Efficacy and safety of TiNO-coated stents versus drug-eluting coronary stents. Systematic literature review and meta-analysis.

Background: Randomized clinical trials (RCTs) comparing percutaneous coronary interventions (PCI) with titanium-nitride-oxide coated stents (TiNOS) versus drug-eluting stents (DES) in coronary artery disease (CAD) have been published. Objectives: To compare the efficacy and safety of PCI with TiNOS versus DES at 1 and 5-year follow-up, in all CAD including acute coronary syndrome (ACS). Methods: A prospective systematic literature review and meta-analysis of RCTs were conducted according to published methods (Cochrane, PRISMA, GRADE). Medline, Embase, Cochrane database, Web of Science were searched on March 08, 2018. Fixed-effects Mantel-Haenszel pooled risk ratios (RR), TiNOS over DES, with 95% confidence intervals (CI) were computed with sensitivity analysis. Results: Five RCTs were eligible with n = 1,855 TiNOS vs. n = 1,363 DES at 1-year and n = 783 vs. n = 771 at 5-year follow-up. One-year RRs in ACS patients: Major Adverse Cardiac Events (MACE) 0.93 [0.72, 1.20], recurrent myocardial infarction (MI) 0.42 [0.28, 0.63], probable or definite stent thrombosis (ST): 0.35 [0.20, 0.64]. Estimates were robust to sensitivity analysis. Certainty of evidence was high in MACE, moderate in MI and ST due to the limited number of cases. Data were insufficient to draw conclusions about stable CAD patients and 5-year outcomes. Conclusions: This meta-analysis showed in ACS patients, similar risk of MACE with TiNOS and DES, at 1-year follow-up, and suggested a lower risk of MI and ST with TiNOS than with DES. These two safety signals in MI and ST with the current use of DES require further investigations. SLR registration: PROSPERO CRD42018090622 https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=90622