4-Year outcome of bioactive stents versus everolimus-eluting stents in acute coronary syndrome.
OBJECTIVE
The BASE-ACS trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), versus everolimus-eluting stents (EES), for major adverse cardiac events (MACE) at 1- and 2-year follow-up, in patients with acute coronary syndrome (ACS). We presented the 4-year outcome of the BASE-ACS trial.


METHODS
We randomized 827 patients with ACS to receive either BAS (417) or EES (410). MACE was a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analyses were performed by intention to treat. Follow-up was planned at 12 months, and yearly thereafter for 5 years.


RESULTS
Four-year clinical follow-up was completed in 753 (91.1%) patients. At 4 years, BAS were non-inferior to EES for MACE (14.7% versus 17.8%, respectively; p = 0.24 for superiority; p = 0.001 for non-inferiority). Non-fatal MI was less frequent with BAS (5.0% versus 9.2%, respectively; p = 0.025). Cardiac death and ischemia-driven TLR were comparable (2.9% versus 3.5%, and 8.6% versus 9.2%; p = 0.62 and p = 0.80, respectively). Independent predictors of MACE were calcified lesions (HR 1.54, p = 0.021), the number of vessels treated (HR 1.53, p = 0.025), and reference vessel diameter (HR 0.54, p = 0.006).


CONCLUSIONS
In patients presenting with ACS, BAS was associated with a clinical outcome non-inferior to EES at 4-year follow-up.
a Heart Center, Satakunta Central Hospital , Pori , Finland ;
Pasi P
PP
Karjalainen
b Department of Internal Medicine, Division of Cardiology , University of Oulu , Oulu , Finland ;
Matti
M
Niemelä
c Heart Center, Turku University Hospital , Turku , Finland ;
Mikko
M
Pietilä
d Department of Cardiology , Kokkola Central Hospital , Kokkola , Finland ;
Jussi
J
Sia
e Department of Cardiology , Brighton and Sussex University Hospital NHS Trust , Brighton , UK ;
Adam
A
de Belder
f Interventional Cardiology Section, La Princesa University Hospital , Madrid , Spain ;
Fernando
F
Rivero-Crespo
g Cardiovascular Center Aalst, OLV-Clinic , Aalst , Belgium.
Bernard
B
de Bruyne
a Heart Center, Satakunta Central Hospital , Pori , Finland ;
Wail
W
Nammas
D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000628:therapy; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D011474:Prosthesis Design; D014025:Titanium / Q000627:therapeutic use*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; C434243:titanium-nitride-oxide; D000068338:Everolimus; D014025:Titanium
Acute coronary syndrome; everolimus-eluting stents; titanium-nitride-oxide-coated stents