Safety and efficacy of polymer-free drug-eluting stents: Amphilimus-eluting Cre8 versus biolimus-eluting biofreedom stents

Mauro Chiarito, Gennaro Sardella, Antonio Colombo, Carlo Briguori, Luca Testa, Francesco Bedogni, Franco Fabbiocchi, Anita Paggi, Altin Palloshi, Corrado Tamburino, Alberto Margonato, Carlo Andrea Pivato, Usman Baber, Simone Calcagno, Arturo Giordano, Cosmo Godino, Giulio G. Stefanini

Research output: Contribution to journalArticlepeer-review


Background: Polymer-free drug-eluting stents are based on different technologies for drug binding and release without the use of polymer coatings. It is unknown whether different polymer-free drug-eluting stents are comparable in terms of safety and efficacy profiles. Methods and Results: Polymer-free BioFreedom biolimus-eluting stents (BES) and polymer-free Cre8 amphilimus-eluting stents (AES) were investigated in 2 recent multicenter registries including 2320 all-comer patients undergoing percutaneous coronary interventions at 22 Italian centers. Using propensity score matching, safety and efficacy outcomes were compared among 1280 patients (640 matched pairs) treated with BioFreedom BES or Cre8 AES. The primary end point was target lesion failure- A composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR). At 1 year, target lesion failure occurred in 4.0% of BES and 4.2% of AES-treated patients (hazard ratio [HR] 0.98, 95% CI, 0.57-1.70). Risks of cardiac death (2.0% versus 2.1%; HR, 1.03; 95% CI, 0.47-2.26), target vessel myocardial infarction (0.8% versus 0.3%; HR, 1.89; 95% CI, 0.50-6.80), TLR (1.5% versus 2.2%; HR, 0.74; 95% CI, 0.34-1.62), and definite/probable stent thrombosis (0.9% versus 0.8%; HR, 1.17; 95% CI, 0.36-3.81) were comparable in patients treated with BioFreedom BES and Cre8 AES. A differential treatment effect by diabetes mellitus status was observed, indicating a benefit of AES in patients with diabetes mellitus (P interaction=0.003). Conclusions: The present study shows that BioFreedom BES and Cre8 AES have favorable and comparable safety and efficacy profiles in all-comer patients undergoing percutaneous coronary intervention. Further evaluation in large-scale, randomized trials are necessary to confirm our findings.

Original languageEnglish
Article numbere007311
JournalCirculation: Cardiovascular Interventions
Issue number2
Publication statusPublished - Feb 1 2019


  • diabetes mellitus
  • drug-eluting stents
  • percutaneous coronary intervention
  • polymers
  • thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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