Safety and effectiveness of the Catania Polyzene-F coated stent in real world clinical practice: 12-month results from the ATLANTA 2 registry.
OBJECTIVE
The pivotal ATLANTA first-in-man study showed the promising safety and efficacy profile of the novel Catania™ stent in a population with ~20% American College of Cardiology/American Heart Association (ACC/AHA) type C coronary lesions. The ATLANTA 2 registry was designed to evaluate the 12-month safety and efficacy of the Catania stent in a broader real world scenario.


RESULTS
The ATLANTA 2 registry was a prospective, non-randomised, single-arm study of patients with symptomatic ischaemic heart disease and de novo lesions of native coronary arteries. A total of 300 patients (396 lesions) were recruited and 482 Catania stents were implanted. At 12 months, major adverse cardiac events were 8.8%, mainly driven by target lesion revascularisation (6.5%). Cardiac death and non-fatal myocardial infarction occurred in 2.5% and 0.7% of patients, respectively. Subacute definite or probable stent thrombosis was 0.7%. No late stent thrombosis was recorded. Compared with patients treated with drug-eluting stents or bare metal stents in the study period, those treated with Catania stents experienced similar outcomes at one year.


CONCLUSIONS
The 12-month results of the ATLANTA 2 registry confirmed the positive results of the ATLANTA first-in-man trial in a more complex population. A randomised trial is needed to assess the comparative value of the Catania stent over currently-used drug-eluting stents or bare metal stents.
Cardiovascular Department, Ferrarotto Hospital, Catania, Italy.
Corrado
C
Tamburino
Davide
D
Capodanno
Maria Elena
ME
Di Salvo
Alessandra
A
Sanfilippo
Irene
I
Cascone
Valentina
V
Incardona
Giovanni
G
Longo
Daniele
D
Giacoppo
Piera
P
Capranzano
Carmelo
C
Sgroi
Gianpaolo
G
Ussia
Alfio
A
Monaco
Alessio
A
La Manna
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D002858:Chromium Alloys / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D017202:Myocardial Ischemia / Q000628:therapy*; D011446:Prospective Studies; D012042:Registries; D012189:Retrospective Studies; D015607:Stents / Q000009:adverse effects; D013927:Thrombosis / Q000453:epidemiology; D016896:Treatment Outcome
D002858:Chromium Alloys