Key result
Phosphorylcholine polymer-zotarolimus-eluting stents resulted in a similar 3-year cumulative incidence of major adverse cardiac events compared to BioLinx polymer-zotarolimus-eluting stents (HR 1.525).
Why the study?
Long-term outcome data comparing BioLinx polymer-zotarolimus-eluting stents with phosphorylcholine polymer-zotarolimus-eluting stents were limited.
Does BioLinx polymer-zotarolimus-eluting stents reduce major adverse cardiac events compared to phosphorylcholine polymer-zotarolimus-eluting stents in patients undergoing percutaneous coronary intervention?
Observational (n=1,245)
No
Does BioLinx polymer-zotarolimus-eluting stents reduce major adverse cardiac events compared to phosphorylcholine polymer-zotarolimus-eluting stents in patients undergoing percutaneous coronary intervention?
Effect estimate: HR 1.525 (95% CI 0.920-2.526)
Absolute Event Rate: 13.8% vs 9.1%
p-value: p=0.101
In a real-world all-comers registry, BioLinx polymer and phosphorylcholine polymer zotarolimus-eluting stents demonstrated comparable 3-year safety and efficacy outcomes.
Comparable MACE rates suggest no stent preference in practice; leaves open need for randomized confirmation of equivalence.
There are limited long-term outcome data comparing BioLinx polymer (B)-zotarolimus-eluting stents (ZES) with phosphorylcholine polymer (P)-ZES. The aim of this study was to compare the efficacy and safety of B-ZES with P-ZES in patients who underwent percutaneous coronary intervention (PCI) during a 3-year follow-up period.One thousand two hundred fifty four patients who underwent PCI with P-ZES (Endeavor [ZES-E] or Endeavor sprint [ZES-S], n = 356) or B-ZES (Endeavor resolute [ZES-R] or Resolute Integrity [ZES-I], n = 889) were enrolled. The primary endpoint was major adverse cardiac events (MACE); the composite of total death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), non-target vessel revascularization (Non-TVR), and the secondary endpoint was stent thrombosis (ST).After PSM, 2 propensity-matched (PSM) groups (275 pairs, n = 550, C-statistic = 0.730) were generated. During the 3-year follow-up period, the cumulative incidence of MACE (hazard ratio [HR], 1.525; 95% confidence interval [CI], 0.920-2.526; P = .101) and ST (HR, 1.248; 95% CI, 0.335-4.4649; P = .741) were similar between P-ZES and B-ZES after PSM. However, TLR rate was significantly higher in ZES-S than ZES-I (11.3% vs 3.8%, log rank P = .029) and TVR rate was higher in ZES-S than ZES-R (14.1% vs 4.8%, log rank P = .025).In this single-center, all-comer registry, despite different polymers, P-ZES, and B-ZES showed comparable safety and efficacy during a 3-year follow-up period after PCI.
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Kim et al. (2019) conducted an observational in Coronary artery disease requiring percutaneous coronary intervention (n=1,245). Phosphorylcholine polymer-zotarolimus-eluting stents (P-ZES) vs. BioLinx polymer-zotarolimus-eluting stents (B-ZES) was evaluated on Major adverse cardiac events (MACE) (HR 1.525, 95% CI 0.920-2.526, p=0.101). Phosphorylcholine polymer-zotarolimus-eluting stents resulted in a similar 3-year cumulative incidence of major adverse cardiac events compared to BioLinx polymer-zotarolimus-eluting stents (HR 1.525).
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