Study Design:

  • Multi-center, international, prospective, randomized, controlled trial 
  • 12 sites
  • 1491 patients
  • Primary Efficacy Endpoint at 12 months: MACE (cardiac death, MI or TLR)
  • Co-Primary Safety Endpoint at 18 months: A composite of cardiac death, MI or major bleeding  
  • Secondary Endoints : individual components of the primary endpoint, rate of thrombosis
  • Follow-up 18 & 60 months

Key Findings at 12 and 18 months follow ups:

The clinical trial met both its co-primary endpoint of MACE non-inferiority at 12 months and Safety composite superiority at 18 months. The novel TiTAN OPTIMAX TiNO coated bioactive stent achieved a very low 6.3% MACE rate compared to 7.0% for Synergy DES (p for non-inferiority <0.001), as well as a rate of cardiac death, MI or major bleeding rate of 3.7% compared to 7.8% for Synergy DES (p for superiority = 0.001). In this study a patient receiving a TiTAN OPTIMAX stent is 52% less likely to experience a hard clinical event in the following 18 months than a patient receiving a Synergy stent. The rate of definite and probable thrombosis was significantly lower for the OPTIMAX sent (1.1% versus 3.0%, p=0.012) while the rate of clinical restenosis (TLR) was not statistically different between both groups.

In safety endpoint
3.7% vs 7.8% for Synergy ™
(p superiority = 0.001)