Author + information
- Received January 23, 2020
- Revision received March 9, 2020
- Accepted April 10, 2020
- Published online July 20, 2020.
- Pim A.L. Tonino, MD, PhDa,∗ (, )
- Nico H.J. Pijls, MD, PhDa,b,
- Carlos Collet, MD, PhDc,
- Wail Nammas, MD, PhDd,
- Jan Van der Heyden, MD, PhDe,
- Hannu Romppanen, MD, PhDf,
- Kari Kervinen, MD, PhDg,
- Juhani K.E. Airaksinen, MD, PhDh,
- Jussi Sia, MDi,
- Jacques Lalmand, MD, PhDj,
- Peter Frambach, MD, PhDk,
- Antonio Serra Penaranda, MD, PhDl,
- Bernard De Bruyne, MD, PhDc,m,∗∗ (, )
- Pasi P. Karjalainen, MD, PhDd,n,
- for the TIDES-ACS Study Group
- aDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands
- bDepartment of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, the Netherlands
- cCardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
- dHeart Center, Satakunta Central Hospital, Pori, Finland
- eDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands
- fDepartment of Cardiology, Kuopio University Hospital, Kuopio, Finland
- gClinical Research Center, Oulu University Hospital, Oulu, Finland
- hDepartment of Cardiology, Turku University Hospital, Turku, Finland
- iDepartment of Cardiology, Kokkola Central Hospital, Kokkola, Finland
- jDepartment of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium
- kDepartment of Cardiology, INCCI Luxembourg Hospital, Luxembourg City, Luxembourg
- lDepartment of Cardiology, Hospital Sant Pau, Barcelona, Spain
- mDepartment of Cardiology, Lausanne University Center Hospital, Lausanne, Switzerland
- nHeart and Lung Center, Helsinki University Hospital, Helsinki, Finland
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).
Background Previous generation TiNO-coated stents showed acceptable performance in patients with ACS.
Methods In 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™) to the Drug (Everolimus) -Eluting Stent (Synergy™) in Acute Coronary Syndrome [TIDES-ACS]; NCT02049229)
- acute coronary syndrome
- drug-eluting stent
- everolimus-eluting stent
- stent thrombosis
- titanium-nitride-oxide–coated stent
This work was supported by unrestricted institutional grants from Hexacath (Paris, France); however, the sponsor had no role in trial design, data collection, analysis or interpretation, drafting of the manuscript, or the decision to submit the manuscript for publication. Dr. Pijls has received institutional research grant support from Hexacath (for the EURO-ICE study) and Abbott; has received consulting fees from Abbott and Opsens; and owns equity in Philips, HeartFlow, ASML, and General Electric. Dr. Collet has received research grant support from Biosensors, HeartFlow, and Abbott Vascular; and has received consulting fees from HeartFlow, Abbott Vascular, and Philips Volcano. Dr. de Bruyne has received institutional grant support from Abbott, Boston Scientific, Medtronic, and Biotronik; has received consulting fees from Abbott, Opsens, and Boston Scientific, outside of the submitted work; and is a shareholder for Siemens, GE, Bayer, Philips, HeartFlow, Edwards Lifesciences, and Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received January 23, 2020.
- Revision received March 9, 2020.
- Accepted April 10, 2020.
- 2020 American College of Cardiology Foundation
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