Gender-based analysis of the 3-year outcome of bioactive stents versus paclitaxel-eluting stents in patients with acute myocardial infarction: an insight from the TITAX-AMI trial.

Background: The TITAX-AMI trial demonstrated a better clinical outcome of titanium-nitride-oxide-coated bioactive stents (BAS) as compared with paclitaxel-eluting stents (PES) in patients with acute myocardial infarction (MI) undergoing early percutaneous coronary intervention (PCI). We explored the gender-based 3-year outcome of BAS as compared with PES in a subgroup analysis of the TITAX-AMI trial.

Methods: A total of 214 patients (52 women) with acute MI were randomly assigned to BAS, and 211 patients (54 women) to PES. The primary endpoint was major adverse cardiac events (MACE) including cardiac death, recurrent MI, and target lesion revascularization (TLR). Secondary endpoints were all-cause death, a composite of cardiac death or recurrent MI, and stent thrombosis (ST).

Results: Women were older and had smaller reference vessel diameter (P<.001 for both) as compared with men. At 3-year follow-up, both MACE and TLR showed a trend to be higher in women as compared with men (24.5% versus 16.3% [P=.059] and 15.1% versus 8.8% [P=.065], respectively). The rate of all-cause death was significantly higher in women as compared with men (13.2% versus 6.0%, respectively; P=.02). Among female patients, MACE, cardiac death, recurrent MI, TLR, and ST were all statistically similar between the two stent groups (P>.05 for all).

Conclusions: In the current post hoc gender-based analysis of the TITAX-AMI trial, the 3-year outcome of patients undergoing PCI for acute MI was slightly worse in female patients as compared with their male counterparts, as reflected by a trend toward a higher primary composite endpoint of MACE and TLR.