Outcomes of the tacrolimus drug-eluting Janus stent: A prospective two-centre registry in high-risk patients

Francesco Burzotta, Carlo Trani, Filippo Crea, Elisa Romagnoli, Antonio Maria Leone, Gabriella Angeloni, Giampaolo Niccoli, Massimo Perfetti, Mario Attilio Mazzari, Antonio Giuseppe Rebuzzi, Giovanni Schiavoni

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12 Citazioni (Scopus)

Abstract

BACKGROUND: To date, only two drug-eluting stents (DES) have been extensively tested in both randomized controlled clinical trials and large 'real world' registries: sirolimus-DES (Cypher stent, Cordis, Miami Lakes, Florida, USA) and paclitaxel-DES (Taxus stent, Boston Scientific, Natick, Massachusetts, USA). Recently, a new polymer-free tacrolimus-eluting Carbofilm-coated stent, the Janus stent (Sorin Biomedica, Saluggia, Italy), has entered the market but only few clinical data testing its safety and efficacy in selected patients are available. Thus, we performed a prospective registry of consecutive, unselected patients receiving this new DES. METHODS: A total of 118 patients scheduled for percutaneous coronary intervention (PCI) with DES were enrolled in two separate centers. End-points were: (i) immediate angiographic failure; (ii) major adverse coronary events (MACE) defined as the composite of cardiovascular death, nonfatal myocardial infarction (MI) and target lesion revascularization (TLR); (iii) clinically driven TLR; (iv) and stent thrombosis at 6-month follow-up. RESULTS: A total of 192 Janus stents were successfully implanted during elective (36%) or urgent PCIs (64%), including patients with ST elevation MI (16%). Twenty-four percent of patients were diabetics and 27% underwent multivessel PCI. Target lesions were B2-C type in 54%, in-stent restenosis in 8%, and located in degenerated venous grafts in 9%. Angiographic failure was observed in five of the 147 (3.4%) lesions treated. Total MACE rate at 6-month follow-up was 22% and clinically-driven TLR was carried out in 14% of patients. Stent thrombosis occurred in 4% of cases. CONCLUSION: This registry of the new tacrolimus-eluting Carbofilm-coated Janus stent showed an incidence of MACE, TLR and stent thrombosis higher than that reported in previous similar studies on DES. Whether this risk is due to this specific device or to the unselected (i.e. high-risk) population warrants further research. © 2008 Italian Federation of Cardiology.
Lingua originaleEnglish
pagine (da-a)589-594
Numero di pagine6
RivistaJournal of Cardiovascular Medicine
Volume9
DOI
Stato di pubblicazionePubblicato - 2008

Keywords

  • Coronary Disease
  • Coronary Thrombosis
  • Drug-Eluting Stents
  • Drug-eluting stent
  • Equipment Failure
  • Female
  • Humans
  • Immunosuppressive Agents
  • Male
  • Middle Aged
  • Myocardial Infarction
  • Myocardial Revascularization
  • Percutaneous coronary interventions
  • Prospective Studies
  • Registries
  • Registry
  • Tacrolimus
  • Treatment Outcome

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