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

Objectives To compare clinical outcomes after percutaneous coronary intervention (PCI) using titanium-nitride-oxide coated stents (TiNOS) versus drug-eluting stents (DES) in coronary artery disease (CAD) including acute coronary syndrome (ACS). Design Prospective systematic literature (SLR) conducted according to PRISMA. Medline, Embase, Cochrane, Web of Science were searched in March 2018 and updated. Setting Interventional cardiology. Participants Patients with CAD, including ACS, requiring PCI. Interventions All prospective randomized controlled trials (RCTs) that compared clinical outcomes after PCI with DES versus TiNOS. Outcome measures The pooled risk ratios (RR), TiNOS over DES, with 95% confidence intervals (CI) are computed for device-oriented Major Adverse Cardiac Events (MACE), non-fatal myocardial infarction (MI), cardiac death (CD), clinically driven target lesion revascularization (TLR), probable or definite stent thrombosis (ST), total mortality, at one to five years after PCI. Pooled RRs are stratified according to baseline ACS versus other CAD. Sensitivity analysis (SA) and certainty of the evidence are rated per GRADE. Results Five RCTs are eligible with 1,855 patients with TiNOS versus 1,363 with DES at 1-year follow-up and 783 versus 771 at 5-year. Three RCTs included patients with ACS only. One-year RRs in ACS are: MACE 0.93 [0.72, 1.20], MI 0.48 [0.31, 0.73], CD 0.66 [0.33, 1.31], TLR 1.55 [1.10, 2.19] and ST 0.35 [0.20, 0.64]. One-year MACE, MI, and ST are robust to SA. The certainty of the evidence is high in MACE, moderate in MI, and low or very low in the other endpoints. There are too few observations to conclude about other CAD and 5-year outcomes. However, 5-year interim results are consistent with 1-year conclusions. Conclusions A similar risk of MACE is found in TiNOS and DES, with potentially fewer MI and ST but more TLR in TiNOS. TiNOS are safe and effective in ACS at 1-year follow-up. Registration PROSPERO CRD42018090622 Strengths and limitations of this study - Strengths: The level of certainty of the evidence is high for the primary endpoint at one-year follow-up in patients treated for acute coronary syndrome. The primary endpoint and critical secondary endpoints are robust to sensitivity analysis. - Limitations: Outcomes in patients treated for chronic coronary artery disease cannot be analyzed. The level of certainty of the evidence of secondary endpoints is moderate or low. Analysis of five-year outcomes is still at an interim stage.