Early and mid-term clinical outcomes with the CATANIA coronary stent system vs. bare metal stents in patients with coronary artery disease.
BACKGROUND
The potential for the CATANIA (CAT) stent to be an alternative to both bare-metal stents (BMS) and drug-eluting stents (DES) has been recently demonstrated in the Assessment of The LAtest Non-Thrombogenic Angioplasty stent (ATLANTA) first-in-human study. The aim of the present study was to compare short-term outcomes of patients treated with the CAT stent with those treated with BMS.


METHODS
Based on an internal registry, the 30-day and 6-month risk-adjusted outcomes for patients who received the CAT stent (n=254) were compared against outcomes of a historical cohort of patients who received BMS (n=552) between January 2001 and December 2001.


RESULTS
At 30 days, use of BMS vs. the CAT stent resulted in borderline significant differences with respect to major adverse cardiac and cerebrovascular events (MACCE) and cardiac death or myocardial infarction. At 6 months, BMS showed a statistically significant higher adjusted risk of MACCE (HR 2.79, 95% CIs 1.20-6.48, P=.017) and no differences with respect to the subcomponent end points. The cumulative incidence of definite stent thrombosis (Academic Research Consortium defined) at 6 months was 0.39% for the CAT stent and 2.35% for the BMS.


CONCLUSIONS
This study confirms the favorable early and mid-term safety profile and the high-level efficacy of the CAT stent in the treatment of de novo coronary lesions seen in the ATLANTA trial. The use of stents with a nanothin Polyzene-F surface treatment provided improved results with respect to BMS and lower risk of acute and subacute stent thrombosis.
Capodanno
Davide
D
Department of Cardiovascular Diseases, Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. dcapodanno@gmail.com
La Manna
Alessio
A
Di Salvo
Maria Elena
ME
Sanfilippo
Alessandra
A
Corcos
Thierry
T
Tamburino
Corrado
C
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002561:Cerebrovascular Disorders / Q000209:etiology / Q000401:mortality; D020099:Coated Materials, Biocompatible; D015331:Cohort Studies; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D008670:Metals