What question did this study set out to answer?

To compare the safety and efficacy of polymer-free drug-eluting stents (PF–DES) versus biodegradable polymer drug-eluting stents (BP–DES) in patients undergoing percutaneous coronary interventions.

February 22, 2026Open Access

Safety, efficacy, OCT-assessed vascular healing and angiographic outcomes of polymer-free versus biodegradable-polymer drug-eluting stents in patients undergoing percutaneous coronary intervention: a systematic review and meta-analysis

Key Points

To compare the safety and efficacy of polymer-free drug-eluting stents (PF–DES) versus biodegradable polymer drug-eluting stents (BP–DES) in patients undergoing percutaneous coronary interventions.
Included RCTs comparing PF–DES and BP–DES in patients undergoing percutaneous coronary interventions.
Primary endpoints included target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis, and angiographic outcomes.
Risk of bias assessed using Cochrane’s ROB 2.0; meta-analysis performed using RevMan 5.4.
PF–DES showed significantly higher TLR rates at 12 months (2.08% vs. 1.36%, RR 1.55), lasting to 24 months (RR = 2.01).
OCT analyses at 1–3 months indicated no significant differences in uncovered struts; findings on malapposed struts varied.
PF–DES had greater in-stent late lumen loss at 6–8 months (MD: 0.24 mm), while minimal lumen diameter was similar.
No significant differences found in TVR, stent thrombosis, myocardial infarction, or mortality at 1- or 2-year follow-up.

Abstract

Abstract Background Biodegradable polymer (BP) and polymer-free (PF) drug eluting stents were designed to reduce late adverse events linked to durable-polymer coatings. However, concerns remain regarding the efficacy of PF–DES particularly due to variations in drug-release mechanisms. Methods RCTs comparing PF–DES and BP–DES in patients undergoing percutaneous coronary interventions were included. Primary endpoints were Target lesion revascularization (TLR), Target vessel revascularization (TVR), definite stent thrombosis, Cardiac death (CD), angiographic outcomes and optical coherence tomography (OCT) findings. Risk of bias was assessed using Cochrane’s ROB 2.0 and meta-analysis performed using RevMan 5.4. Results Ten RCTs including 9020 patients (4043 PF–DES; 4977 BP–DES) were included. At 12 months, PF–DES showed a significantly higher TLR rate (2.08% vs. 1.36%; RR 1.55, 95% CI 1.087–2.21; P = 0.02), persisting at 24 months (RR = 2.01, 95% CI 1.46–2.77, P < 0.0001). At 1–3 months, OCT-derived analyses demonstrated no statistically significant differences in uncovered struts or neointimal thickness between stent types, while findings related to malapposed struts were heterogenous and dependant on sensitivity analyses. Angiographically, PF–DES showed greater in-stent late lumen loss at 6–8 months (MD: 0.24 mm, 95% CI 0.17–0.30, P < 0.00001), whereas minimal lumen diameter was comparable. However, no significant differences were found in target vessel revascularization (TVR), stent thrombosis, myocardial infarction, or mortality at 1- or 2-year follow-up. Conclusions PF–DES were associated with comparable safety to BP–DES; however, it exhibited higher rates of target lesion revascularization and greater late lumen loss were observed. OCT-derived findings were heterogenous and should be interpreted cautiously. Further RCTs with standardized imaging protocols and longer follow-up are warranted.

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