The results of the meta-analysis pooling all existing randomised controlled trials comparing Ti-no coated bio-active stents (such as Optimax, Hexacath) and drug-eluting stents were presented at the 2018 American Heart Association (AHA) scientific sessions (10–12 November, Chicago, USA) by Frederic Daoud (Clinical epidemiologist and Biostatistician, University Hospital of Bordeaux, Bordeaux, France).
Five randomised controlled trials were identified and were all included in this meta-analysis, with 3,218 enrolled patients at one year (1,855 patients in the bio-active stents group vs. 1,363 patients in the drug-eluting stent group) and 1,554 patients at five years (respectively, 783 patients in the bio-active stents group vs. 771 patients in the drug-eluting stent group). All five included studies were investigator initiated, multicentre prospective randomised controlled trials, had ethics committee approval and required patient informed consent and required patients to be 18 years of age or older. All were registered in clinicaltrials.gov.
All had a statistical plan with sample size justification. All studies were analysed on an intention-to-treat basis. No publication bias was detected. Risk of bias within studies was present mainly due to the inability to blind operators. Odds ratios presented no significant heterogeneity. At one year and five years follow up the clinical outcomes were as follows:
- Stent-oriented major adverse cardiac events (MACE) relative risk (RR): 1.05, 95%CI [0.84, 1.31] & 0.82 [0.66, 1.02]; p=0.07
- Probable or definite stent thromboses (stent thrombosis as per the ARC definition): 0.39 [0.22, 0.69] & 0.25 [0.11, 0.56]; myocardial infarction: 0.39 [0.27, 0.57] & 0.54 [0.38, 0.76].
In the acute coronary syndrome patients, the clinical outcomes were:
- MACE: 0.93 [0.72, 1.20] & 0.74 [0.58, 0.95]
- Probable or definite stent thromboses: 0.35 [0.20, 0.64] & 0.20 [0.09, 0.49]
- Myocardial infarction: 0.42 [0.28, 0.63] & 0.51 [0.35, 0.74].
A press release reports that no significant difference was found in total deaths between both groups. Results were robust to sensitivity analysis and were driven to a large extent by results in acute coronary syndromes.
Daoud comments: “The evidence given from all existing randomised controlled trials shows a similar incidence of MACE in bio-active stents and drug-eluting stents but a significantly lower incidence of stent thrombosis and myocardial infarction with bio-active stents at both one and five years in all patients. This difference was even more significant in the acute coronary syndrome population.”