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


CONCLUSIONS
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.
Romagnoli
Enrico
E
Department of Cardiovascular Disease, Catholic University, Campobasso, Italy. enromagnolimd@gmail.com
Leone
Antonio Maria
AM
Burzotta
Francesco
F
Trani
Carlo
C
Angeloni
Giulia
G
Materazzo
Guido
G
Niccoli
Giampaolo
G
De Vita
Maria
M
Perfetti
Matteo
M
Mazzari
Mario Attilio
MA
Mongiardo
Rocco
R
Rebuzzi
Antonio Giuseppe
AG
Schiavoni
Giovanni
G
Crea
Filippo
F
D003327:Coronary Disease / Q000209:etiology; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents / Q000009:adverse effects; D004868:Equipment Failure; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy; D009204:Myocardial Revascularization; D011446:Prospective Studies; D012042:Registries; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D016559:Tacrolimus