Clinical outcomes of real-world patients treated with an amphilimus polymer-free stent versus new generation everolimus-eluting stents.
OBJECTIVE
To compare the 1-year clinical outcomes after implantation of the amphilimus, polymer-free stent (Cre8) versus new generation everolimus-eluting stents (EESs) in a real-world patient registry.


METHODS
A total of 187 consecutive patients treated with Cre8 between January 2011 and August 2013 in four Italian centers were included. These were propensity matched with 150 patients treated with new generation EES during the same period. Primary outcome was 1-year major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, and target vessel revascularization.


RESULTS
Both groups had similar baseline characteristics, including diabetes (28% Cre8 vs. 27.3% EES, P = 0.972) and previous percutaneous coronary intervention (56% Cre8 vs. 58% EES, P = 0.726). There was a higher prevalence of B2/C lesions in the EES group (70.1% vs. 83.8%, P < 0.001). Total stent length per patient was similar. There were no significant differences in 1-year estimated MACE (7.4% Cre8 vs. 10.2% EES, P = 0.261), all-cause mortality (1.3% Cre8 vs. 1.4% EES, P = 0.823), target vessel revascularization (5.2% Cre8 vs. 8.8% EES, P = 0.169), and target lesion revascularization (3% Cre8 vs. 7.4% EES, P = 0.108) between the two groups. When adjusting for differences in baseline lesion characteristics, hazard ratio(Cre8/EES) for MACE was not significantly different between the two groups (0.75, 95% confidence interval 0.37-1.53, P(noninferiority) = 0.001, P(superiority) = 0.432). In patients with diabetes (Cre8, n = 42; EEE, n = 41), 1-year target lesion revascularization was 2.5% in the Cre8 group versus 14.6% in the EES group (P = 0.056).


CONCLUSIONS
In a "real-world" patient registry, the Cre8 stent is associated with noninferior 1-year MACE rates compared with that of new generation EES. Trends of superior efficacy in patients with diabetes treated with Cre8 require further investigation.
Cardiovascular science division, Faculty of Medicine, National Heart and Lung Institute, Imperial College London, London, Greater London, United Kingdom.|Interventional Cardiology Department, EMO GVM Centro Cuore Columbus, Milan, Italy.|Interventional Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.
Vasileios F
VF
Panoulas
Interventional Cardiology Department, EMO GVM Centro Cuore Columbus, Milan, Italy.|Interventional Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.
Azeem
A
Latib
Interventional Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.
Charbel
C
Naim
Interventional Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.
Katsumasa
K
Sato
Interventional Cardiology Department, Azienda Ospedaliera Bolognini, Seriate, Bergamo, Italy.
Alfonso
A
Ielasi
Interventional Cardiology Department, Istituto Clinico San Ambrogio, Milan, Italy.
Maurizio
M
Tespili
Interventional Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.
Cosmo
C
Godino
Interventional Cardiology Department, Istituto Clinico San Ambrogio, Milan, Italy.
Luca
L
Testa
Interventional Cardiology Department, Istituto Clinico San Ambrogio, Milan, Italy.
Francesco
F
Bedogni
Interventional Cardiology Department, EMO GVM Centro Cuore Columbus, Milan, Italy.|Interventional Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.
Antonio
A
Colombo
D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers; D015995:Prevalence; D057216:Propensity Score; D011474:Prosthesis Design; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D011108:Polymers; D000068338:Everolimus
drug-eluting stent; new generation; polymer free; real world