Why the study?
Polymer-free drug-eluting stents have the potential to mitigate risks associated with biodegradable polymer drug-eluting stents, but their relative efficacy and safety remain to be fully elucidated.
Do polymer-free drug-eluting stents improve clinical outcomes compared to biodegradable polymer drug-eluting stents in patients undergoing PCI?
Do polymer-free drug-eluting stents improve clinical outcomes compared to biodegradable polymer drug-eluting stents in patients undergoing PCI?
Polymer-free drug-eluting stents demonstrate comparable safety and efficacy to biodegradable polymer drug-eluting stents in patients undergoing PCI.
Supports interchangeable use of PF-DES or BP-DES in PCI; confirms comparable efficacy and safety across RCTs.
BACKGROUND: Biodegradable polymer drug-eluting stents (BP-DES) are currently used in percutaneous coronary intervention (PCI). Polymer-free drug-eluting stents (PF-DES) have the potential to mitigate any risk associated with BP-DES; however, the relative efficacy and safety of these interventions remain to be fully elucidated. METHODS: A systematic search of PubMed, Embase, and Cochrane Central was performed from inception to January 2025 to identify randomized controlled trials and observational studies comparing PF-DES with BP-DES in patients undergoing PCI. Heterogeneity was assessed using the I ² statistic. A two-sided P value less than 0.05 was considered statistically significant. Prespecified subgroup analyses were conducted based on follow-up duration. RESULTS: A total of seven randomized controlled trials (RCTs) and four observational studies comprising 11 954 patients were included, of whom 5947 (49.7%) received PF-DES. In the pooled analysis, no statistically significant differences were observed between PF-DES and BP-DES in terms of cardiac death [risk ratio: 1.12, 95% confidence interval (CI): 0.96-1.31, P = 0.15], target lesion failure (risk ratio: 1.09, 95% CI: 0.81-1.46, P = 0.58), stent thrombosis (risk ratio: 0.90, 95% CI: 0.58-1.41, P = 0.64), target lesion revascularization (risk ratio: 1.28, 95% CI: 0.81-2.02, P = 0.28), or target vessel revascularization (risk ratio: 1.05, 95% CI: 0.70-1.58, P = 0.79). Likewise, no significant subgroup effect was observed regarding longer-term follow-up outcomes. CONCLUSION: This meta-analysis found comparable safety and efficacy outcomes between PF-DES and BP-DES in patients undergoing PCI; however, further RCTs are needed to evaluate long-term outcomes and newer-generation stent models.
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Jaramillo et al. (2025) studied this question.
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