints (respectively CV death: OR [95% CI]= 0.92 [0.71, 1.18] p=.50, I2= 0.50; phet= 0.84; MI: OR [95% CI]= 1.08 [0.90, 1.29], p=.42; I2= 0%, phet= 0.98; TLR: OR [95% CI]= 1.02 [0.78, 1.32], p=.91; I2= 0.63 phet = 0.0003; ST: OR [95% CI]= 0.98 [0.87, 1.10], p=.72; I2= 0% phet= 0.64). By meta-regression analysis, the mortality benefits of PF-DES were not conditioned by the rate of diabetes mellitus or acute coronary syndromes.Conclusions: Based on the current meta-analysis, PF-DES are associated to a significant reduction in mortality as compared to PC-DES, but not in the occurrence of major ischemic events. Future larger studies are certainly needed to further investigate and confirm our findings, especially in particular subsets of patients, such as those with high bleeding risk or acute myocardial infarction. (c) 2019 Elsevier Inc. All rights reserved.
Polymer-Free vs. Polymer-Coated Drug-Eluting Stents for the Treatment of Coronary Artery Disease: A Meta-Analysis of 16 Randomized Trials
De Luca, Giuseppe
2020-01-01
Abstract
Background: Polymer-coating represents one of components of drug-eluting stents (DES) to have experienced a more intensive technological evolution. Polymer-free DES (PF-DES) have offered promising angiographic results, with earlier complete re-endothelization, potentially reducing the thrombotic risk and offering the option of a shorter antiplatelet therapy. However, contrasting prognostic data have been reported so far with PF-DES. Therefore, the aim of the present study was to perform a comprehensive updated meta-analysis of randomized trials (RCT) comparing the impact of PF-DES vs polymer- coated DES (PC-DES) on clinical outcome.Methods: Literature and main scientific session abstracts were searched for RCTs comparing PF-DES vs PC-DES for the treatment of CAD. The primary efficacy endpoint was mortality, secondary endpoints were cardiovascular death, myocardial infarction, target lesion revascularization (TLR) and stent thrombosis.Results: We included 16 randomized clinical trials, with a total of 15,689 patients, including 50.6% randomized to PF-DES. At a median follow-up of 24 months, PF-DES were associated to a significant reduction in mortality as compared to PC-DES (0.82 [0.68, 0.99], p=.03, I2 = 0%; phet = 0.93). However, no significant benefit was observed in terms of cardiovascular death or major ischemic endpoints (respectively CV death: OR [95% CI]= 0.92 [0.71, 1.18] p=.50, I2= 0.50; phet= 0.84; MI: OR [95% CI]= 1.08 [0.90, 1.29], p=.42; I2= 0%, phet= 0.98; TLR: OR [95% CI]= 1.02 [0.78, 1.32], p=.91; I2= 0.63 phet = 0.0003; ST: OR [95% CI]= 0.98 [0.87, 1.10], p=.72; I2= 0% phet= 0.64). By meta-regression analysis, the mortality benefits of PF-DES were not conditioned by the rate of diabetes mellitus or acute coronary syndromes.Conclusions: Based on the current meta-analysis, PF-DES are associated to a significant reduction in mortality as compared to PC-DES, but not in the occurrence of major ischemic events. Future larger studies are certainly needed to further investigate and confirm our findings, especially in particular subsets of patients, such as those with high bleeding risk or acute myocardial infarction. (c) 2019 Elsevier Inc. All rights reserved.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
