THE TIDES-ACS RANDOMIZED CONTROLLED TRIAL

The TIDES-ACS randomized controlled trial is the first trial comparing the new Optimax Titan bioactive stent (Co-Cr platform) against the Best-in-Class 3^rd generation Everolimus-Eluting Stent Synergy, from Boston Scientific in ACS (STEMI/NSTEMI) patients at 18 months and 60 months follow ups.

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.