French Ministry of Health prospective multicentre study using bio-active stents coated with titanium nitride oxide: the EVIDENCE registry.

Michaël Angioi, Paul Barragan, Simon Cattan, Frédéric Collet, Patrick Dupouy, Philippe Durand, Jean Fajadet, Gérard Finet, Benoit Gerardin, Antoine Gommeaux, Bernard Karsenty, Christophe Loubeyre, Pierre Meyer, Marie-Claude Morice, Marc-Éric Moulichon, Smain Sayah, Marc Silvestri, Xavier Tabone, Thierry Unterseeh, Olivier Wittenberg, Jean-Marc Lablanche

Index: Arch. Cardiovasc. Dis. 105(2) , 60-7, (2012)

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Abstract

Coronary stents have evolved over time, from bare-metal stents to drug-eluting stents, and now to bioactive stents.We sought to explore the immediate outcome of the titanium-nitride-oxide-coated bioactive stent, Titan2(®), in real-world practice, and the incidence of major cardiac events at follow-up.Consecutive patients admitted for percutaneous intervention for at least one significant (≥50%) lesion in a native coronary artery were treated with Titan2(®) stent implantation. The primary endpoint was total major adverse cardiac events at 12-month follow-up. Secondary endpoints included target lesion revascularization at 12-month follow-up and the duration of dual antiplatelet therapy.Among 356 patients (mean age 67.4 ± 12.1 years), 77.2% were male and 39.3% were treated for myocardial infarction (MI). A total of 546 Titan2(®) stents were implanted in 420 lesions. Angiographic and clinical procedural success was achieved in all cases. No cases of in-hospital major adverse cardiac events or acute stent thrombosis were reported. Of 335 patients (94.1%) with 12-month clinical follow-up, four (1.2%) died, MI occurred in five (1.5%), target lesion revascularization was performed in 17 (5.1%) and major adverse cardiac events occurred in 24 (7.2%). One patient (0.3%) suffered late stent thrombosis during follow-up, but no cases of acute or subacute stent thrombosis occurred. Dual antiplatelet therapy continued beyond 6 months in 64.5% of patients.In real-world practice, Titan2(®) stent implantation achieves an excellent immediate outcome, with a low incidence of major adverse cardiac events at 12-month follow-up.Copyright © 2012 Elsevier Masson SAS. All rights reserved.