Results of the TIDES-ACS randomised controlled trial, confirming the superior safety and sustained non-inferior efficacy of the Bio-Active Stent technology (Hexacath) at 18 months follow-up versus a drug-eluting stent, have been published.
Conducted in 12 international sites, the study randomised 1,491 acute coronary syndrome (ACS) patients (2:1) to receive either TiNO bio-active coated stent (OPTIMAX, Hexacath) versus Everolimus pharmacologically active stent (SYNERGY, Boston Scientific) in ACS patients.
The co-primary safety endpoint (a composite of cardiac death, re-infarction and major bleeding) occurred in 3.7% of patients receiving TiNO-coated stents versus 7.8% of those receiving EES (HR 0.64 [95% CI 0.51 – 0.80] p=0.001) demonstrating the superiority of the TiNO bio-active stent.
Individual cardiac safety events components at 18 months were cardiac death (0.6% versus 2.6%; HR 0.49 [95% CI 0.36 – 0.67], p=0.002), non-fatal MI (2.2% versus 5.0%; HR 0.62 [95% CI 0.47 – 0.82], p=0.007) and major bleeding (1.4% versus 2.4%; HR 0.73 [95% CI 0.48 – 1.11], p=0.209). Definite or probable stent thrombosis occurred in 1.1% with OPTIMAXTM versus 3.0% with SYNERGYTM (HR 0.58 [95% CI 0.41 – 0.81], p=0.012). Interestingly, ischaemia-driven TLR difference was not significant between both groups (5.8% versus 4.4%; HR 1.22 [95% CI 0.85 – 1.75], p=0.274).
“At 18 months post percutaneous coronary intervention (PCI), the TIDES-ACS results reveal that the OPTIMAX nitride-oxide coated stent is superior in patients with acute coronary syndrome compared to one of the top drug-eluting stents (SYNERGY) used in current interventional cardiology,” said Pasi Karjalainen, Helsinki University Hospital, Helsinki, Finland.
The co-primary non-inferiority endpoint was the rate of major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI) and ischemia-driven target lesion revascularisation (TLR) at 12 months. The co-primary endpoint was met at 12 months, as MACEoccurred in 6.3% with OPTIMAXTM versus 7.0% with SYNERGYTM (HR 0.93 [95% CI 0.71 – 1.22] p for non-inferiority <0.001, p for superiority=0.66). The 18 months published results demonstrated the sustained efficacy in terms of efficacy of the TiNO bio-active stent technology as the rate of MACE was 7.2% with OPTIMAXTM versus 8.8% with SYNERGYTM (HR 0.87 [95% CI 0.68 – 1.11], p=0.304).
“The TIDES-ACS results show that the OPTIMAX nitride-oxide coated stent is non-inferior (MACE) in patients with acute coronary syndrome compared to one of the best-in-class drug-eluting stents (SYNERGY) used in current interventional cardiology,” said Pim Tonino, Heart center Catharina Hospital, Eindhoven, the Netherlands.
In conclusion, in patients with ACS, cobalt-chromium based TiNO coated stents were non-inferior to platinum-chromium–based biodegradable polymer EES for major cardiac events at 12 and 18 months and were superior for the co-primary safety endpoint a composite of cardiac death, MI, and major bleeding at 18 months follow up without compromising the TLR rate (p=0.274).