A1 Vertaisarvioitu alkuperäisartikkeli tieteellisessä lehdessä
Titanium-Nitride-Oxide-Coated Versus Everolimus-Eluting Stents in Acute Coronary Syndrome The Randomized TIDES-ACS Trial
Tekijät: Tonino PAL, Pijls NHJ, Collet C, Nammas W, Van der Heyden J, Romppanen H, Kervinen K, Airaksinen JKE, Sia J, Lalmand J, Frambach P, Penaranda AS, De Bruyne B, Karjalainen PP
Kustantaja: ELSEVIER SCIENCE INC
Julkaisuvuosi: 2020
Journal: JACC: Cardiovascular Interventions
Tietokannassa oleva lehden nimi: JACC-CARDIOVASCULAR INTERVENTIONS
Lehden akronyymi: JACC-CARDIOVASC INTE
Vuosikerta: 13
Numero: 14
Aloitussivu: 1697
Lopetussivu: 1705
Sivujen määrä: 9
ISSN: 1936-8798
DOI: https://doi.org/10.1016/j.jcin.2020.04.021
Verkko-osoite: https://www.sciencedirect.com/science/article/pii/S1936879820309626?via%3Dihub
OBJECTIVES This study sought to compare next-generation cobalt-chromium-based titanium-nitride-oxide (TiNO)-coated stents with a platinum-chromium-based biodegradable polymer everolimus-eluting stent (EES) in patients with acute coronary syndrome (ACS).
BACKGROUNDPrevious generation TiNO-coated stents showed acceptable performance in patients with ACS.
METHODSIn a multicenter, randomized trial, we randomly assigned 1,491 ACS patients (2:1) to receive either a TiNO-coated stent (n = 989) or EES (n = 502). The primary endpoint was the rate of a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 12-month follow-up. The co-primary endpoint was a composite of cardiac death, MI, or major bleeding at 18 months.
RESULTS A primary endpoint event occurred in 6.3% of patients in the TiNO-coated stent group versus in 7.0% in the EES group (hazard ratio: 0.93; 95% confidence interval: 0.71 to 1.22; p = 0.66 for superiority; p < 0.001 for noninferiority). A co-primary endpoint event occurred in 3.7% of the patients in the TiNO group and in 7.8% in the EES group (hazard ratio: 0.64; 95% confidence interval: 0.51 to 0.80; p = 0.001). TiNO-coated stents were associated with lower rates of cardiac death (0.6% vs. 2.6%; p = 0.002) and MI (2.2% vs. 5.0%; p = 0.007) at 18 months of follow-up. Rates of target lesion revascularization were not significantly different at 18 months (5.8% vs. 4.4%; p = 0.27).
CONCLUSIONS In patients with ACS, cobalt-chromium-based TiNO-coated stents were noninferior to platinum-chromium-based biodegradable polymer EES for major cardiac events at 12 months, and were superior for the co-primary endpoint of cardiac death, MI, and bleeding at 18 months. (Comparison of Titanium-Nitride-Oxide-Coated Bio-Active-Stent (Optimax (TM)) to the Drug (Everolimus)-Eluting Stent (Synergy (TM)) in Acute Coronary Syndrome [TIDES-ACS]; NCT02049229) (C) 2020 by the American College of Cardiology Foundation.
