Pooled Analysis of Two Randomized Trials Comparing Titanium-nitride-oxide-coated Stent Versus Drug-eluting Stent in STEMI

• Published in: Revista española de cardiología (English ed.) 2014-07, Vol.67 (7), p.531-537
• Main Authors: Tuomainen, Petri O., Sia, Jussi, Nammas, Wail, Niemelä, Matti, Airaksinen, Juhani K.E., Biancari, Fausto, Karjalainen, Pasi P.
• Format: Article
• Language: English
• Subjects: Bioactive stents; Drug-Eluting Stents - adverse effects; Everolimus-eluting stents; Female; Humans; Infarto agudo de miocardio con elevación del segmento ST; Male; Middle Aged; Myocardial Infarction - mortality; Myocardial Infarction - surgery; Outcome; Paclitaxel-eluting stents; Propensity Score; Recurrence; Resultados clínicos; ST-segment elevation myocardial infarction; Stents bioactivos; Stents liberadores de everolimus; Stents liberadores de paclitaxel; Titanium - administration & dosage; Titanium - therapeutic use; Treatment Outcome
• ISSN: 1885-5857; 1885-5857
• DOI: 10.1016/j.rec.2014.01.024

We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P=.49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P=.51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P=.04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P=.30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar. Análisis combinado basado en los datos de pacientes de los ensayos TITAX-AMI y BASE-ACS para evaluar los resultados clínicos obtenidos con stents bioactivos con recubrimiento de titanio-óxido nítrico comparados con los stents liberadores de fármacos en pacientes con infarto agudo de miocardio con elevación del segmento ST tras un seguimiento de 2 años. El ensayo TITAX-AMI comparó los stents bioactivos con los liberadores de paclitaxel en 425 pacientes con infarto agudo de miocardio. El ensayo BASE-ACS comparó stents bioactivos con stents liberadores de everolimus en 827 pacientes con síndrome coronario agudo. El objetivo principal para el análisis combinado fuer