Aims: We sought to present the 5-year clinical outcome of the titanium-nitride-oxide-coated bioactive stents (BAS), as compared to paclitaxel-eluting stents (PES), in a real-world patient population.
Methods: From May 2003 to November 2004, we enrolled 405 consecutive patients who underwent percutaneous coronary intervention with either BAS or PES implantation. Patients were prospectively followed up for 5 years. The primary end-point was major adverse cardiac events (MACE) at 5-year follow-up including cardiac death, nonfatal myocardial infarction (MI), or target lesion revascularization.
Results: A total of 201 patients received BAS (218 lesions/221 stents) while 204 patients received PES (244 lesions/247 stents). Clinical follow-up for 5 years was completed in all patients. Cumulative MACE at the end of 5-year follow-up occurred in 34 (16.9%) patients in the BAS group, as compared to 53 (26%) in the PES group (OR 1.7, 95% CI 1.1-2.8, P = 0.03). This difference was mainly driven by a lower incidence of MI in the BAS group as compared with the PES group (9.5% vs. 20.6%, OR 2.5, 95% CI 1.4-4.4, P = 0.002). Stent thrombosis occurred in 16 (7.8%) patients in the PES group, while no one suffered stent thrombosis in the BAS group.
Conclusion: BAS implantation in a real-world patient population achieves an excellent clinical outcome over 5-year follow-up, with a significantly lower incidence of MI, MACE, and stent thrombosis as compared to PES.
©2010, Wiley Periodicals, Inc.